299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details
臨床試験数 : 1,696 / 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT04580368 (ClinicalTrials.gov) | March 30, 2022 | 2/10/2020 | Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 Trials | Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 Trials | Cystic Fibrosis | Drug: CFTR Modulators | Children's Hospital Medical Center, Cincinnati | NULL | Not yet recruiting | 6 Years | N/A | All | 50 | N/A | NULL |
| 2 | EUCTR2021-000694-85-DK (EUCTR) | 17/03/2022 | 27/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Norway;Sweden | ||
| 3 | NCT03921060 (ClinicalTrials.gov) | March 2022 | 26/3/2019 | Markers of Osteoporosis in Cystic Fibrosis | Markers of Osteoporosis in Cystic Fibrosis | Cystic Fibrosis | Drug: Denosumab | University of Texas Southwestern Medical Center | NULL | Recruiting | 18 Years | 64 Years | All | 100 | Phase 4 | United States |
| 4 | NCT05274269 (ClinicalTrials.gov) | March 2022 | 1/3/2022 | Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA;Other: Placebo (matched to ELX/TEZ/IVA);Other: Placebo (matched to IVA) | Vertex Pharmaceuticals Incorporated | NULL | Not yet recruiting | 6 Years | N/A | All | 270 | Phase 3 | NULL |
| 5 | NCT05276960 (ClinicalTrials.gov) | February 22, 2022 | 21/2/2022 | Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum vitD Levels in Pediatric Patients With CF | A Randomized, Double-blind Study of the Efficacy of Intensive Cholecalciferol Monitoring and Supplementation on Serum Vitamin D Levels in Pediatric Patients With Cystic Fibrosis | Vitamin D Deficiency;Cystic Fibrosis;Bone Density, Low;Inflammation Chronic;Cystic Fibrosis in Children;Cystic Fibrosis Pulmonary Exacerbation | Drug: Cholecalciferol Pill | Hospital Infantil de Mexico Federico Gomez | NULL | Recruiting | 5 Years | 18 Years | All | 40 | Phase 4 | Mexico |
| 6 | NCT05225805 (ClinicalTrials.gov) | February 15, 2022 | 7/1/2022 | Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic Fibrosis | A Phase 1, Open-Label, Randomized, Crossover Study to Assess the Safety and Pharmacokinetics Following Single Doses of Oral and Intravenous Xenleta (Lefamulin) in Adult Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Lefamulin | Nabriva Therapeutics AG | NULL | Not yet recruiting | 18 Years | 80 Years | All | 12 | Phase 1 | NULL |
| 7 | NCT03435939 (ClinicalTrials.gov) | February 15, 2022 | 5/2/2018 | Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240 | Anti-Inflammatory Therapy to Augment CFTR Rescue in CF Patients | Cystic Fibrosis | Drug: Losartan | University of Kansas Medical Center | NULL | Recruiting | 18 Years | N/A | All | 16 | Early Phase 1 | United States |
| 8 | NCT05239611 (ClinicalTrials.gov) | February 14, 2022 | 10/1/2022 | Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis | Feasibility of Home-based Exercise Program for Adults With Cystic Fibrosis to Improve Patient-centered Outcomes, Including a Novel Measure of Ventilation | Cystic Fibrosis | Drug: Exercise | University of Kansas Medical Center | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 9 | NCT04530383 (ClinicalTrials.gov) | February 14, 2022 | 24/8/2020 | Effects of Metformin on Airway Ion Channel Dysfunction in Cystic Fibrosis-related Diabetes | A Randomized, Double-blind, Crossover Clinical Trial of Metformin in Those With CFRD on CFTR Modulator Therapy to Improve Ion Channel Function | Cystic Fibrosis-related Diabetes;Cystic Fibrosis | Drug: Metformin Hydrochloride | University of Kansas Medical Center | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 2 | United States |
| 10 | NCT05223881 (ClinicalTrials.gov) | February 14, 2022 | 24/1/2022 | Gastroparesis in Cystic Fibrosis | 13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis | Gastroparesis | Device: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT) | University of Miami | NULL | Not yet recruiting | 4 Years | N/A | All | 100 | N/A | United States |
| 11 | NCT05248230 (ClinicalTrials.gov) | February 2022 | 10/2/2022 | An Open-label, Phase 1/2 Trial of Gene Therapy 4D-710 in Adults With Cystic Fibrosis | An Open-label, Phase 1/2 Trial of Gene Therapy 4D-710 in Adults With Cystic Fibrosis | Cystic Fibrosis Lung | Biological: 4D-710 | 4D Molecular Therapeutics | NULL | Recruiting | 18 Years | N/A | All | 21 | Phase 1/Phase 2 | United States |
| 12 | EUCTR2019-004511-31-ES (EUCTR) | 31/01/2022 | 30/08/2021 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil | Bambino Gesù Children´s Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 13 | EUCTR2021-005320-38-ES (EUCTR) | 21/01/2022 | 01/12/2021 | Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Belgium;Spain;Austria;Netherlands;Germany;Switzerland;Italy | ||
| 14 | NCT04732195 (ClinicalTrials.gov) | January 20, 2022 | 25/1/2021 | Pilocarpine Microneedles for Sweat Induction (PMN-SI) | A Pilot Study to Compare the Efficacy of Pilocarpine Microneedles With Iontophoresis Method for Sweat Induction in Healthy Human Subjects | Cystic Fibrosis | Device: Pilocarpine microneedle patch;Device: Pilocarpine Iontophoresis | Emory University | Georgia Institute of Technology | Recruiting | 18 Years | N/A | All | 50 | N/A | United States |
| 15 | EUCTR2021-000712-31-SE (EUCTR) | 18/01/2022 | 22/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden | ||
| 16 | NCT05153317 (ClinicalTrials.gov) | January 17, 2022 | 29/11/2021 | Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis (CF) Participants 2 Years and Older | A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | 2 Years | N/A | All | 70 | Phase 3 | United States |
| 17 | EUCTR2021-000712-31-PT (EUCTR) | 14/01/2022 | 16/11/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden | ||
| 18 | NCT05111145 (ClinicalTrials.gov) | January 14, 2022 | 27/10/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Participants With Cystic Fibrosis (CF) | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | 12 Years | N/A | All | 195 | Phase 3 | Australia;Spain |
| 19 | EUCTR2021-000712-31-DE (EUCTR) | 12/01/2022 | 23/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden | ||
| 20 | EUCTR2019-004511-31-DE (EUCTR) | 10/01/2022 | 30/07/2021 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil INN or Proposed INN: Posaconazole Other descriptive name: Posaconazole Trade Name: Noxafil 100 mg Product Name: Noxafil INN or Proposed INN: Posaconazole Other descriptive name: Posaconazole | Bambino Gesù Children's Hospital | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 21 | EUCTR2019-004511-31-NL (EUCTR) | 03/01/2022 | 29/04/2021 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil | Bambino Gesù Children's Hospital | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czechia;Greece;Spain;Ireland;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden | ||
| 22 | NCT03931252 (ClinicalTrials.gov) | January 2022 | 25/4/2019 | Thermic Effect of Feeding in Cystic Fibrosis | Thermic Effect of Feeding in Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Boost VHC;Dietary Supplement: Ensure High Protein | Virginia Commonwealth University | NULL | Enrolling by invitation | 18 Years | N/A | All | 10 | N/A | United States |
| 23 | EUCTR2021-000694-85-IT (EUCTR) | 21/12/2021 | 15/10/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation - A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kalydeco Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: ivacaftor Product Name: VX-121/tezacaftor/deutivacaftor Product Code: [VX-121/TEZ/D-IVA] INN or Proposed INN: tezacaftor INN or Proposed INN: deutivacaftor Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: [ELX/TEZ/IVA] INN or Proposed INN: elexacaftor INN or Proposed INN: tezacaftor INN or Proposed INN: ivacaftor | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 24 | EUCTR2021-000694-85-DE (EUCTR) | 20/12/2021 | 27/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 25 | EUCTR2021-000694-85-NL (EUCTR) | 09/12/2021 | 27/10/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Norway;Sweden | ||
| 26 | EUCTR2021-000694-85-GR (EUCTR) | 07/12/2021 | 19/10/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Norway;Sweden | ||
| 27 | EUCTR2021-000694-85-NO (EUCTR) | 03/12/2021 | 20/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden | ||
| 28 | NCT05090904 (ClinicalTrials.gov) | November 30, 2021 | 14/10/2021 | A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis | A Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis | Cystic Fibrosis | Drug: Brensocatib;Drug: Placebo | Insmed Incorporated | NULL | Recruiting | 18 Years | N/A | All | 48 | Phase 2 | United States |
| 29 | EUCTR2020-004885-21-ES (EUCTR) | 18/11/2021 | 19/10/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 143 | Phase 3 | Czechia;Czech Republic;Belgium;Spain;Netherlands | ||
| 30 | EUCTR2020-004885-21-CZ (EUCTR) | 12/11/2021 | 31/08/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 143 | Phase 3 | Czechia;Czech Republic;Canada;Spain;Belgium;Australia;Netherlands | ||
| 31 | EUCTR2020-005805-25-BE (EUCTR) | 10/11/2021 | 02/07/2021 | A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis. | A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Galicaftor Product Code: ABBV-2222 INN or Proposed INN: GALICAFTOR Other descriptive name: ABBV-2222 Product Name: Navocaftor Product Code: ABBV-3067 INN or Proposed INN: Navocaftor Product Name: ABBV-119 Product Code: ABBV-119 Other descriptive name: ABBV-119 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Hungary;Belgium;Netherlands | ||
| 32 | EUCTR2021-000694-85-SE (EUCTR) | 10/11/2021 | 22/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden | ||
| 33 | NCT04938726 (ClinicalTrials.gov) | November 1, 2021 | 9/6/2021 | Ketone Supplementation in Cystic Fibrosis | Ketone Monoester Supplementation in Cystic Fibrosis: A Pilot and Feasibility Study | Cystic Fibrosis | Dietary Supplement: Ketone Monoester | University of Alabama at Birmingham | NULL | Not yet recruiting | 18 Years | 89 Years | All | 25 | N/A | NULL |
| 34 | EUCTR2020-005805-25-NL (EUCTR) | 28/10/2021 | 23/09/2021 | A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis. | A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Galicaftor Product Code: ABBV-2222 INN or Proposed INN: GALICAFTOR Other descriptive name: ABBV-2222 Product Name: Navocaftor Product Code: ABBV-3067 INN or Proposed INN: Navocaftor Product Name: ABBV-119 Product Code: ABBV-119 Other descriptive name: ABBV-119 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Hungary;Slovakia;Belgium;Australia;Germany;Netherlands;United Kingdom;New Zealand | ||
| 35 | NCT05076149 (ClinicalTrials.gov) | October 27, 2021 | 29/9/2021 | A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis | Drug: VX-121/TEZ/D-IVA;Drug: ELX/TEZ/IVA;Drug: IVA;Drug: Placebo (matched to VX-121/TEZ/D-IVA);Drug: Placebo (matched to ELX/TEZ/IVA);Drug: Placebo (matched to IVA) | Vertex Pharmaceuticals Incorporated | NULL | Recruiting | 12 Years | N/A | All | 550 | Phase 3 | United States;Australia;Canada;France;Germany;Italy;Netherlands;United Kingdom |
| 36 | NCT05069597 (ClinicalTrials.gov) | October 14, 2021 | 27/9/2021 | Study to Evaluate Symptoms of Exocrine Pancreatic Insufficiency in Adult Participants With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon | A Phase 4 Study to Assess Symptoms of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis or Chronic Pancreatitis Treated With Creon® (Pancrelipase) With an Alternate Source of Active Pharmaceutical Ingredient | Cystic Fibrosis;Chronic Pancreatitis | Drug: CREON | AbbVie | NULL | Recruiting | 18 Years | N/A | All | 30 | Phase 4 | United States |
| 37 | NCT04969224 (ClinicalTrials.gov) | October 12, 2021 | 9/7/2021 | A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects With Cystic Fibrosis (CF) | A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Recruiting | 12 Years | N/A | All | 100 | Phase 3 | Australia;Belgium;Canada;Spain |
| 38 | NCT03925194 (ClinicalTrials.gov) | October 1, 2021 | 19/4/2019 | A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CF | A Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic Fibrosis | Cystic Fibrosis, 10011762 | Drug: Anakinra | Heidelberg University | NULL | Not yet recruiting | 12 Years | N/A | All | 52 | Phase 2 | Germany |
| 39 | NCT05010577 (ClinicalTrials.gov) | October 2021 | 11/8/2021 | Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection | A Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects With Chronic Pseudomonas Aeruginosa (PsA) Pulmonary Infection | Chronic Pseudomonas Aeruginosa Infection;Cystic Fibrosis | Drug: BX004-A;Drug: Placebo | BiomX, Inc. | NULL | Not yet recruiting | 18 Years | N/A | All | 32 | Phase 1/Phase 2 | NULL |
| 40 | EUCTR2020-002251-38-DE (EUCTR) | 28/09/2021 | 20/07/2021 | Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years | A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 80mg ELX / 40mg TEZ / 60mg IVA Product Code: ELX/TEZ/IVA INN or Proposed INN: IVACAFTOR INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: IVACAFTOR 59,5mg Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100g ELX / 50mg TEZ / 75mg IVA INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: IVACAFTOR 75mg INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Germany;United Kingdom | ||
| 41 | EUCTR2019-004511-31-GR (EUCTR) | 16/09/2021 | 04/03/2021 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil | Bambino Gesù Children's Hospital | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 42 | NCT05033080 (ClinicalTrials.gov) | September 14, 2021 | 26/8/2021 | A Phase 3 Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis (CF) Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: VX-121/TEZ/D-IVA;Drug: ELX/TEZ/IVA;Drug: IVA;Drug: Placebo (matched to VX-121/TEZ/D-IVA);Drug: Placebo (matched to ELX/TEZ/IVA);Drug: Placebo (matched to IVA) | Vertex Pharmaceuticals Incorporated | NULL | Recruiting | 12 Years | N/A | All | 400 | Phase 3 | United States;Czechia;Germany;United Kingdom |
| 43 | NCT04853368 (ClinicalTrials.gov) | September 13, 2021 | 19/4/2021 | Study to Evaluate Adverse Events and Change in Disease Activity With Oral Capsules of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Adult Participants With Cystic Fibrosis | A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis (CF) | Drug: Galicaftor;Drug: Placebo;Drug: Navocaftor;Drug: ABBV-119 | AbbVie | NULL | Recruiting | 18 Years | N/A | All | 90 | Phase 2 | Australia;Belgium;Germany;Hungary;Netherlands;New Zealand;Slovakia;Czechia |
| 44 | EUCTR2020-005805-25-HU (EUCTR) | 13/09/2021 | 15/07/2021 | A Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis. | A Phase 2 Study of Galicaftor/Navocaftor/ABBV-119 Combination Therapy in Subjects with Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation. | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Galicaftor Product Code: ABBV-2222 INN or Proposed INN: GALICAFTOR Other descriptive name: ABBV-2222 Product Name: Navocaftor Product Code: ABBV-3067 INN or Proposed INN: Navocaftor Product Name: ABBV-119 Product Code: ABBV-119 Other descriptive name: ABBV-119 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Hungary | ||
| 45 | EUCTR2021-001628-16-ES (EUCTR) | 30/07/2021 | 20/07/2021 | A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects with Cystic Fibrosis (CF) | A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508delMutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Canada;Belgium;Spain;Australia | ||
| 46 | NCT05006573 (ClinicalTrials.gov) | July 21, 2021 | 23/6/2021 | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) | Non-cystic Fibrosis Bronchiectasis | Biological: Benralizumab;Biological: Placebo to Benralizumab | AstraZeneca | NULL | Recruiting | 18 Years | 130 Years | All | 420 | Phase 3 | United States;Argentina;Australia;Canada;China;Denmark;Germany;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Spain;United Kingdom;Vietnam |
| 47 | NCT04777344 (ClinicalTrials.gov) | July 8, 2021 | 23/2/2021 | Clinical Effort Against Smoke Exposure in Cystic Fibrosis | Clinical Effort Against Smoke Exposure in Cystic Fibrosis (CEASE-CF) | Cystic Fibrosis | Behavioral: Tobacco Treatment Specialist (TTS) intervention | University of Alabama at Birmingham | Cystic Fibrosis Foundation | Recruiting | 19 Years | N/A | All | 36 | N/A | United States |
| 48 | NCT04531410 (ClinicalTrials.gov) | July 1, 2021 | 18/8/2020 | NETwork of Linoleic Acid Supplementation in Cystic Fibrosis | Double-blind Randomized Controlled Study of Linoleic Acid Supplementation for 1 Year in Patients With Cystic Fibrosis - Influence on Clinical Status and Metabolism | Cystic Fibrosis | Dietary Supplement: linoleic acid supplementation;Dietary Supplement: oleic acid supplementation | Karolinska Institutet | European Society of Pediatric Gastroenterology, Hepatology and Nutrition | Enrolling by invitation | 5 Years | 15 Years | All | 90 | N/A | Italy;Norway;Poland;Sweden |
| 49 | NCT04460586 (ClinicalTrials.gov) | July 1, 2021 | 1/7/2020 | Pharmacokinetics of Omadacycline in Cystic Fibrosis | Pharmacokinetics of Omadacycline in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Omadacycline Injection [Nuzyra];Drug: Omadacycline Oral Tablet [Nuzyra] | Paul Beringer | Paratek Pharmaceuticals Inc | Recruiting | 18 Years | N/A | All | 12 | Phase 4 | United States |
| 50 | NCT04702360 (ClinicalTrials.gov) | June 23, 2021 | 6/1/2021 | ELX/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients With at Least One F508del Mutation | ELX/TEZ/IVA Expanded Access Program for Patients 6 Through 11 Years of Age With Cystic Fibrosis Who Have At Least One F508del Mutation | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 6 Years | 11 Years | All | NULL | ||
| 51 | EUCTR2019-004511-31-PT (EUCTR) | 18/06/2021 | 18/01/2021 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil | Bambino Gesù Children's Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 135 | Phase 2;Phase 3 | France;Portugal;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 52 | NCT04294043 (ClinicalTrials.gov) | June 17, 2021 | 1/3/2020 | IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study) | A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study) | Nontuberculous Mycobacterium Infection | Drug: Gallium nitrate | Chris Goss | Cystic Fibrosis Foundation | Recruiting | 18 Years | N/A | All | 40 | Phase 1 | United States |
| 53 | NCT04926701 (ClinicalTrials.gov) | June 11, 2021 | 10/6/2021 | A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy Subjects | A First in Human Randomised, Double Blind, Placebo-controlled, Two-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD and MAD) of Inhaled ETD001 in Healthy Male and Female Subjects | Cystic Fibrosis | Drug: ETD001 single dose;Drug: Placebo single dose;Drug: ETD001 multiple twice daily doses;Drug: Placebo multiple twice daily doses;Drug: ETD001 multiple once daily doses;Drug: Placebo multiple once daily doses | Enterprise Therapeutics Ltd | NULL | Active, not recruiting | 18 Years | 50 Years | All | 98 | Phase 1 | United Kingdom |
| 54 | EUCTR2020-003688-25-SK (EUCTR) | 01/06/2021 | 10/12/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan | ||
| 55 | EUCTR2020-004068-24-IT (EUCTR) | 21/05/2021 | 02/08/2021 | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE | Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: NA Product Name: benralizumab Product Code: [MEDI-563] INN or Proposed INN: benralizumab Other descriptive name: benralizumab Product Name: Atropina Product Code: [NA] Product Name: Antistaminici H1 - H2 Product Code: [na] Product Name: C01CA04 - Dopamina Product Code: [na] Product Name: Adrenalina Product Code: [NA] Product Name: Salbutamolo Product Code: [NA] Product Name: H02 - Corticosteroidi Sistemici Product Code: [NA] | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Vietnam;Canada;Argentina;Poland;Australia;Denmark;Germany;China;Korea, Republic of | ||
| 56 | EUCTR2020-005224-12-NL (EUCTR) | 01/05/2021 | 04/01/2021 | Kaftrio in cystic fibrosis patients currently using tacrolimus, a drug drug interaction study | Elexacaftor/tezacaftor/ivacaftor in patients with cystic fibrosis using tacrolimus, a drug - drug interaction study - Kaftac | cystic fibrosis patients;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kaftrio | Haga Teaching Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 5 | Phase 4 | Netherlands | ||
| 57 | JPRN-jRCT2031210048 | 30/04/2021 | 22/04/2021 | A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - ASPEN | Non-Cystic Fibrosis Bronchiectasis | - Experimental: Brensocatib 10 mg Participants will receive brensocatib 10 mg once daily, for 52 weeks. - Experimental: Brensocatib 25 mg Participants will receive brensocatib 25 mg once daily, for 52 weeks. - Placebo Comparator: Placebo Participants will receive a brensocatib-matching placebo once daily. | Fernandez C | NULL | Recruiting | >= 18age old | <= 85age old | Both | 1620 | Phase 3 | United States;Canada;Germany;Australia;New Zealand;Taiwan;Japan |
| 58 | NCT04884308 (ClinicalTrials.gov) | April 28, 2021 | 7/5/2021 | Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against Infections | Effects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy Volunteers | Cystic Fibrosis;Bronchiectasis Adult;Non-Tuberculous Mycobacteria | Biological: BCG TICE Vaccine | Johns Hopkins University | Cystic Fibrosis Foundation | Recruiting | 18 Years | 65 Years | All | 180 | Phase 2 | United States |
| 59 | NCT04966234 (ClinicalTrials.gov) | April 22, 2021 | 19/3/2021 | A New Posaconazole Dosing Regimen for Paediatric Patients With Cystic Fibrosis and Aspergillus Infection | Prospective Validation and Clinical Evaluation of a New Posaconazole Dosing Regimen for Children and Adolescents With Cystic Fibrosis and Aspergillus Infection | Cystic Fibrosis;Aspergillosis | Drug: Posaconazole 100 MG [Noxafil];Drug: Posaconazole 40 MG/ML | Bambino Gesù Hospital and Research Institute | University of Exeter;Radboud University;Consorzio per Valutazioni Biologiche e Farmacologiche | Recruiting | 8 Years | 17 Years | All | 135 | Phase 2/Phase 3 | Czechia;France;Germany;Greece;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom |
| 60 | NCT04731272 (ClinicalTrials.gov) | April 20, 2021 | 26/1/2021 | GLP-1 Agonist Therapy in Cystic Fibrosis-Related Glucose Intolerance | Effect of GLP-1 Agonist Therapy on Insulin Secretion in Adults With Pancreatic Insufficient Cystic Fibrosis and Abnormal Glucose Tolerance: a Randomized, Open-label, Cross-over Trial | Cystic Fibrosis;Pancreatic Insufficiency;Abnormal Glucose Tolerance;Diabetes | Drug: Dulaglutide 0.75Mg/0.5Ml Inj Pen | University of Pennsylvania | Children's Hospital of Philadelphia | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 61 | EUCTR2020-003688-25-DE (EUCTR) | 08/04/2021 | 12/10/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 62 | EUCTR2020-004068-24-DE (EUCTR) | 06/04/2021 | 21/01/2021 | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE | Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fasenra Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Canada;Argentina;Poland;Viet Nam;Australia;Denmark;Germany;China;Japan;Korea, Republic of | ||
| 63 | EUCTR2020-005931-58-FR (EUCTR) | 02/04/2021 | 04/02/2021 | ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis | ACTIVE : ACid tranexamic or Terlipressin for Initial emergency treatment of mild to seVere hEmoptysis - ACTIVE | Hemoptysis, whatever the cause, with the exception of cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: GLYPRESSINE 1 mg/5 mL, poudre et solvant pour solution injectable (I.V.) INN or Proposed INN: TERLIPRESSIN Other descriptive name: Terlipressin acetate Trade Name: ACIDE TRANEXAMIQUE MYLAN 0,5 g/ 5 mL, solution injectable INN or Proposed INN: TRANEXAMIC ACID Other descriptive name: TRANEXAMIC ACID | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 315 | Phase 3 | France | ||
| 64 | NCT04684641 (ClinicalTrials.gov) | March 29, 2021 | 18/12/2020 | CYstic Fibrosis bacterioPHage Study at Yale (CYPHY) | CYstic Fibrosis bacterioPHage Study at Yale (CYPHY): A Single-site, Randomized, Double-blind, Placebo-controlled Study of Bacteriophage Therapy YPT-01 for Pseudomonas Aeruginosa Infections in Adults With Cystic Fibrosis | Cystic Fibrosis | Drug: Standard Dose YPT-01;Other: Placebo | Yale University | NULL | Recruiting | 18 Years | N/A | All | 36 | Phase 1/Phase 2 | United States |
| 65 | NCT04533646 (ClinicalTrials.gov) | March 17, 2021 | 23/8/2020 | Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes | Comparison of Meal-Time Dosing of Rapid Acting Insulin Using Carbohydrate Counting vs. Fixed Doses Utilizing Continuous Glucose Monitoring In Patients With Cystic Fibrosis Related Diabetes | Cystic Fibrosis-related Diabetes | Drug: Insulin;Device: Continuous glucose monitor (CGM) | Jagdeesh Ullal | Wake Forest University Health Sciences | Recruiting | 18 Years | 80 Years | All | 20 | Phase 4 | United States |
| 66 | EUCTR2019-003501-10-NO (EUCTR) | 08/03/2021 | 29/05/2020 | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a phase 4 multicenter randomized controlled study. | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a phase 4 multicenter randomized controlled study. - MBWtodetectPEXinCF | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Amoxicillin Product Name: Amoxicillin INN or Proposed INN: AMOXICILLIN Trade Name: Amoxicillin and Clavulanic acid Product Name: Augmentin INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID Trade Name: Heracillin Product Name: Heracillin INN or Proposed INN: FLUCLOXACILLIN Trade Name: Dicloxacillin Product Name: Dicloxacillin INN or Proposed INN: DICLOXACILLIN Trade Name: Trimethoprim and Sulfamethoxazole Product Name: Bactrim INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: SULFAMETHOXAZOLE Trade Name: Clarithromycin Product Name: Klacid INN or Proposed INN: Klacid Other descriptive name: CLARITHROMYCIN Trade Name: Rifampicin Product Name: Rimactan INN or Proposed INN: RIFAMPICIN Trade Name: Doxycycline Product Name: Doxycyclin INN or Proposed INN: DOXYCYCLINE Product Name: Fucidin Tablets INN or Proposed INN: Fusidin Other descriptive name: FUSIDIC ACID Trade Name: Ciprofloxacin Product Name: Ciprofloxacin INN or Proposed INN: Ciproxin Other descriptive name: CIPROFLOXACIN Trade Name: Linez | Vãstre Gõtalandsregionen, Sweden | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Denmark;Norway;Sweden | ||
| 67 | EUCTR2020-003688-25-LT (EUCTR) | 05/03/2021 | 07/12/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1620 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 68 | NCT04656275 (ClinicalTrials.gov) | March 4, 2021 | 1/12/2020 | A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of Inflammation | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Oral Doses of BI 1323495 Bid Versus Placebo in Patients With Non-cystic Fibrosis Bronchiectasis (Randomised, Double-blind, Placebo-controlled, Parallel Group Trial) | Non-cystic Fibrosis Bronchiectasis | Drug: BI 1323495;Drug: Placebo | Boehringer Ingelheim | NULL | Suspended | 18 Years | 80 Years | All | 36 | Phase 1 | Germany;United Kingdom |
| 69 | EUCTR2020-003688-25-EE (EUCTR) | 01/03/2021 | 06/01/2021 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 70 | NCT04579939 (ClinicalTrials.gov) | February 25, 2021 | 29/9/2020 | Oral Glucose Tolerance Testing Using Candy for Cystic Fibrosis | Oral Glucose Tolerance Testing Using Candy: A Sweet Solution to Improve Screening Compliance in Cystic Fibrosis | Cystic Fibrosis | Diagnostic Test: Candy Glucose Tolerance Test | Mayo Clinic | NULL | Recruiting | 10 Years | 21 Years | All | 10 | N/A | United States |
| 71 | EUCTR2020-004068-24-DK (EUCTR) | 15/02/2021 | 22/12/2020 | Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis Bronchiectasis | A Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE | Non-cystic fibrosis bronchiectasis (NCFB) MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Fasenra Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Vietnam;Canada;Argentina;Poland;Denmark;Australia;Germany;China;Japan;Korea, Republic of | ||
| 72 | EUCTR2020-003688-25-AT (EUCTR) | 11/02/2021 | 10/12/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 73 | EUCTR2020-001404-42-DK (EUCTR) | 09/02/2021 | 05/10/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Australia;Denmark;Israel;Netherlands;Germany;United Kingdom;Switzerland | ||
| 74 | NCT04793867 (ClinicalTrials.gov) | February 8, 2021 | 23/2/2021 | Regional Phenotyping of CF and Non-CF Bronchiectasis | Regional Phenotyping of Cystic Fibrosis Lung Disease and Non-CF Bronchiectasis | Cystic Fibrosis;Non-CF Bronchiectasis | Diagnostic Test: Xenon | Children's Hospital Medical Center, Cincinnati | NULL | Recruiting | 5 Years | 100 Years | All | 100 | United States | |
| 75 | EUCTR2020-003688-25-BG (EUCTR) | 27/01/2021 | 04/12/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1660 | Phase 3 | United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Bulgaria;Germany;New Zealand;Japan | ||
| 76 | EUCTR2019-003501-10-DK (EUCTR) | 22/01/2021 | 22/04/2020 | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. - MBWtodetectPEXinCF | Cystic fibrosis MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID INN or Proposed INN: AMOXICILLIN INN or Proposed INN: FLUCLOXACILLIN INN or Proposed INN: DICLOXACILLIN INN or Proposed INN: SULFAMETHOXAZOLE INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: RIFAMPICIN INN or Proposed INN: DOXYCYCLINE INN or Proposed INN: Fusidic acid Other descriptive name: FUSIDIC ACID INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN INN or Proposed INN: Linezolid Other descriptive name: LINEZOLID INN or Proposed INN: CLINDAMYCIN Other descriptive name: CLINDAMYCIN INN or Proposed INN: Cefuroxim Other descriptive name: CEFUROXIME INN or Proposed INN: CEFALEXIN | Västra Götalandsregionen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Denmark;Norway;Sweden | ||
| 77 | EUCTR2020-003688-25-IE (EUCTR) | 18/01/2021 | 30/10/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 78 | NCT04599465 (ClinicalTrials.gov) | January 18, 2021 | 21/10/2020 | A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF) | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose Metabolism | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 69 | Phase 3 | Spain;Netherlands;Italy;France;Czechia;Belgium;Australia |
| 79 | EUCTR2019-002840-26-DE (EUCTR) | 15/01/2021 | 01/10/2020 | Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasis | A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis | Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Icenticaftor Other descriptive name: CFTR potentiator | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Spain;Germany;United Kingdom;China | ||
| 80 | EUCTR2020-003688-25-BE (EUCTR) | 15/01/2021 | 15/01/2021 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 81 | EUCTR2020-003688-25-PT (EUCTR) | 15/01/2021 | 16/10/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Lithuania;Latvia;Netherlands;Denmark;Australia;Peru;Malaysia;France;Italy;Colombia;Chile;Israel;Russian Federation;Ireland;Ukraine;Thailand;Spain;Greece;Slovakia;Estonia;Taiwan;United States;Serbia;Portugal;Germany;New Zealand;Japan | ||
| 82 | EUCTR2020-003688-25-IT (EUCTR) | 15/01/2021 | 15/06/2021 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis –The ASPEN Study - ASPEN | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: [INS1007] INN or Proposed INN: Brensocatib Product Name: Brensocatib Product Code: [INS1007] INN or Proposed INN: Brensocatib | INSMED INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Denmark;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan | ||
| 83 | NCT04545515 (ClinicalTrials.gov) | January 11, 2021 | 3/9/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF Genotypes | A Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 6 Years | N/A | All | 120 | Phase 3 | Australia;Canada;Denmark;France;Germany;Israel;Netherlands;Spain;Switzerland;United Kingdom |
| 84 | EUCTR2020-001404-42-NL (EUCTR) | 06/01/2021 | 07/10/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Germany;Netherlands;United Kingdom;Switzerland | ||
| 85 | EUCTR2020-003688-25-HU (EUCTR) | 06/01/2021 | 16/11/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | United States;Serbia;Portugal;Estonia;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan;New Zealand | ||
| 86 | NCT04687319 (ClinicalTrials.gov) | January 2021 | 7/12/2020 | RHEology of the Pulmonary MUcus | Protocol for the Collection of Lung Mucus Samples From Care for a Rheology Research Programme | Bronchial Mucus in COPD and Cystic Fibrosis | Biological: bronchial mucus collection | University Hospital, Grenoble | University Grenoble Alps | Not yet recruiting | 18 Years | N/A | All | 100 | NULL | |
| 87 | EUCTR2019-002840-26-GB (EUCTR) | 22/12/2020 | 03/09/2020 | Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasis | A randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis | Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Icenticaftor Other descriptive name: CFTR potentiator | Novartis Pharma AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 72 | Phase 2 | Spain;Germany;China;United Kingdom | ||
| 88 | NCT04596319 (ClinicalTrials.gov) | December 22, 2020 | 15/10/2020 | Ph 1/2 Study Evaluating Safety and Tolerability of Inhaled AP-PA02 in Subjects With Chronic Pseudomonas Aeruginosa Lung Infections and Cystic Fibrosis | A Phase 1b/2a, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety and Tolerability of AP-PA02 Multi-Phage Therapeutic Candidate for Inhalation in Subjects With Cystic Fibrosis and Chronic Pulmonary Pseudomonas Aeruginosa (Pa) Infection | Cystic Fibrosis;Pseudomonas Aeruginosa;Pseudomonas;Lung Infection;Lung Infection Pseudomonal | Biological: AP-PA02;Other: Placebo | Armata Pharmaceuticals, Inc. | Cystic Fibrosis Foundation | Recruiting | 18 Years | N/A | All | 48 | Phase 1/Phase 2 | United States |
| 89 | EUCTR2020-003688-25-GR (EUCTR) | 18/12/2020 | 23/11/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 90 | EUCTR2020-003170-44-IT (EUCTR) | 14/12/2020 | 15/06/2021 | NA | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic FibrosisSubjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) Product Code: [NA] INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: [VX-770] INN or Proposed INN: IVACAFTOR | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | ||
| 91 | EUCTR2020-003688-25-DK (EUCTR) | 09/12/2020 | 22/10/2020 | A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 Product Name: Brensocatib Product Code: INS1007 INN or Proposed INN: Brensocatib Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1620 | Phase 3 | Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan | ||
| 92 | NCT04643587 (ClinicalTrials.gov) | December 7, 2020 | 19/11/2020 | Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB) | A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Nebulized CSL787 in Healthy Subjects and Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) | Noncystic Fibrosis Bronchiectasis (NCFB) | Biological: CSL787;Drug: Placebo | CSL Behring | NULL | Recruiting | 18 Years | N/A | All | 64 | Phase 1 | United Kingdom |
| 93 | EUCTR2020-003170-44-CZ (EUCTR) | 03/12/2020 | 22/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | ||
| 94 | NCT04594369 (ClinicalTrials.gov) | December 1, 2020 | 14/10/2020 | A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study | Non-Cystic Fibrosis Bronchiectasis | Drug: Brensocatib 10 mg;Drug: Brensocatib 25 mg;Drug: Placebo | Insmed Incorporated | NULL | Recruiting | 18 Years | 85 Years | All | 1620 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Serbia;Slovakia;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Estonia;Lithuania |
| 95 | NCT03698448 (ClinicalTrials.gov) | December 1, 2020 | 3/10/2018 | A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic Fibrosis | A Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: OligoG Dry powder for inhalation | AlgiPharma AS | Imperial College London;Cystic Fibrosis Foundation;European Cystic Fibrosis Society;University Hospital of Cologne;Cystic Fibrosis Europe | Not yet recruiting | 12 Years | N/A | All | 120 | Phase 2/Phase 3 | Germany |
| 96 | EUCTR2016-004558-13-DE (EUCTR) | 01/12/2020 | 09/04/2020 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;France;United States;Greece;Canada;Argentina;Poland;Germany;Italy | ||
| 97 | NCT02547116 (ClinicalTrials.gov) | December 2020 | 9/9/2015 | Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic Fibrosis | Epidemiology and Treatment of Small-colony Variant Staphylococcus Aureus in Cystic Fibrosis | Cystic Fibrosis;MRSA | Drug: Rifampin | Johns Hopkins University | NULL | Withdrawn | 12 Years | N/A | All | 0 | Phase 4 | United States |
| 98 | NCT03058068 (ClinicalTrials.gov) | December 2020 | 6/2/2017 | Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis | A Phase I, Randomized and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human MesenchymAl Stem Cells Infusion in Patients With Cystic Fibrosis - HAPI | Cystic Fibrosis | Biological: Allo-hMSCs;Biological: Placebo | Joshua M Hare | NULL | Withdrawn | 20 Years | 45 Years | All | 0 | Phase 1 | United States |
| 99 | NCT04537793 (ClinicalTrials.gov) | November 19, 2020 | 28/8/2020 | Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 Years | A Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of Age | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 2 Years | 5 Years | All | 93 | Phase 3 | United States;Australia;Canada;Germany;United Kingdom |
| 100 | NCT04509050 (ClinicalTrials.gov) | November 18, 2020 | 6/8/2020 | Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young Children | A Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN Study) | Cystic Fibrosis | Drug: Ivacaftor or elexacaftor/tezacaftor/ivacaftor | Sonya Heltshe | Cystic Fibrosis Foundation;University of Washington;University of Alabama at Birmingham | Active, not recruiting | N/A | 5 Years | All | 210 | United States | |
| 101 | NCT04322929 (ClinicalTrials.gov) | November 12, 2020 | 24/3/2020 | Roflumilast in Non-CF Bronchiectasis Study (2019) | Anti-inflammatory Effects of Roflumilast Treatment for 12 Weeks in Stable-state Non-cystic Fibrosis Bronchiectasis | Non-cystic Fibrosis Bronchiectasis | Drug: Roflumilast Oral Tablet | The University of Hong Kong | NULL | Recruiting | 18 Years | N/A | All | 27 | Phase 2 | Hong Kong |
| 102 | NCT04624490 (ClinicalTrials.gov) | November 2, 2020 | 31/10/2020 | Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease | Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease | Asthma;COPD;Interstitial Lung Disease;Cystic Fibrosis;Pulmonary Hypertension;Pulmonary Infection;Other Lung Disease | Drug: Hyperpolarized Xe129 | Mario Castro, MD, MPH | NULL | Recruiting | 3 Years | N/A | All | 260 | Phase 1 | United States |
| 103 | EUCTR2019-003554-86-FR (EUCTR) | 29/10/2020 | 02/04/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland | ||
| 104 | EUCTR2019-004511-31-IT (EUCTR) | 21/10/2020 | 07/10/2020 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE Product Name: Noxafil Product Code: [NA] INN or Proposed INN: Posaconazolo Trade Name: Noxafil Product Name: Noxafil Product Code: [NA] INN or Proposed INN: POSACONAZOLO Trade Name: Noxafil Product Name: Noxafil Product Code: [NA] INN or Proposed INN: POSACONAZOLO Product Name: Noxafil Product Code: [na] INN or Proposed INN: POSACONAZOLO Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE Product Name: Noxafil Product Code: [na] INN or Proposed INN: POSACONAZOLO Trade Name: Noxafil Product Name: Noxafil Product Code: [na] INN or Proposed INN: Posaconazolo | IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 105 | EUCTR2016-004558-13-IT (EUCTR) | 19/10/2020 | 21/10/2020 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin Product Name: Colistimethate sodium Product Code: [NA] Other descriptive name: Colistimethate Sodium Trade Name: Salbutamol-ratiopharm® N metered-dose aerosol inhaler Product Name: Salbutamol-ratiopharm® N metereddose aerosol inhaler Product Code: [Salbutamol] INN or Proposed INN: SALBUTAMOL Other descriptive name: Salbutamol | ZAMBON SPA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;United States;France;Greece;Canada;Argentina;Poland;Germany;Italy | ||
| 106 | EUCTR2020-001404-42-GB (EUCTR) | 12/10/2020 | 25/08/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3b Open-label Study of ELX/TEZ/IVA in subjects 6 years & older | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | Israel;Netherlands;Germany;Switzerland;United Kingdom;France;Canada;Spain;Denmark;Australia | ||
| 107 | NCT04658277 (ClinicalTrials.gov) | October 1, 2020 | 31/8/2020 | Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations | Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian Populations | Bronchiectasis Adult | Drug: Clarithromycin;Other: Usual care | Chinese University of Hong Kong | NULL | Recruiting | 50 Years | N/A | All | 40 | N/A | Hong Kong |
| 108 | NCT04467957 (ClinicalTrials.gov) | October 1, 2020 | 19/6/2020 | Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis | Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic Fibrosis | Cystic Fibrosis | Drug: Initiation of CFTR Modulator;Drug: Hyperpolarized Xenon 129 | Children's Hospital Medical Center, Cincinnati | NULL | Not yet recruiting | 6 Years | 21 Years | All | 26 | Phase 4 | NULL |
| 109 | EUCTR2020-001762-11-GB (EUCTR) | 17/09/2020 | 23/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 110 | EUCTR2019-000750-63-PL (EUCTR) | 15/09/2020 | 21/07/2020 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067 | AbbVie Deutschland GmbH & Co. KG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | United States;Serbia;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Poland;Belgium;Netherlands | ||
| 111 | NCT04602468 (ClinicalTrials.gov) | September 3, 2020 | 20/10/2020 | Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER) | Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER) | Cystic Fibrosis;Cystic Fibrosis Liver Disease;Cystic Fibrosis in Children;Adherence, Medication;Cystic Fibrosis Gastrointestinal Disease | Drug: Kaftrio | Royal College of Surgeons, Ireland | Imperial College London;University College Dublin;University of Limerick;Cystic Fibrosis Registry of Ireland;Erasmus Medical Center;Medizinische Hochschule Brandenburg Theodor Fontane;Queen's University, Belfast;Teagasc;The Hospital for Sick Children | Recruiting | 6 Years | N/A | All | 237 | Phase 4 | Ireland;United Kingdom |
| 112 | NCT04509661 (ClinicalTrials.gov) | September 1, 2020 | 22/4/2020 | Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow Limitation | Efficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled Trial | Bronchiectasis Adult | Drug: LABA/LAMA or Placebo inhalation | Shanghai Pulmonary Hospital, Shanghai, China | NULL | Not yet recruiting | 18 Years | N/A | All | 200 | Phase 4 | NULL |
| 113 | EUCTR2020-001762-11-HU (EUCTR) | 26/08/2020 | 02/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | ||
| 114 | NCT04378153 (ClinicalTrials.gov) | August 25, 2020 | 4/5/2020 | Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy | A Master Protocol to Test the Impact of Discontinuing Chronic Therapies in People With Cystic Fibrosis on Highly Effective CFTR Modulator Therapy (SIMPLIFY) | Cystic Fibrosis | Other: Discontinuation of hypertonic saline (HS);Other: Continuation of hypertonic saline (HS);Other: Discontinuation of dornase alfa (dnase);Other: Continuation of dornase alfa (dnase) | David Nichols, MD | Cystic Fibrosis Foundation;Dartmouth-Hitchcock Medical Center;University of Washington | Recruiting | 12 Years | N/A | All | 800 | N/A | United States |
| 115 | EUCTR2019-003554-86-DK (EUCTR) | 19/08/2020 | 27/03/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | Germany;United Kingdom;Switzerland;France;Canada;Spain;Australia;Denmark;Israel;Netherlands | ||
| 116 | NCT04381429 (ClinicalTrials.gov) | August 17, 2020 | 30/4/2020 | Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes | Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE Trial | Cystic Fibrosis-related Diabetes | Drug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP);Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid) | University Hospital, Strasbourg, France | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 4 | France |
| 117 | EUCTR2019-003554-86-DE (EUCTR) | 14/08/2020 | 12/03/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland | ||
| 118 | NCT04496921 (ClinicalTrials.gov) | August 10, 2020 | 21/7/2020 | Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis | Vitamin K Supplementation to Reduce Deficiencies in Adults With Cystic Fibrosis : A Pilot Study | Cystic Fibrosis | Dietary Supplement: Vitamin K supplementation, dose #1;Dietary Supplement: Vitamin K supplementation, dose #2 | Institut de Recherches Cliniques de Montreal | Université de Montréal | Withdrawn | 18 Years | N/A | All | 0 | N/A | Canada |
| 119 | NCT04375514 (ClinicalTrials.gov) | August 10, 2020 | 30/4/2020 | Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis | A Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-ENaC in Normal Healthy Volunteers and Safety, Tolerability and Efficacy in Patients With Cystic Fibrosis | Cystic Fibrosis, Pulmonary | Drug: ARO-ENaC;Drug: Placebo | Arrowhead Pharmaceuticals | NULL | Recruiting | 18 Years | 55 Years | All | 92 | Phase 1/Phase 2 | Australia;New Zealand |
| 120 | EUCTR2019-003554-86-NL (EUCTR) | 28/07/2020 | 01/05/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Germany;Netherlands;United Kingdom;Switzerland | ||
| 121 | EUCTR2016-004558-13-PT (EUCTR) | 27/07/2020 | 20/04/2020 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | France;United States;Portugal;Greece;Canada;Argentina;Poland;Germany;Italy | ||
| 122 | NCT04553419 (ClinicalTrials.gov) | July 27, 2020 | 11/9/2020 | Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF | Antibiotic Treatment Of Staphylococcus Aureus In Stable People With CF (ASAP-CF) Clinical Research Protocol | Cystic Fibrosis | Drug: Cephalexin;Drug: Placebo | University of British Columbia | The Hospital for Sick Children | Recruiting | 3 Years | 17 Years | All | 86 | Phase 3 | Canada |
| 123 | NCT04058210 (ClinicalTrials.gov) | July 21, 2020 | 13/8/2019 | VX-445/TEZ/IVA Expanded Access Program for Cystic Fibrosis (CF) Patients Heterozygous for F508del Mutation and a Minimal Function Mutation (F/MF Genotypes) | VX-445/TEZ/IVA Triple Combination Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function CFTR Mutation | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 12 Years | N/A | All | NULL | ||
| 124 | NCT04375878 (ClinicalTrials.gov) | July 20, 2020 | 30/4/2020 | OPTION 2: A Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Cystic Fibrosis | OPTION 2: A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819 in Enteric Capsules in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis; With an Extension Phase Evaluation of Immediate Release MS1819 Capsules | Exocrine Pancreatic Insufficiency (EPI);Cystic Fibrosis (CF) | Drug: MS1819;Drug: Porcine PERT | AzurRx BioPharma, Inc. | NULL | Completed | 18 Years | N/A | All | 27 | Phase 2 | United States;Poland |
| 125 | NCT04458129 (ClinicalTrials.gov) | July 8, 2020 | 30/6/2020 | Polyethylene Glycol and Intestinal Inflammation in Cystic Fibrosis | EFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN | Cystic Fibrosis | Drug: Treatment with polyethylene glycol (Macrogol 4000) | University Hospital, Bordeaux | NULL | Not yet recruiting | 4 Years | 17 Years | All | 23 | Phase 2 | NULL |
| 126 | EUCTR2016-004558-13-GR (EUCTR) | 07/07/2020 | 14/05/2020 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;France;United States;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;Italy;New Zealand | ||
| 127 | NCT04279769 (ClinicalTrials.gov) | July 3, 2020 | 10/2/2020 | Study to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis | A Phase 1b Randomized, Double-blind, Placebo-Controlled Trial to Evaluate the Safety of CB-280 in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: CB-280;Drug: Placebos | Calithera Biosciences, Inc | NULL | Recruiting | 18 Years | N/A | All | 32 | Phase 1 | United States;Canada |
| 128 | NCT04353817 (ClinicalTrials.gov) | June 19, 2020 | 16/4/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes | A Phase 3b, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA;Other: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 121 | Phase 3 | Australia;Canada;Denmark;France;Germany;Israel;Netherlands;Spain;Switzerland;United Kingdom |
| 129 | NCT04415268 (ClinicalTrials.gov) | June 9, 2020 | 28/5/2020 | Combined Effect of CFTR Protein Modulator Drugs and Exercise in Cystic Fibrosis | Combined Effect of CFTR Protein Modulator Drugs and Exercise on Pulmonary Function, Fitness, Sweat Test and Quality of Life in Children With Cystic Fibrosis | Cystic Fibrosis in Children | Behavioral: Exercise;Behavioral: Unsupervised exercise;Drug: CFTR Modulators | Universidad Europea de Madrid | NULL | Recruiting | 6 Years | 18 Years | All | 11 | N/A | Spain |
| 130 | NCT04315311 (ClinicalTrials.gov) | May 6, 2020 | 18/3/2020 | Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer | A Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic Cancer | Exocrine Pancreatic Insufficiency (EPI) | Drug: CREON | AbbVie | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 4 | United States |
| 131 | NCT04362761 (ClinicalTrials.gov) | May 4, 2020 | 22/4/2020 | A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy | A Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 172 | Phase 3 | Australia;Belgium;Germany;United Kingdom |
| 132 | EUCTR2019-003554-86-GB (EUCTR) | 01/05/2020 | 01/04/2020 | A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypes | A Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - Phase 3b Study of ELX/TEZ/IVA in CF subjects 6 Through 11 Years of Age | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ Product Name: 150-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;Switzerland;United Kingdom | ||
| 133 | ChiCTR2000031817 | 2020-04-30 | 2020-04-11 | Evaluation and comparison of quality of life between acetylcysteine tablets and placebo in patients with non cystic fibrosis bronchiectasis | A Randomized, Double-Blinded, Placebo-Controlled, Multiple-Center Clinical Trial to Compare the Quality of Life of Acetylcysteine Tablets 600 Mg BID Treatment With Placebo in Patients With Non-Cystic Fibrosis Bronchiectasis | bronchiectasia | experimental group:Acetylcysteine;control group:placebo; | West China Hospital, Sichuan University | NULL | Pending | 18 | Both | experimental group:79;control group:40; | Phase 4 | China | |
| 134 | EUCTR2019-003501-10-SE (EUCTR) | 08/04/2020 | 07/04/2020 | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. | Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a multicenter randomized controlled study. - MBWtodetectPEXinCF | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | INN or Proposed INN: AMOXICILLIN INN or Proposed INN: CLAVULANIC ACID INN or Proposed INN: AMOXICILLIN INN or Proposed INN: FLUCLOXACILLIN INN or Proposed INN: DICLOXACILLIN INN or Proposed INN: SULFAMETHOXAZOLE INN or Proposed INN: Trimetoprim Other descriptive name: TRIMETHOPRIM INN or Proposed INN: Clarithromycin Other descriptive name: CLARITHROMYCIN INN or Proposed INN: RIFAMPICIN INN or Proposed INN: DOXYCYCLINE INN or Proposed INN: Fusidic acid Other descriptive name: FUSIDIC ACID INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN INN or Proposed INN: Linezolid Other descriptive name: LINEZOLID INN or Proposed INN: CLINDAMYCIN Other descriptive name: CLINDAMYCIN INN or Proposed INN: Cefuroxim Other descriptive name: CEFUROXIME INN or Proposed INN: CEFALEXIN | Västra Götalandsregionen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 4 | Denmark;Norway;Sweden | ||
| 135 | EUCTR2019-003455-11-DE (EUCTR) | 08/04/2020 | 09/12/2019 | Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: Ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | ||
| 136 | EUCTR2019-004958-29-FR (EUCTR) | 07/04/2020 | 04/06/2020 | Polyethylene glycol and intestinal inflammation in cystic fibrosis | EFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDREN - MUCOLAX | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: FORLAX 4 g, poudre pour solution buvable en sachet | CHU de Bordeaux | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 23 | Phase 2 | France | ||
| 137 | EUCTR2019-004940-31-DK (EUCTR) | 24/03/2020 | 24/03/2020 | Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial | Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial | GI pains and fat malabsorption in cysticfibrosis patients with pancreas insufficiency MedDRA version: 20.1;Level: LLT;Classification code 10025479;Term: Malabsorption syndrome;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Creon 10.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN Trade Name: Creon 25.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN Trade Name: Creon 40.000, hårde enterokapsler INN or Proposed INN: Pankreatin Other descriptive name: PANCREATIN | Terese Katzenstein | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 4 | Denmark | ||
| 138 | EUCTR2019-003455-11-BE (EUCTR) | 17/03/2020 | 23/12/2019 | Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kaftrio Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: Ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | ||
| 139 | NCT04118010 (ClinicalTrials.gov) | March 13, 2020 | 4/10/2019 | Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis | Vitamin D and Prebiotics for Intestinal Health in Cystic Fibrosis | Cystic Fibrosis;Dysbiosis | Drug: Vitamin D3;Drug: Placebo vitamin D3;Drug: Inulin;Drug: Placebo Inulin | Emory University | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 4 | United States |
| 140 | EUCTR2018-000378-30-DE (EUCTR) | 04/03/2020 | 06/06/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20, 17,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20, 27,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20, 37,5 mg, Hartkapsel mit Pulver zur Inhalation INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | ||
| 141 | EUCTR2018-000378-30-GB (EUCTR) | 03/03/2020 | 26/06/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 - 17.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 27.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 37.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | ||
| 142 | EUCTR2019-001827-11-IE (EUCTR) | 28/02/2020 | 20/12/2019 | Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Trade Name: Kalydeco 150 mg film-coated tablets Product Name: IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Product Name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 3 | United States;Canada;Ireland;Australia;United Kingdom | ||
| 143 | NCT04235140 (ClinicalTrials.gov) | February 24, 2020 | 15/1/2020 | Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation | A Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment Initiation | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Months | N/A | All | 52 | Phase 3 | United States;Canada |
| 144 | NCT04166396 (ClinicalTrials.gov) | February 17, 2020 | 14/11/2019 | Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis | Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Resveratrol;Dietary Supplement: NR;Dietary Supplement: Placebo | Virginia Commonwealth University | NULL | Recruiting | 18 Years | N/A | All | 36 | N/A | United States |
| 145 | NCT04183790 (ClinicalTrials.gov) | February 17, 2020 | 28/11/2019 | Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 6 Years | N/A | All | 64 | Phase 3 | United States;Australia;Canada;Ireland;United Kingdom |
| 146 | EUCTR2019-000955-16-AT (EUCTR) | 28/01/2020 | 07/01/2020 | Characterization of lung concentrations of the antibiotics piperacillin/tazobactam and levofloxacin | Pulmonary pharmacokinetics of piperacillin/tazobactam and levofloxacin in patients with chronic obstructive pulmonary disease or cystic fibrosis: Comparison of epithelial lining fluid, in-vivo microdialysis and tissue biopsy | Pneumonia;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Piperacillin/Tazobactam Kabi - Fresenius Kabi Austria INN or Proposed INN: piperacillin Other descriptive name: PIPERACILLIN INN or Proposed INN: tazobactam Other descriptive name: TAZOBACTAM Trade Name: Levofloxacin Kabi INN or Proposed INN: levofloxacin Other descriptive name: LEVOFLOXACIN HEMIHYDRATE | Medical University of Vienna | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 18 | Phase 4 | Austria | ||
| 147 | EUCTR2018-003831-31-ES (EUCTR) | 24/01/2020 | 02/12/2019 | MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis. | A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs | Exocrine Pancreatic Insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MS1819-SD INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica Other descriptive name: LIPASE LIP2 | AzurRx | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Hungary;Poland;Spain | ||
| 148 | EUCTR2019-000833-37-DE (EUCTR) | 23/01/2020 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Trikafta Product Name: 100-mg ELX (VX-455) / 50-mg TEZ / 75-mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 149 | EUCTR2018-002835-76-NL (EUCTR) | 22/01/2020 | 17/09/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy | ||
| 150 | EUCTR2019-000833-37-NL (EUCTR) | 22/01/2020 | 17/09/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy | ||
| 151 | EUCTR2019-003455-11-GB (EUCTR) | 17/01/2020 | 09/12/2019 | Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: SUB185183 Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 158 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Belgium;Australia;Germany;United Kingdom | ||
| 152 | EUCTR2018-004652-38-IE (EUCTR) | 15/01/2020 | 17/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 481 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom;Switzerland | ||
| 153 | NCT04259970 (ClinicalTrials.gov) | January 13, 2020 | 15/1/2020 | Hyperpolarized Imaging for New Treatments | Hyperpolarized Imaging for New Treatments (HyPOINT) Study | Cystic Fibrosis | Drug: Initiation of CFTR Modulator | Children's Hospital Medical Center, Cincinnati | University of Virginia;University of Wisconsin, Madison;The Hospital for Sick Children | Recruiting | 6 Years | 18 Years | All | 64 | Phase 4 | United States;Canada |
| 154 | NCT04301856 (ClinicalTrials.gov) | January 1, 2020 | 21/2/2020 | Response to CFTR Modulators in CF Patients Under 18 Years | Evaluation of the Response to CFTR Modulators in Patients With Cystic Fibrosis Less Than 18 Years of Age | Cystic Fibrosis in Children | Drug: CFTR Modulators | Societe Francaise de la Mucoviscidose | NULL | Recruiting | N/A | 18 Years | All | 600 | France | |
| 155 | NCT04206436 (ClinicalTrials.gov) | December 18, 2019 | 18/12/2019 | CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis | CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis | Cystic Fibrosis;Bone Loss;Muscle Loss | Drug: Cftr Modulators | Indiana University | Cystic Fibrosis Foundation | Enrolling by invitation | 18 Years | N/A | All | 60 | United States | |
| 156 | NCT03894657 (ClinicalTrials.gov) | December 18, 2019 | 12/2/2019 | Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®. | Validation of Respiratory Epithelial Functional Assessment to Predict Clinical Efficacy of Orkambi®. Pathway to Personalized Therapy in Cystic Fibrosis | Cystic Fibrosis;Homozygous F508del Mutation | Diagnostic Test: Nasal brushing;Other: Sputum sample;Other: blood sample;Drug: Orkambi | Assistance Publique - Hôpitaux de Paris | NULL | Recruiting | 5 Years | N/A | All | 104 | N/A | France |
| 157 | EUCTR2019-001441-40-IT (EUCTR) | 17/12/2019 | 24/05/2021 | Study of the use of the drug Thymosin alpha 1 in adults patients with Cystic Fibrosis. | A phase II trial to assess the activity and tolerability of Thymosin alpha 1 in Cystic Fibrosis Patients. - Thymosin alpha 1 in Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Zadaxin Product Code: [Ta1] Other descriptive name: Thymosin alpha 1 | SciClone Pharmaceuticals Limited Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 24 | Phase 2 | Italy | ||
| 158 | NCT04210427 (ClinicalTrials.gov) | December 12, 2019 | 18/12/2019 | Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit | Cystic Fibrosis and Gut Dysmotility: The Effect of Polyethylene Glycol (PEG) on Intestinal Transit | Cystic Fibrosis Gastrointestinal Disease | Drug: Polyethylene Glycol 3350;Device: SmartPill Motility System & PillCam Patency Capsule | St. Louis University | NULL | Recruiting | 18 Years | 40 Years | All | 15 | Phase 4 | United States |
| 159 | NCT03969888 (ClinicalTrials.gov) | December 11, 2019 | 30/5/2019 | A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 | A Phase 2 Study of ABBV-3067 Alone and in Combination With ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | Cystic Fibrosis | Drug: ABBV-3067;Drug: Placebo ABBV-3067;Drug: ABBV-2222;Drug: Placebo ABBV-2222 | AbbVie | NULL | Recruiting | 18 Years | N/A | All | 189 | Phase 2 | United States;Belgium;Canada;Czechia;France;Hungary;Netherlands;New Zealand;Poland;Romania;Serbia;Slovakia;Spain;United Kingdom |
| 160 | NCT03988816 (ClinicalTrials.gov) | December 6, 2019 | 14/6/2019 | Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis | Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis: a Cross-over, Unicentric, Double-blind and Placebo-controlled Study | Bronchiectasis Adult | Drug: Roflumilast;Drug: Placebo oral tablet | University of Sao Paulo General Hospital | FAPESP - Fundação de Apoio à Pesquisa do Estado de São Paulo | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | Brazil |
| 161 | NCT04058366 (ClinicalTrials.gov) | December 5, 2019 | 14/8/2019 | Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 251 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;United Kingdom |
| 162 | NCT04135495 (ClinicalTrials.gov) | November 25, 2019 | 16/8/2019 | A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X Allele | A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients With Cystic Fibrosis With at Least One G542X Allele | Cystic Fibrosis | Drug: ELX-02;Drug: Ivacaftor | Eloxx Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | N/A | All | 16 | Phase 2 | United States;Canada |
| 163 | EUCTR2019-000833-37-ES (EUCTR) | 19/11/2019 | 09/08/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 164 | EUCTR2019-003178-25-HU (EUCTR) | 19/11/2019 | 20/11/2019 | A study of safety, tolerability and effect of SNSP113 in Cystic Fibrosis | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Effect of Inhaled SNSP113 in Adult Subjects with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SNSP113 Product Code: SNSP113 INN or Proposed INN: not assigned Other descriptive name: PAAG15 | Synspira Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 56 | Phase 2 | Hungary | ||
| 165 | EUCTR2018-000966-12-DE (EUCTR) | 18/11/2019 | 25/06/2019 | A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic Fibrosis | A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic Fibrosis with at Least One G542X Allele | Cystic fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Code: ELX-02 INN or Proposed INN: Not Assigned Trade Name: Kalydeco Product Name: Kalydeco INN or Proposed INN: Ivacaftor | Eloxx Pharmaceuticals Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 2 | Australia;Israel;Germany | ||
| 166 | EUCTR2019-000750-63-FR (EUCTR) | 15/11/2019 | 22/08/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067 | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;France;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom | ||
| 167 | EUCTR2018-004652-38-GB (EUCTR) | 06/11/2019 | 19/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 481 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Germany;Switzerland;United Kingdom | ||
| 168 | EUCTR2019-000261-21-GB (EUCTR) | 05/11/2019 | 05/06/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM) 1 | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM) 1 | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Sweden;United Kingdom;Germany;Ireland;Belgium;Spain;Canada;France;United States | ||
| 169 | NCT04126473 (ClinicalTrials.gov) | November 5, 2019 | 16/8/2019 | A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X Allele | A Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients With Cystic Fibrosis With at Least One G542X Allele | Cystic Fibrosis | Drug: ELX-02 | Eloxx Pharmaceuticals, Inc. | NULL | Recruiting | 16 Years | N/A | All | 16 | Phase 2 | Australia;Germany;Israel |
| 170 | EUCTR2018-000378-30-AT (EUCTR) | 04/11/2019 | 05/07/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | ||
| 171 | EUCTR2019-000750-63-NL (EUCTR) | 31/10/2019 | 05/08/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 INN or Proposed INN: TBD Other descriptive name: ABBV-3067 | AbbVie Deutschland | NULL | Not Recruiting | Female: yes Male: yes | 189 | Phase 2 | Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Netherlands | ||
| 172 | EUCTR2019-000750-63-GB (EUCTR) | 31/10/2019 | 26/06/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067 | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | Serbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom | ||
| 173 | EUCTR2018-002835-76-GB (EUCTR) | 29/10/2019 | 27/06/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 174 | EUCTR2019-000833-37-GB (EUCTR) | 29/10/2019 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 175 | NCT04176328 (ClinicalTrials.gov) | October 25, 2019 | 8/11/2019 | Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients | An Open-label, Dose-escalation Study to Evaluate the Pharmacokinetics of Inhaled Teicoplanin in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Teicoplanin Sandoz 200 mg powder and solvent for solution for injection or infusion or oral solution. | Neupharma Srl | Sintesi Research Srl;Aptuit Srl;Pari Pharma GmbH | Completed | 18 Years | N/A | All | 12 | Phase 1 | Italy |
| 176 | NCT03924947 (ClinicalTrials.gov) | October 23, 2019 | 18/4/2019 | A Study to Compare US Marketed Creon Manufactured With a Modernized Process at an Alternate Manufacturing Site and Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Participants With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Phase 4 Study to Compare US Marketed Creon Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing Site and With Drug Product Manufactured With the Approved Manufacturing Process at an Alternate Active Pharmaceutical Ingredient Site, in Subjects With EPI Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase | AbbVie | NULL | Recruiting | 12 Years | N/A | All | 46 | Phase 4 | United States;Spain |
| 177 | NCT04437641 (ClinicalTrials.gov) | October 22, 2019 | 26/3/2020 | Impact of Pediatrician Intervention on the Smoking Habits of Parents of Sick Children | Impact of Pediatrician Intervention on the Smoking Habits of Parents of Children With Cystic Fibrosis, Type 1 Diabetes or Children Hospitalized for a First Episode of Bronchiolitis. | Tobacco Consumption;Bronchiolitis | Other: Tobacco questionnaire | University Hospital, Toulouse | NULL | Recruiting | 18 Years | 65 Years | All | 600 | France | |
| 178 | EUCTR2018-002835-76-IE (EUCTR) | 21/10/2019 | 28/06/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 179 | EUCTR2018-002835-76-DE (EUCTR) | 21/10/2019 | 03/07/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 180 | EUCTR2019-000833-37-IE (EUCTR) | 21/10/2019 | 27/06/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 181 | EUCTR2018-004652-38-DK (EUCTR) | 18/10/2019 | 28/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 506 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Australia;Denmark;Israel;Germany;United Kingdom;Switzerland | ||
| 182 | EUCTR2019-000833-37-DK (EUCTR) | 17/10/2019 | 09/07/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Australia;Denmark;Netherlands;Germany;United Kingdom;Italy | ||
| 183 | EUCTR2018-002835-76-DK (EUCTR) | 16/10/2019 | 09/07/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United Kingdom;Italy;Germany;Netherlands;Denmark;Australia;Ireland;Spain;Belgium;Canada;United States;France | ||
| 184 | EUCTR2019-000261-21-ES (EUCTR) | 10/10/2019 | 05/07/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | Spain;United States;France;Canada;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 185 | EUCTR2018-001695-38-GB (EUCTR) | 09/10/2019 | 19/08/2019 | Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Trade Name: Kalydeco 150 mg film-coated tablets Product Name: IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Product Name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | United States;Canada;Ireland;Australia;United Kingdom | ||
| 186 | EUCTR2019-000833-37-IT (EUCTR) | 08/10/2019 | 22/01/2021 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) - NA | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75- mg IVA FDC Product Code: [VX-445/TEZ/IVA] INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: ivacaftor Product Code: [VX-770] INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 187 | EUCTR2019-000261-21-SE (EUCTR) | 08/10/2019 | 29/04/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 188 | EUCTR2019-000261-21-BE (EUCTR) | 07/10/2019 | 29/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1 | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis – BALANCE – CF(TM)1 | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 189 | EUCTR2018-002835-76-IT (EUCTR) | 04/10/2019 | 12/02/2021 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF)Subjects Heterozygous for F508del and a Gating or Residual FunctionMutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating theEfficacy and Safety of VX-445 Combination Therapy in Subjects With CysticFibrosis Who Are Heterozygous for the F508del Mutation and a Gating orResidual Function Mutation (F/G and F/RF Genotypes) - NA | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75- mg IVA FDC Product Code: [VX-445/TEZ/IVA] INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: VX-661 / VX-770 Product Code: [VX-661 / VX-770] INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | ||
| 190 | NCT04105972 (ClinicalTrials.gov) | October 3, 2019 | 24/9/2019 | A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del | A Phase 3b, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 176 | Phase 3 | Australia;Belgium;Germany;United Kingdom |
| 191 | NCT04090294 (ClinicalTrials.gov) | October 1, 2019 | 21/8/2019 | Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis | Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Roflumilast | Assiut University | NULL | Not yet recruiting | 18 Years | 75 Years | All | 35 | Early Phase 1 | NULL |
| 192 | EUCTR2019-000750-63-BE (EUCTR) | 27/09/2019 | 07/08/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067 | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Spain;Belgium;Netherlands;United Kingdom | ||
| 193 | NCT04059094 (ClinicalTrials.gov) | September 16, 2019 | 15/8/2019 | A 4-week Study to Test Different Doses of BI 1265162 in Adolescents and Adults With Cystic Fibrosis Using the Respimat® Inhaler - BALANCE - CF™1 | A Randomised, Double-blind, Placebo-controlled and Parallel Group Trial to Evaluate Efficacy and Safety of Twice Daily Inhaled Doses of BI 1265162 Delivered by Respimat® Inhaler as add-on Therapy to Standard of Care Over 4 Weeks in Patients With Cystic Fibrosis - BALANCE - CF™ 1 | Cystic Fibrosis | Drug: BI 1265162;Drug: Placebo | Boehringer Ingelheim | NULL | Terminated | 12 Years | N/A | All | 52 | Phase 2 | United States;Belgium;Canada;France;Germany;Spain;Sweden;United Kingdom |
| 194 | EUCTR2019-001735-31-GB (EUCTR) | 13/09/2019 | 24/06/2019 | A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic Fibrosis | A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: ELEXACAFTOR Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | ||
| 195 | EUCTR2018-003970-28-NL (EUCTR) | 12/09/2019 | 09/05/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom | ||
| 196 | NCT04038710 (ClinicalTrials.gov) | September 5, 2019 | 26/7/2019 | Clinical Outcomes of Triple Combination Therapy in Severe Cystic Fibrosis Disease. | An Observational Study of the Effects on Clinical Outcomes of Expanded Access Program of Vertex Triple Combination Therapy. | Cystic Fibrosis | Drug: Triple combination therapy | National Jewish Health | NULL | Completed | 12 Years | N/A | All | 8 | United States | |
| 197 | NCT04056702 (ClinicalTrials.gov) | September 5, 2019 | 27/7/2019 | Impact of Triple Combination CFTR Therapy on Sinus Disease. | Impact of Elexacaftor-tezacaftor-ivacaftor Triple Combination CFTR Therapy on Sinus Disease: Quantitative Sinus Computed Tomography, Patient Reported Outcomes and Cellular and Molecular Changes | Cystic Fibrosis | Drug: Elexacaftor-tezacaftor-ivacaftor exposure | Jennifer Taylor-Cousar | Cystic Fibrosis Foundation | Recruiting | 18 Years | 89 Years | All | 31 | United States | |
| 198 | NCT04039087 (ClinicalTrials.gov) | September 5, 2019 | 28/7/2019 | Sildenafil Exercise: Role of PDE5 Inhibition | Mechanisms of Exercise Intolerance in Cystic Fibrosis: Role of PDE5 Inhibition | Cystic Fibrosis | Drug: Sildenafil 40mg oral capsule;Drug: Placebo Oral capsule | National Jewish Health | Augusta University;Cystic Fibrosis Foundation | Recruiting | 9 Years | N/A | All | 40 | Phase 2/Phase 3 | United States |
| 199 | NCT03506061 (ClinicalTrials.gov) | September 4, 2019 | 13/4/2018 | Trikafta in Cystic Fibrosis Patients | iPS Cell Response to CFTR Modulators: Study of Trikafta in CF Patients Carrying Partial Function Mutations | Cystic Fibrosis | Drug: Trikafta | Emory University | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 12 Years | N/A | All | 22 | Phase 2 | United States |
| 200 | EUCTR2019-000750-63-HU (EUCTR) | 03/09/2019 | 01/07/2019 | Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutation | A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: ABBV-2222 Product Code: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 INN or Proposed INN: Galicaftor Other descriptive name: ABBV-2222 Product Name: ABBV-3067 Product Code: ABBV-3067 Other descriptive name: ABBV-3067 | AbbVie Deutschland | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 189 | Phase 2 | Serbia;France;United States;Czech Republic;Hungary;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom | ||
| 201 | NCT04006873 (ClinicalTrials.gov) | September 3, 2019 | 2/7/2019 | Gut Imaging for Function & Transit in Cystic Fibrosis Study 2 | A Randomised Crossover Pilot Study of the Effects of Tezacaftor/Ivacaftor and Ivacaftor on Gastrointestinal Function Using Magnetic Resonance Imaging Parameters in People With Cystic Fibrosis | Cystic Fibrosis | Drug: Tezacaftor/Ivacaftor + Ivacaftor;Drug: Placebo oral tablet | Nottingham University Hospitals NHS Trust | Vertex Pharmaceuticals Incorporated;Cystic Fibrosis Foundation;Cystic Fibrosis Trust;University of Nottingham;Nottingham University Hospitals Charity | Completed | 12 Years | 40 Years | All | 12 | Phase 2 | United Kingdom |
| 202 | EUCTR2019-000833-37-FR (EUCTR) | 02/09/2019 | 12/07/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | ||
| 203 | NCT04302428 (ClinicalTrials.gov) | August 29, 2019 | 6/3/2020 | Zinc Status and Growth in Cystic Fibrosis | Zinc Status and Growth in Cystic Fibrosis | Cystic;Fibrosis | Biological: Serum Zn;Biological: Red Blood Cell Zn | Indiana University | NULL | Active, not recruiting | 3 Months | 3 Years | All | 35 | United States | |
| 204 | NCT04058353 (ClinicalTrials.gov) | August 28, 2019 | 14/8/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA;Drug: TEZ/IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 271 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;United Kingdom |
| 205 | EUCTR2018-003970-28-DE (EUCTR) | 12/08/2019 | 21/05/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 206 | EUCTR2019-000261-21-DE (EUCTR) | 12/08/2019 | 16/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 207 | NCT04043806 (ClinicalTrials.gov) | August 9, 2019 | 31/7/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: ELX/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 458 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom |
| 208 | NCT03903913 (ClinicalTrials.gov) | August 8, 2019 | 15/2/2019 | Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis | A Phase IIa Open Label Study to Evaluate the Safety, Tolerability and Efficacy of S-1226 Administered by Nebulization in Subjects With Mild to Moderate Cystic Fibrosis and Non CF Bronchiectasis | Cystic Fibrosis;Bronchiectasis | Drug: S-1226 | SolAeroMed Inc. | NULL | Recruiting | 14 Years | 50 Years | All | 12 | Phase 2 | Canada |
| 209 | NCT03587961 (ClinicalTrials.gov) | August 1, 2019 | 3/7/2018 | Personalized Theratyping Trial | Personalized Theratyping Trial | Cystic Fibrosis | Drug: Symdeko | University of Alabama at Birmingham | NULL | Recruiting | 6 Years | N/A | All | 20 | Early Phase 1 | United States |
| 210 | NCT04058340 (ClinicalTrials.gov) | July 30, 2019 | 12/8/2019 | Taste Receptors Regulation in CF Patients | The Effects of Taste Receptors Regulation in Upper Airway Innate Immunity of CF Patients | Cystic Fibrosis | Dietary Supplement: lactizole nebulization;Other: Placebo | Medical Universtity of Lodz | NULL | Recruiting | 6 Years | N/A | All | 30 | N/A | Poland |
| 211 | EUCTR2019-000261-21-IE (EUCTR) | 26/07/2019 | 30/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM)1 | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM)1 | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim Limited | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 98 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Ireland;Germany;United Kingdom;Sweden | ||
| 212 | EUCTR2019-000261-21-FR (EUCTR) | 19/07/2019 | 21/05/2019 | A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhaler | A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BI 1265162 10 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 25 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 50 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 Product Name: BI 1265162 100 µg INN or Proposed INN: not yet available Other descriptive name: BI 1265162 | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 98 | Phase 2 | United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden | ||
| 213 | EUCTR2017-004134-29-DE (EUCTR) | 12/07/2019 | 05/03/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 214 | EUCTR2018-002496-18-NL (EUCTR) | 08/07/2019 | 13/02/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Portugal;Germany;Netherlands;United Kingdom | ||
| 215 | EUCTR2018-003970-28-BE (EUCTR) | 04/07/2019 | 23/04/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 216 | NCT03650712 (ClinicalTrials.gov) | July 1, 2019 | 18/7/2018 | EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis | EnVision CF Multicenter Study of Glucose Tolerance in Cystic Fibrosis | Cystic Fibrosis-related Diabetes | Diagnostic Test: Oral glucose tolerance test;Diagnostic Test: Continuous glucose monitoring;Diagnostic Test: Dexa scan | Katie Larson Ode | NULL | Active, not recruiting | 6 Years | N/A | All | 404 | N/A | United States |
| 217 | NCT04302662 (ClinicalTrials.gov) | June 27, 2019 | 4/3/2020 | Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs | A Multicenter, Open-label Phase 2 Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEs, to Investigate the Efficacy and Safety of This Combination for the Compensation of Severe Exocrine Pancreatic Insufficiency in CF Patients Not Fully Compensated With Only PPEs | Cystic Fibrosis;Cystic Fibrosis Gastrointestinal Disease;Cystic Fibrosis of Pancreas | Drug: MS1819-SD | AzurRx SAS | NULL | Completed | 12 Years | N/A | All | 20 | Phase 2 | Hungary;Turkey |
| 218 | NCT03597347 (ClinicalTrials.gov) | June 20, 2019 | 12/7/2018 | Trial of Inhaled Molgramostim in CF Subjects With NTM Infection | An Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) Infection | Mycobacterium Infections, Nontuberculous;Cystic Fibrosis (CF) | Drug: Molgramostim nebulizer solution;Device: PARI eFlow nebulizer system | Savara Inc. | NULL | Terminated | 18 Years | N/A | All | 14 | Phase 2 | United States |
| 219 | EUCTR2018-003970-28-GB (EUCTR) | 18/06/2019 | 17/04/2019 | A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Deutivacaftor Product Code: VX-561 INN or Proposed INN: DEUTIVACAFTOR INN or Proposed INN: DEUTIVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 88 | Phase 2 | United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom | ||
| 220 | NCT03734744 (ClinicalTrials.gov) | June 17, 2019 | 6/11/2018 | PK/PD of Vitamin D3 in Adults With CF | A Pilot Study Evaluating Single, High-dose Pharmacokinetics/Pharmacodynamics of Vitamin D3 in CF | Vitamin D Deficiency;Cystic Fibrosis | Dietary Supplement: Vitamin D3 | University of Southern California | NULL | Suspended | 18 Years | N/A | All | 12 | N/A | United States |
| 221 | NCT03485456 (ClinicalTrials.gov) | May 29, 2019 | 26/3/2018 | DPI-Tobra-Kind Cyclops® in Children With Cystic Fibrosis | Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin Via the Cyclops® in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin | University Medical Center Groningen | NULL | Recruiting | 6 Years | 18 Years | All | 10 | Phase 1/Phase 2 | Netherlands |
| 222 | NCT04010799 (ClinicalTrials.gov) | May 27, 2019 | 10/6/2019 | A Clinical Study to Investigate Safety, Tolerability and Distribution of CHF 6333 After One or After Repeated Inhalation in Patients With Cystic Fibrosis (CF) and in Patients With Non Cystic Fibrosis (NCFB) Bronchiectasis | A Phase Ib, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Patients Affected by Cystic Fibrosis and Non Cystic Fibrosis Bronchiectasis | Cystic Fibrosis;Non-Cystic Fibrosis Bronchiectasis | Drug: CHF 6333;Drug: Placebo | Chiesi Farmaceutici S.p.A. | NULL | Completed | 18 Years | N/A | All | 68 | Phase 1 | Germany |
| 223 | NCT03965832 (ClinicalTrials.gov) | May 24, 2019 | 24/5/2019 | HFNT During Exercise in CF | A Pilot Study to Evaluate the Feasibility of Using High-flow Nasal Therapy During Exercise in Patients With Cystic Fibrosis and Severe Lung Disease | Cystic Fibrosis | Device: HFNT during exercise;Device: Standard oxygen therapy/RA | The Leeds Teaching Hospitals NHS Trust | NULL | Recruiting | 18 Years | N/A | All | 20 | N/A | United Kingdom |
| 224 | EUCTR2018-002496-18-PT (EUCTR) | 20/05/2019 | 05/02/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | United States;Portugal;Netherlands;Germany;United Kingdom | ||
| 225 | NCT03822455 (ClinicalTrials.gov) | May 16, 2019 | 29/1/2019 | A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic Fibrosis | A Phase 2b Randomised, Double-blind, Parallel-group Study of Alginate Oligosaccharide (OligoG) Dry Powder Inhalation in Addition to Standard of Care Compared to Placebo in Addition to Standard of Care in Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: OligoG DPI | AlgiPharma AS | AlgiPharma Australia Pty. Ltd. | Active, not recruiting | 18 Years | N/A | All | 20 | Phase 2 | Australia |
| 226 | EUCTR2017-003723-29-PL (EUCTR) | 09/05/2019 | 07/11/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 227 | EUCTR2019-001314-41-NL (EUCTR) | 06/05/2019 | 06/05/2019 | This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor. | Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS | Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Orkambi: contains lumacaftor and ivacaftor Product Name: Orkambi Trade Name: Symkevi Product Name: Symkevi Trade Name: Kalydeco Product Name: Kalydeco | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 4 | Netherlands | |||
| 228 | EUCTR2018-002496-18-DE (EUCTR) | 02/05/2019 | 28/01/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 108 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Portugal;United States;Netherlands;Germany;United Kingdom | ||
| 229 | NCT03961516 (ClinicalTrials.gov) | May 1, 2019 | 16/5/2019 | Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis | Glycemic Characterization and Pancreatic Imaging Correlates in Cystic Fibrosis | Cystic Fibrosis;Cystic Fibrosis-related Diabetes;Cystic Fibrosis Liver Disease;Pancreatic Steatosis;Hepatic Steatosis | Device: Frequently Sampled Oral Glucose Tolerance Test and CGM;Radiation: MRI Pancreas and Liver | University Hospitals Cleveland Medical Center | NULL | Active, not recruiting | 6 Years | 40 Years | All | 40 | United States | |
| 230 | NCT02748798 (ClinicalTrials.gov) | May 2019 | 19/4/2016 | Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung Disorders | Developing Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung Disorders | Lung Transplant;Lung Resection;Lung Cancer;Asthma;Cystic Fibrosis;Chronic Obstructive Pulmonary Disease;Emphysema;Mesothelioma;Asbestosis;Pulmonary Embolism;Interstitial Lung Disease;Pulmonary Fibrosis;Bronchiectasis;Seasonal Allergies;Cold Virus;Lung Infection;Pulmonary Hypertension;Pulmonary Dysplasia;Obstructive Sleep Apnea | Drug: HP 3He;Drug: HP 129Xe;Drug: PFP;Drug: SF6;Device: 129Xe Small and Large Human Lung Coil;Device: 3He Human Lung Coil;Device: PFP and SF6 Human Lung Coil | Thunder Bay Regional Research Institute | Thunder Bay Regional Health Sciences Centre;St. Joseph's Care Group;Lakehead University | Unknown status | 18 Years | N/A | All | 160 | Early Phase 1 | Canada |
| 231 | NCT03912233 (ClinicalTrials.gov) | April 30, 2019 | 10/4/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-121;Drug: TEZ;Drug: VX-561;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 87 | Phase 2 | United States;Germany;Netherlands;Portugal;United Kingdom |
| 232 | NCT03911713 (ClinicalTrials.gov) | April 17, 2019 | 9/4/2019 | A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-561;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 77 | Phase 2 | United States;Australia;Belgium;Germany;Ireland;Netherlands;United Kingdom |
| 233 | NCT03795363 (ClinicalTrials.gov) | April 10, 2019 | 28/12/2018 | Orkambi Treatment in 2 to 5 Year Old Children With CF | Nutritional Impact of Orkambi Treatment in 2 to 5 Year Old Children Homozygous for F508del Mutations | Cystic Fibrosis | Drug: Orkambi | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Completed | 2 Years | 5 Years | All | 28 | United States | |
| 234 | NCT03870841 (ClinicalTrials.gov) | April 3, 2019 | 24/10/2018 | The Effect of PC945 on Aspergillus Fumigatus Lung Infection in Patients With Cystic Fibrosis | An Open-label Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of Inhaled PC945 in Adult Cystic Fibrosis (CF) Patients With Persistent Pulmonary Aspergillus Fumigatus Infection | Aspergillosis;Cystic Fibrosis | Drug: PC945 | Pulmocide Ltd | NULL | Terminated | 18 Years | N/A | All | 4 | Phase 2 | United Kingdom |
| 235 | NCT03710538 (ClinicalTrials.gov) | April 1, 2019 | 20/6/2018 | The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis | The Effect of a Pre-meal Snack and/or Exercise on Post-prandial Glycemic Excursions in Adults With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Snack beverage;Behavioral: Exercise | Institut de Recherches Cliniques de Montreal | NULL | Recruiting | 18 Years | N/A | All | 14 | N/A | Canada |
| 236 | NCT03724955 (ClinicalTrials.gov) | April 2019 | 29/10/2018 | Pilot E2 for Hypogonadal Women With CFBD | Pilot Study Evaluating the Effects of Estradiol for Hypogonadal Women With Cystic Fibrosis and Osteopenia | Cystic Fibrosis Related Bone Disease | Drug: Estradiol 2 mg;Other: Placebo | Emory University | NULL | Withdrawn | 18 Years | N/A | Female | 0 | Phase 4 | United States |
| 237 | EUCTR2018-003831-31-HU (EUCTR) | 28/03/2019 | 09/10/2018 | MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis. | A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs - MS1819/18/02 | Exocrine Pancreatic Insufficiency MedDRA version: 20.0;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MS1819-SD | AzurRx | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Hungary;Poland;Spain | ||
| 238 | EUCTR2017-001259-29-GB (EUCTR) | 12/03/2019 | 21/12/2018 | A study to establish the tolerabilty and adverse effects in people with a severe form of Cystic Fibrosi (delta F 508 homozygous) when using a combination of two products - cyteamine (a licensed medicine being used in a new disease) and EGCG (a food supplement). | A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE (CYSTAGON) IN ADULTS AND CHILDREN WITH HOMOZYGOUS ?F508 CYSTIC FIBROSIS, IN PATIENTS TAKING EPIGALLOCATECHIN-3-GALLATE (EGCG, EPINERVE) FOOD SUPPLEMENTATION - Delta Dose Study | DeltaF508 Homozygous Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cystagon Product Name: Cystagon INN or Proposed INN: cysteamine bitartrate Other descriptive name: 2-aminoethanethiol;2,3-dihydroxybutanedioic acid | University of LIverpool | NULL | Not Recruiting | Female: yes Male: yes | 44 | Phase 1;Phase 2 | United Kingdom | ||
| 239 | EUCTR2018-002496-18-GB (EUCTR) | 08/03/2019 | 30/01/2019 | A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: N/A Other descriptive name: VX-121 Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: VX-561 INN or Proposed INN: N/A Other descriptive name: VX-561 Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 108 | Phase 2 | Portugal;United States;Netherlands;Germany;United Kingdom | ||
| 240 | NCT03902236 (ClinicalTrials.gov) | March 1, 2019 | 1/4/2019 | Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis | Evaluation of Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis | Cystic Fibrosis;Bronchiectasis | Other: Reaction Time and Postural Control;Other: Muscle oxygenation;Other: Exercise capacity;Other: Balance | Hacettepe University | NULL | Recruiting | 6 Years | 18 Years | All | 60 | Turkey | |
| 241 | EUCTR2018-000185-11-AT (EUCTR) | 27/02/2019 | 19/10/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 242 | EUCTR2017-003723-29-NL (EUCTR) | 25/02/2019 | 20/06/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 243 | NCT03632525 (ClinicalTrials.gov) | February 22, 2019 | 21/6/2018 | Intravenous Iron in Adults With Cystic Fibrosis | A Pilot Trial of Intravenous Iron for the Treatment of Iron Deficiency in Adult Patients With Cystic Fibrosis | Cystic Fibrosis;Iron-deficiency | Drug: Ferric carboxymaltose | University of Oxford | NULL | Recruiting | 18 Years | N/A | All | 20 | Phase 4 | United Kingdom |
| 244 | NCT03783286 (ClinicalTrials.gov) | February 6, 2019 | 18/12/2018 | Ivacaftor Treatment in 4 Month to 2 Year Old CF Subjects | Nutritional Impact of Ivacaftor Treatment in 4 Month to 2 Year Old Children With CF Gating Mutations | Cystic Fibrosis | Drug: Ivacaftor | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Completed | 4 Months | 2 Years | All | 15 | United States | |
| 245 | EUCTR2017-002533-32-BE (EUCTR) | 17/01/2019 | 28/09/2018 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 246 | NCT03746483 (ClinicalTrials.gov) | January 10, 2019 | 15/11/2018 | OPTION: A Trial to Assess the Safety & Efficacy of MS1819 in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Phase 2, Open-Label, Multicenter, 2x2 Crossover Trial to Assess the Safety and Efficacy of MS1819-SD in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Exocrine Pancreatic Insufficiency (EPI);Cystic Fibrosis (CF) | Drug: MS1819-SD;Drug: Porcine PERT | AzurRx BioPharma, Inc. | NULL | Completed | 18 Years | N/A | All | 32 | Phase 2 | United States;Poland |
| 247 | NCT04589897 (ClinicalTrials.gov) | January 7, 2019 | 24/9/2020 | Manuka Honey Sinus Rinse Study | A Pilot Study Investigating the Effects of a Manuka Honey Sinus Rinse on Sino-nasal Outcome Test Scores in Cystic Fibrosis Patients | Cystic Fibrosis;Infection, Bacterial | Device: Manuka honey sinus rinse;Device: Standard sinus rinse | Swansea University | University Hospital of Wales | Recruiting | 18 Years | N/A | All | 40 | N/A | United Kingdom |
| 248 | EUCTR2018-000185-11-GR (EUCTR) | 20/12/2018 | 28/11/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 249 | EUCTR2015-004143-39-IT (EUCTR) | 19/12/2018 | 20/09/2018 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy | ||
| 250 | EUCTR2015-002743-33-NL (EUCTR) | 14/12/2018 | 18/07/2018 | A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM | Zambon S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Netherlands;Germany;New Zealand | ||
| 251 | NCT03647228 (ClinicalTrials.gov) | December 13, 2018 | 23/8/2018 | A Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of IONIS-ENaCRx in Healthy Volunteers and Patients With Cystic Fibrosis | A Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2a Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of ION-827359, an Antisense Oligonucleotide Inhibitor of ENaC, Administered to Healthy Volunteers and Patients With Cystic Fibrosis | Healthy Subjects;Cystic Fibrosis | Drug: IONIS-ENaCRx;Drug: Placebo | Ionis Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 50 Years | All | 98 | Phase 1 | Germany;United Kingdom |
| 252 | NCT03669614 (ClinicalTrials.gov) | December 7, 2018 | 30/8/2018 | SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects | A Phase 1/2a Randomized, Double-Blind, Two-Part, Dose-Ascending, Multicenter Study of the Safety and PK of AR-501 (Gallium Citrate), Administered Via Inhalation, in Healthy Adult and P. Aeruginosa Infected Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: Inhaled AR-501;Drug: Inhaled Placebo | Aridis Pharmaceuticals, Inc. | NULL | Recruiting | 18 Years | 49 Years | All | 90 | Phase 1/Phase 2 | United States |
| 253 | NCT02323100 (ClinicalTrials.gov) | December 2, 2018 | 18/12/2014 | Glycerol Phenylbutyrate Corrector Therapy For CF (Cystic Fibrosis) | A Double Blind, Placebo Controlled, Dose Escalation Trial of Glycerol Phenylbutyrate Corrector Therapy for Cystic Fibrosis | Cystic Fibrosis | Drug: Ravicti low dose;Drug: Ravicti high dose;Drug: Placebo | National Jewish Health | University of Alabama at Birmingham;Children's Hospital of Philadelphia;Johns Hopkins University;Horizon Pharma Ireland, Ltd., Dublin Ireland | Recruiting | 18 Years | N/A | All | 36 | Phase 1/Phase 2 | United States |
| 254 | NCT03624101 (ClinicalTrials.gov) | December 1, 2018 | 7/8/2018 | Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations | Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon Mutations | Cystic Fibrosis | Drug: Trikafta;Drug: symdeko/Trikafta;Drug: Ivacaftor/Trikafta | University of Alabama at Birmingham | NULL | Completed | 18 Years | N/A | All | 1 | Phase 4 | United States |
| 255 | EUCTR2015-002743-33-GR (EUCTR) | 27/11/2018 | 14/11/2018 | A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM | Zambon S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | New Zealand;Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands | ||
| 256 | EUCTR2017-003723-29-CZ (EUCTR) | 27/11/2018 | 09/07/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 257 | NCT03756922 (ClinicalTrials.gov) | November 27, 2018 | 27/11/2018 | A DDI Study of FDL169 and FDL176 in Healthy Subjects | A Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: FDL169;Drug: FDL176 | Flatley Discovery Lab LLC | NULL | Suspended | 18 Years | 55 Years | All | 78 | Phase 1/Phase 2 | United Kingdom |
| 258 | EUCTR2017-003723-29-PT (EUCTR) | 19/11/2018 | 21/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden;Canada;Hungary;Czech Republic;France | ||
| 259 | EUCTR2018-000243-87-GB (EUCTR) | 19/11/2018 | 21/08/2018 | A study in people with cystic fibrosis who have a fungal lung infection, looking at the safety of inhaled PC945, it's effect on the body and how the body affects the drug. | An open-label study to assess the safety, pharmacokinetics and pharmacodynamics of inhaled PC945 in adult Cystic Fibrosis (CF) patients with persistent pulmonary Aspergillus fumigatus infection. | Pulmonary aspergillosis MedDRA version: 20.0;Level: LLT;Classification code 10059259;Term: Pulmonary aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: PC945 | Pulmocide Ltd | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | United Kingdom | ||
| 260 | EUCTR2017-003723-29-DE (EUCTR) | 19/11/2018 | 14/02/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 261 | EUCTR2018-000185-11-NL (EUCTR) | 14/11/2018 | 19/09/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trifakta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 262 | EUCTR2017-003319-21-BE (EUCTR) | 08/11/2018 | 21/08/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | United States;France;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 263 | NCT03748199 (ClinicalTrials.gov) | November 8, 2018 | 5/11/2018 | Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CF | Phase-Ib/IIa Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Inhaled Multiple Doses of POL6014 in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: POL6014;Drug: Placebo | Santhera Pharmaceuticals | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1/Phase 2 | Germany |
| 264 | NCT03617718 (ClinicalTrials.gov) | November 1, 2018 | 19/7/2018 | Project 2 Airway Potential Hydrogen (pH) in Asthma | Methods to Identify and Treat Severe Asthma Patients Project 2: Airway pH Phenotyping | Cystic Fibrosis;Asthma;Severe Persistent Asthma;Healthy | Drug: Glycine Buffer | University Hospitals Cleveland Medical Center | National Institutes of Health (NIH) | Recruiting | 18 Years | 50 Years | All | 75 | Phase 1/Phase 2 | United States |
| 265 | EUCTR2017-002968-40-PL (EUCTR) | 31/10/2018 | 29/06/2018 | A Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in subjects with cistic fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation - Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 266 | EUCTR2018-000185-11-GB (EUCTR) | 19/10/2018 | 04/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 267 | EUCTR2017-003723-29-GR (EUCTR) | 15/10/2018 | 08/08/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 268 | EUCTR2018-000185-11-CZ (EUCTR) | 15/10/2018 | 09/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 269 | NCT03265288 (ClinicalTrials.gov) | October 10, 2018 | 21/2/2017 | Study of LAU-7b in the Treatment of Cystic Fibrosis in Adults | APPLAUD: A Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Efficacy and Safety of LAU-7b in the Treatment of Cystic Fibrosis in Adults | Cystic Fibrosis | Drug: LAU-7b;Drug: Placebo oral capsule | Laurent Pharmaceuticals Inc. | Cystic Fibrosis Foundation | Completed | 18 Years | N/A | All | 166 | Phase 2 | United States;Australia;Canada |
| 270 | NCT03525574 (ClinicalTrials.gov) | October 9, 2018 | 2/5/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis | Drug: VX-445;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 507 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom |
| 271 | EUCTR2018-000185-11-IT (EUCTR) | 04/10/2018 | 22/01/2021 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation - NA | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX/50 mg TEZ /75 mg IVA FDC Product Code: [ELX/TEZ/IVA] INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: IVACAFTOR | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 272 | NCT03691779 (ClinicalTrials.gov) | October 2, 2018 | 28/9/2018 | Evaluation of VX 445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age | Cystic Fibrosis | Drug: VX-445;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 66 | Phase 3 | United States;Australia;Ireland;United Kingdom |
| 273 | NCT03956589 (ClinicalTrials.gov) | October 1, 2018 | 2/5/2019 | Functional Respiratory Imaging and Orkambi in CF | Functional Respiratory Imaging (FRI) to Assess the Short-term Effect of the Product ORKAMBI (Lumacaftor/ Ivacaftor) on Lung Function in ORKAMBInaive Patients With Cystic Fibrosis Homozygous for Phe508del | Cystic Fibrosis | Drug: Orkambi | University Hospital, Antwerp | NULL | Terminated | 12 Years | N/A | All | 12 | Phase 4 | Belgium |
| 274 | EUCTR2018-000183-28-GR (EUCTR) | 01/10/2018 | 25/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 275 | EUCTR2018-000183-28-CZ (EUCTR) | 01/10/2018 | 09/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 276 | EUCTR2018-000184-89-GB (EUCTR) | 27/09/2018 | 04/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F). | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Product Name: 100 mg TEZ/150 mg IVA FDC Product Code: TEZ/IVA INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Belgium;Netherlands;United Kingdom | ||
| 277 | EUCTR2018-000183-28-GB (EUCTR) | 27/09/2018 | 04/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 278 | EUCTR2016-004479-35-PL (EUCTR) | 26/09/2018 | 17/05/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation - A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic F | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 279 | EUCTR2017-004134-29-PL (EUCTR) | 24/09/2018 | 13/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 280 | EUCTR2017-003723-29-BG (EUCTR) | 21/09/2018 | 08/05/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 281 | EUCTR2018-000183-28-DE (EUCTR) | 20/09/2018 | 03/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 282 | EUCTR2018-000183-28-IT (EUCTR) | 17/09/2018 | 09/02/2021 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - NA | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: [VX-445/TEZ/IVA] INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: [VX-770] INN or Proposed INN: Ivacaftor | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 283 | EUCTR2018-000184-89-NL (EUCTR) | 12/09/2018 | 16/08/2018 | A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F). | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Product Name: 100 mg TEZ/150 mg IVA FDC Product Code: TEZ/IVA INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belgium;Netherlands;United Kingdom | ||
| 284 | EUCTR2018-002550-71-DE (EUCTR) | 12/09/2018 | 18/07/2018 | A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis | Phase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: POL6014 INN or Proposed INN: lonodelestat Other descriptive name: CYCLO[L-ALANYL-L-SERYL-L-ISOLEUCYL-L-PROLYL-L-PROLYL-L-GLUTAMINYL-L-LYSYL-L-TYROSYL-D-PROLYL-L-PROLYL-(2S)-2-AMINODECANOYL-L-ALPHA-GLUTAMYL-L-THREONYL] | Santhera Pharmaceuticals (Switzerland) Ltd | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 1;Phase 2 | Germany | ||
| 285 | EUCTR2017-003723-29-IT (EUCTR) | 11/09/2018 | 12/02/2021 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: [JBT-101] Other descriptive name: Lenabasum Product Name: Lenabasum Product Code: [JBT-101] Other descriptive name: Lenabasum | CORBUS PHARMACEUTICALS, INC | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden | ||
| 286 | EUCTR2018-000183-28-BE (EUCTR) | 07/09/2018 | 09/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 287 | EUCTR2018-000185-11-BE (EUCTR) | 07/09/2018 | 17/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX /50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 288 | EUCTR2018-000184-89-BE (EUCTR) | 07/09/2018 | 09/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F). | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor Product Name: 100 mg TEZ/150 mg IVA FDC Product Code: TEZ/IVA INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Belgium;Netherlands;United Kingdom | ||
| 289 | EUCTR2018-000183-28-NL (EUCTR) | 03/09/2018 | 18/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 290 | NCT04966897 (ClinicalTrials.gov) | August 31, 2018 | 8/7/2021 | Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis | Randomized, Double-blind, Cross-over Trial Assessing a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Dietary Supplement: GlycosBio Nutritional Supplement + PERT placebo;Dietary Supplement: Standard Nutritional Supplement + PERT | GlycosBio, Inc. | Baylor College of Medicine | Completed | 12 Years | N/A | All | 10 | N/A | United States |
| 291 | EUCTR2017-004134-29-DK (EUCTR) | 29/08/2018 | 03/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 292 | EUCTR2017-002533-32-DK (EUCTR) | 28/08/2018 | 09/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 293 | EUCTR2018-000183-28-SE (EUCTR) | 27/08/2018 | 29/06/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 294 | EUCTR2018-002579-16-SE (EUCTR) | 26/08/2018 | 16/07/2018 | Measurement of the posaconazole concentration in exhaled breath in CF patients after a single dose posaconazole to correlate to the concentration in blood and saliva. | Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus spp. related lung-disease. Part 1. Pharmacokinetic single center study. | Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene on chromosome seven, which encodes a chloride channel. In the lung defective channel activity leads to thick, viscous secretion and impaired mucociliary clearance. This causes trapping of mucus, colonization with bacteria and fungi, and a persistent inflammatory response. MedDRA version: 20.0;Level: PT;Classification code 10074549;Term: Cystic fibrosis respiratory infection suppression;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Noxafil® | Karolinska University Hospital, Stockholm CF center | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 2 | Sweden | ||
| 295 | EUCTR2018-000183-28-AT (EUCTR) | 24/08/2018 | 20/07/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 296 | EUCTR2018-002366-39-GB (EUCTR) | 23/08/2018 | 20/06/2019 | A pilot trial of intravenous iron for the treatment of low iron levels in adult patients with cystic fibrosis. | A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis - Intravenous iron in adults with cystic fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Ferinject Product Name: Ferinject INN or Proposed INN: Ferric carboxymaltose | University of Oxford / Clinical Trials and Research Governance | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 297 | NCT03601637 (ClinicalTrials.gov) | August 23, 2018 | 18/7/2018 | Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del | A Phase 3, 2-part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor in Subjects 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis | Drug: LUM;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Months | 23 Months | All | 60 | Phase 3 | United States;Canada |
| 298 | EUCTR2017-004134-29-GB (EUCTR) | 22/08/2018 | 23/02/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom | ||
| 299 | NCT03591094 (ClinicalTrials.gov) | August 21, 2018 | 6/7/2018 | Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Effect of PTI-428 in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: PTI-428;Drug: Placebo | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 40 | Phase 2 | United States |
| 300 | NCT03625466 (ClinicalTrials.gov) | August 10, 2018 | 7/8/2018 | A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double-blind, Placebo-controlled Study With a Long-term, Open-label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis | Drug: LUM;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 2 Years | 5 Years | All | 51 | Phase 2 | Germany |
| 301 | EUCTR2016-004479-35-FR (EUCTR) | 08/08/2018 | 04/06/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 302 | NCT03551691 (ClinicalTrials.gov) | August 7, 2018 | 29/5/2018 | PPIs and Fat Absorption in CF and EPI | Proton Pump Inhibitors and Fat Absorption in Subjects With Cystic Fibrosis and Pancreatic Insufficiency | Pancreatic Insufficiency;Cystic Fibrosis | Drug: Omeprazole 40mg Capsule;Drug: Placebo oral capsule | Children's Hospital of Philadelphia | Chiesi USA, Inc. | Active, not recruiting | 12 Years | N/A | All | 16 | Phase 2 | United States |
| 303 | NCT03633526 (ClinicalTrials.gov) | August 3, 2018 | 27/7/2018 | Evaluation of VX-659/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years of Age | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-659/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age | Cystic Fibrosis | Drug: VX-659/TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 6 Years | 11 Years | All | 18 | Phase 3 | United States |
| 304 | NCT03525548 (ClinicalTrials.gov) | August 3, 2018 | 2/5/2018 | A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | Cystic Fibrosis | Drug: VX-445/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 113 | Phase 3 | United States;Belgium;Netherlands;United Kingdom |
| 305 | NCT03655249 (ClinicalTrials.gov) | August 1, 2018 | 28/8/2018 | Effects of AD on VI in Patients With CF | Effects of Autogenic Drainage on Ventilation Inhomogeneity in Patients With Cystic Fibrosis | Cystic Fibrosis | Other: Autogenic drainage;Drug: Aerosoltherapy | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Recruiting | 6 Years | N/A | All | 30 | N/A | Belgium |
| 306 | NCT03593434 (ClinicalTrials.gov) | July 30, 2018 | 28/6/2018 | Airway Clearance Therapy on Hyperpolarized 129Xenon and MRI | The Effect of Airway Clearance Therapy on Hyperpolarized 129Xenon MRI Compared With Lung Clearance Index and Spirometry in Cystic Fibrosis | Cystic Fibrosis | Drug: hyperpolarized Xenon gas | Children's Hospital Medical Center, Cincinnati | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 6 Years | 21 Years | All | 20 | United States | |
| 307 | EUCTR2017-003319-21-DE (EUCTR) | 20/07/2018 | 09/04/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | United States;France;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 308 | NCT03447262 (ClinicalTrials.gov) | July 13, 2018 | 21/2/2018 | A Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long Term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis | Drug: VX-659;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 484 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom |
| 309 | NCT03565692 (ClinicalTrials.gov) | July 1, 2018 | 31/5/2018 | Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor | Lum-Iva-biota: Exploring the Respiratory Mycobiota and Microbiota Profile in French CF Patients Taking Lumacaftor-Ivacaftor | Cystic Fibrosis | Biological: the lung mycobiota and microbiota profile;Biological: the gut mycobiota and microbiota profile | University Hospital, Bordeaux | Societe Francaise de la Mucoviscidose | Recruiting | 2 Years | N/A | All | 250 | France | |
| 310 | NCT04732910 (ClinicalTrials.gov) | July 1, 2018 | 25/1/2021 | Cystic Fibrosis Transmembrane Regulator (CFTR) Biomarker Study to Evaluate the Rescue of Mutant CFTR in Patients With Cystic Fibrosis Treated With CFTR-modulators | CFTR Biomarker Studie Bei Patient*Innen Mit Mukoviszidose Und CFTR-Modulatortherapie | Cystic Fibrosis | Drug: Treatment with cystic fibrosis transmembrane regulator (CFTR) modualtors Ivacaftor, Lumacaftor-Ivacaftor, Tezacaftor-Ivacaftor, Elexacaftor-Tezacaftor-Ivacaftor | Charite University, Berlin, Germany | Hannover Medical School;Heidelberg University;University of Giessen | Recruiting | 6 Months | N/A | All | 90 | Germany | |
| 311 | EUCTR2017-002968-40-GB (EUCTR) | 28/06/2018 | 07/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom | ||
| 312 | EUCTR2017-002968-40-DK (EUCTR) | 28/06/2018 | 24/06/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland | ||
| 313 | EUCTR2017-003723-29-BE (EUCTR) | 27/06/2018 | 29/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 314 | EUCTR2017-003761-99-DE (EUCTR) | 27/06/2018 | 19/02/2018 | A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | An Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Orkambi 100 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Germany | ||
| 315 | EUCTR2016-004479-35-BE (EUCTR) | 26/06/2018 | 30/03/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 316 | EUCTR2017-002968-40-BE (EUCTR) | 26/06/2018 | 30/03/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 317 | NCT03502070 (ClinicalTrials.gov) | June 26, 2018 | 29/3/2018 | Human Factors Study to Validate the User Interface of TOBI Podhaler Using Placebo Capsules | A Multicenter, Human Factors Validation Study in Cystic Fibrosis Patients Aged 6 Years and Older to Evaluate the User Interface of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules | Cystic Fibrosis | Drug: Placebo;Device: Tobi Podhaler | Mylan Inc. | NULL | Completed | 6 Years | N/A | All | 47 | Phase 4 | United States |
| 318 | EUCTR2016-004479-35-DE (EUCTR) | 26/06/2018 | 06/04/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 319 | EUCTR2018-000098-61-GB (EUCTR) | 22/06/2018 | 01/06/2018 | A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in adult patients with cystic fibrosis | A Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG3067 Product Code: G914167 INN or Proposed INN: Not applicable Other descriptive name: GLPG3067 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 144 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;France;United States;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;New Zealand;United Kingdom | ||
| 320 | NCT04278040 (ClinicalTrials.gov) | June 20, 2018 | 7/2/2020 | Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis Bronchiectasis | Safety, Tolerability and Efficacy of Ultra-low Doses of Alkylating Drug Melphalan Inhalations for the Treatment of Non-cystic Fibrosis Bronchiectasis | Non-cystic Fibrosis Bronchiectasis | Drug: Melphalan | Federal State Budgetary Institution, Pulmonology Scientific Research Institute | Moscow State University of Medicine and Dentistry | Recruiting | 18 Years | 70 Years | All | 7 | Phase 2 | Russian Federation |
| 321 | NCT03525444 (ClinicalTrials.gov) | June 15, 2018 | 2/5/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: VX-445/TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 405 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom |
| 322 | EUCTR2018-001573-24-BE (EUCTR) | 11/06/2018 | 08/05/2018 | Evaluation of the short-term effect of ORKAMBI on lung function in patients with cystic fibrosis who have two copies of the F508del mutation using functional respiratory imaging | Functional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaftor/ ivacaftor) on lung function in ORKAMBI-naive patients with Cystic Fibrosis Homozygous for Phe508del. | Cystic Fibrosis Homozygous (homozygous for the F508del mutation) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Orkambi INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Antwerp University Hospital | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 4 | Belgium | ||
| 323 | EUCTR2017-003723-29-SE (EUCTR) | 07/06/2018 | 01/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 324 | EUCTR2017-003319-21-GB (EUCTR) | 04/06/2018 | 03/07/2018 | Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | A Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide Product Code: PTI-808 INN or Proposed INN: None Other descriptive name: PTI-808 Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca Product Code: PTI-801 INN or Proposed INN: None Other descriptive name: PTI-801 Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 INN or Proposed INN: None Other descriptive name: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 1;Phase 2 | France;United States;Canada;Belgium;Denmark;Germany;United Kingdom | ||
| 325 | NCT03540524 (ClinicalTrials.gov) | May 31, 2018 | 27/4/2018 | A Study Looking at the Safety, Tolerability and Efficacy of the Combination of the Study Drugs GLPG2451 and GLPG2222 With or Without GLPG2737 in Patients With Cystic Fibrosis. | Assessment of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Oral Doses of the Combination of GLPG2451 and GLPG2222, With or Without GLPG2737, in Adult Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: GLPG2451 dose regimen A;Drug: GLPG2451 dose regimen B;Drug: GLPG2222;Drug: GLPG2737 | Galapagos NV | NULL | Completed | 18 Years | N/A | All | 10 | Phase 1 | Belgium;Bulgaria;Germany;Greece;Netherlands;Serbia;Sweden;United Kingdom |
| 326 | EUCTR2016-001440-18-NL (EUCTR) | 30/05/2018 | 16/01/2018 | The influence of cytochrome P450 3A4 inhibitors on serum levels of Ivacaftor in cystic fibrosis patients and healthy subjects. | Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACI | cystic fibrosis and healthy subjects;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Ivacaftor Trade Name: claritromycin 500mg film coated tablets Product Name: Claritromycin Trade Name: Azithromycin 500 mg film-coated tablet Product Name: azithromycin Trade Name: Norvir 100 mg film-coated tablets Product Name: Norvir | university medical center utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 12 | Phase 4 | Netherlands | ||
| 327 | NCT03482960 (ClinicalTrials.gov) | May 29, 2018 | 23/3/2018 | Comparison of 129Xe MRI With 19F MRI in CF Lung Disease | Comparison of 129Xe MRI With 19F MRI in CF Lung Disease | Cystic Fibrosis | Drug: Hyperpolarized Xenon gas;Drug: PFP | University of North Carolina, Chapel Hill | Cystic Fibrosis Foundation | Completed | 18 Years | N/A | All | 11 | Early Phase 1 | United States |
| 328 | EUCTR2017-003723-29-ES (EUCTR) | 21/05/2018 | 09/04/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden | ||
| 329 | EUCTR2017-004134-29-ES (EUCTR) | 18/05/2018 | 21/03/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 330 | EUCTR2017-004132-11-ES (EUCTR) | 18/05/2018 | 05/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 331 | EUCTR2017-004133-82-ES (EUCTR) | 18/05/2018 | 15/03/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United Kingdom;Germany;Australia;Ireland;Spain;United States | ||
| 332 | NCT03462056 (ClinicalTrials.gov) | May 17, 2018 | 5/3/2018 | Ready to Use Therapeutic Food (RUTF) to Promote Growth in Cystic Fibrosis | Pilot Study of Ready to Use Therapeutic Food to Promote Weight Gain in Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Cystic Fibrosis Ready to Use Supplemental Food | Washington University School of Medicine | Cystic Fibrosis Foundation | Completed | 2 Years | 12 Years | All | 16 | Phase 1/Phase 2 | United States |
| 333 | EUCTR2017-003723-29-AT (EUCTR) | 17/05/2018 | 28/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 334 | NCT03559062 (ClinicalTrials.gov) | May 17, 2018 | 5/6/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 Through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 67 | Phase 3 | Australia;Belgium;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom |
| 335 | EUCTR2017-004134-29-IE (EUCTR) | 15/05/2018 | 05/03/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/ TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 460 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 336 | EUCTR2017-003723-29-GB (EUCTR) | 11/05/2018 | 05/02/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: LENABASUM Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 337 | NCT03375047 (ClinicalTrials.gov) | May 10, 2018 | 7/9/2017 | Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis | A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled, Combined Single and Multiple Ascending Dose Study Evaluating the Safety, Tolerability, and Biological Activity of MRT5005 Administered by Nebulization to Adult Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: MRT5005;Drug: Normal saline | Translate Bio, Inc. | NULL | Recruiting | 18 Years | N/A | All | 40 | Phase 1/Phase 2 | United States |
| 338 | NCT03428334 (ClinicalTrials.gov) | May 10, 2018 | 26/1/2018 | Roflumilast in Non-CF Bronchiectasis Study | A 4-week Single-arm Study of Roflumilast in Stable-state Non-cystic Fibrosis Bronchiectasis | Non-cystic Fibrosis Bronchiectasis | Drug: Oral roflumilast | The University of Hong Kong | NULL | Completed | 18 Years | N/A | All | 20 | Phase 2 | Hong Kong |
| 339 | EUCTR2016-002749-42-NL (EUCTR) | 09/05/2018 | 29/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Netherlands;Germany | ||
| 340 | NCT03579173 (ClinicalTrials.gov) | May 8, 2018 | 25/6/2018 | Determinants of Early Cystic Fibrosis Lung Disease | Determinants of Early Cystic Fibrosis Lung Disease | Cystic Fibrosis in Children | Diagnostic Test: Infant PFT;Diagnostic Test: Lung Clearance Index;Diagnostic Test: Passive tidal breathing | Indiana University | NULL | Active, not recruiting | 1 Month | 5 Years | All | 55 | United States | |
| 341 | EUCTR2017-004132-11-DK (EUCTR) | 08/05/2018 | 02/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 342 | EUCTR2017-004133-82-GB (EUCTR) | 02/05/2018 | 14/06/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Australia;Germany;United Kingdom | ||
| 343 | EUCTR2017-004132-11-GB (EUCTR) | 02/05/2018 | 23/02/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom | ||
| 344 | EUCTR2017-004133-82-IE (EUCTR) | 01/05/2018 | 05/03/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ireland;Australia;Germany;United Kingdom | ||
| 345 | NCT03460990 (ClinicalTrials.gov) | May 1, 2018 | 1/3/2018 | A Study of VX-659 Combination Therapy in CF Subjects Homozygous for F508del (F/F) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | Cystic Fibrosis | Drug: VX-659/TEZ/IVA;Drug: TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 116 | Phase 3 | United States;Australia;Germany;Ireland;Spain;United Kingdom |
| 346 | EUCTR2017-004132-11-IE (EUCTR) | 01/05/2018 | 05/03/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | ||
| 347 | NCT03522831 (ClinicalTrials.gov) | May 1, 2018 | 19/3/2018 | CF Bronchodilation | A Double-blind Placebo-controlled Crossover Study to Assess the Effects of Bronchodilation on Dyspnea, Ventilatory Responses, and Exercise Tolerance in Adults With Cystic Fibrosis | Lung Diseases;Cystic Fibrosis | Drug: Salbutamol;Drug: Placebo | University of British Columbia | NULL | Recruiting | 19 Years | N/A | All | 20 | N/A | Canada |
| 348 | EUCTR2017-002968-40-IE (EUCTR) | 27/04/2018 | 08/03/2018 | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||
| 349 | EUCTR2017-002533-32-NL (EUCTR) | 26/04/2018 | 29/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of | ||
| 350 | EUCTR2017-003723-29-SK (EUCTR) | 26/04/2018 | 23/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden | ||
| 351 | NCT03492567 (ClinicalTrials.gov) | April 25, 2018 | 3/4/2018 | Study of Circulating Blood Cell Monocytes as Predictive Biomarker of Bone Cystic Fibrosis Disease. Impact of CFTR Correctors. | Study of Circulating Monocytes as Predictive Biomarker of Osteoclastogenesis in Cystic Fibrosis-related Bone Loss. Impact of CFTR Correctors. | Cystic Fibrosis | Biological: Blood test | Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose | Completed | 18 Years | N/A | All | 25 | N/A | France |
| 352 | EUCTR2017-004132-11-DE (EUCTR) | 25/04/2018 | 27/02/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Germany;United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;United Kingdom;Switzerland | ||
| 353 | NCT03537651 (ClinicalTrials.gov) | April 25, 2018 | 15/5/2018 | A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR Mutation | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 6 Years | N/A | All | 130 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom |
| 354 | EUCTR2016-004479-35-GB (EUCTR) | 24/04/2018 | 26/04/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom | ||
| 355 | EUCTR2016-004479-35-DK (EUCTR) | 18/04/2018 | 22/02/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland | ||
| 356 | EUCTR2017-003723-29-HU (EUCTR) | 16/04/2018 | 27/02/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | ||
| 357 | NCT03527095 (ClinicalTrials.gov) | April 5, 2018 | 4/5/2018 | A Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects | A Phase 1, Open-label, Randomised, Cross Over Study to Compare the Pharmacokinetics of Different Oral Formulations of FDL169 in Healthy Subjects Following Single Doses | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom |
| 358 | NCT03489629 (ClinicalTrials.gov) | April 3, 2018 | 29/3/2018 | STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) | STaph Aureus Resistance-Treat Early and Repeat (STAR-TER) | Cystic Fibrosis | Drug: Trimethoprim Sulfamethoxazole (TMP/SMX);Drug: Minocycline;Drug: Mupirocin;Drug: Chlorhexidine Gluconate;Behavioral: Environmental Decontamination | University of North Carolina, Chapel Hill | University of Washington;Cook Children's Medical Center;Indiana University;University of Michigan;University of Texas Southwestern Medical Center;St. Louis Children's Hospital | Recruiting | 2 Years | 45 Years | All | 42 | Phase 2 | United States |
| 359 | EUCTR2017-002533-32-ES (EUCTR) | 29/03/2018 | 22/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 360 | EUCTR2017-002533-32-PL (EUCTR) | 28/03/2018 | 18/01/2018 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Poland;Belgium;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 361 | EUCTR2017-002533-32-BG (EUCTR) | 23/03/2018 | 01/12/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 362 | EUCTR2017-002533-32-GB (EUCTR) | 22/03/2018 | 23/10/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United Kingdom;United States;Spain;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 363 | NCT03768089 (ClinicalTrials.gov) | March 20, 2018 | 5/12/2018 | Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis | A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-121;Drug: TEZ/IVA;Drug: IVA;Drug: Matched Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 114 | Phase 1/Phase 2 | Netherlands;United Kingdom |
| 364 | EUCTR2018-000126-55-NL (EUCTR) | 15/03/2018 | 15/05/2018 | A study to investigate the safety and the movement of the study drug VX-121 around the body in healthy people and patients with cystic fibrosis | A Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121 INN or Proposed INN: Not yet assigned Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 1;Phase 2 | Netherlands | ||
| 365 | EUCTR2017-002533-32-DE (EUCTR) | 15/03/2018 | 03/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Korea, Republic of;Sweden | ||
| 366 | NCT03516331 (ClinicalTrials.gov) | March 7, 2018 | 24/4/2018 | A Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects | A Phase 1, Open Label, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects | Cystic Fibrosis | Drug: FDL176 & FDL169 coadministration | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 16 | Phase 1 | United Kingdom |
| 367 | NCT03447249 (ClinicalTrials.gov) | March 7, 2018 | 21/2/2018 | A Phase 3 Study of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis | Drug: VX-659/TEZ/IVA;Drug: IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 385 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom |
| 368 | NCT03367494 (ClinicalTrials.gov) | March 1, 2018 | 22/11/2017 | A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor | A New Optical Sweat Test Method Based on a Citric Acid-derived Multi-halide Sensor | Cystic Fibrosis | Diagnostic Test: Measurement of Sweat Chloride and Sweat Bromide | Milton S. Hershey Medical Center | NULL | Suspended | 18 Years | N/A | All | 50 | N/A | United States |
| 369 | NCT03421366 (ClinicalTrials.gov) | March 1, 2018 | 27/12/2017 | Modified Release Posaconazole in Patients With Cystic Fibrosis | Modified Release Posaconazole in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Posaconazole | Bayside Health | NULL | Recruiting | 18 Years | N/A | All | 20 | Australia | |
| 370 | NCT04411901 (ClinicalTrials.gov) | March 1, 2018 | 22/5/2020 | The Role of Vitamin D3 in Pediatric Bronchiectasis Severity | The Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis) | Cystic Fibrosis and Non CF Bronchiectasis | Drug: Cholecalciferol (vitaminD3) | Heba Omara | NULL | Completed | 1 Year | 17 Years | All | 40 | Phase 2/Phase 3 | Egypt |
| 371 | NCT03589313 (ClinicalTrials.gov) | February 12, 2018 | 9/7/2018 | Pharmacokinetics of GLPG3067 in Male Subjects With Cystic Fibrosis. | Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG3067 Administered as Solid Formulation in Male Subjects With Cystic Fibrosis. | Cystic Fibrosis | Drug: GLPG3067 single dose | Galapagos NV | NULL | Completed | 18 Years | N/A | Male | 6 | Phase 1 | Belgium |
| 372 | EUCTR2017-002533-32-SE (EUCTR) | 30/01/2018 | 14/11/2017 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis. | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 Product Name: INS1007 INN or Proposed INN: not available Other descriptive name: AZD7986 | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 240 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Spain;United Kingdom;Italy;France;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 373 | NCT03500263 (ClinicalTrials.gov) | January 30, 2018 | 9/4/2018 | Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 1 / 2, Randomized, Double-Blind, Placebo-Controlled Study Designed to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808, PTI-801, and PTI-428 Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: PTI-808;Drug: Placebo;Drug: PTI-801;Drug: PTI-428 | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 12 | Phase 1/Phase 2 | United Kingdom |
| 374 | NCT03460704 (ClinicalTrials.gov) | January 29, 2018 | 14/2/2018 | Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS II) | A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa) | Non Cystic Fibrosis Bronchiectasis | Drug: Colistimethate sodium;Drug: Saline Solution | Zambon SpA | NULL | Active, not recruiting | 18 Years | 90 Years | All | 287 | Phase 3 | United States;Argentina;Australia;Canada;France;Germany;Greece;Israel;Italy;New Zealand;Poland;Portugal |
| 375 | EUCTR2017-002533-32-IT (EUCTR) | 23/01/2018 | 05/11/2020 | A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study - N/A | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: INS1007 Product Code: [N/A] Product Name: INS1007 Product Code: [N/A] | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 240 | Phase 2 | United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of | ||
| 376 | EUCTR2016-002749-42-GR (EUCTR) | 12/01/2018 | 03/10/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 377 | NCT02653027 (ClinicalTrials.gov) | January 1, 2018 | 7/1/2016 | Effect of Lumacaftor-ivacaftor on Glucose Handling and Tolerance in Cystic Fibrosis Phe508del | A Study of the Effect of Combination Lumacaftor and Ivacaftor on Glucose Tolerance in Persons With Cystic Fibrosis Who Are Homozygous for the Phe508del Cystic Fibrosis Transmembrane Conductance Regulator Mutation. | Diabetes;Cystic Fibrosis | Drug: Lumacaftor-ivacaftor;Other: OGTT | Massachusetts General Hospital | NULL | Withdrawn | 18 Years | 65 Years | All | 0 | N/A | NULL |
| 378 | NCT03451045 (ClinicalTrials.gov) | December 22, 2017 | 23/2/2018 | Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis | Cystic Fibrosis | Drug: Lenabasum 20 mg;Drug: Lenabasum 5 mg;Other: Placebo | Corbus Pharmaceuticals Inc. | Cystic Fibrosis Foundation | Completed | 12 Years | N/A | All | 425 | Phase 2 | United States;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;Spain;Sweden;United Kingdom |
| 379 | NCT03424252 (ClinicalTrials.gov) | December 18, 2017 | 31/1/2018 | An Phase 1 Study to Evaluate the Pharmacokinetic (PK) Profile of FDL169 New Formulations in Healthy Subjects | A Phase 1, Open-label, Crossover, Randomised Study to Evaluate the Pharmacokinetic Profile of FDL169 Sublingual Formulations in the Fed State in Healthy Subjects | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom |
| 380 | EUCTR2016-002749-42-DK (EUCTR) | 15/12/2017 | 11/10/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 381 | EUCTR2016-002749-42-FR (EUCTR) | 12/12/2017 | 01/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 382 | NCT03218917 (ClinicalTrials.gov) | December 1, 2017 | 11/7/2017 | Assessment of INS1007 in Subjects With Non-Cystic Fibrosis Bronchiectasis | Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety & Tolerability, and PK of INS1007 Administered Once Daily for 24 Weeks in Subjects With Non-CF Bronchiectasis - The Willow Study | Non-Cystic Fibrosis Bronchiectasis | Drug: INS1007 10 mg oral tablet;Drug: INS1007 25 mg oral tablet;Drug: Placebo Oral Tablet | Insmed Incorporated | NULL | Completed | 18 Years | 85 Years | All | 256 | Phase 2 | United States;Australia;Belgium;Bulgaria;Denmark;Germany;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Singapore;Spain;United Kingdom;Sweden |
| 383 | NCT03474042 (ClinicalTrials.gov) | November 29, 2017 | 15/3/2018 | GLPG2737 on Top of Orkambi in Subjects With Cystic Fibrosis | A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del Mutation | Cystic Fibrosis | Drug: GLPG2737;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | N/A | All | 22 | Phase 2 | Germany |
| 384 | NCT03219164 (ClinicalTrials.gov) | November 28, 2017 | 13/7/2017 | Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa Infection | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects With Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas Aeruginosa (PA) Infection/Colonization | Pseudomonas Aeruginosa Respiratory Tract Infection;Cystic Fibrosis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 3 Months | 18 Years | All | 149 | Phase 3 | United Kingdom;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United States |
| 385 | EUCTR2016-002749-42-IT (EUCTR) | 24/11/2017 | 14/09/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 386 | EUCTR2016-005110-22-DE (EUCTR) | 20/11/2017 | 23/06/2017 | A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis | Phase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: POL6014 | Santhera Pharmaceuticals (Switzerland) Ltd | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 1;Phase 2 | Germany | ||
| 387 | EUCTR2016-005230-30-IT (EUCTR) | 15/11/2017 | 05/11/2020 | A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe. | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SPX-101 Product Code: [SPX-101] INN or Proposed INN: SPX-101 | SPYRYX BIOSCIENCES, INC. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Portugal;France;Canada;Australia;United Kingdom;Italy | ||
| 388 | EUCTR2015-004263-36-DE (EUCTR) | 13/11/2017 | 06/09/2017 | Study to assess the effects of inhaled RPL554 in adults with cystic fibrosis. | A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis. - Study to assess the effects of inhaled RPL554 in patients with cystic fibrosis. | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: RPL554 Product Code: RPL554 INN or Proposed INN: RPL554 Other descriptive name: RPL554 | Verona Pharma plc | NULL | Not Recruiting | Female: yes Male: yes | 10 | Phase 2 | Germany;United Kingdom | ||
| 389 | NCT03206788 (ClinicalTrials.gov) | November 11, 2017 | 29/6/2017 | Losartan and Inflammation in Cystic Fibrosis | Losartan as Anti-inflammatory Therapy to Augment F508del Cystic Fibrosis Transmembrane (CFTR) Recovery | Cystic Fibrosis | Drug: Losartan;Drug: placebo | University of Miami | University of Alabama at Birmingham;Children's Hospital Medical Center, Cincinnati;University of Kansas Medical Center;Cystic Fibrosis Foundation | Terminated | 12 Years | N/A | All | 7 | Phase 2 | United States |
| 390 | EUCTR2017-000540-18-DE (EUCTR) | 08/11/2017 | 13/09/2017 | Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi | Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Germany | ||
| 391 | EUCTR2017-002181-42-DE (EUCTR) | 27/10/2017 | 28/07/2017 | GLPG2737 on top of Orkambi in subjects with cystic fibrosis | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2737 Product Code: G1117337 INN or Proposed INN: Not applicable Other descriptive name: GLPG2737 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 392 | EUCTR2016-002749-42-GB (EUCTR) | 09/10/2017 | 25/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | ||
| 393 | EUCTR2017-000797-11-NL (EUCTR) | 06/10/2017 | 30/05/2017 | A Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Belgium;Australia;Netherlands | ||
| 394 | NCT03309358 (ClinicalTrials.gov) | September 28, 2017 | 5/10/2017 | A Study of the Safety and Tolerability of Inhaled SNSP113 in Healthy Subjects and Subjects With Stable Cystic Fibrosis | A Multiple-Site, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose (SAD) Study to Assess the Safety and Tolerability of Inhaled SNSP113 in Healthy Male Subjects (Part A) and Subjects With Stable Cystic Fibrosis (Part B) | Lung Diseases;Pulmonary Disease;Cystic Fibrosis;Cystic Fibrosis Lung;Cystic Fibrosis Pulmonary Exacerbation;Cystic Fibrosis With Exacerbation;Respiratory Tract Disease;Pulmonary Inflammation;Multi-antibiotic Resistance;Antibiotic Resistant Infection;Lung Infection;Lung Infection Pseudomonal;Lung; Infection, Atypical Mycobacterium;Burkholderia Infections;Burkholderia Cepacia Infection;Lung Inflammation | Drug: Inhaled SNSP113;Drug: Inhaled Placebo | Synspira, Inc. | NULL | Terminated | 18 Years | 50 Years | All | 32 | Phase 1 | United Kingdom |
| 395 | NCT02566044 (ClinicalTrials.gov) | September 27, 2017 | 18/9/2015 | Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic Fibrosis | A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Inhaled QBW276 in Patients With Cystic Fibrosis | Pulmonary Cystic Fibrosis | Other: Placebo;Drug: QBW276 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 16 | Phase 1/Phase 2 | United States;Germany;United Kingdom |
| 396 | EUCTR2016-002749-42-DE (EUCTR) | 22/09/2017 | 02/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 397 | NCT03181932 (ClinicalTrials.gov) | September 20, 2017 | 1/6/2017 | AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis | A Phase III, Randomized, Double-blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients | MRSA;Cystic Fibrosis | Drug: Vancomycin inhalation powder;Drug: Placebo inhalation powder | Savara Inc. | NULL | Completed | 6 Years | N/A | All | 188 | Phase 3 | United States;Canada |
| 398 | EUCTR2017-000571-85-GB (EUCTR) | 19/09/2017 | 11/05/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom | ||
| 399 | EUCTR2016-002749-42-BE (EUCTR) | 18/09/2017 | 24/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 400 | EUCTR2017-000571-85-LT (EUCTR) | 15/09/2017 | 20/07/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123 MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 401 | NCT02769637 (ClinicalTrials.gov) | September 7, 2017 | 10/5/2016 | Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF) | Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: PPI treatment | University of Colorado, Denver | Cystic Fibrosis Foundation | Terminated | 10 Years | 21 Years | All | 2 | United States | |
| 402 | NCT03771313 (ClinicalTrials.gov) | September 1, 2017 | 11/7/2018 | Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis | Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic Fibrosis | Cystic Fibrosis | Drug: Ceftaroline | Children's Hospital Medical Center, Cincinnati | NULL | Active, not recruiting | 2 Years | 21 Years | All | 24 | Phase 4 | United States |
| 403 | NCT04468100 (ClinicalTrials.gov) | August 30, 2017 | 8/7/2020 | Efficacy and Safety of Tigerase® vs. Pulmozyme® in Patients With Cystic Fibrosis | A Multicenter Prospective Randomized Comparative Study of Pharmacokinetics, Clinical Efficacy and Safety of Tigerase® (JSC GENERIUM, Russia) vs. Pulmozyme® (Hoffmann-La Roche, Switzerland) as Part of Complex Therapy in Patients With Cystic Fibrosis | Cystic Fibrosis;Fibrosis | Biological: Tigerase®;Biological: Pulmozyme® | AO GENERIUM | NULL | Completed | 18 Years | N/A | All | 100 | Phase 3 | Russian Federation |
| 404 | EUCTR2017-000797-11-BE (EUCTR) | 28/08/2017 | 15/06/2017 | A Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: VX-445 Other descriptive name: VX-445 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) INN or Proposed INN: VX-561 Other descriptive name: VX-561 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 104 | Phase 2 | United States;Belgium;Australia;Netherlands | ||
| 405 | EUCTR2016-005230-30-PT (EUCTR) | 28/08/2017 | 31/05/2017 | A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe. | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SPX-101 INN or Proposed INN: SPX-101 Product Name: SPX-101 INN or Proposed INN: SPX-101 | Spyryx Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | France;Portugal;Canada;Australia;Italy;United Kingdom | ||
| 406 | EUCTR2015-003040-39-NL (EUCTR) | 28/08/2017 | 23/01/2017 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom;Switzerland | ||
| 407 | NCT03278314 (ClinicalTrials.gov) | August 27, 2017 | 6/9/2017 | Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis | Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: tezacaftor/ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 12 Years | N/A | All | NULL | ||
| 408 | NCT03093714 (ClinicalTrials.gov) | August 23, 2017 | 16/3/2017 | A Study to Evaluate Safety, PK and PD of FDL169 in Cystic Fibrosis Subjects | A Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate Safety, Pharmacokinetics (PK) and Pharmacodynamics(PD) of FDL169 in Cystic Fibrosis (CF) Subjects Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: FDL169;Drug: Placebo | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 85 Years | All | 27 | Phase 1 | Australia;Czechia;Germany;United Kingdom |
| 409 | EUCTR2015-001997-16-IE (EUCTR) | 17/08/2017 | 11/04/2017 | A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Ivacaftor-responsive CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 35 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | ||
| 410 | NCT03277196 (ClinicalTrials.gov) | August 16, 2017 | 6/9/2017 | A Study to Evaluate the Safety of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Cystic Fibrosis | Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Enrolling by invitation | N/A | 24 Months | All | 75 | Phase 3 | United States;Australia;Canada;Germany;Ireland;United Kingdom |
| 411 | EUCTR2016-004558-13-PL (EUCTR) | 14/08/2017 | 30/06/2017 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | United States;Portugal;France;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;New Zealand;Italy | ||
| 412 | EUCTR2016-003585-11-GB (EUCTR) | 10/08/2017 | 10/07/2017 | Study to Evaluate the Safety and Efficacy of VX-659 drug in combination with other drugs in Subjects Aged 18 Years and Older With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659 Product Code: VX-659 INN or Proposed INN: VX-659 Other descriptive name: VX-659 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: TEZACAFTOR Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) INN or Proposed INN: Deuterated Ivacaftor Other descriptive name: VX-561 (CTP-656) | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;Ireland;Israel;United Kingdom | ||
| 413 | NCT03172793 (ClinicalTrials.gov) | August 8, 2017 | 9/5/2017 | Telavancin Pharmacokinetics in Cystic Fibrosis Patients | Pharmacokinetics and Tolerability of Telavancin at Differing Dosing Regimens in Cystic Fibrosis Adults Admitted With Acute Pulmonary Exacerbations | Cystic Fibrosis | Drug: Telavancin Injection | Joseph L. Kuti, PharmD | Cumberland Pharmaceuticals, Inc. | Completed | 18 Years | N/A | All | 18 | Phase 4 | United States |
| 414 | NCT03224351 (ClinicalTrials.gov) | August 8, 2017 | 18/7/2017 | A Study Evaluating the Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: TEZ/IVA;Drug: VX-659;Drug: IVA;Drug: Matched Placebos;Drug: TEZ;Drug: VX-561 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 124 | Phase 2 | United States;Ireland;Israel;United Kingdom |
| 415 | EUCTR2016-002749-42-AT (EUCTR) | 07/08/2017 | 27/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands | ||
| 416 | EUCTR2016-002749-42-ES (EUCTR) | 04/08/2017 | 08/08/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 140 | Phase 3 | France;United States;Greece;Belgium;Spain;Ireland;Austria;Israel;Netherlands;Germany;Italy;United Kingdom | ||
| 417 | EUCTR2017-001379-21-GB (EUCTR) | 01/08/2017 | 20/07/2017 | A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 3 | United Kingdom;Germany;Ireland;Canada;United States | ||
| 418 | NCT03229252 (ClinicalTrials.gov) | August 1, 2017 | 14/7/2017 | An Efficacy and Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | A Randomized, Double-blind, Placebo-controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis (HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness) | Cystic Fibrosis | Drug: Placebo Inhalation Solution;Drug: SPX-101 | Spyryx Biosciences, Inc. | NULL | Completed | 18 Years | 50 Years | All | 91 | Phase 2 | Canada;France;Italy;Portugal;United Kingdom |
| 419 | NCT03258424 (ClinicalTrials.gov) | July 28, 2017 | 18/8/2017 | Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background Therapy | A Phase I, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis. | Cystic Fibrosis | Drug: PTI-428;Drug: Placebo | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 15 | Phase 1 | United Kingdom |
| 420 | EUCTR2016-001214-24-DE (EUCTR) | 27/07/2017 | 10/04/2017 | A Multi-center, Randomized, Placebo-Controlled Phase I/II Study Designed to Assess the Safety, Tolerability, and how the body breaks down the drug PTI-428 in Subjects with Cystic Fibrosis | A Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428 | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: PTI-428 Product Code: PTI-428 | Proteostasis Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 132 | Phase 1;Phase 2 | France;United States;Czech Republic;Canada;Denmark;Germany;Italy;United Kingdom | ||
| 421 | EUCTR2014-004915-35-DE (EUCTR) | 26/07/2017 | 14/10/2015 | Safety and effect of QBW276 in patients with cystic fibrosis | A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: QBW276 300mcg Product Code: QBW276 INN or Proposed INN: Not established Other descriptive name: QBW276 Succinate Product Name: QBW276 1500mcg Product Code: QBW276 INN or Proposed INN: Not established Other descriptive name: QBW276 Succinate | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Germany;United Kingdom | ||
| 422 | NCT02819856 (ClinicalTrials.gov) | July 21, 2017 | 16/6/2016 | SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPI-1005 in Cystic Fibrosis (CF) Patients With Acute Pulmonary Exacerbation (APE) Receiving IV Tobramycin at Risk for Ototoxicity | Ototoxicity | Drug: Placebo;Drug: SPI-1005 Ebselen 200mg Capsule x1;Drug: SPI-1005 Ebselen 200mg Capsule x2;Drug: SPI-1005 Ebselen 200mg Capsule x3 | Sound Pharmaceuticals, Incorporated | Medical University of South Carolina;Cystic Fibrosis Foundation | Enrolling by invitation | 18 Years | N/A | All | 80 | Phase 2 | United States |
| 423 | NCT03068312 (ClinicalTrials.gov) | July 18, 2017 | 24/2/2017 | A Study to Evaluate Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Have a 3849 + 10KB C?T or D1152H CFTR Mutation | A Randomized, Double-blind, Placebo-controlled, Crossover Study to Evaluate the Efficacy of Ivacaftor in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older and Have Either a 3849 + 10KB C?T or D1152H-CFTR Mutation | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | N/A | All | 38 | Phase 3 | Israel |
| 424 | NCT03251092 (ClinicalTrials.gov) | July 17, 2017 | 7/8/2017 | Study Designed to Assess the Safety, Tolerability and PK of PTI-808 in Healthy Volunteers and in Adults With Cystic Fibrosis | A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults With Cystic Fibrosis | Healthy Volunteer - Complete;Cystic Fibrosis - Complete | Drug: PTI-808;Drug: Placebo;Drug: PTI-428;Drug: PTI-801 | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | 99 Years | All | 179 | Phase 1/Phase 2 | United States;Australia;Belgium;Canada;Denmark;France;Germany;New Zealand;United Kingdom |
| 425 | EUCTR2016-005230-30-GB (EUCTR) | 14/07/2017 | 03/05/2017 | A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe. | A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SPX-101 INN or Proposed INN: SPX-101 Product Name: SPX-101 INN or Proposed INN: SPX-101 | Spyryx Biosciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Portugal;France;Canada;Australia;Italy;United Kingdom | ||
| 426 | EUCTR2015-002743-33-PT (EUCTR) | 13/07/2017 | 10/07/2017 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand | ||
| 427 | EUCTR2016-001214-24-DK (EUCTR) | 10/07/2017 | 28/04/2017 | A Multi-center, Randomized, Placebo-Controlled Phase I/II Study Designed to Assess the Safety, Tolerability, and how the body breaks down the drug PTI-428 in Subjects with Cystic Fibrosis | A Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428 | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: PTI-428 Product Code: PTI-428 Product Code: PTI-428 Product Code: PTI-428 | Proteostasis Therapeutics | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 1;Phase 2 | United States;France;Czech Republic;Canada;Denmark;Germany;United Kingdom;Italy | ||
| 428 | NCT03450720 (ClinicalTrials.gov) | June 28, 2017 | 23/2/2018 | Pharmacokinetics of GLPG2737 in Male Subjects With Cystic Fibrosis | Evaluation of the Pharmacokinetics, Safety and Tolerability of a Single Dose of GLPG2737 Administered as Oral Suspension in Male Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: GLPG2737 single dose | Galapagos NV | NULL | Completed | 18 Years | N/A | Male | 6 | Phase 1 | Belgium |
| 429 | NCT03173573 (ClinicalTrials.gov) | June 27, 2017 | 30/5/2017 | A Study to Assess the Safety, Tolerability and PK Profile of FDL176 in Healthy and CF Participants | A Five Part Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetic (PK) Profile of Single and Repeat Oral Doses of FDL176 in Healthy and Cystic Fibrosis (CF) Participants | Cystic Fibrosis | Drug: FDL176;Drug: Placebo | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | All | 109 | Phase 1 | Australia |
| 430 | EUCTR2016-004033-25-ES (EUCTR) | 19/06/2017 | 31/03/2017 | Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis | Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial | Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10074550;Term: Preventive antimicrobial therapy in cystic fibrosis;System Organ Class: 100000004865 MedDRA version: 20.0;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Sodium bicarbonate INN or Proposed INN: Sodium Bicarbonate Other descriptive name: SODIUM BICARBONATE BP Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: sodium chloride INN or Proposed INN: Sodium chloride Other descriptive name: SODIUM CHLORIDE Product Name: Water for injections INN or Proposed INN: water for injections Other descriptive name: WATER FOR INJECTIONS, EP | Fundació Parc Taulí | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Spain | |||
| 431 | EUCTR2017-000571-85-HU (EUCTR) | 15/06/2017 | 13/04/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 432 | NCT03078088 (ClinicalTrials.gov) | June 15, 2017 | 1/3/2017 | Airway Alkalinization and Nasal Colonization | Airway Alkalinization and Nasal Colonization | Healthy Subjects;Cystic Fibrosis | Drug: Tham;Drug: Saline | Lakshmi Durairaj | NULL | Completed | 16 Years | N/A | All | 32 | Phase 1 | United States |
| 433 | NCT03020719 (ClinicalTrials.gov) | June 14, 2017 | 11/1/2017 | The Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis | A Multi Center Placebo Controlled Double Blind Randomized Study Evaluating the Role of Oral Glutathione on Growth Parameters in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Oral Glutathione;Drug: Placebo | University of Minnesota | Cystic Fibrosis Foundation | Completed | 2 Years | 11 Years | All | 60 | Phase 2 | United States |
| 434 | NCT03066453 (ClinicalTrials.gov) | June 13, 2017 | 23/2/2017 | Evaluation of Short Antibiotic Combination Courses Followed by Aerosols in Cystic Fibrosis | Evaluation of an Antibiotic Treatment With 14 Days of Intravenous Tobramycin Versus the Same Antibiotic Associated With 5 Days of Intravenous Tobramycin Followed by Tobramycin Aerosol for 9 Days in Cystic Fibrosis. | Cystic Fibrosis | Drug: Tobi Inhalant Product;Drug: Nebcin | University Hospital, Lille | NULL | Terminated | 8 Years | N/A | All | 23 | Phase 3 | France |
| 435 | NCT03154541 (ClinicalTrials.gov) | June 6, 2017 | 3/5/2017 | SynRinse Irrigation Pilot (SIP) Trial | SynRinse Irrigation Pilot (SIP) Trial | Sinusitis, Chronic;Cystic Fibrosis With Other Manifestations | Drug: Synrinse | University of Washington | NULL | Completed | 18 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
| 436 | NCT03093974 (ClinicalTrials.gov) | June 6, 2017 | 9/3/2017 | Long Term Efficacy and Safety of Inhaled Colistimethate Sodium in Bronchiectasis Subjects With Chronic Pseudomonas Aeruginosa Infection. | A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa) | Non Cystic Fibrosis Bronchiectasis | Drug: Colistimethate Sodium;Drug: Saline Solution | Zambon SpA | NULL | Completed | 18 Years | N/A | All | 377 | Phase 3 | Australia;Belgium;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Portugal;Spain;Switzerland;United Kingdom |
| 437 | EUCTR2017-000571-85-ES (EUCTR) | 01/06/2017 | 21/04/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Poland;Spain;Lithuania;Israel | ||
| 438 | EUCTR2016-004477-40-ES (EUCTR) | 31/05/2017 | 10/03/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 439 | NCT03056989 (ClinicalTrials.gov) | May 31, 2017 | 15/2/2017 | A Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | A Phase 1, Single-Center, Open-Label Safety Study of SPX-101 Inhalation Solution in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: SPX-101 | Spyryx Biosciences, Inc. | NULL | Completed | 18 Years | 50 Years | All | 5 | Phase 1 | Canada |
| 440 | EUCTR2016-004558-13-FR (EUCTR) | 30/05/2017 | 20/03/2017 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Phase 3 | United States;France;Canada;Poland | ||
| 441 | NCT02950805 (ClinicalTrials.gov) | May 30, 2017 | 23/8/2016 | A Study to Assess the Effect of AZD5634 on Mucociliary Clearance, Safety, Tolerability and Pharmacokinetic Parameters in Patients With Cystic Fibrosis | A Phase 1b Randomized Blinded Placebo-Controlled, Cross-Over Study to Assess the Effect of AZD5634 on Mucociliary Clearance as Well as Safety, Tolerability, and Pharmacokinetic Parameters Following Single Inhaled Dose Administration to Patients With Cystic Fibrosis. | Pulmonary/Respiratory Diseases | Drug: Placebo;Drug: AZD5634 | AstraZeneca | Parexel | Completed | 18 Years | 60 Years | All | 9 | Phase 1 | United States |
| 442 | EUCTR2015-002743-33-DE (EUCTR) | 29/05/2017 | 01/03/2017 | A clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Not Recruiting | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand | ||
| 443 | EUCTR2016-004477-40-GB (EUCTR) | 26/05/2017 | 06/02/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 444 | NCT03150719 (ClinicalTrials.gov) | May 24, 2017 | 3/5/2017 | A Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Orkambi® (Lumacaftor/Ivacaftor) -Experienced Subjects With Cystic Fibrosis (CF) | Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del CFTR Mutation | Cystic Fibrosis | Drug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 98 | Phase 3 | United States;France;Germany |
| 445 | NCT03125395 (ClinicalTrials.gov) | May 12, 2017 | 19/4/2017 | A Rollover Safety Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | A Phase 3, Rollover Study to Evaluate the Safety of Long-term Treatment With Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 2 Years | N/A | All | 57 | Phase 3 | United States;Canada |
| 446 | EUCTR2016-004477-40-BE (EUCTR) | 08/05/2017 | 21/02/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United States;Serbia;Spain;Belgium;Netherlands;United Kingdom | ||
| 447 | EUCTR2016-000454-36-NL (EUCTR) | 05/05/2017 | 02/11/2016 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 448 | EUCTR2016-004996-33-ES (EUCTR) | 03/05/2017 | 10/03/2017 | A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del-CFTR Mutation | A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation | Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Orkambi Product Name: Orkambi INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR | Vertex Pharmaceuticals Incoporated | NULL | Not Recruiting | Female: yes Male: yes | 75 | Phase 4 | United States;Canada;Spain;Australia;United Kingdom | ||
| 449 | NCT03070522 (ClinicalTrials.gov) | May 1, 2017 | 8/2/2017 | Prednisone in Cystic Fibrosis Pulmonary Exacerbations | Randomized Controlled Trial of Prednisone in Cystic Fibrosis Pulmonary Exacerbations | Cystic Fibrosis Pulmonary Exacerbation | Drug: Prednisone;Drug: Placebos | The Hospital for Sick Children | Canadian Cystic Fibrosis Foundation | Recruiting | N/A | N/A | All | 84 | Phase 3 | Canada |
| 450 | NCT03051490 (ClinicalTrials.gov) | April 28, 2017 | 9/2/2017 | RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Liprotamase;Drug: porcine PERT | Anthera Pharmaceuticals | NULL | Unknown status | 7 Years | N/A | All | 140 | Phase 3 | United States;Hungary;Israel;Lithuania;Poland;Spain;United Kingdom |
| 451 | EUCTR2015-004143-39-ES (EUCTR) | 19/04/2017 | 31/03/2017 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Hypertonic saline INN or Proposed INN: HYPERTONIC SALINE Other descriptive name: SALINE Product Name: Isotonic saline INN or Proposed INN: ISOTONIC SALINE Other descriptive name: STERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V) | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Denmark;Australia;Netherlands | ||
| 452 | EUCTR2016-004477-40-NL (EUCTR) | 10/04/2017 | 14/02/2017 | A study looking at the safety, tolerability and efficacy of the study drug GLPG2222 in patients with cystic fibrosis who have the F508del CFTR mutation on both alleles | A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | ||
| 453 | NCT03140527 (ClinicalTrials.gov) | April 10, 2017 | 27/4/2017 | Study Assessing the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis | A Multi-Center, Randomized, Placebo-Controlled, Phase 1, Two-Part Study Designed to Assess the Safety, Tolerability, Pharmacokinetics, Food Effect, and Drug-Drug Interactions of PTI-801 in Healthy Volunteers, and Safety, Tolerability, and Pharmacokinetics of PTI-801 in Subjects With Cystic Fibrosis | Healthy Volunteer;Cystic Fibrosis | Drug: PTI-801;Drug: Placebo;Drug: PTI-808 | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 171 | Phase 1 | United States;Canada;Denmark;Germany;Sweden;Portugal |
| 454 | NCT03104855 (ClinicalTrials.gov) | April 3, 2017 | 17/2/2017 | Clearance of 25-hydroxyvitamin D in Cystic Fibrosis | Clearance of 25-hydroxyvitamin D in Cystic Fibrosis | Cystic Fibrosis | Drug: d6-25-hydroxyvitamin D3 | University of Washington | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Active, not recruiting | 18 Years | N/A | All | 10 | Phase 1 | United States |
| 455 | NCT03584841 (ClinicalTrials.gov) | March 31, 2017 | 27/5/2018 | Implementation of a Non-invasive Version of the Imaging ß-adrenergic-dependent Sweat Secretion Test | Implementation of a Non-invasive Version of the Imaging ß-adrenergic-dependent Sweat Secretion Test: Value for Diagnosis and Efficacy of Target Therapies for Cystic Fibrosis | Mucoviscidosis Involving the Lung | Diagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpine | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Recruiting | 18 Years | 100 Years | All | 120 | N/A | Belgium |
| 456 | EUCTR2016-001619-19-NL (EUCTR) | 27/03/2017 | 27/03/2017 | Genistein as an add-on treatment for CF? | Genistein as an add-on treatment for CF? - | Cystic Fibrosis ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Genistein INN or Proposed INN: genistein Other descriptive name: GENISTEIN | UMC Utrecht | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 457 | NCT03119649 (ClinicalTrials.gov) | March 18, 2017 | 11/4/2017 | A Study to Evaluate Multiple Doses of GLPG2222 in Adult Subjects With Cystic Fibrosis | A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate Multiple Doses of GLPG2222 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation | Cystic Fibrosis | Drug: GLPG2222 50 mg;Drug: GLPG2222 100 mg;Drug: Placebo;Drug: GLPG2222 200 mg;Drug: GLPG2222 400 mg | Galapagos NV | NULL | Completed | 18 Years | 99 Years | All | 59 | Phase 2 | United States;Belgium;Netherlands;Serbia;Spain;United Kingdom |
| 458 | NCT03256799 (ClinicalTrials.gov) | March 17, 2017 | 18/8/2017 | Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense Mutations | An Open Label Study to Investigate the Role of Ivacaftor for the Treatment of Cystic Fibrosis in Combination With Ataluren (PTC124) in Cystic Fibrosis Patients Using Ataluren for Nonsense Mutations | Cystic Fibrosis | Drug: Ivacaftor/Ataluren | University of Alabama at Birmingham | NULL | Completed | 19 Years | N/A | All | 1 | Phase 4 | United States |
| 459 | EUCTR2015-002743-33-ES (EUCTR) | 13/03/2017 | 10/02/2017 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 264 | Phase 3 | Portugal;Belgium;Spain;Germany;Italy;United Kingdom | ||
| 460 | NCT02950116 (ClinicalTrials.gov) | March 9, 2017 | 11/10/2016 | Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease | Lung Clearance Index in Pediatric Patients With Obstructive Lung Disease | Asthma;Bronchiectasis;Cystic Fibrosis | Device: Perform three multiple breath nitrogen washout tests (N2-MBW-test) | Universitair Ziekenhuis Brussel | NULL | Terminated | 6 Years | 17 Years | All | 27 | N/A | Belgium |
| 461 | EUCTR2015-002743-33-IT (EUCTR) | 02/03/2017 | 25/01/2021 | A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis 1 | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin/Tadim Product Name: Colistimethate sodium Product Code: [-] INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: - Trade Name: Ventolin¿ Evohaler¿ Product Name: Ventolin Product Code: [Ventolin] INN or Proposed INN: SALBUTAMOL Other descriptive name: Ventolin® Evohaler | ZAMBON SPA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand | ||
| 462 | NCT02498535 (ClinicalTrials.gov) | February 22, 2017 | 12/7/2015 | Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients | Prospective, Randomized, Placebo Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients | Cystic Fibrosis | Drug: Nitric Oxide 160 ppm | Novoteris, LLC | Cystic Fibrosis Foundation;Mallinckrodt | Terminated | 18 Years | N/A | All | 49 | Phase 2 | United States;Canada |
| 463 | EUCTR2015-002743-33-GB (EUCTR) | 21/02/2017 | 13/12/2016 | A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) | A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I | Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin/Tadim Product Name: Colistimethate sodium INN or Proposed INN: COLISTIMETHATE SODIUM Other descriptive name: Colistimethate Sodium | Zambon S.p.A. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 420 | Phase 3 | New Zealand;Netherlands;Germany;Australia;Belgium;France;Switzerland;Italy;United Kingdom;Israel;Spain;Greece;Portugal | ||
| 464 | NCT02888730 (ClinicalTrials.gov) | February 16, 2017 | 22/6/2016 | Tobramycin Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients | Efficacy of Antibiotic (Tobramycin) Delivered by Nebulized Sonic Aerosol for Chronic Rhinosinusitis Treatment of Cystic Fibrosis Patients: A Multicenter Double-blind Randomized Controlled Trial | Cystic Fibrosis;Rhinosinusitis;Lung Diseases | Drug: Tobramycin nebulized nasally;Drug: Physiologic serum nebulized nasally | Virginie ESCABASSE | Henri Mondor University Hospital | Recruiting | 7 Years | N/A | All | 86 | Phase 3 | France |
| 465 | NCT02976519 (ClinicalTrials.gov) | February 15, 2017 | 25/11/2016 | BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects | A Phase Ib, Multicentre, Double Blind, Randomized, Two-part Study, First Part Multiple Rising Dose and Second Part Two-way Cross-over, to Assess Safety, Tolerability, Efficacy and Pharmacokinetics of BI 443651 Compared to Placebo Via Respimat® in Healthy Volunteers and CF Subjects. | Cystic Fibrosis | Drug: BI 443651;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 18 Years | 55 Years | All | 64 | Phase 1 | Germany;United Kingdom |
| 466 | EUCTR2015-004143-39-DK (EUCTR) | 14/02/2017 | 25/10/2016 | Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study | Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Hypertonic saline INN or Proposed INN: sodium chloride 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Australia;Denmark;Netherlands;Italy | ||
| 467 | NCT02712983 (ClinicalTrials.gov) | February 8, 2017 | 5/2/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A Randomized, Blinded, Parallel Group, Multi-center Dose-finding Study, to Assess the Efficacy, Safety and Tolerability of Different Doses of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | Non-cystic Fibrosis Bronchiectasis | Drug: TIP;Drug: TIP and placebo;Drug: Placebo | Novartis Pharmaceuticals | Queen's University Belfast, UK;University Hospital Antwerp, BE;University of Milan, IT;Fundacion Clinic per a la Recerca Biomedica;Erasmus Medical Center;Papworth Hospital Cambridge, UK;Royal Brompton Hospital Trust, UK;University of Dundee;University of Edinburgh, UK | Completed | 18 Years | N/A | All | 107 | Phase 2 | Belgium;France;Germany;Italy;Spain;United Kingdom;Netherlands |
| 468 | NCT02919995 (ClinicalTrials.gov) | February 8, 2017 | 21/9/2016 | A Study of RPL554 in Patients With Cystic Fibrosis | A Phase IIa, Randomised, Double Blind, Placebo Controlled, Three Way Crossover Study to Assess the Pharmacokinetics of RPL554 Administered to Adult Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: RPL554;Drug: Placebo | Verona Pharma plc | Cystic Fibrosis Trust | Completed | 18 Years | N/A | All | 10 | Phase 2 | United Kingdom |
| 469 | NCT03061331 (ClinicalTrials.gov) | January 31, 2017 | 9/2/2017 | Lumacaftor/Ivacaftor Combination Therapy in Subjects With CF Who Have an A455E CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 20 | Phase 2 | Netherlands |
| 470 | NCT03256968 (ClinicalTrials.gov) | January 27, 2017 | 18/8/2017 | PTC Study to Evaluate Ataluren in Combination With Ivacaftor | An Open Label N of 1 Study to Evaluate the Study and Efficacy of Long-Term Treatment With Ivacaftor in Combination With Ataluren (PTC124) in Subjects With Nonsense Mutation Cystic Fibrosis | Cystic Fibrosis | Drug: Ataluren | University of Alabama at Birmingham | NULL | Completed | 6 Years | N/A | All | 1 | Phase 4 | United States |
| 471 | EUCTR2016-000454-36-BE (EUCTR) | 24/01/2017 | 25/10/2016 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | United States;Canada;Spain;Belgium;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 472 | NCT03227471 (ClinicalTrials.gov) | January 23, 2017 | 18/7/2017 | A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis | A Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: IVA;Drug: TEZ/IVA;Drug: VX-445;Drug: Matched Placebo;Drug: TEZ;Drug: VX-561 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 230 | Phase 1/Phase 2 | United States;Australia;Belgium;Netherlands |
| 473 | EUCTR2016-000454-36-ES (EUCTR) | 18/01/2017 | 26/10/2016 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 474 | EUCTR2016-000454-36-IT (EUCTR) | 16/01/2017 | 27/02/2018 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVACAFTOR | VERTEX PHARMACEUTICALS INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 475 | EUCTR2015-003399-58-DK (EUCTR) | 14/01/2017 | 07/01/2016 | Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? | Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? - Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease) | Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin INN or Proposed INN: ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Piperacillin/Tazobactam INN or Proposed INN: piperacillin sodium , tazobactam sodium Other descriptive name: PIPERACILLIN SODIUM | COP:TRIN Region Hovedstaden (Gentofte hospital) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 4 | Denmark | ||
| 476 | EUCTR2015-004986-99-IT (EUCTR) | 11/01/2017 | 06/09/2016 | A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease. | A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (CF) Being Treated for an Exacerbation of CF-associated Lung Disease. | exacerbation of Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: cysteamine bitartrate | NovaBiotics, Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 2 | United States;Netherlands;United Kingdom;Italy | ||
| 477 | EUCTR2016-000454-36-GB (EUCTR) | 10/01/2017 | 07/10/2016 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 198 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 478 | EUCTR2016-002837-31-CZ (EUCTR) | 04/01/2017 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 479 | EUCTR2016-000454-36-DE (EUCTR) | 04/01/2017 | 12/10/2016 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 480 | EUCTR2015-004841-13-CZ (EUCTR) | 04/01/2017 | 10/08/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 481 | NCT02955888 (ClinicalTrials.gov) | January 3, 2017 | 21/10/2016 | Study of Safety, Tolerability & Efficacy in Cystic Fibrosis Patients With Abnormal Glucose Tolerance | A Phase 2, Double-Blind, Placebo Controlled Study to Evaluate the Safety & Tolerability of PBI-4050 and Its Effects on Pancreatic and Pulmonary Function in Cystic Fibrosis Patients With Abnormal Glucose Tolerance | Cystic Fibrosis | Drug: PBI4050;Drug: Placebo | Liminal BioSciences Ltd. | NULL | Terminated | 18 Years | N/A | All | 11 | Phase 2 | Canada |
| 482 | EUCTR2016-000454-36-AT (EUCTR) | 03/01/2017 | 07/10/2016 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Australia;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 483 | NCT02894684 (ClinicalTrials.gov) | January 2017 | 1/9/2016 | Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis | Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis. An Randomised, Crossover Pilot Study of AZLI Plus Intravenous Colistin® Versus Standard Dual Intravenous Therapy | Cystic Fibrosis;Infection;Pseudomonas | Drug: Aztreonam;Drug: Standard Care | Liverpool Heart and Chest Hospital NHS Foundation Trust | University of Liverpool | Completed | 16 Years | 65 Years | Male | 16 | Phase 4 | United Kingdom |
| 484 | NCT02730793 (ClinicalTrials.gov) | January 2017 | 3/11/2015 | Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease | Aztreonam Aerosol to Treat Cystic Fibrosis Nasal Disease | Cystic Fibrosis | Drug: Oral Aztreonam;Drug: Nasal Aztreonam;Drug: Nasal Placebo | Virginia Commonwealth University | Eastern Virginia Medical School | Completed | 7 Years | 100 Years | All | 10 | Phase 2 | United States |
| 485 | NCT02947126 (ClinicalTrials.gov) | January 2017 | 25/10/2016 | Multilevel Models of Therapeutic Response in the Lungs | Multilevel Models of Therapeutic Response in the Lungs | Cystic Fibrosis | Drug: Hypertonic Saline;Drug: Isotonic Saline;Drug: Indium-DTPA;Drug: Technetium Sulfur Colloid | Tim Corcoran | National Heart, Lung, and Blood Institute (NHLBI) | Active, not recruiting | 12 Years | N/A | All | 62 | Phase 1 | United States |
| 486 | NCT03045523 (ClinicalTrials.gov) | January 2017 | 26/1/2017 | A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis | A Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis Harbouring One F508del CFTR Mutation and a Second Gating (Class III) Mutation | Cystic Fibrosis | Drug: GLPG2222 150 mg q.d.;Drug: GLPG2222 300 mg q.d.;Drug: Placebo | Galapagos NV | NULL | Completed | 18 Years | 99 Years | All | 37 | Phase 2 | Australia;Belgium;Czechia;Germany;Ireland;United Kingdom |
| 487 | NCT04623879 (ClinicalTrials.gov) | December 29, 2016 | 12/10/2020 | Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftor on F508del Homozygous Cystic Fibrosis Patients. | Real Life Evaluation of the Multi-organ Effects of Lumacaftor/Ivacaftor on F508del Homozygous Cystic Fibrosis Patients. | Cystic Fibrosis | Drug: Lumacaftor, Ivacaftor Drug Combination | Carmel Medical Center | NULL | Completed | 18 Years | 99 Years | All | 13 | NULL | |
| 488 | EUCTR2016-002837-31-DE (EUCTR) | 29/12/2016 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation - Albatross | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 489 | EUCTR2015-003040-39-BE (EUCTR) | 27/12/2016 | 01/09/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 490 | EUCTR2015-003040-39-DE (EUCTR) | 23/12/2016 | 11/10/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 491 | EUCTR2016-001585-29-NL (EUCTR) | 21/12/2016 | 18/07/2016 | Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Orkambi 200 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Netherlands | ||
| 492 | EUCTR2016-002837-31-BE (EUCTR) | 16/12/2016 | 24/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 493 | EUCTR2015-003040-39-FR (EUCTR) | 16/12/2016 | 21/09/2018 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 494 | EUCTR2015-003040-39-IE (EUCTR) | 16/12/2016 | 16/12/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 495 | NCT03205904 (ClinicalTrials.gov) | December 12, 2016 | 15/6/2017 | Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis. | Nutritional Intervention and Glycemic Improvement in Patients With Pre-diabetic Cystic Fibrosis. | Cystic Fibrosis-related Diabetes;Cystic Fibrosis | Dietary Supplement: Diet | Hospital de Clinicas de Porto Alegre | NULL | Completed | 10 Years | N/A | All | 20 | N/A | Brazil |
| 496 | EUCTR2009-012575-10-SE (EUCTR) | 08/12/2016 | 04/10/2016 | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF | Product Name: Ceftazidime INN or Proposed INN: Ceftazidime Other descriptive name: N/A Product Name: Tobramycin INN or Proposed INN: Tobramycin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A | University Hospitals Bristol NHS Foundation Trust | University of Liverpool | Not Recruiting | Female: yes Male: yes | 260 | Phase 4 | United Kingdom;Sweden | |||
| 497 | EUCTR2015-004263-36-GB (EUCTR) | 07/12/2016 | 30/08/2016 | Study to assess the effects of inhaled RPL554 in adults with cystic fibrosis. | A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis. - To assess the effects of inhaled RPL554 in adults with cystic fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: RPL554 Product Code: RPL554 INN or Proposed INN: RPL554 Other descriptive name: RPL554 | Verona Pharma plc | NULL | Not Recruiting | Female: yes Male: yes | 10 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany;United Kingdom | ||
| 498 | EUCTR2016-002837-31-GB (EUCTR) | 05/12/2016 | 17/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 499 | EUCTR2016-002837-31-IE (EUCTR) | 02/12/2016 | 04/10/2016 | A study looking at the safety and tolerability of the drug GLPG2222 in patients with cystic fibrosis with the F508del CFTR mutation and a second gating (class III) mutation | A phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 Product Name: GLPG2222 Product Code: G957389 INN or Proposed INN: Not Applicable Other descriptive name: GLPG2222 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 500 | NCT03000348 (ClinicalTrials.gov) | December 2016 | 11/12/2016 | A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis Exacerbations | A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients Being Treated for an Exacerbation of CF-associated Lung Disease | Cystic Fibrosis | Drug: Cysteamine;Drug: Placebo Oral Capsule | NovaBiotics Ltd. | Agility Clinical, Inc.;PSR Group B.V. | Completed | 18 Years | N/A | All | 91 | Phase 2 | United States;Italy;United Kingdom |
| 501 | NCT02971839 (ClinicalTrials.gov) | December 2016 | 21/11/2016 | Study to Evaluate the Safety and Efficacy of CTP-656 in Patients With Cystic Fibrosis With CFTR Gating Mutations | A Phase 2, Randomized, Parallel-Group, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of CTP-656 With an Open-Label Active Comparator in Patients With Cystic Fibrosis With CFTR Gating Mutations. | Cystic Fibrosis | Drug: VX-561;Drug: Placebo;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 18 Years | N/A | All | 11 | Phase 2 | United States |
| 502 | EUCTR2015-004143-39-BE (EUCTR) | 30/11/2016 | 13/10/2016 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 19.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Belgium;Denmark;Australia;Netherlands | ||
| 503 | EUCTR2016-000454-36-DK (EUCTR) | 18/11/2016 | 10/10/2016 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-440 INN or Proposed INN: VX-440 Other descriptive name: VX-440 Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor Product Code: VX-661 INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | United States;Canada;Belgium;Spain;Austria;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 504 | EUCTR2016-002832-34-GB (EUCTR) | 11/11/2016 | 03/10/2016 | The use of an inhaled antibiotic called Cayston to treat acute chest infections in people with CF | Aztreonam for inhalation for the treatment of acute exacerbations in cystic fibrosis. An open-label, randomised, cross-over pilot study of AZLI plus intravenous Colistin versus standard dual intravenous therapy. - AZTEC-CF | Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Cayston INN or Proposed INN: Aztreonam Other descriptive name: Cayston | Liverpool Heart & Chest Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 16 | Phase 4 | United Kingdom | ||
| 505 | NCT02759562 (ClinicalTrials.gov) | November 4, 2016 | 29/4/2016 | Effect of Andecaliximab on FEV1 in Adults With Cystic Fibrosis | A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Andecaliximab;Drug: Placebo | Gilead Sciences | NULL | Terminated | 18 Years | N/A | All | 6 | Phase 2 | Australia;France;Germany;Spain;United Kingdom;Belgium;Canada;Ireland;United States |
| 506 | NCT02934698 (ClinicalTrials.gov) | November 1, 2016 | 13/10/2016 | An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations | An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing Mutations | Cystic Fibrosis | Drug: Ivacaftor | Medical University of South Carolina | Vertex Pharmaceuticals Incorporated | Completed | 18 Years | N/A | Female | 2 | Phase 3 | NULL |
| 507 | NCT02951195 (ClinicalTrials.gov) | November 2016 | 26/10/2016 | A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis | A Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-152;Drug: Tezacaftor;Drug: Ivacaftor;Drug: Triple Placebo;Drug: Placebo for VX-152 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 80 | Phase 2 | United States |
| 508 | NCT02953314 (ClinicalTrials.gov) | November 2016 | 18/10/2016 | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF) | A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis | Drug: TEZ;Drug: TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 83 | Phase 3 | United States;Canada |
| 509 | NCT03029455 (ClinicalTrials.gov) | November 2016 | 11/1/2017 | A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic Fibrosis | A Phase 1, Randomized, Double Blind, Placebo Controlled, Dose Escalation, and Bioavailability Study Evaluating the Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: VX-659;Drug: Tezacaftor;Drug: Ivacaftor;Drug: VX-659 Matching Placebo;Drug: Triple Combination (TC) Matching Placebos | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 163 | Phase 1 | United Kingdom |
| 510 | NCT03056326 (ClinicalTrials.gov) | November 2016 | 3/2/2017 | A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects | A Phase I, Randomised, Double-blind, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Inhaled CHF 6333 After Single and Repeated Ascending Doses in Healthy Male Subjects | Non-Cystic Fibrosis Bronchiectasis;Cystic Fibrosis | Drug: CHF6333 (Part 1 - SAD);Drug: Placebo (Part 1 - SAD);Drug: CHF6333 (Part 2 - MAD);Drug: Placebo (Part 2 - MAD) | Chiesi Farmaceutici S.p.A. | NULL | Completed | 18 Years | 55 Years | Male | 72 | Phase 1 | Belgium |
| 511 | NCT02613884 (ClinicalTrials.gov) | November 2016 | 20/11/2015 | Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis | Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic Fibrosis | Vitamin D Deficiency | Drug: Treatment | Johns Hopkins All Children's Hospital | NULL | Completed | 36 Months | 18 Years | All | 30 | Phase 2 | United States |
| 512 | EUCTR2015-004986-99-GB (EUCTR) | 31/10/2016 | 06/09/2016 | A study to identify whether it is safe, if it works, and how much and how often cysteamine should be given to adult patients with Cystic Fibrosis (CF) who are being treated for a worsening of CF associated lung disease. | A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Study Investigating the Optimal Dose Regimen, Efficacy, and Safety of Adding Oral Cysteamine in Adult Patients with Cystic Fibrosis (CF) Being Treated for an Exacerbation of CF-associated Lung Disease. | exacerbation of Cystic Fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: cysteamine bitartrate | NovaBiotics, Ltd | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | United States;Netherlands;Italy;United Kingdom | ||
| 513 | NCT02677701 (ClinicalTrials.gov) | October 21, 2016 | 29/1/2016 | Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With Cystic Fibrosis (CF) | TEACH Trial: Testing the Effect of Adding CHronic Azithromycin to Inhaled Tobramycin. A Randomized, Placebo-controlled, Double-blinded Trial of Azithromycin 500mg Thrice Weekly in Combination With Inhaled Tobramycin | Cystic Fibrosis | Drug: azithromycin;Drug: placebo (for azithromycin);Drug: inhaled tobramycin | Seattle Children's Hospital | National Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating Center | Completed | 12 Years | N/A | All | 119 | Phase 4 | United States |
| 514 | EUCTR2015-003040-39-GB (EUCTR) | 18/10/2016 | 30/01/2017 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;Switzerland;United Kingdom | ||
| 515 | EUCTR2016-002851-92-CZ (EUCTR) | 05/10/2016 | 02/08/2016 | NA | An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Liprotamase INN or Proposed INN: NOT ASSIGNED Other descriptive name: LIPASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: PROTEASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: AMYLASE | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 4 | United States;Hungary;Czech Republic;Canada;Spain;Poland;Israel | ||
| 516 | NCT02951182 (ClinicalTrials.gov) | October 2016 | 26/10/2016 | A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis | Cystic Fibrosis | Drug: TEZ;Drug: IVA;Drug: VX-440;Drug: Matched Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 74 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Denmark;Germany;Italy;Spain;United Kingdom |
| 517 | NCT02934139 (ClinicalTrials.gov) | October 2016 | 10/10/2016 | MAD Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Cavosonstat (N91115) in Healthy Subjects (SNO-9) | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of N91115 in Healthy Subjects | Cystic Fibrosis | Drug: Cavosonstat;Other: Placebo | Nivalis Therapeutics, Inc. | NULL | Completed | 18 Years | 55 Years | All | 32 | Phase 1 | United States |
| 518 | NCT02912637 (ClinicalTrials.gov) | October 2016 | 13/9/2016 | Hyperpolarized Xenon Imaging in Patients With Cystic Fibrosis | Hyperpolarised 129Xe MRI for Non-invasive Assessment of Ventilation, Perfusion and the Alveolar Membrane - a Physiological Study in Healthy Volunteers & Cystic Fibrosis Patients | Cystic Fibrosis | Other: Hyperpolarized Xenon MRI | Papworth Hospital NHS Foundation Trust | University of Sheffield | Suspended | 18 Years | 70 Years | All | 30 | United Kingdom | |
| 519 | EUCTR2015-003040-39-ES (EUCTR) | 29/09/2016 | 30/08/2016 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 19.0;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 520 | EUCTR2016-002851-92-ES (EUCTR) | 19/09/2016 | 08/08/2016 | NA | An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Liprotamasa INN or Proposed INN: SIN ASIGNAR Other descriptive name: LIPASA INN or Proposed INN: SIN ASIGNAR Other descriptive name: PROTEASA INN or Proposed INN: SIN ASIGNAR Other descriptive name: AMILASA | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;Hungary;Canada;Poland;Spain;Israel | ||
| 521 | EUCTR2016-002578-11-GB (EUCTR) | 16/09/2016 | 09/08/2016 | A trial to determine the safest and most effective antibiotic strategy for infants diagnosed with CF. | The cystic fibrosis (CF) anti-staphylococcal antibiotic prophylaxis trial (CF START); a randomised registry trial to assess the safety and efficacy of flucloxacillin as a longterm prophylaxis agent for infants with CF. - CF START | Cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Flucloxacillin 250mg/5ml Sugar-Free Powder for Oral Solution Product Name: Flucloxacillin Product Code: na INN or Proposed INN: Flucloxacillin | Alder Hey Children's NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 480 | Phase 4 | United Kingdom | ||
| 522 | EUCTR2015-003040-39-IT (EUCTR) | 14/09/2016 | 28/09/2018 | Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection | A randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection - Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder i | Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis MedDRA version: 20.1;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.1;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE Product Name: Tobramicina polvere inalatoria Product Code: TBM100 INN or Proposed INN: TOBRAMICINA Other descriptive name: TOBRAMICINA | NOVARTIS PHARMA SERVICES AG | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 2 | France;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 523 | EUCTR2016-002851-92-HU (EUCTR) | 08/09/2016 | 25/07/2016 | NA | An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Liprotamase INN or Proposed INN: NOT ASSIGNED Other descriptive name: LIPASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: PROTEASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: AMYLASE | ANTHERA Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 70 | Phase 3 | United States;Hungary;Canada;Spain;Israel | ||
| 524 | NCT02875366 (ClinicalTrials.gov) | September 2016 | 15/8/2016 | A Study of the Effects of Lumacaftor/Ivacaftor (LUM/IVA) on Exercise Tolerance in Subjects With Cystic Fibrosis (CF), Homozygous for the F508del-CFTR Mutation | A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 70 | Phase 4 | Australia;United Kingdom |
| 525 | NCT02730208 (ClinicalTrials.gov) | September 2016 | 31/3/2016 | A Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | A Phase 2, Randomized, Placebo-Controlled, Double-blind Study to Evaluate the Effect of VX-661 in Combination With Ivacaftor on Chest Imaging Endpoints in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis | Drug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 41 | Phase 2 | Australia |
| 526 | NCT02823964 (ClinicalTrials.gov) | September 2016 | 29/6/2016 | EASY: Extended Access to Sollpura Over Years | An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Liprotamase | Anthera Pharmaceuticals | NULL | Completed | 7 Years | N/A | All | 25 | Phase 4 | United States;Czechia;Hungary;Israel;Poland;Spain;Czech Republic |
| 527 | NCT02717650 (ClinicalTrials.gov) | August 25, 2016 | 10/3/2016 | The Alfred Step Test Exercise Protocol (A-STEP), for Adults With Cystic Fibrosis. | Development; Feasibility/Safety and Validation of the Alfred Step Test Exercise Protocol (A-STEP) Developed for Adults With Cystic Fibrosis: | Cystic Fibrosis;Fibrosis;Lung Diseases;Respiratory Diseases;Genetic Diseases;Pancreatic Diseases | Other: A-STEP;Other: A-STEP (New Protocol);Other: Comparator: CPET cycle ergometer (Gold Standard) | The Alfred | Monash University | Suspended | 18 Years | N/A | All | 30 | N/A | Australia |
| 528 | EUCTR2015-002192-23-ES (EUCTR) | 16/08/2016 | 09/06/2016 | An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis. | A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis. | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Australia;Germany;United Kingdom | ||
| 529 | EUCTR2014-004838-25-DE (EUCTR) | 16/08/2016 | 17/05/2016 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 155 | Phase 3 | United States;France;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy | ||
| 530 | EUCTR2016-001785-29-IE (EUCTR) | 15/08/2016 | 10/05/2016 | Study of the effects of combined treatment with the CFTR corrector ivacaftor and IV antibiotics on infection in CF. | Combined Effect of CFTR Modifiers and Intensive Antibiotic Treatment | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kalydeco INN or Proposed INN: IVACAFTOR Trade Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Product Name: Flucloxicillin INN or Proposed INN: FLUCLOXACILLIN SODIUM Trade Name: Fortum INN or Proposed INN: CEFTAZIDIME Product Name: Tobramycin INN or Proposed INN: TOBRAMYCIN SULFATE Trade Name: Meropenem INN or Proposed INN: Meropenem Other descriptive name: MEROPENEM Trade Name: Colistin INN or Proposed INN: COLISTIMETHATE SODIUM | St. Vincent's University Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 4 | Ireland | |||
| 531 | NCT02657473 (ClinicalTrials.gov) | August 13, 2016 | 13/1/2016 | Inhaled Nebulized Tobramycin in Non-cystic Fibrosis Bronchiectasis | Long-term Inhaled Nebulized Tobramycin in Patients With Non-cystic Fibrosis Bronchiectasis. A Randomized Placebo Controlled Trial. The BATTLE Study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy. | Non-CF Bronchiectasis | Drug: tobramycin inhalation solution;Drug: Saline 0.9% inhalation solution | Medical Center Alkmaar | NULL | Completed | 18 Years | N/A | All | 58 | Phase 2/Phase 3 | Netherlands |
| 532 | EUCTR2015-004143-39-NL (EUCTR) | 09/08/2016 | 21/12/2015 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Hypertonic saline INN or Proposed INN: SODIUM CHLORIDE 7% Other descriptive name: SODIUM CHLORIDE 7% Product Name: Isotonic saline INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9% Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9% | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy | ||
| 533 | EUCTR2016-000166-35-NL (EUCTR) | 08/08/2016 | 17/05/2016 | Inhaled nebulized tobramycin in non-CF bronchiectasis | Effects of long term ToBrAmycin InhalaTion SoluTion (TIS) once daiLy on Exacerbation rate in patients with non-cystic fibrosis bronchiectasis. A double blind, randomized, placebo and TIS twice daily (open label) controlled trial. The BATTLE study. | Patients with non-cystic fibrosis bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Tobramycin Steri-Neb 300 mg/5 ml, inhalation solution | Noordwest Ziekenhuisgroep | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Phase 2;Phase 3 | Netherlands | |||
| 534 | EUCTR2015-004841-13-IE (EUCTR) | 08/08/2016 | 07/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic Saline INN or Proposed INN: 4.2% NaCl/Inhalation solution | Vertex Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 535 | NCT02858843 (ClinicalTrials.gov) | August 1, 2016 | 5/7/2016 | The Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia | A Study of the Effect of Combination Lumacaftor and Ivacaftor on Markers of Hyperglycemia in Persons With Cystic Fibrosis | Cystic Fibrosis;Diabetes | Drug: lumacaftor-ivacaftor | Massachusetts General Hospital | NULL | Terminated | 18 Years | 65 Years | All | 1 | N/A | NULL |
| 536 | NCT02918409 (ClinicalTrials.gov) | August 2016 | 12/4/2016 | IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy | IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy | Cystic Fibrosis | Drug: Colistin;Drug: Tobramycin | National Jewish Health | NULL | Active, not recruiting | 18 Years | N/A | All | 51 | Phase 4 | United States |
| 537 | NCT02866721 (ClinicalTrials.gov) | August 2016 | 7/8/2016 | Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic Fibrosis | A Phase I, Single Center, Open Label, Single Dose, Dose Escalation Study Assessing the Safety and Tolerability of AllogeneiC MEsenchymAl Stem CEll Infusion in Adults With Cystic Fibrosis-CEASE CF | Cystic Fibrosis | Biological: Mesenchymal Stem Cells | Erica Roesch | Case Western Reserve University;Cystic Fibrosis Foundation | Active, not recruiting | 18 Years | N/A | All | 14 | Phase 1 | United States |
| 538 | NCT03486236 (ClinicalTrials.gov) | July 20, 2016 | 27/3/2018 | A Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With Tezacaftor/Ivacaftor in Healthy Adult Subjects | A Phase 1, Randomized, Double Blind, Placebo Controlled, Multiple Dose Escalation Study Evaluating Safety and Pharmacokinetics of VX-440 in Combination With VX-661/Ivacaftor in Healthy Adult Subjects | Cystic Fibrosis | Drug: VX-440;Drug: TEZ;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | All | 16 | Phase 1 | United Kingdom |
| 539 | NCT02750501 (ClinicalTrials.gov) | July 20, 2016 | 20/4/2016 | Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study | Absorption and Safety With Sustained Use of RELiZORB Evaluation (ASSURE) Study in Patients With Cystic Fibrosis Receiving Enteral Feeding | Cystic Fibrosis | Device: RELiZORB (immobilized lipase) cartridge;Other: Impact Peptide 1.5 | Alcresta Therapeutics, Inc. | Cystic Fibrosis Foundation | Completed | 4 Years | N/A | All | 49 | N/A | United States |
| 540 | EUCTR2015-004841-13-GB (EUCTR) | 20/07/2016 | 09/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/Inhalation solution | Vertex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Czech Republic;Ireland;United Kingdom | ||
| 541 | NCT02718495 (ClinicalTrials.gov) | July 19, 2016 | 10/3/2016 | Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis | A Phase I/II, Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: PTI-428;Drug: Placebo | Proteostasis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 56 | Phase 1/Phase 2 | United States;Canada;Denmark;France;Germany;Czechia;United Kingdom |
| 542 | EUCTR2015-002192-23-BE (EUCTR) | 18/07/2016 | 18/05/2016 | An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis | A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Canada;Spain;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 543 | NCT02555059 (ClinicalTrials.gov) | July 15, 2016 | 18/9/2015 | Special Drug Use Investigation of Ciproxan Injection in Pediatrics | Special Drug Use Investigation of Ciproxan® Injection in Pediatrics | Cystitis / Pyelonephritis / Cystic Fibrosis / Anthrax | Drug: Cipro (Ciprofloxacin, BAYQ3939) | Bayer | NULL | Completed | N/A | 14 Years | All | 48 | Japan | |
| 544 | NCT02810691 (ClinicalTrials.gov) | July 2016 | 14/6/2016 | The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis | The Effect of Soluble Fiber to Reduce Post-prandial Glycemic Excursion in Adults With Cystic Fibrosis | Cystic Fibrosis-related Diabetes;Cystic Fibrosis | Dietary Supplement: Soluble fiber supplementation;Dietary Supplement: Placebo (for fiber supplementation) | Institut de Recherches Cliniques de Montreal | Canadian Cystic Fibrosis Foundation;Université de Montréal | Completed | 18 Years | N/A | All | 14 | N/A | Canada |
| 545 | EUCTR2016-000066-34-GB (EUCTR) | 24/06/2016 | 25/07/2017 | A Study of the Effects of Lumacaftor/Ivacaftor on Exercise Tolerance in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | A Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation. | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Orkambi Product Name: lumacaftor/ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: lumacaftor Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 66 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Australia;United Kingdom | ||
| 546 | EUCTR2015-001267-39-GB (EUCTR) | 20/06/2016 | 24/08/2015 | A study to assess the efficacy and safety of ivacaftor in children aged 3 to 5 with Cystic Fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 50 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Canada;Australia;United Kingdom | ||
| 547 | EUCTR2015-002192-23-DE (EUCTR) | 03/06/2016 | 11/05/2016 | An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis | A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: GS-5745 INN or Proposed INN: GS-5745 Other descriptive name: GS-5745 | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | France;United States;Canada;Belgium;Spain;Ireland;Australia;Germany;United Kingdom | ||
| 548 | EUCTR2014-004788-18-BE (EUCTR) | 03/06/2016 | 03/03/2016 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 549 | EUCTR2014-004838-25-AT (EUCTR) | 02/06/2016 | 20/04/2016 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 155 | Phase 3 | France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 550 | NCT02807415 (ClinicalTrials.gov) | June 1, 2016 | 16/6/2016 | ICM to Evaluate the Activation of p.Phe508del-CFTR by Lumacaftor in Combination With Ivacaftor | Intestinal Current Measurements (ICM) to Evaluate the Activation of Mutant CFTR in Subjects With Cystic Fibrosis Aged 12 Years and Older, Homozygous for the p.Phe508del-CFTR Mutation, Treated With Lumacaftor in Combination With Ivacaftor | Cystic Fibrosis | Drug: Lumacaftor plus Ivacaftor | Hannover Medical School | Heidelberg University;University of Giessen | Completed | 6 Years | N/A | All | 104 | Germany | |
| 551 | EUCTR2013-005357-79-SE (EUCTR) | 01/06/2016 | 02/04/2016 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL | Pharmaxis Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;New Zealand;Sweden | ||
| 552 | NCT02734810 (ClinicalTrials.gov) | June 2016 | 6/4/2016 | SIMPLICITY: Studying Impacts on Malabsorption With Liprotamase in Cystic Fibrosis | A Phase 3, Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Liprotamase Powder for Oral Solution | Anthera Pharmaceuticals | NULL | Completed | N/A | N/A | All | 15 | Phase 3 | United States |
| 553 | NCT02823470 (ClinicalTrials.gov) | June 2016 | 1/7/2016 | A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del CFTR Mutation | A Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallel-group, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA;Device: activated smart device;Device: de-activated smart device | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 16 Years | N/A | All | 24 | Phase 4 | United States;Canada |
| 554 | NCT02781610 (ClinicalTrials.gov) | June 2016 | 12/5/2016 | Standardized Treatment of Pulmonary Exacerbations II | Standardized Treatment of Pulmonary Exacerbations II (STOP2) | Pulmonary Cystic Fibrosis | Drug: Standard of care IV antibiotic(s) | Chris Goss | Cystic Fibrosis Foundation;CF Therapeutics Development Network Coordinating Center;Medical University of South Carolina;University of Washington | Completed | 18 Years | N/A | All | 1048 | Phase 4 | United States;Canada |
| 555 | EUCTR2015-001644-11-DE (EUCTR) | 25/05/2016 | 31/03/2016 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 556 | EUCTR2015-003291-77-DE (EUCTR) | 25/05/2016 | 11/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 557 | EUCTR2015-003881-96-IT (EUCTR) | 17/05/2016 | 05/11/2020 | Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosis | Pseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with | cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML Product Name: NA Product Code: [NA] INN or Proposed INN: COLISTIMETATO SODICO Other descriptive name: COLISTIN | AZIENDA OSPEDALIERO-UNIVERSITARIA MEYER | NULL | Not Recruiting | Female: yes Male: yes | 112 | Phase 3 | Italy | ||
| 558 | EUCTR2016-000354-35-DK (EUCTR) | 12/05/2016 | 10/02/2016 | High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine | High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine | cystic fibrosis MedDRA version: 19.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Mucolysin INN or Proposed INN: ACETYLCYSTEINE SODIUM Trade Name: AAC Hexal INN or Proposed INN: ACETYLCYSTEINE SODIUM | Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 559 | EUCTR2015-002677-38-BE (EUCTR) | 11/05/2016 | 03/03/2016 | An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton | Celtaxsys Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;United States;Canada;Belgium;Germany;Italy;United Kingdom | ||
| 560 | EUCTR2015-002677-38-DE (EUCTR) | 09/05/2016 | 03/11/2015 | An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton | Celtaxsys Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;United States;Canada;Belgium;Germany;Italy;United Kingdom | ||
| 561 | NCT02722122 (ClinicalTrials.gov) | May 2016 | 23/3/2016 | Study to Evaluate the Safety,Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme® | A Proof-of-Concept, Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Exploratory Efficacy Parameters of AIR DNase™in Patients With Cystic Fibrosis Previously Treated With Pulmozyme® | Cystic Fibrosis | Drug: AIR DNase™ | Protalix | NULL | Recruiting | 12 Years | N/A | Both | 15 | Phase 2 | Israel |
| 562 | NCT02797132 (ClinicalTrials.gov) | May 2016 | 25/5/2016 | Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del | A Phase 3, 2-Part, Open-label Study to Evaluate the Safety and Pharmacokinetics of Lumacaftor/Ivacaftor Combination Therapy in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 2 Years | 5 Years | All | 62 | Phase 3 | United States;Canada |
| 563 | NCT02742519 (ClinicalTrials.gov) | May 2016 | 14/4/2016 | A Study to Evaluate Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation | A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long-term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation | Cystic Fibrosis | Drug: ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Terminated | 3 Years | 5 Years | All | 14 | Phase 3 | Australia;Canada;United Kingdom |
| 564 | EUCTR2013-004302-26-SK (EUCTR) | 22/04/2016 | 26/01/2016 | Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed. | A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients. | Glaucoma or Ocular Hypertension MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Tafluprost INN or Proposed INN: tafluprost Other descriptive name: TAFLUPROST | Santen Oy | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1 | United States;Hungary;Slovakia;Poland;United Kingdom | ||
| 565 | EUCTR2015-002581-23-DE (EUCTR) | 20/04/2016 | 26/10/2015 | A study of safety and efficacy of JBT-101 in cystic fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | United States;France;Poland;Belgium;Israel;Germany;United Kingdom;Italy | ||
| 566 | NCT02850692 (ClinicalTrials.gov) | April 18, 2016 | 16/6/2016 | Portal Hypertension and Systemic Endothelial Function | Portal Hypertension and Systemic Endothelial Function: Investigation of Systemic Endothelial Dysfunction in Case of Portal Hypertension Associated With Cystic Fibrosis. | Cystic Fibrosis;Portal Hypertension | Other: measure of endothelial function;Biological: Blood sample;Other: Hepatic elastography;Diagnostic Test: Injected abdominal CT | Hopital Foch | NULL | Recruiting | 18 Years | N/A | All | 60 | N/A | France |
| 567 | EUCTR2015-001644-11-BE (EUCTR) | 06/04/2016 | 08/01/2016 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 568 | EUCTR2015-002677-38-IT (EUCTR) | 06/04/2016 | 25/11/2015 | An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton | Celtaxsys Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 195 | Phase 2 | France;United States;Belgium;Netherlands;Germany;United Kingdom;Italy | ||
| 569 | EUCTR2014-005355-83-GR (EUCTR) | 05/04/2016 | 08/02/2016 | Confirmatory extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 570 | NCT02724527 (ClinicalTrials.gov) | April 2016 | 11/3/2016 | Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With Ivacaftor | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 for Efficacy and Safety in Patients With CF Heterozygous for F508del-CFTR + Gating Mutation Being Treated With Ivacaftor | Cystic Fibrosis | Drug: Cavosonstat;Drug: Placebo | Nivalis Therapeutics, Inc. | NULL | Active, not recruiting | 18 Years | N/A | Both | 19 | Phase 2 | United States |
| 571 | NCT02767297 (ClinicalTrials.gov) | April 2016 | 5/5/2016 | Bioavailability and Pharmacokinetics Study of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis | A Three-Part Phase 1b Bioavailability and Pharmacokinetics Study of Two Formulations of FDL169 in Healthy Subjects and Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | N/A | Both | 46 | Phase 1/Phase 2 | United Kingdom |
| 572 | EUCTR2014-005355-83-GB (EUCTR) | 22/03/2016 | 15/02/2016 | Confirmatory extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 extension Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 573 | EUCTR2015-001644-11-FR (EUCTR) | 16/03/2016 | 20/04/2016 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 574 | EUCTR2015-001644-11-DK (EUCTR) | 15/03/2016 | 08/02/2016 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden | ||
| 575 | EUCTR2015-002739-17-CZ (EUCTR) | 09/03/2016 | 13/10/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: Not assigned Other descriptive name: LIPASE INN or Proposed INN: PROTEASE INN or Proposed INN: Amylase Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: Not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Hungary;Czech Republic;Canada;Spain;Israel | ||
| 576 | EUCTR2016-000398-19-BE (EUCTR) | 08/03/2016 | 09/02/2016 | Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. | Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. - pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem | Cystic fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie INN or Proposed INN: Meropenem Fresenius Kabi Other descriptive name: MEROPENEM TRIHYDRATE Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie INN or Proposed INN: Ceftazidim Fresenius Kabi Other descriptive name: CEFTAZIDIME PENTAHYDRATE Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM | Ghent University | NULL | Not Recruiting | Female: yes Male: yes | 45 | Phase 4 | Belgium | ||
| 577 | NCT02725567 (ClinicalTrials.gov) | March 2016 | 14/3/2016 | A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation | A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR Mutation | Cystic Fibrosis | Drug: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | N/A | 24 Months | All | 56 | Phase 3 | United States;Australia;Canada;Ireland;United Kingdom |
| 578 | NCT02354859 (ClinicalTrials.gov) | March 2016 | 30/7/2014 | A Phase 2 IV Gallium Study for Patients With Cystic Fibrosis (IGNITE Study) | A Phase 2, Multi-Center, Randomized, Placebo-Controlled Study of IV Gallium Nitrate in Patients With Cystic Fibrosis (IGNITE Study) | Cystic Fibrosis | Drug: Gallium nitrate;Drug: Normal Saline | University of Washington | Cystic Fibrosis Foundation | Completed | 18 Years | N/A | All | 119 | Phase 2 | United States |
| 579 | NCT02848560 (ClinicalTrials.gov) | March 2016 | 26/7/2016 | Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI | Validation of MRI as a Sensitive Tool to Longitudinally Monitor CF Lung Disease Progression and Response to CFTR Modulator Therapy in Young Children With CF | Cystic Fibrosis | Drug: Hyperpolarized Xenon | Children's Hospital Medical Center, Cincinnati | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 6 Years | 12 Years | All | 38 | United States | |
| 580 | EUCTR2013-004302-26-HU (EUCTR) | 29/02/2016 | 21/12/2015 | Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed. | A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients. | Glaucoma or Ocular Hypertension MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Tafluprost INN or Proposed INN: tafluprost Other descriptive name: TAFLUPROST | Santen Oy | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 1 | United States;Hungary;Slovakia;Poland;United Kingdom | ||
| 581 | EUCTR2015-003292-30-NL (EUCTR) | 26/02/2016 | 02/12/2015 | A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutation | A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. | Cystic fibrosis with the S1251N mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Belgium;Netherlands | ||
| 582 | EUCTR2014-004827-29-DE (EUCTR) | 24/02/2016 | 21/09/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 583 | NCT02649751 (ClinicalTrials.gov) | February 22, 2016 | 6/1/2016 | Evaluation of (R)-Roscovitine Safety and Effects in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | A Phase II, Dose Ranging, Multicenter, Double-blind, Placebo Controlled Study to Evaluate Safety and Effects of (R)-Roscovitine in Adults Subjects With Cystic Fibrosis, Carrying 2 Cystic Fibrosis Causing Mutations With at Least One F508del-CFTR Mutation and Chronically Infected With Pseudomonas Aeruginosa, a Study Involving 36 CF Patients (24 Treated, 12 Controls). ROSCO-CF. | Cystic Fibrosis | Drug: Roscovitine;Drug: Placebo | University Hospital, Brest | ManRos Therapeutics;Cyclacel Pharmaceuticals, Inc. | Terminated | 18 Years | N/A | All | 49 | Phase 2 | France |
| 584 | EUCTR2014-005355-83-BG (EUCTR) | 19/02/2016 | 16/12/2015 | Confirmatory extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 585 | EUCTR2013-005357-79-BG (EUCTR) | 12/02/2016 | 11/01/2016 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL | Pharmaxis Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden | ||
| 586 | NCT02679729 (ClinicalTrials.gov) | February 11, 2016 | 3/2/2016 | To Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Inhaled and Intravenous (IV)Dose Administration | A Phase I, Randomized, Single-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD5634 Following Single-Ascending Inhaled Doses (Part A) and After Single Inhaled and Intravenous Doses (Part B) in Healthy Subjects | Cystic Fibrosis | Drug: AZD5634 for inhalation;Drug: AZD5634 for infusion;Other: Placebo | AstraZeneca | NULL | Completed | 18 Years | 50 Years | All | 63 | Phase 1 | United States |
| 587 | NCT03512119 (ClinicalTrials.gov) | February 11, 2016 | 15/1/2018 | Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor | Observational Study of Glucose Tolerance Abnormalities in Patient With Cystic Fibrosis Homozygous for Phe 508 Del CFTR Treated by Lumacaftor-Ivacaftor | Cystic Fibrosis Homozygous for Phe 508 Del CFTR;Glucose Intolerance or Newly Diagnosis Diabetes | Drug: Lumacaftor-Ivacaftor treatment | University Hospital, Strasbourg, France | NULL | Completed | 12 Years | N/A | All | 55 | France | |
| 588 | NCT02625246 (ClinicalTrials.gov) | February 4, 2016 | 4/12/2015 | Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non-Cystic Fibrosis Bronchiectasis | A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell (hMSC) Infusion in Patients With Non-Cystic Fibrosis Bronchiectasis | Bronchiectasis | Biological: hMSCs | Marilyn Glassberg | NULL | Completed | 30 Years | 87 Years | All | 6 | Phase 1 | United States |
| 589 | EUCTR2015-002677-38-GB (EUCTR) | 04/02/2016 | 27/10/2015 | An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosis | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton Product Name: CTX-4430 Product Code: CTX-4430 INN or Proposed INN: acebilustat Other descriptive name: CRC3357, ZK-355322, Leukoton | Celtaxsys Inc. | NULL | Not Recruiting | Female: yes Male: yes | 195 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Germany;Italy;United Kingdom | ||
| 590 | EUCTR2015-003291-77-IE (EUCTR) | 03/02/2016 | 03/12/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 591 | EUCTR2013-005357-79-GR (EUCTR) | 02/02/2016 | 17/12/2015 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL | Pharmaxis Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden | ||
| 592 | EUCTR2015-003291-77-GB (EUCTR) | 02/02/2016 | 03/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 593 | NCT02694393 (ClinicalTrials.gov) | February 2016 | 11/1/2016 | Inhaled Sodium Nitrite as an Antimicrobial for Cystic Fibrosis | Phase I/II Study of Inhaled Sodium Nitrite as an Antimicrobial for Pseudomonas Infection in Cystic Fibrosis | Cystic Fibrosis | Drug: sodium nitrite | Schmidhofer, Mark, MD | Mast Therapeutics, Inc.;Cystic Fibrosis Foundation | Active, not recruiting | 18 Years | N/A | All | 35 | Phase 1/Phase 2 | United States |
| 594 | NCT02684552 (ClinicalTrials.gov) | February 2016 | 12/2/2016 | Non Invasive Ventilation During Physical Training in Cystic Fibrosis | Physiotherapist in Charge of the Study | Cystic Fibrosis | Device: Non invasive ventilation;Device: Oxygen | Karolinska University Hospital | NULL | Completed | 18 Years | 90 Years | Both | 8 | N/A | Sweden |
| 595 | NCT02709109 (ClinicalTrials.gov) | February 2016 | 29/2/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | Cystic Fibrosis | Drug: VX-371;Drug: Saline;Drug: Placebo;Drug: Orkambi | Parion Sciences | Vertex Pharmaceuticals Incorporated | Completed | 12 Years | N/A | All | 142 | Phase 2 | United States;France;Ireland;United Kingdom |
| 596 | NCT02840136 (ClinicalTrials.gov) | February 2016 | 18/7/2016 | LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients | Optimisation, Valorisation and Application of UPLC-MS/MS Based Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis Patients - Part 3: Non-blank Sputum Samples for Method Optimisation and Validation | Cystic Fibrosis | Drug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: Ceftazidime | University Ghent | King Baudouin Foundation;Belgische Vereniging voor Strijd tegen Mucoviscidose | Suspended | 12 Years | N/A | All | 40 | N/A | Belgium |
| 597 | NCT02508207 (ClinicalTrials.gov) | February 2016 | 23/7/2015 | A Phase 2 Study to Evaluate Effects of VX-661/Ivacaftor on Lung and Extrapulmonary Systems in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo Controlled, Parallel-Group, Exploratory Study to Evaluate Effects of VX-661 in Combination With Ivacaftor on Lung and Extrapulmonary Systems in Subjects Aged 18 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: Tezacaftor/Ivacaftor;Drug: Ivacaftor;Drug: Tezacaftor/Ivacaftor matching placebo;Drug: Ivacaftor matching placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 34 | Phase 2 | United States |
| 598 | NCT02707562 (ClinicalTrials.gov) | February 2016 | 22/2/2016 | Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation) | A Phase IIa, Open-label Study of Multiple Doses of GLPG1837 in Subjects With Cystic Fibrosis and the G551D Mutation | Cystic Fibrosis | Drug: GLPG1837 dose 1;Drug: GLPG1837 dose 2;Drug: GLPG1837 dose 3 | Galapagos NV | NULL | Completed | 18 Years | N/A | Both | 26 | Phase 2 | Australia;Czech Republic;Germany;Ireland;United Kingdom |
| 599 | EUCTR2015-003291-77-CZ (EUCTR) | 26/01/2016 | 16/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutation | A phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation | Cystic fibrosis with the G551D mutation MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 32 | Phase 2 | Czech Republic;Ireland;Australia;Germany;United Kingdom | ||
| 600 | NCT03475381 (ClinicalTrials.gov) | January 22, 2016 | 4/1/2018 | Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*) | Real-life Follow-up of Cystic Fibrosis Patients Treated With Ivacaftor+Lumacaftor (Orkambi*) | Cystic Fibrosis | Drug: Ivacaftor+lumacaftor | Assistance Publique - Hôpitaux de Paris | Effi-Stat;Societe Francaise de la Mucoviscidose | Completed | 12 Years | N/A | All | 852 | France | |
| 601 | EUCTR2014-005355-83-NL (EUCTR) | 22/01/2016 | 25/11/2015 | Confirmatory extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 602 | EUCTR2015-001644-11-GB (EUCTR) | 22/01/2016 | 10/11/2015 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 256 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 603 | EUCTR2015-003292-30-BE (EUCTR) | 18/01/2016 | 26/11/2015 | A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutation | A phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. | Cystic fibrosis with the S1251N mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 Product Name: GLPG1837 Product Code: GLPG1837 INN or Proposed INN: Not Applicable Other descriptive name: GLPG1837 | Galapagos NV | NULL | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Belgium;Netherlands | ||
| 604 | NCT02661438 (ClinicalTrials.gov) | January 12, 2016 | 30/12/2015 | Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo | Multicenter Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation in Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB) or Chronic Obstructive Pulmonary Disease (COPD) Using Matching Placebo | Bronchiectasis;Pulmonary Disease, Chronic Obstructive | Drug: Placebo to Ciprofloxacin DPI (BAYQ3939) | Bayer | Novartis | Completed | 40 Years | N/A | All | 46 | N/A | United States |
| 605 | EUCTR2014-004827-29-ES (EUCTR) | 12/01/2016 | 18/11/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 606 | NCT02646995 (ClinicalTrials.gov) | January 2016 | 22/12/2015 | Lipid Formulation to Increase the Bioavailability of Fatty Acids in Cystic Fibrosis (CF) Patients | Cystic Fibrosis | Dietary Supplement: modified lipid formulation;Dietary Supplement: Fish oil | Nestlé | NULL | Completed | 5 Years | 18 Years | All | 16 | N/A | Switzerland | |
| 607 | NCT02690519 (ClinicalTrials.gov) | January 2016 | 16/2/2016 | Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation) | A Phase IIa, Open-label Study of Two Doses of GLPG1837 in Subjects With Cystic Fibrosis and the S1251N Mutation | Cystic Fibrosis | Drug: GLPG1837 dose 1;Drug: GLPG1837 dose 2 | Galapagos NV | NULL | Completed | 18 Years | N/A | Both | 7 | Phase 2 | Belgium;Netherlands |
| 608 | EUCTR2015-002739-17-HU (EUCTR) | 30/12/2015 | 13/10/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: Not assigned Other descriptive name: LIPASE INN or Proposed INN: PROTEASE INN or Proposed INN: Amylase Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: Not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Israel | ||
| 609 | EUCTR2015-002581-23-FR (EUCTR) | 23/12/2015 | 18/01/2016 | A study of safety and efficacy of JBT-101 in cystic fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic Fibrosis Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Poland;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 610 | EUCTR2015-002581-23-GB (EUCTR) | 22/12/2015 | 21/03/2016 | A study of safety and efficacy of JBT-101 in cystic fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic Fibrosis Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 611 | EUCTR2015-002739-17-ES (EUCTR) | 16/12/2015 | 03/11/2015 | Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: Not assigned Other descriptive name: LIPASE INN or Proposed INN: PROTEASE INN or Proposed INN: Amylase Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: Not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Israel | ||
| 612 | EUCTR2014-004837-13-DE (EUCTR) | 15/12/2015 | 21/04/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 613 | EUCTR2014-004827-29-SE (EUCTR) | 09/12/2015 | 27/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 614 | EUCTR2014-005355-83-FR (EUCTR) | 08/12/2015 | 04/12/2015 | Confirmatory extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 615 | EUCTR2015-002581-23-BE (EUCTR) | 03/12/2015 | 12/10/2015 | A study of safety and efficacy of JBT-101 in cystic fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function. MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: JBT-101 Product Code: JBT-101 INN or Proposed INN: JBT-101 Other descriptive name: JBT-101 | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom | ||
| 616 | EUCTR2014-004915-35-GB (EUCTR) | 02/12/2015 | 16/10/2015 | Safety and effect of QBW276 in patients with cystic fibrosis | A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: QBW276 300mcg Product Code: QBW276 INN or Proposed INN: Not established Other descriptive name: QBW276 Succinate Product Name: QBW276 1500mcg Product Code: QBW276 INN or Proposed INN: Not established Other descriptive name: QBW276 Succinate | Novartis Pharma AG | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 1;Phase 2 | United States;Germany;United Kingdom | ||
| 617 | NCT02626182 (ClinicalTrials.gov) | December 2015 | 3/12/2015 | Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe CF | Evaluation and Treatment of Pulmonary Vascular Disease in Moderate to Severe Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: sildenafil;Drug: placebo | National Jewish Health | NULL | Completed | 18 Years | N/A | All | 14 | Phase 1/Phase 2 | United States |
| 618 | NCT02605590 (ClinicalTrials.gov) | December 2015 | 10/11/2015 | Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of AIR-DNase When Administered by Inhalation to Healthy Adult Subjects | Cystic Fibrosis (CF) | Drug: AIR DNase;Drug: Placebo | Protalix | NULL | Completed | 18 Years | 55 Years | Male | 18 | Phase 1 | Israel |
| 619 | NCT02680418 (ClinicalTrials.gov) | December 2015 | 2/2/2016 | Pharmacokinetics of FDL169 in Healthy Female Subjects | A Phase I Dose Escalation Study to Assess the Pharmacokinetics (PK) of FDL169 in Healthy Female Volunteers | Cystic Fibrosis | Drug: FDL169 | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 55 Years | Female | 8 | Phase 1 | United Kingdom |
| 620 | NCT02589444 (ClinicalTrials.gov) | December 2015 | 20/10/2015 | Vitamin D and Microbiota in Cystic Fibrosis | Pilot Study Evaluating the Role of Vitamin D Repletion on Gut and Lung Microbiota in Cystic Fibrosis | Vitamin D Deficiency;Cystic Fibrosis | Dietary Supplement: High-Dose Vitamin D3;Other: Stool Sample;Other: Sputum Sample;Other: Sham Comparator;Procedure: Blood draw | Emory University | NULL | Completed | 18 Years | N/A | All | 41 | N/A | United States |
| 621 | EUCTR2014-004827-29-DK (EUCTR) | 30/11/2015 | 11/09/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 622 | EUCTR2014-004827-29-AT (EUCTR) | 27/11/2015 | 27/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 623 | EUCTR2015-003662-87-DK (EUCTR) | 13/11/2015 | 22/09/2015 | Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life | Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin | Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa. MedDRA version: 18.1;Level: LLT;Classification code 10051190;Term: Pneumonia Pseudomonas aeruginosa;System Organ Class: 100000004862 MedDRA version: 18.1;Classification code 10050700;Term: Chronic respiratory disease NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: colistimethate sodium (promixin) INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: Piperacillin with Tazobactam (tazocin) INN or Proposed INN: PIPERACILLIN Other descriptive name: PIPERACILLIN INN or Proposed INN: TAZOBACTAM Other descriptive name: TAZOBACTAM | Aarhus University Hospital, Department of Respiratory Medicine | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 624 | EUCTR2014-004827-29-NL (EUCTR) | 03/11/2015 | 21/09/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 625 | EUCTR2014-004827-29-GB (EUCTR) | 03/11/2015 | 05/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Symkevi Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 626 | NCT02598999 (ClinicalTrials.gov) | November 2015 | 4/11/2015 | Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis Patients | Randomized, Double Blind, Placebo-controlled Study of the Safety, Tolerability and Pharmacokinetics After Single Ascending Doses or Multiple Ascending Doses of OSCN-, bLF or ALX-009 in Healthy Male and CF and Non-CF Bronchiectasis Patients | Cystic Fibrosis;Bronchiectasis | Drug: ALX-009;Drug: OSCN-;Drug: bLF;Drug: Placebo | Alaxia SAS | NULL | Recruiting | 18 Years | 50 Years | All | 103 | Phase 1 | France |
| 627 | NCT02589236 (ClinicalTrials.gov) | November 2015 | 26/10/2015 | Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of N91115 to Evaluate Efficacy and Safety in Patients With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation Treated With Lumacaftor/Ivacaftor | Cystic Fibrosis | Drug: Cavosonstat;Drug: Placebo | Nivalis Therapeutics, Inc. | Medidata Solutions | Completed | 18 Years | N/A | All | 138 | Phase 2 | United States |
| 628 | NCT02443688 (ClinicalTrials.gov) | October 30, 2015 | 8/5/2015 | EMPIRE CF: A Phase 2 Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 in Adult Cystic Fibrosis (CF) Patients | A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: CTX-4430;Drug: Placebo | Celtaxsys, Inc. | NULL | Completed | 18 Years | 30 Years | All | 200 | Phase 2 | United States;Belgium;Canada;France;Germany;Italy;United Kingdom |
| 629 | EUCTR2014-004787-37-ES (EUCTR) | 26/10/2015 | 25/08/2015 | A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs. | A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) | Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Spain;Austria;Australia;Israel;Germany | ||
| 630 | EUCTR2014-004827-29-BE (EUCTR) | 21/10/2015 | 06/08/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 631 | EUCTR2014-004827-29-IE (EUCTR) | 19/10/2015 | 09/07/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1375 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 632 | EUCTR2014-005355-83-IT (EUCTR) | 16/10/2015 | 26/08/2015 | Confirmatory extension study of ataluren (PTC124) in patients with Cystic Fibrosis | A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis - NA | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 633 | EUCTR2013-004595-35-NL (EUCTR) | 15/10/2015 | 09/07/2015 | Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients | Multi-center, randomized, double-blind, placebo-controlled phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 2 | France;United States;Canada;Belgium;Germany;Netherlands;United Kingdom | ||
| 634 | EUCTR2015-000543-16-DE (EUCTR) | 14/10/2015 | 18/05/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 635 | EUCTR2014-005355-83-ES (EUCTR) | 08/10/2015 | 02/09/2015 | Confirmatory extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 636 | EUCTR2014-005355-83-BE (EUCTR) | 01/10/2015 | 24/08/2015 | Confirmatory extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany | ||
| 637 | EUCTR2013-004581-34-BE (EUCTR) | 01/10/2015 | 31/07/2014 | Confirmatory study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany | ||
| 638 | NCT02518672 (ClinicalTrials.gov) | October 2015 | 3/8/2015 | Pro-resolving Effect of MAG-DHA in Cystic Fibrosis (PREMDIC) | Role of DHA Monoglyceride (MAG-DHA) in the Resolution of Pulmonary Inflammation of Patients With Cystic Fibrosis. | Cystic Fibrosis | Dietary Supplement: MAG-DHA;Dietary Supplement: Placebo | SCF Pharma | Centre de recherche du Centre hospitalier universitaire de Sherbrooke;Solutex (Spain) | Terminated | 18 Years | N/A | All | 11 | Phase 2 | Canada |
| 639 | NCT02703155 (ClinicalTrials.gov) | October 2015 | 9/2/2016 | The Use of Home Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes | The Use of Self-Administered Electronic Oral Glucose Tolerance Test Kit in Screening Cystic Fibrosis Related Diabetes in Children With Cystic Fibrosis | Cystic Fibrosis Related Diabetes;Cystic Fibrosis | Device: Home Oral Glucose Tolerance Test kit | Great Ormond Street Hospital for Children NHS Foundation Trust | University College, London | Recruiting | 10 Years | 17 Years | Both | 30 | N/A | United Kingdom |
| 640 | NCT01132482 (ClinicalTrials.gov) | October 2015 | 16/4/2010 | Effects of Sildenafil on CFTR-dependent Ion Transport Activity | Phase II Study of the Effects of Sildenafil on CFTR-dependent Ion Transport Activity | Cystic Fibrosis | Drug: Sildenafil;Drug: Placebo | National Jewish Health | NULL | Completed | 18 Years | N/A | All | 19 | Phase 2 | United States |
| 641 | NCT02465450 (ClinicalTrials.gov) | September 29, 2015 | 4/6/2015 | Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 (Lenabasum) in Cystic Fibrosis | A Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis | Cystic Fibrosis | Drug: JBT-101 (lenabasum);Other: Placebo | Corbus Pharmaceuticals Inc. | NULL | Completed | 18 Years | 65 Years | All | 85 | Phase 2 | United States;Belgium;France;Germany;Italy;Poland;United Kingdom |
| 642 | EUCTR2015-000543-16-BE (EUCTR) | 24/09/2015 | 08/06/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 643 | EUCTR2014-004787-37-DE (EUCTR) | 24/09/2015 | 19/06/2015 | A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs. | A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Spain;Austria;Australia;Israel;Germany | ||
| 644 | EUCTR2015-000543-16-DK (EUCTR) | 23/09/2015 | 22/05/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden | ||
| 645 | EUCTR2014-004787-37-AT (EUCTR) | 21/09/2015 | 18/06/2015 | A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs. | A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Spain;Australia;Austria;Israel;Germany | ||
| 646 | EUCTR2015-002911-13-FR (EUCTR) | 15/09/2015 | 05/08/2015 | A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis. | A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis, homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa, a study involving 36 CF patients (24 treated, 12 controls). - ROSCO-CF | Cystic Fibrosis treated by 'roscovitine' in subjects homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa. MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: SELICICLIB Product Code: CYC202 | CHRU de Brest | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France | ||
| 647 | EUCTR2013-004595-35-BE (EUCTR) | 03/09/2015 | 23/07/2015 | Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients | Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521 INN or Proposed INN: RIOCIGUAT Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 648 | NCT02605538 (ClinicalTrials.gov) | September 1, 2015 | 4/5/2015 | Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively | Hepatitis B in Cystic Fibrosis and Latent Tuberculosis Respectively | Cystic Fibrosis;Hepatitis A;Hepatitis B;Tuberculosis | Biological: Vaccination with vaccine against hepatitis A and B | Karolinska University Hospital | Karolinska Institutet | Enrolling by invitation | 1 Year | N/A | All | 250 | N/A | Sweden |
| 649 | EUCTR2014-004827-29-IT (EUCTR) | 01/09/2015 | 08/07/2015 | A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease) | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 1375 | Phase 3 | United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 650 | NCT02564354 (ClinicalTrials.gov) | September 2015 | 29/9/2015 | Exploratory Study to Evaluate QR-010 in Subjects With Cystic Fibrosis ?F508 CFTR Mutation | Open-Label, Exploratory Study to Evaluate the Effects of QR-010 on Nasal Potential Difference in Subjects With CF With the ?F508 CFTR Mutation | Cystic Fibrosis | Drug: QR-010 | ProQR Therapeutics | European Commission | Completed | 18 Years | N/A | All | 18 | Phase 1 | United States;Belgium;France |
| 651 | NCT02421120 (ClinicalTrials.gov) | September 2015 | 13/4/2015 | Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients | A Prospective, Multicenter, Open-Label Study to Assess Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients Admitted With Acute Pulmonary Exacerbation | Cystic Fibrosis;Cystic Fibrosis Pulmonary Exacerbation;Pseudomonas Aeruginosa Infection | Drug: Ceftolozane/Tazobactam | Joseph L. Kuti, PharmD | Cubist Pharmaceuticals LLC;Indiana University Health;University of North Carolina;St. Christopher's Hospital for Children | Completed | 18 Years | N/A | All | 21 | Phase 4 | United States |
| 652 | NCT02504827 (ClinicalTrials.gov) | September 2015 | 20/7/2015 | Steady-state Pharmacokinetics of Ceftazidime/Avibactam in Cystic Fibrosis | Steady-state Pharmacokinetics of Ceftazidime/Avibactam in CF | Cystic Fibrosis | Drug: Ceftazidime/avibactam | University of Southern California | NULL | Completed | 18 Years | N/A | All | 12 | Phase 4 | United States |
| 653 | NCT02456103 (ClinicalTrials.gov) | August 31, 2015 | 26/5/2015 | Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis | Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Cystic Fibrosis | Cystic Fibrosis | Drug: Ataluren | PTC Therapeutics | NULL | Terminated | 6 Years | N/A | All | 246 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |
| 654 | NCT03497117 (ClinicalTrials.gov) | August 25, 2015 | 29/3/2018 | 19F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation | 19F Magnetic Resonance Imaging of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation | Cystic Fibrosis | Device: Lung Clearance Index;Drug: MRI with PFP | University of North Carolina, Chapel Hill | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Terminated | 18 Years | 99 Years | All | 5 | Early Phase 1 | United States |
| 655 | EUCTR2013-005449-35-FR (EUCTR) | 25/08/2015 | 18/06/2015 | Extension study of ataluren in patients with Cystic Fibrosis | An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 3 | United States;France;Spain;Belgium;Israel;Germany;Italy;Sweden | ||
| 656 | EUCTR2015-000543-16-SE (EUCTR) | 19/08/2015 | 20/05/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 657 | NCT02516410 (ClinicalTrials.gov) | August 2015 | 28/7/2015 | A Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) | Cystic Fibrosis | Drug: VX-661 plus ivacaftor combination;Drug: Ivacaftor;Drug: Placebo (matched to VX-661 plus ivacaftor combination);Drug: Placebo (matched to ivacaftor) | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 168 | Phase 3 | United States;Australia;Austria;Canada;France;Israel;Spain |
| 658 | NCT02531984 (ClinicalTrials.gov) | August 2015 | 21/8/2015 | The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis Bronchiectasis | Open Trial With Randomized Withdrawal of Treatment, to Evaluate the Efficacy of Azithromycin in the Treatment of Children With Non Cystic Fibrosis Bronchiectasis ( AZI-STOP Study ) | Non Cystic Fibrosis Bronchiectasis in Children | Drug: Azithromycin | Assistance Publique Hopitaux De Marseille | NULL | Active, not recruiting | 3 Years | 17 Years | Both | 100 | Phase 3 | NULL |
| 659 | NCT02544451 (ClinicalTrials.gov) | August 2015 | 1/9/2015 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: LUM/IVA | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | N/A | All | 246 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom |
| 660 | NCT02496780 (ClinicalTrials.gov) | August 2015 | 18/6/2015 | The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients | The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis Patients | Cystic Fibrosis | Drug: novolog insulin;Drug: levemir insulin;Drug: placebo | University of Minnesota | NULL | Active, not recruiting | 10 Years | 25 Years | All | 66 | Phase 2/Phase 3 | United States |
| 661 | NCT02565914 (ClinicalTrials.gov) | August 2015 | 18/9/2015 | A Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis Who Have an F508del-CFTR Mutation | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long Term Treatment With VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: TEZ/IVA;Drug: IVA | Vertex Pharmaceuticals Incorporated | NULL | Active, not recruiting | 12 Years | N/A | All | 1044 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 662 | NCT02535130 (ClinicalTrials.gov) | August 2015 | 24/8/2015 | Evaluation of Nebulization and Positive Expiratory Pressure Combination | Cystic Fibrosis;Healthy Subjects | Device: Positive expiratory pressure;Drug: amikacine nebulization | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Recruiting | 16 Years | 55 Years | Both | 15 | N/A | Belgium | |
| 663 | NCT02740868 (ClinicalTrials.gov) | August 2015 | 19/8/2015 | Xenon-129 Lung Magnetic Resonance Imaging: Study of Healthy Volunteers and Participants With Pulmonary Disease | Development of Hyperpolarized Xenon-129 Lung Magnetic Resonance Imaging: Comparative Pilot Study of Healthy Volunteers and Participants With Pulmonary Disease | Cystic Fibrosis;Asthma | Drug: Xenon-129;Device: Magnetic Resonance Imaging;Device: Lung Clearance Index | The Hospital for Sick Children | NULL | Recruiting | 8 Years | N/A | All | 30 | Phase 2 | Canada |
| 664 | NCT02310789 (ClinicalTrials.gov) | July 31, 2015 | 3/9/2014 | (Study: Vertex IIS) Does Ivacaftor Alter Wild Type CFTR-Open Probability In The Sweat Gland Secretory Coil? | (Study: Vertex IIS) A Study To Access the Effects of Ivacaftor on Wild Type CFTR-Open Probability (PO) In The Sweat Gland Secretory Coil | Cystic Fibrosis | Drug: Ivacaftor;Drug: ß-Adrenergic cocktail;Drug: Pilocarpine Nitrate 5%;Device: Macroduct sweat stimulator | Richard Barry Moss | NULL | Completed | 18 Years | N/A | All | 8 | N/A | United States |
| 665 | EUCTR2014-004838-25-BE (EUCTR) | 31/07/2015 | 26/05/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 666 | EUCTR2015-001317-28-NL (EUCTR) | 30/07/2015 | 19/05/2015 | A B2-agonist as a CFTR activator in CF - Part 2 | A B2-agonist as a CFTR activator in CF - Part 2 - ABBA 2 | Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Salbutamol | UMC Utrecht | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 667 | EUCTR2013-004581-34-GR (EUCTR) | 29/07/2015 | 23/07/2015 | Confirmatory study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany | ||
| 668 | EUCTR2014-004788-18-DE (EUCTR) | 24/07/2015 | 31/03/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland | ||
| 669 | EUCTR2014-004837-13-IT (EUCTR) | 22/07/2015 | 27/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 670 | EUCTR2014-004788-18-IT (EUCTR) | 15/07/2015 | 19/03/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy | ||
| 671 | EUCTR2014-004788-18-NL (EUCTR) | 10/07/2015 | 08/04/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | France;United States;Canada;Belgium;Australia;Israel;Germany;Netherlands;Italy;United Kingdom | ||
| 672 | EUCTR2014-004837-13-NL (EUCTR) | 10/07/2015 | 08/04/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Germany;Netherlands;Italy;United Kingdom;Switzerland;Sweden | ||
| 673 | EUCTR2014-004837-13-ES (EUCTR) | 02/07/2015 | 15/06/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 674 | NCT03489590 (ClinicalTrials.gov) | July 1, 2015 | 29/3/2018 | 19F MRI to Evaluate Regional Ventilation in Healthy Subjects and Subjects With Cystic Fibrosis | 19F Magnetic Resonance Imaging to Evaluate Regional Ventilation in Healthy Subjects and Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: PFP | University of North Carolina, Chapel Hill | NULL | Completed | 18 Years | 99 Years | All | 42 | Early Phase 1 | United States |
| 675 | NCT02444234 (ClinicalTrials.gov) | July 2015 | 6/5/2015 | Pharmacokinetics of Tedizolid Phosphate in Cystic Fibrosis | Steady-State Pharmacokinetics of Tedizolid in Plasma and Sputum of Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Tedizolid PO;Drug: Tedizolid IV | University of Southern California | Merck Sharp & Dohme Corp. | Completed | 18 Years | N/A | All | 11 | Phase 4 | United States |
| 676 | NCT02514473 (ClinicalTrials.gov) | July 2015 | 23/7/2015 | A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: VX-809;Drug: Placebo;Drug: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 206 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom |
| 677 | EUCTR2014-004837-13-DK (EUCTR) | 24/06/2015 | 26/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 678 | EUCTR2014-004838-25-IE (EUCTR) | 22/06/2015 | 10/04/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 155 | Phase 3 | France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 679 | EUCTR2015-000543-16-GB (EUCTR) | 19/06/2015 | 15/05/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||
| 680 | EUCTR2014-004837-13-IE (EUCTR) | 11/06/2015 | 05/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden | ||
| 681 | EUCTR2014-004788-18-GB (EUCTR) | 08/06/2015 | 08/04/2015 | A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftor | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150 mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 204 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;Switzerland;United Kingdom | ||
| 682 | NCT02412111 (ClinicalTrials.gov) | June 2015 | 3/4/2015 | A Phase 3 Study of Tezacaftor (VX-661) in Combination With Ivacaftor (VX-770) in Subjects Aged 12 Years and Older With Cystic Fibrosis (CF), Who Have One F508del-CFTR Mutation and a Second Mutation That Has Been Demonstrated to be Clinically Responsive to Ivacaftor | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | Cystic Fibrosis | Drug: Ivacaftor;Drug: Tezacaftor/Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 156 | Phase 3 | United States;Australia;Austria;Belgium;Canada;France;Germany;Ireland;Italy;United Kingdom |
| 683 | NCT02569229 (ClinicalTrials.gov) | June 2015 | 12/8/2015 | Glucose Tolerance in Children With Cystic Fibrosis | Glucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic Fibrosis | Glucose Intolerance;Cystic Fibrosis | Other: Diagnostics for glucose tolerance with 3 different methods. | Christoph Saner | University Hospital Inselspital, Berne | Active, not recruiting | 10 Years | 20 Years | All | 14 | Switzerland | |
| 684 | NCT02239458 (ClinicalTrials.gov) | June 2015 | 8/9/2014 | DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Saxagliptin | Ram Weiss | NULL | Not yet recruiting | 18 Years | 65 Years | Both | 60 | N/A | Israel | |
| 685 | NCT02532764 (ClinicalTrials.gov) | June 2015 | 13/8/2015 | Dose Escalation Study of QR-010 in Homozygous ?F508 Cystic Fibrosis Patients | Phase 1b, Randomized, Double-blind, Placebo-controlled, Dose Escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetics of QR-010 in Subjects With Homozygous ?F508 Cystic Fibrosis | Cystic Fibrosis | Drug: QR-010;Drug: Placebo | ProQR Therapeutics | European Commission | Completed | 18 Years | 60 Years | All | 70 | Phase 1/Phase 2 | United States;Belgium;Canada;Czechia;Denmark;France;Germany;Italy;Spain;United Kingdom;Czech Republic;Netherlands |
| 686 | NCT02279498 (ClinicalTrials.gov) | June 2015 | 28/10/2014 | SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic Fibrosis | A Phase 3, Randomized, Open-Label, Assessor-Blind, Noninferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Liprotamase;Drug: porcine (pig) PERT | Anthera Pharmaceuticals | NULL | Completed | 7 Years | N/A | All | 128 | Phase 3 | United States;Canada;Czechia;Hungary;Israel;Poland;Spain;Czech Republic |
| 687 | EUCTR2011-005085-37-FR (EUCTR) | 21/05/2015 | 17/06/2015 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients | cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 140 | United States;France;Belgium;Ireland;Germany;United Kingdom | |||
| 688 | EUCTR2014-004838-25-IT (EUCTR) | 20/05/2015 | 30/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive | Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy | ||
| 689 | EUCTR2013-005366-19-FR (EUCTR) | 19/05/2015 | 22/06/2015 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Germany;Netherlands;New Zealand | ||
| 690 | EUCTR2014-004837-13-GB (EUCTR) | 12/05/2015 | 20/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden | ||
| 691 | EUCTR2011-005085-37-BE (EUCTR) | 06/05/2015 | 26/03/2015 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients | cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | France;United States;Belgium;Ireland;United Kingdom | |||
| 692 | NCT02449031 (ClinicalTrials.gov) | May 5, 2015 | 4/5/2015 | Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs | A Prospective Observational Study in Cystic Fibrosis Patients With Chronic Respiratory Pseudomonas Aeruginosa Infection Treated With TOBI® Podhaler™ (Tobramycin Inhalation Powder) or Other FDA Approved Inhaled Antipseudomonal Antibacterial Drugs | Pseudomonas Aeruginosa in Cystic Fibrosis | Drug: TOBI Podhaler;Drug: TOBI;Drug: Bethkis;Drug: Cayston | Mylan Inc. | Cystic Fibrosis Foundation | Active, not recruiting | 6 Years | N/A | All | 260 | United States | |
| 693 | NCT02468908 (ClinicalTrials.gov) | May 2015 | 3/6/2015 | Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects | A Randomized, Double-Blind, Placebo-Controlled, Single-Centre, Single Ascending Dose and Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Molgramostim When Administered by Inhalation to Healthy Adult Subjects | Pulmonary Alveolar Proteinosis;Bronchiectasis;Cystic Fibrosis;Acute Respiratory Distress Syndrome | Drug: Molgramostim;Drug: Placebo | Savara Inc. | Celerion | Completed | 18 Years | 55 Years | All | 42 | Phase 1 | United Kingdom |
| 694 | EUCTR2014-004837-13-SE (EUCTR) | 24/04/2015 | 06/03/2015 | A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: Not yet assigned Other descriptive name: VRT-893661 VRT-0893661 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 490 | Phase 3 | United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | ||
| 695 | NCT02343445 (ClinicalTrials.gov) | April 2015 | 13/1/2015 | Clearing Lungs With Epithelial Sodium Channel (ENaC) Inhibition in Cystic Fibrosis (CF) | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of P-1037 Solution for Inhalation in Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: P-1037;Drug: Hypertonic Saline;Drug: Saline | Parion Sciences | Vertex Pharmaceuticals Incorporated | Completed | 12 Years | 80 Years | All | 142 | Phase 2 | United States |
| 696 | NCT02690064 (ClinicalTrials.gov) | April 2015 | 19/2/2016 | Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF | Mechanisms for Vascular Dysfunction and Exercise Tolerance in CF | Cystic Fibrosis | Dietary Supplement: Acute Antioxidant;Dietary Supplement: Chronic Antioxidant;Other: Placebo | Augusta University | NULL | Recruiting | 7 Years | N/A | All | 80 | N/A | United States |
| 697 | NCT02445053 (ClinicalTrials.gov) | April 2015 | 11/5/2015 | Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study) | Observational Study of Outcomes in Cystic Fibrosis Patients With Selected Gating Mutations on a CFTR Allele (The VOCAL Study) | Cystic Fibrosis | Drug: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | N/A | All | 75 | Italy;Netherlands;United Kingdom | |
| 698 | NCT02950883 (ClinicalTrials.gov) | March 24, 2015 | 27/10/2016 | Saline Hypertonic in Preschoolers + CT | Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT) | Cystic Fibrosis | Drug: Active Treatment Group 7% Hypertonic Saline;Drug: Control Group 0.9% Isotonic Saline | University of Washington, the Collaborative Health Studies Coordinating Center | Cystic Fibrosis Foundation | Completed | 3 Years | 5 Years | All | 116 | Phase 2/Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Italy;Netherlands;Spain |
| 699 | NCT02325362 (ClinicalTrials.gov) | March 17, 2015 | 10/12/2014 | Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation | Single Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover, Proof-of-mechanism Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Adult Patients With Cystic Fibrosis Homozygous for the F508del Mutation | Cystic Fibrosis | Drug: Miglustat ; placebo;Drug: Placebo ; Miglustat | Assistance Publique - Hôpitaux de Paris | Actelion;CRCM (Centres de Ressources et de Compétences de la Mucoviscidose) | Completed | 18 Years | N/A | All | 16 | Phase 2/Phase 3 | France |
| 700 | NCT02378467 (ClinicalTrials.gov) | March 1, 2015 | 27/2/2015 | Saline Hypertonic in Preschoolers | Saline Hypertonic in Preschoolers | Cystic Fibrosis | Drug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS) | University of Washington, the Collaborative Health Studies Coordinating Center | Cystic Fibrosis Foundation | Completed | 3 Years | 5 Years | All | 150 | N/A | United States;Canada |
| 701 | NCT02398383 (ClinicalTrials.gov) | March 2015 | 22/1/2015 | Role of Glucagon In Glucose Control in Cystic Fibrosis Related Diabetes | Role of Glucagon in Glucose Control in Cystic Fibrosis Related Diabetes | Cystic Fibrosis;Cystic Fibrosis Related Diabetes | Other: Oral Glucose Tolerance Test;Other: Mixed Meal Tolerance Test;Other: Hypoglycemic Clamp | Yale University | NULL | Completed | 12 Years | 45 Years | All | 7 | Early Phase 1 | United States |
| 702 | NCT02390219 (ClinicalTrials.gov) | March 2015 | 11/3/2015 | Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease | A Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis;Advanced Lung Disease | Drug: Lumacaftor;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 46 | Phase 3 | United States |
| 703 | NCT02392234 (ClinicalTrials.gov) | March 2015 | 12/3/2015 | A Phase 3 Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-cystic Fibrosis Transmembrane Conductance Regulator (CFTR) Mutation | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function | Cystic Fibrosis | Drug: VX-661/Ivacaftor;Drug: Ivacaftor;Drug: Placebo matched to VX-661/ ivacaftor;Drug: Placebo matched to Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 248 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Switzerland;United Kingdom |
| 704 | NCT02415959 (ClinicalTrials.gov) | March 2015 | 19/3/2015 | Efficacy and Safety Study of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Drug: Creon IR;Drug: Creon® (DR/GR) | Abbott | AbbVie;LKF Laboratorium für Klinische Forschung GmbH;Analytical Biochemical Laboratory;Parexel;Datamap;Linical Co., Ltd. | Completed | 12 Years | N/A | All | 70 | Phase 2 | Czech Republic;Hungary;Poland;Spain |
| 705 | EUCTR2013-004581-34-NL (EUCTR) | 26/02/2015 | 06/08/2014 | Confirmatory study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany | ||
| 706 | EUCTR2014-004519-35-GB (EUCTR) | 23/02/2015 | 08/12/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (PAncreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 707 | EUCTR2014-004519-35-CZ (EUCTR) | 18/02/2015 | 19/11/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (PAncreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Hungary;Czech Republic;Spain;United Kingdom | ||
| 708 | EUCTR2013-005366-19-PL (EUCTR) | 11/02/2015 | 26/11/2014 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis. The study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | Serbia;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand | ||
| 709 | EUCTR2013-005348-28-PL (EUCTR) | 11/02/2015 | 26/11/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany | ||
| 710 | EUCTR2013-004581-34-BG (EUCTR) | 05/02/2015 | 06/01/2015 | Confirmatory study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany | ||
| 711 | NCT02489955 (ClinicalTrials.gov) | February 2015 | 18/5/2015 | Antibiotic Nephrotoxicity in Adult Patients With Cystic Fibrosis | Prospective Randomised Trial of 'Area Under the Curve' (AUC) Dosing Strategy for Intravenous Tobramycin Versus Standard Trough Dosing for Pulmonary Exacerbations in Adult Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: Amikacin;Drug: Tobramycin;Drug: Colomycin | The Leeds Teaching Hospitals NHS Trust | NULL | Recruiting | 18 Years | N/A | Both | N/A | United Kingdom | |
| 712 | NCT02275936 (ClinicalTrials.gov) | February 2015 | 14/10/2014 | Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Parallel, Group Study of N91115 to Evaluate Safety and Pharmacokinetics in Patients With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: N91115 | Nivalis Therapeutics, Inc. | NULL | Completed | 18 Years | 80 Years | Both | 51 | Phase 1 | United States |
| 713 | NCT02453789 (ClinicalTrials.gov) | February 2015 | 14/5/2015 | A Study of OligoG in Cystic Fibrosis Subjects With Burkholderia Spp. Infection | A Randomized Double-blind, Placebo-controlled Cross-over Study of Inhaled Alginate Oligosaccharide (OligoG) for 28 Days in Subjects With Cystic Fibrosis Using Aztreonam Due to Chronic Colonization With Burkholderia Spp. | Cystic Fibrosis;Burkholderia Infection | Drug: Alginate oligosaccharide;Drug: Placebo | AlgiPharma AS | NULL | Completed | 18 Years | N/A | All | 15 | Phase 2 | Germany |
| 714 | ChiCTR-IPC-15005915 | 2015-01-31 | 2014-07-06 | A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis | A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis | non-cystic fibrosis bronchiectasis | Experimental group:Routine treatment combining with the therapy of bronchoalveolar lavage and local drug injection (Amikacin); | Department of Respiratory Medicine, Shanghai Pulmonary Hospital, Tongji University School of Medicine | NULL | Recruiting | 18 | 80 | Both | Experimental group:50; | NULL | |
| 715 | EUCTR2014-004519-35-ES (EUCTR) | 30/01/2015 | 04/12/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: KREON de Liberación Inmediata INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATINA (Páncreas Polvo Trade Name: Kreon 25 000 Product Name: Kreon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATINA (Páncreas Polvo) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 716 | NCT02248922 (ClinicalTrials.gov) | January 27, 2015 | 22/9/2014 | Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa | An 8 Week Open-label Interventional Multicenter Study to Evaluate the Lung Clearance Index as Endpoint for Clinical Trials in Cystic Fibrosis Patients = 6 Years of Age, Chronically Infected With Pseudomonas Aeruginosa | Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis | Drug: TIS or TIP | Novartis Pharmaceuticals | NULL | Terminated | 6 Years | N/A | All | 17 | Phase 4 | Germany |
| 717 | EUCTR2014-004519-35-HU (EUCTR) | 09/01/2015 | 12/11/2014 | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | A Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON IR INN or Proposed INN: NOT APPLICABLE Other descriptive name: PANCREATIN (Pancreas Powder) Trade Name: Kreon 25 000 Product Name: Creon® 25,000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN (Pancreas Powder) | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | ||
| 718 | EUCTR2012-001565-33-IE (EUCTR) | 08/01/2015 | 11/09/2014 | An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin | An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 17.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 67 | Phase 4 | Switzerland;United Kingdom;Germany;Ireland;Spain | ||
| 719 | NCT02359357 (ClinicalTrials.gov) | January 2015 | 13/1/2015 | FTIH - Single and Repeat Oral Doses of FDL169 in Healthy Volunteers | A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Dose-Escalation First-Time-in-Human Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of Single and Repeat Oral Doses of FDL169 in Healthy Volunteers | Cystic Fibrosis | Drug: FDL169;Drug: Placebo | Flatley Discovery Lab LLC | NULL | Completed | 18 Years | 45 Years | Male | 130 | Phase 1 | United Kingdom |
| 720 | NCT04122547 (ClinicalTrials.gov) | January 2015 | 8/10/2019 | Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis | Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled Trial | Exacerbation Copd;Bronchiectasis;Lung Function Decreased | Drug: Roflumilast;Drug: Placebo | Prince of Songkla University | NULL | Completed | 18 Years | 80 Years | All | 40 | Phase 3 | Thailand |
| 721 | NCT02526004 (ClinicalTrials.gov) | January 2015 | 10/8/2015 | Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified | Cystic Fibrosis Microbiome-determined Antibiotic Therapy Trial in Exacerbations: Results Stratified | Cystic Fibrosis | Drug: Ceftazidime;Drug: Tobramycin | University College Cork | Queen's University, Belfast;Paris Descartes University;University of Dundee;University of Washington;University Hospital Heidelberg;Teagasc;Clininfo;GABO:mi;Papworth Hospital;Katholieke Universiteit Leuven;Assistance Publique - Hôpitaux de Paris;European Union | Recruiting | 16 Years | 80 Years | Both | 252 | N/A | Ireland |
| 722 | NCT02347657 (ClinicalTrials.gov) | January 2015 | 12/1/2015 | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis | Drug: VX-661 Plus Ivacaftor Combination;Drug: Ivacaftor;Drug: VX-661 Plus Ivacaftor Combination Placebo;Drug: Ivacaftor placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 510 | Phase 3 | United States;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 723 | NCT02507843 (ClinicalTrials.gov) | January 2015 | 22/7/2015 | Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis | Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled Trial | Bronchiectasis | Drug: Cholecalciferol;Drug: Placebo | Shanghai Pulmonary Hospital, Shanghai, China | NULL | Recruiting | 18 Years | N/A | Both | 200 | Phase 4 | China |
| 724 | EUCTR2014-002125-35-DE (EUCTR) | 18/12/2014 | 21/07/2014 | A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp. | A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization with Burkholderia spp. - A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp. | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20 | Algipharma AS | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Germany | ||
| 725 | EUCTR2013-004659-19-SK (EUCTR) | 15/12/2014 | 06/10/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer Healthcare AG, D-51368 Leverkusen, Germany | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 492 | Phase 3 | United States;Portugal;Serbia;Philippines;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 726 | EUCTR2013-002202-31-DE (EUCTR) | 03/12/2014 | 08/10/2014 | Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment. | A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 | Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: POL7080 Product Code: POL7080 INN or Proposed INN: POL7080 | Polyphor Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Spain;Germany;United Kingdom | ||
| 727 | NCT02262871 (ClinicalTrials.gov) | December 2014 | 7/10/2014 | HFN Versus NIV in Cystic Fibrosis. The HIFEN Study | Randomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN Study | Cystic Fibrosis | Device: High flow nasal oxygen cannula;Device: Noninvasive ventilation | St. Michael's Hospital, Toronto | NULL | Completed | 18 Years | N/A | All | 15 | N/A | Canada |
| 728 | EUCTR2013-004581-34-DE (EUCTR) | 25/11/2014 | 05/08/2014 | Confirmatory study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany | ||
| 729 | NCT02273661 (ClinicalTrials.gov) | November 19, 2014 | 22/10/2014 | Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded). | Evaluation of a Therapeutic Strategy Including Nebulised Liposomal Amphotericin B (Ambisome®) in Maintenance Treatment of Allergic Bronchopulmonary Aspergillosis (Cystic Fibrosis Excluded) | Allergic Bronchopulmonary Aspergillosis | Drug: Liposomal amphotericin B (Ambisome®);Drug: placebo | Poitiers University Hospital | NULL | Completed | 18 Years | N/A | All | 174 | Phase 2 | France |
| 730 | EUCTR2011-004208-39-SK (EUCTR) | 18/11/2014 | 21/10/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Germany;Latvia;New Zealand;Japan | ||
| 731 | EUCTR2013-005357-79-IT (EUCTR) | 18/11/2014 | 06/06/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 17.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL | Pharmaxis Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Sweden | ||
| 732 | EUCTR2014-001204-21-DE (EUCTR) | 17/11/2014 | 22/08/2014 | An open-label clinical trial that evaluates the lung clearance index in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa | An 8 week open-label interventional multicenter study to evaluate the lung clearance index as endpoint for clinical trials in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | |||
| 733 | EUCTR2013-005357-79-HU (EUCTR) | 13/11/2014 | 06/06/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 18.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL | Pharmaxis Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden | ||
| 734 | EUCTR2013-004659-19-LV (EUCTR) | 11/11/2014 | 30/09/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer Healthcare AG, D-51368 Leverkusen, Germany | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 735 | EUCTR2011-004208-39-LV (EUCTR) | 11/11/2014 | 26/09/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Latvia;Germany;New Zealand;Japan | |||
| 736 | EUCTR2013-005348-28-IE (EUCTR) | 07/11/2014 | 11/09/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia | ||
| 737 | NCT03312140 (ClinicalTrials.gov) | November 6, 2014 | 4/10/2017 | Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis | Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic Fibrosis | Cystic Fibrosis Liver Disease | Drug: Choline Chloride | University Hospital Tuebingen | NULL | Completed | 18 Years | N/A | Male | 10 | N/A | NULL |
| 738 | NCT02202876 (ClinicalTrials.gov) | November 2014 | 25/7/2014 | Redox Imbalance and the Development of Cystic Fibrosis Diabetes | Redox Imbalance and the Development of Cystic Fibrosis Diabetes | Diabetes Mellitus, Type 2;Cystic Fibrosis | Other: Oral Glucose Tolerance Test;Other: High Glycemic Index Meal;Other: Low Glycemic Index Meal;Other: Test Soda;Other: Fruit juice | Emory University | Cystic Fibrosis Foundation | Completed | 1 Year | N/A | All | 34 | N/A | United States |
| 739 | EUCTR2014-000844-13-SE (EUCTR) | 21/10/2014 | 21/07/2014 | A phase IIb study of OligoG in subjects with cystic fibrosis | A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20 | Algipharma AS | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | Denmark;Germany;Sweden | ||
| 740 | EUCTR2013-005357-79-CZ (EUCTR) | 15/10/2014 | 04/06/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 19.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL | Pharmaxis Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden | ||
| 741 | EUCTR2013-005449-35-DE (EUCTR) | 01/10/2014 | 04/08/2014 | Extension study of ataluren in patients with Cystic Fibrosis | An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) | Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 3 | France;United States;Belgium;Spain;Israel;Germany;Italy;Sweden | ||
| 742 | NCT02227888 (ClinicalTrials.gov) | October 2014 | 26/8/2014 | PK Study of N91115 in Cystic Fibrosis Patients | A Phase 1, Open-Label Study Evaluating the Pharmacokinetics of N91115 in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: N91115 | Nivalis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | Both | 6 | Phase 1 | United States |
| 743 | NCT02372383 (ClinicalTrials.gov) | October 2014 | 20/6/2014 | Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic Fibrosis | Pharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus Controls | Cystic Fibrosis | Drug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: Pancrelipase | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences Institute | Completed | 16 Years | 45 Years | Both | 32 | N/A | United States |
| 744 | NCT02194881 (ClinicalTrials.gov) | October 2014 | 17/7/2014 | Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation | Ivacaftor in French Patients With Cystic Fibrosis and a G551D Mutation - Efficacy and Safety Results After the First Year of Treatment in the Real Life Setting. | Cystic Fibrosis | Drug: CF patients with a G551D mutation and treated with Ivacaftor | Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose | Completed | 6 Years | N/A | All | 57 | N/A | France |
| 745 | NCT02157922 (ClinicalTrials.gov) | October 2014 | 4/6/2014 | A Phase IIb Study of OligoG in Subjects With Cystic Fibrosis | A Double-blind, Randomized, Placebo-controlled Cross Over Study of Inhaled Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: alginate oligosaccharide | AlgiPharma AS | Eurostars;Smerud Medical Research International AS | Completed | 18 Years | N/A | All | 65 | Phase 2 | Denmark;Germany;Norway;Sweden;United Kingdom |
| 746 | NCT02170025 (ClinicalTrials.gov) | September 30, 2014 | 20/6/2014 | Early Signs of Efficacy Study With Riociguat in Adult Homozygous Delta F508 Cystic Fibrosis Patients | Multi-center Phase 2 Study to Assess the Safety, Tolerability and Early Signs of Efficacy of Tid Orally Administered BAY63-2521 in Adult Delta F508 Homozygous Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Riociguat (Adempas, BAY63-2521);Drug: Placebo | Bayer | Merck Sharp & Dohme Corp. | Terminated | 18 Years | N/A | All | 21 | Phase 2 | United States;Belgium;Canada;France;Germany;Netherlands;United Kingdom;Greece;Italy |
| 747 | EUCTR2013-004659-19-BG (EUCTR) | 26/09/2014 | 05/08/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 748 | EUCTR2014-000844-13-DK (EUCTR) | 25/09/2014 | 08/07/2014 | A phase IIb study of OligoG in subjects with cystic fibrosis | A double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis | Cystic Fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: Oligomer of Sodium Alginate Other descriptive name: OLIGOG CF-5/20 | Algipharma AS | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | Denmark;Germany;Sweden | ||
| 749 | EUCTR2013-005449-35-IT (EUCTR) | 16/09/2014 | 25/06/2014 | An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) | An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) | Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 3 | United States;France;Spain;Belgium;Israel;Germany;Italy;Sweden | ||
| 750 | EUCTR2013-004581-34-IT (EUCTR) | 15/09/2014 | 10/06/2014 | Confirmatory study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands | ||
| 751 | EUCTR2013-004581-34-GB (EUCTR) | 12/09/2014 | 25/09/2014 | Confirmatory study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany | ||
| 752 | EUCTR2013-004595-35-GB (EUCTR) | 11/09/2014 | 16/05/2014 | Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients | Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521 | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 753 | EUCTR2013-005357-79-SK (EUCTR) | 11/09/2014 | 26/08/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL | PHARMAXIS LTD | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Sweden | ||
| 754 | EUCTR2013-004302-26-GB (EUCTR) | 05/09/2014 | 01/05/2014 | Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed. | A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients. | Glaucoma or Ocular Hypertension MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11] | Trade Name: Tafluprost INN or Proposed INN: tafluprost Other descriptive name: TAFLUPROST | Santen Oy | NULL | Not Recruiting | Female: yes Male: yes | 18 | Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Hungary;Slovakia;Poland;United Kingdom | ||
| 755 | EUCTR2013-004659-19-PT (EUCTR) | 02/09/2014 | 03/07/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer Healthcare AG, D-51368 Leverkusen, Germany | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand | ||
| 756 | EUCTR2013-004581-34-ES (EUCTR) | 01/09/2014 | 14/08/2014 | Confirmatory study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis | Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 210 | Phase 3 | United States;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands | ||
| 757 | EUCTR2013-005449-35-ES (EUCTR) | 01/09/2014 | 11/08/2014 | Extension study of ataluren in patients with Cystic Fibrosis | An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) | Nonsense Mutation Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 76 | Phase 3 | France;United States;Belgium;Spain;Israel;Germany;Italy;Sweden | ||
| 758 | NCT02803944 (ClinicalTrials.gov) | September 2014 | 14/6/2016 | Continuous Azithromycin in Cystic Fibrosis Patients Beyond Two Years | Long Term Effects of Azithromycin in Patients With Cystic Fibrosis Using the National Database | Cystic Fibrosis | Drug: Azithromycin | Hospices Civils de Lyon | NULL | Completed | 7 Years | N/A | Both | 2055 | N/A | France |
| 759 | NCT02212587 (ClinicalTrials.gov) | September 2014 | 6/8/2014 | Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex | Pilot Study of the in Vivo Efficacy of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Patients Infected With Burkholderia Cepacia Complex | Cystic Fibrosis;Burkholderia Cepacia Infection | Drug: TOBI | St. Michael's Hospital, Toronto | NULL | Completed | 6 Years | N/A | All | 10 | Phase 1 | Canada |
| 760 | NCT02134353 (ClinicalTrials.gov) | September 2014 | 16/4/2014 | A Safety and Efficacy Trial of Inhaled Mannitol in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: Inhaled mannitol;Drug: Placebo Comparator: Arm B - Control | Pharmaxis | NULL | Completed | 18 Years | 99 Years | All | 423 | Phase 3 | United States;Argentina;Australia;Belgium;Canada;Czechia;Hungary;Israel;Italy;Mexico;New Zealand;Poland;Romania;Russian Federation;Slovakia;South Africa;Spain;Ukraine;Czech Republic;France |
| 761 | EUCTR2013-004595-35-DE (EUCTR) | 29/08/2014 | 29/08/2014 | Safety and tolerability of BAY63-2521 in Cystic Fibrosis patients | Multi-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Adempas Product Name: Adempas 0.5 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 INN or Proposed INN: Riociguat Other descriptive name: RIOCIGUAT Product Name: Adempas 0.125 mg Product Code: BAY63-2521 INN or Proposed INN: RIOCIGUAT Other descriptive name: RIOCIGUAT | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 762 | EUCTR2013-004987-80-BE (EUCTR) | 28/08/2014 | 18/02/2014 | Colistin dosage through blood samples and sputum in Cystic Fibrosis (CF) population | Colistin use in Cystic Fibrosis patients: pharmacokinetic studies (intravenous administration) in relation with pharmacodynamics, tolerance profile and risk of selection of resistance. | Colistin use in Cystic Fibrosis patients MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: COLISTINEB 2MUI INN or Proposed INN: Colistineb Other descriptive name: COLISTIMETHATE SODIUM (A COMPONENT) | CUB - Hôpital Erasme | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 763 | EUCTR2013-004659-19-CZ (EUCTR) | 27/08/2014 | 20/05/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand | ||
| 764 | EUCTR2013-005449-35-BE (EUCTR) | 26/08/2014 | 04/06/2014 | Extension study of ataluren in patients with Cystic Fibrosis | An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) | Nonsense Mutation Cystic Fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | France;United States;Spain;Belgium;Israel;Germany;Italy;Sweden | ||
| 765 | EUCTR2013-005357-79-BE (EUCTR) | 20/08/2014 | 01/07/2014 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Bronchitol Product Name: Bronchitol INN or Proposed INN: Mannitol Other descriptive name: MANNITOL | Pharmaxis Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Phase 3 | United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden | ||
| 766 | EUCTR2014-000817-30-NL (EUCTR) | 14/08/2014 | 22/05/2014 | Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation | Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation - TICTAC-study | Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Ivacaftor/Kalydeco Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg INN or Proposed INN: curcumin Other descriptive name: CURCUMIN Product Name: Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg INN or Proposed INN: genistein Other descriptive name: GENISTEIN | University Medical Centre Utrecht | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 767 | EUCTR2013-005449-35-SE (EUCTR) | 06/08/2014 | 05/06/2014 | Extension study of ataluren in patients with Cystic Fibrosis | An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) | Nonsense Mutation Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | France;United States;Spain;Belgium;Israel;Germany;Italy;Sweden | ||
| 768 | EUCTR2014-002387-32-GB (EUCTR) | 05/08/2014 | 27/06/2014 | Trial of Rosuvastatin for the Prevention of Kidney Toxicity caused by Tobramycin in Children with Cystic Fibrosis | Phase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis - PROteKT | Aminoglycoside-induced nephrotoxicity MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.0;Classification code 10069022;Term: Kidney injury molecule-1;System Organ Class: 10022891 - Investigations MedDRA version: 18.0;Level: LLT;Classification code 10067571;Term: Nephrotoxicity;System Organ Class: 100000004857;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02] | Trade Name: Crestor Product Name: Crestor INN or Proposed INN: Rosuvastatin calcium | University of Liverpool | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | ||
| 769 | NCT03391414 (ClinicalTrials.gov) | August 2014 | 20/6/2012 | Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis | Effects of Inhaled Bicarbonate on Airway pH in Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic bicarbonate;Drug: sodium chloride | Joseph Pilewski | Cystic Fibrosis Foundation Therapeutics | Completed | 12 Years | N/A | All | 12 | Phase 1 | United States |
| 770 | NCT02178540 (ClinicalTrials.gov) | August 2014 | 24/6/2014 | Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients | A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules | Cystic Fibrosis | Drug: Placebo;Device: Tobi Podhaler | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 45 | Phase 4 | United States |
| 771 | NCT02212431 (ClinicalTrials.gov) | August 2014 | 7/8/2014 | First Study of Oral Cysteamine in Cystic Fibrosis | An Open Label Investigation of the Tolerability and Pharmacokinetics of Oral Cysteamine in Adults With Cystic Fibrosis. | Cystic Fibrosis | Drug: Cysteamine | University of Aberdeen | Cystic Fibrosis Trust;NHS Grampian;University of Huddersfield;Cystic Fibrosis Trust;NHS Grampian;University of Huddersfield | Completed | 18 Years | N/A | Both | 10 | Phase 1/Phase 2 | United Kingdom |
| 772 | NCT02139306 (ClinicalTrials.gov) | August 2014 | 13/5/2014 | Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF) | A Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients With Nonsense Mutation Cystic Fibrosis | Cystic Fibrosis | Drug: Ataluren (PTC124®);Drug: Placebo | PTC Therapeutics | Cystic Fibrosis Foundation;ECFS-Clinical Trial Network (ECFS-CTN) | Completed | 6 Years | N/A | All | 279 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |
| 773 | EUCTR2013-005366-19-RO (EUCTR) | 30/07/2014 | 30/05/2014 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand | ||
| 774 | EUCTR2013-005348-28-RO (EUCTR) | 30/07/2014 | 30/05/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand | ||
| 775 | EUCTR2014-001401-41-NL (EUCTR) | 29/07/2014 | 15/05/2014 | Once daily deep inhalation of tobramycin with smart nebulizer more effective to treat small airways disease in cystic fibrosis? | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis - TAPAS study in patients with CF | Cystic Fibrosis and chronic infection with Pseudomonas aeruginosa;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bramitob 300mg/4ml Nebuliser Solution | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 26 | Netherlands | ||||
| 776 | EUCTR2013-005348-28-LV (EUCTR) | 28/07/2014 | 08/05/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany;New Zealand | ||
| 777 | EUCTR2011-000801-39-ES (EUCTR) | 25/07/2014 | 25/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens? eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Belgium;Spain;Ireland;Austria;Germany;Italy;Sweden | ||
| 778 | EUCTR2013-005366-19-ES (EUCTR) | 17/06/2014 | 11/04/2014 | A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Pulmaquin®(ARD-3150, dual reléase ciprofloxacin for inhalation)in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with non-cystic fibrosis bronchiectasis (ORBIT 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand | ||
| 779 | EUCTR2013-004659-19-AT (EUCTR) | 17/06/2014 | 13/05/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 780 | EUCTR2013-005348-28-ES (EUCTR) | 16/06/2014 | 11/04/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Latvia;Germany;Netherlands;New Zealand | ||
| 781 | EUCTR2011-000801-39-AT (EUCTR) | 11/06/2014 | 24/04/2014 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 782 | EUCTR2014-000284-40-GB (EUCTR) | 05/06/2014 | 29/04/2014 | Cysteamine in Cystic Fibrosis | An open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults with Cystic Fibrosis. - Cysteamine in Cystic Fibrosis (2) | Cystic Fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cystagon (cysteamine bitartrate) immediate-release capsules Product Name: Cystagon (cysteamine bitartrate) immediate-release capsules INN or Proposed INN: cysteamine bitartrate | University of Aberdeen | NHS Grampian | Not Recruiting | Female: yes Male: yes | 12 | Phase 1;Phase 2 | United Kingdom | ||
| 783 | EUCTR2011-005085-37-IE (EUCTR) | 05/06/2014 | 10/04/2014 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients | cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | France;United States;Belgium;Ireland;United Kingdom | |||
| 784 | NCT02054156 (ClinicalTrials.gov) | June 2014 | 1/2/2014 | OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis | OPTIMIZing Treatment for Early Pseudomonas Aeruginosa Infection in Cystic Fibrosis: The OPTIMIZE Multicenter, Placebo-Controlled, Double-Blind, Randomized Trial | Cystic Fibrosis | Drug: azithromycin;Drug: placebo;Drug: Tobramycin solution for inhalation | Bonnie Ramsey | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 6 Months | 18 Years | All | 221 | Phase 3 | United States |
| 785 | NCT01576315 (ClinicalTrials.gov) | June 2014 | 29/3/2012 | ATCF (Azole Therapy in Cystic Fibrosis) | Efficacy of Itraconazole and of Voriconazole in Patients With Cystic Fibrosis and Presenting With Persistent Positive Sputums for Aspergillus. | Cystic Fibrosis;Aspergillus Infections | Drug: Itraconazole/voriconazole | Rennes University Hospital | NULL | Completed | 12 Years | N/A | Both | 11 | Phase 2 | France;United Kingdom |
| 786 | NCT02141191 (ClinicalTrials.gov) | June 2014 | 12/5/2014 | A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD Device | A Randomized Crossover Mucociliary Clearance Study of Aerosolized 7% NaCl Solution Administered Overnight by the tPAD Device to Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: inhaled hypertonic saline (7%) | University of Pittsburgh | Parion Sciences | Completed | 18 Years | N/A | All | 12 | Phase 1 | United States |
| 787 | NCT02104245 (ClinicalTrials.gov) | May 28, 2014 | 28/3/2014 | Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension | Non Cystic Fibrosis Bronchiectasis | Drug: Ciprofloxacin dispersion for inhalation;Drug: Placebo | Aradigm Corporation | Grifols Therapeutics LLC | Completed | 18 Years | N/A | All | 304 | Phase 3 | United States;Australia;Canada;Former Serbia and Montenegro;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Spain;United Kingdom;Germany |
| 788 | EUCTR2012-002699-14-IT (EUCTR) | 28/05/2014 | 20/02/2014 | Trial of inhaled mannitol in children with cystic fibrosis | A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years | Cystic fibrosis in children aged 6 to 17 years MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A | Pharmaxis Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Argentina;Belgium;Netherlands;United Kingdom;Italy;Canada | |||
| 789 | EUCTR2013-005481-19-DK (EUCTR) | 27/05/2014 | 27/05/2014 | High Dose Antioxidant Treatment for Patients with Cystic Fibrosis | High Dose Antioxidant Treatment for Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 17.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Mucolysin INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: Mucomyst INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: ACC INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Trade Name: Tad INN or Proposed INN: GLUTATHIONE Other descriptive name: GLUTATHIONE SODIUM | Aarhus University Hospital | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | |||
| 790 | NCT02107859 (ClinicalTrials.gov) | May 23, 2014 | 4/4/2014 | Study of Ataluren (PTC124) in Cystic Fibrosis | An Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124) | Cystic Fibrosis | Drug: Ataluren | PTC Therapeutics | NULL | Terminated | 6 Years | N/A | All | 61 | Phase 3 | United States;Belgium;France;Israel;Italy;Spain;Sweden;Germany |
| 791 | EUCTR2011-000801-39-HU (EUCTR) | 22/05/2014 | 03/04/2014 | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 792 | EUCTR2013-005348-28-IT (EUCTR) | 22/05/2014 | 24/03/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;Italy;United Kingdom;Hungary;Canada;Poland;Romania;Australia;Latvia;Netherlands;Germany;New Zealand | ||
| 793 | EUCTR2013-005366-19-IT (EUCTR) | 22/05/2014 | 27/03/2014 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand | ||
| 794 | EUCTR2013-004659-19-LT (EUCTR) | 12/05/2014 | 20/03/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Serbia;Portugal;United States;Hong Kong;Taiwan;Slovakia;Thailand;Lithuania;Turkey;Austria;Russian Federation;Czech Republic;Argentina;Poland;Brazil;Romania;Australia;South Africa;Bulgaria;Netherlands;Latvia;Germany;China;Korea, Republic of | ||
| 795 | EUCTR2011-005085-37-DE (EUCTR) | 09/05/2014 | 31/03/2014 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients | cystic fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 1;Phase 2 | France;United States;Belgium;Ireland;Germany;United Kingdom | ||
| 796 | EUCTR2013-005366-19-HU (EUCTR) | 08/05/2014 | 21/03/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Serbia;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand | ||
| 797 | EUCTR2013-005348-28-GB (EUCTR) | 06/05/2014 | 12/03/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study). | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia | ||
| 798 | EUCTR2013-005348-28-HU (EUCTR) | 06/05/2014 | 21/03/2014 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis. MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia | ||
| 799 | NCT02144246 (ClinicalTrials.gov) | May 2014 | 19/5/2014 | Contraceptive Hormones and Women With Cystic Fibrosis | Contraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on Disease | Cystic Fibrosis Exacerbations While on and Off Hormonal Contraception | Other: Non-hormonal period;Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mg | University of Pennsylvania | Society of Family Planning | Terminated | 18 Years | 40 Years | Female | 5 | Phase 1 | United States |
| 800 | EUCTR2013-004295-35-AT (EUCTR) | 30/04/2014 | 02/04/2014 | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study | Lung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT | Chronic lung P. Aeruginosa Infection MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler INN or Proposed INN: aztreonam Other descriptive name: AZTREONAM LYSINE Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel INN or Proposed INN: COLISTIMETHATE SODIUM Trade Name: TOBI Product Name: Tobi INN or Proposed INN: TOBRAMYCIN SULFATE | Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III) | NULL | Not Recruiting | Female: yes Male: yes | 15 | Phase 4 | Austria | ||
| 801 | NCT02106832 (ClinicalTrials.gov) | April 30, 2014 | 4/4/2014 | Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) | Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis. | Bronchiectasis | Drug: Ciprofloxacin (BAYQ3939) dry powder for inhalation;Drug: Placebo | Bayer | Novartis | Completed | 18 Years | N/A | All | 521 | Phase 3 | United States;Argentina;Australia;Austria;Brazil;Bulgaria;China;Czechia;Germany;Hong Kong;Korea, Republic of;Latvia;Lithuania;Netherlands;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Taiwan;Thailand;Turkey;Czech Republic |
| 802 | EUCTR2014-000057-37-NL (EUCTR) | 30/04/2014 | 12/02/2014 | Bronchodilcation as a CFTR activator in CF | A B2-agonist as a CFTR activator in CF - ABBA study | Cystic Fibrosis;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03] | Product Name: Salbutamol Product Code: R03AC02 INN or Proposed INN: SALBUTAMOL Product Name: Salbutamol Product Code: R03CC02 INN or Proposed INN: SALBUTAMOL | University Medical Centre Utrecht | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Netherlands | |||
| 803 | EUCTR2013-005366-19-GB (EUCTR) | 29/04/2014 | 17/03/2014 | A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections withPseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) | Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862 MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Pulmaquin® Product Code: ARD-3150 INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE INN or Proposed INN: Ciprofloxacin Hydrochloride Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 255 | Phase 3 | United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand | ||
| 804 | EUCTR2013-004659-19-NL (EUCTR) | 23/04/2014 | 27/02/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany | ||
| 805 | EUCTR2013-004659-19-DE (EUCTR) | 23/04/2014 | 03/02/2014 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 | non-CF bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Ciprofloxacin DPI Product Code: BAYQ3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer AG | NULL | Not Recruiting | Female: yes Male: yes | 492 | Phase 3 | Serbia;United States;Portugal;Philippines;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Romania;Bulgaria;Germany;New Zealand | ||
| 806 | NCT02088216 (ClinicalTrials.gov) | April 1, 2014 | 5/3/2014 | Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis | Effect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled Trial | Non-Cystic Fibrosis Bronchiectasis | Drug: N-acetylcysteine;Other: On-demand treatment | Qilu Hospital of Shandong University | NULL | Completed | 18 Years | 80 Years | All | 161 | N/A | China |
| 807 | NCT01991028 (ClinicalTrials.gov) | April 2014 | 18/11/2013 | A Study to Investigate Lung Deposition of Radiolabelled OligoG | An Open Label, Randomised, Two-way Crossover Scintigraphic Study to Investigate Lung Deposition of Radiolabelled OligoG Delivered as a Dry Powder and as a Nebulised Solution in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Radiolabelled OligoG CF-5/20 DPI;Drug: Radiolabelled OligoG CF-5/20 6% Solution | Bio-Images Research Ltd | AlgiPharma AS | Completed | 18 Years | N/A | Both | 10 | Phase 2 | United Kingdom |
| 808 | NCT02057458 (ClinicalTrials.gov) | April 2014 | 4/2/2014 | Blood Flow and Vascular Function in Cystic Fibrosis | Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis | Cystic Fibrosis | Drug: Sildenafil (Acute-1 hour);Drug: Sildenafil (Subchronic-4 weeks);Drug: Placebo | Augusta University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 18 Years | N/A | All | 19 | Phase 2 | United States |
| 809 | NCT02141958 (ClinicalTrials.gov) | April 2014 | 13/5/2014 | Safety Study of Fenretinide in Adult Patients With Cystic Fibrosis | An Adaptive Phase I Intra-patient Dose Escalation Study of Fenretinide in Adult Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Fenretinide;Drug: Placebo | Elias Matouk | NULL | Completed | 18 Years | N/A | Both | 15 | Phase 1 | Canada |
| 810 | NCT02113397 (ClinicalTrials.gov) | April 2014 | 9/4/2014 | Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis Lung | Comparative Evaluation of Bacterial Diversity and Richness in CF Lung in Patients Who Use Cycled Every Other Month Tobramycin Inhalation Powder (TOBI™ Podhaler™) Or Continuous Alternating Therapy With Tobramycin Inhalation Powder (TOBI™ Podhaler™) and Inhaled Colistimethate | Cystic Fibrosis | Drug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times daily | Dartmouth-Hitchcock Medical Center | Novartis Pharmaceuticals | Terminated | 12 Years | 75 Years | All | 1 | United States | |
| 811 | NCT01515007 (ClinicalTrials.gov) | March 31, 2014 | 10/1/2012 | Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-3) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Subjects With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) | Non Cystic Fibrosis Bronchiectasis | Drug: Ciprofloxacin dispersion for inhalation;Drug: Placebo | Aradigm Corporation | Grifols Therapeutics LLC | Completed | 18 Years | N/A | All | 278 | Phase 3 | United States;Australia;Canada;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Poland;Romania;South Africa;Spain;Taiwan;United Kingdom;New Zealand |
| 812 | NCT03341741 (ClinicalTrials.gov) | March 11, 2014 | 3/11/2017 | Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients | Combined Dry Powder Tobramycin and Nebulized Colistin Inhalation in CF Patients | Cystic Fibrosis With Pulmonary Manifestations | Drug: Tobramycin Powder;Drug: Colistin | University Hospital Tuebingen | NULL | Completed | 12 Years | N/A | All | 26 | Phase 3 | NULL |
| 813 | EUCTR2012-002699-14-NL (EUCTR) | 10/03/2014 | 02/10/2013 | Trial of inhaled mannitol in children with cystic fibrosis | A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years | Cystic fibrosis in children aged 6 to 17 years MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A | Pharmaxis Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Argentina;France;Canada;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom | |||
| 814 | EUCTR2013-000604-41-DE (EUCTR) | 10/03/2014 | 20/09/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 815 | NCT02081963 (ClinicalTrials.gov) | March 2014 | 6/3/2014 | Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis | A Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | Drug: Amikacin;Drug: Normal saline | Qilu Hospital of Shandong University | NULL | Completed | 18 Years | 80 Years | All | 178 | Phase 4 | China |
| 816 | NCT02070744 (ClinicalTrials.gov) | March 2014 | 21/2/2014 | Study to Evaluate Safety and Efficacy of VX-661 in Combination With Ivacaftor in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation With an Open-Label Expansion | A Phase 2, Randomized, Multicenter, Double Blind, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 in Combination With Ivacaftor for 12 Weeks in Subjects With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation With an Open-Label Extension | Cystic Fibrosis | Drug: VX-661;Drug: Ivacaftor;Drug: Placebo matched to VX-661;Drug: Placebo matched to Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 40 | Phase 2 | United States |
| 817 | NCT02084043 (ClinicalTrials.gov) | March 2014 | 8/3/2014 | In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation | In Vitro Comparison of Continuous and Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive Ventilation: Analysis of Inhaled and Lost Doses. | Respiratory Diseases;Lung Diseases;Cystic Fibrosis;COPD;Asthma | Drug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute) | University Hospital St Luc, Brussels | Université Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, Switzerland | Completed | N/A | N/A | Both | 3 | N/A | Belgium;Switzerland |
| 818 | NCT02148978 (ClinicalTrials.gov) | March 2014 | 15/5/2014 | Cystic Fibrosis Related Diabetes | DPP-IV Inhibition in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Saxagliptin | Ram Weiss | NULL | Recruiting | 18 Years | 65 Years | Both | 30 | N/A | Israel |
| 819 | EUCTR2013-000604-41-NL (EUCTR) | 14/02/2014 | 26/09/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 820 | NCT01937325 (ClinicalTrials.gov) | February 2014 | 4/9/2013 | CPET in CF Patients With One G551D Mutation Taking VX770 | Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor) | Cystic Fibrosis | Drug: ivacaftor;Drug: placebo | The Alfred | NULL | Active, not recruiting | 16 Years | 70 Years | Both | 20 | Phase 4 | Australia |
| 821 | NCT01746784 (ClinicalTrials.gov) | February 2014 | 6/12/2012 | Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Dose Escalation Study of N6022 to Evaluate Safety and Pharmacokinetics in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR Mutation (SNO1) | Cystic Fibrosis | Drug: N6022;Drug: Normal saline | Nivalis Therapeutics, Inc. | NULL | Completed | 18 Years | N/A | All | 66 | Phase 1 | United States |
| 822 | NCT02036879 (ClinicalTrials.gov) | February 2014 | 26/12/2013 | Gender Disparity and Hormones in Cystic Fibrosis | Gender Disparity and Hormones in Cystic Fibrosis | Cystic Fibrosis (CF) | Drug: Loestrin (norethindrone acetate and ethinyl estradiol) | University of Texas Southwestern Medical Center | NULL | Completed | 18 Years | N/A | All | 55 | Early Phase 1 | United States |
| 823 | EUCTR2013-004488-30-NL (EUCTR) | 31/01/2014 | 11/12/2013 | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) | Targeting Antibiotics to Pseudomonas Aeruginosa in Small airways (TAPAS) study in patients with cystic fibrosis: pharmacokinetics (PK) - TAPAS-PK study in patients with CF | Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bramitob INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Haga Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 824 | EUCTR2013-000604-41-IT (EUCTR) | 21/01/2014 | 14/08/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 825 | EUCTR2013-003774-27-GB (EUCTR) | 20/01/2014 | 27/11/2013 | A study to investigate lung deposition of radiolabelled OligoG(v1.0) | An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients - A study to investigate lung deposition of radiolabelled OligoG (v1.0) | Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI) INN or Proposed INN: OligoG Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation INN or Proposed INN: OligoG | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | United Kingdom | ||
| 826 | EUCTR2010-020413-90-IE (EUCTR) | 08/01/2014 | 13/12/2013 | Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 2 | France;United States;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 827 | EUCTR2010-020413-90-GB (EUCTR) | 06/01/2014 | 10/12/2013 | Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Belgium;Ireland;Australia;Germany;United Kingdom | ||
| 828 | NCT02137382 (ClinicalTrials.gov) | January 2014 | 12/2/2014 | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Drug: Creon®;Drug: Creon N | Abbott | NULL | Completed | 12 Years | N/A | All | 41 | Phase 3 | Hungary;Spain;Russian Federation |
| 829 | NCT02015663 (ClinicalTrials.gov) | January 2014 | 13/12/2013 | Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles | A 24-week, Open-label, Parallel-group, Interventional Phase IV Study Comparing Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles for the Treatment of Pulmonary Pseudomonas Aeruginosa in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder | Novartis Pharmaceuticals | NULL | Terminated | 6 Years | N/A | All | 32 | Phase 4 | United States |
| 830 | NCT02015507 (ClinicalTrials.gov) | January 2014 | 9/12/2013 | An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on Ivacaftor and VX-661 in Combination With Ivacaftor | An Open-Label, Phase 1 Study in Healthy Adult Subjects to Examine the Effects of Multiple-Dose Ciprofloxacin on the Multiple-Dose Pharmacokinetics of Ivacaftor and on the Multiple-Dose Pharmacokinetics of VX-661 Administered in Combination With Ivacaftor | Cystic Fibrosis | Drug: ivacaftor;Drug: VX-661;Drug: ciprofloxacin | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 34 | Phase 1 | NULL |
| 831 | NCT02043717 (ClinicalTrials.gov) | January 2014 | 12/1/2014 | Increased Vitamin D Reduces Pulmonary Exacerbations in CF | Increasing Vitamin D Serum Levels Reduces Pulmonary Exacerbations in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Vitamin D | Hadassah Medical Organization | NULL | Completed | 4 Years | N/A | All | 90 | N/A | Israel |
| 832 | EUCTR2013-002819-10-ES (EUCTR) | 26/12/2013 | 12/11/2013 | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: KREON N 25000 INN or Proposed INN: Not applicable Other descriptive name: PANCREATIN Trade Name: Kreon 25000 INN or Proposed INN: not assigned Other descriptive name: PANCREATINA | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | |||
| 833 | EUCTR2013-000604-41-CZ (EUCTR) | 18/12/2013 | 13/09/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 834 | EUCTR2013-000604-41-SE (EUCTR) | 10/12/2013 | 13/09/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 835 | EUCTR2013-000604-41-IE (EUCTR) | 09/12/2013 | 10/10/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 836 | EUCTR2013-000604-41-BE (EUCTR) | 04/12/2013 | 17/09/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 837 | EUCTR2013-000604-41-ES (EUCTR) | 03/12/2013 | 08/10/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 838 | EUCTR2009-016590-15-PL (EUCTR) | 03/12/2013 | 11/10/2013 | A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI 300 mg / 5 mL nebuliser solution INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | United States;Greece;Russian Federation;Switzerland;Italy;France;Egypt;Hungary;Canada;Argentina;Poland;Romania;Germany | |||
| 839 | NCT01946412 (ClinicalTrials.gov) | December 2013 | 16/9/2013 | Roll-Over Study of Ivacaftor in Cystic Fibrosis Pediatric Subjects With a CF Transmembrane Conductance Regulator Gene (CFTR) Gating Mutation | A Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation | Cystic Fibrosis | Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 2 Years | N/A | All | 33 | Phase 3 | United States;Canada;United Kingdom |
| 840 | NCT01958944 (ClinicalTrials.gov) | December 2013 | 6/10/2013 | Evaluation of the Safety and Tolerability of Inhaled Nitric Oxide to Subjects With Cystic Fibrosis | Phase II Prospective, Open Labeled, Multi-Center, Evaluation of the Safety and Tolerability of Nitric Oxide Given Intermittently Via Inhalation to Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Nitric oxide | Advanced Inhalation Therapies Ltd | Soroka University Medical Center;Schneider Children's Medical Center, Israel | Completed | 10 Years | N/A | Both | 9 | Phase 1/Phase 2 | Israel |
| 841 | NCT01975259 (ClinicalTrials.gov) | December 2013 | 11/9/2013 | Investigating the Incretin Effect in Cystic Fibrosis | Investigating the Incretin Effect in Cystic Fibrosis | Cystic Fibrosis | Drug: Oral Glucose Tolerance test (75g 2-hour);Drug: Modified Oral Glucose Tolerance Test (50g 4-hours);Drug: Matched isoglycemic clamp;Drug: Hyperglycemic clamp with concurrent GLP-1 infusion;Drug: Hyperglycemic Clamp with concurrent GIP infusion;Drug: Hyperglycemic clamp with placebo infusion;Other: Liquid Meal Test (Carbohydrate-rich);Other: Liquid Meal Test (Fat-rich);Other: Liquid Meal Test (Mixed);Device: Continuous Glucose Monitoring | Liverpool Heart and Chest Hospital NHS Foundation Trust | NULL | Completed | 17 Years | 50 Years | Both | 50 | N/A | United Kingdom |
| 842 | NCT02096315 (ClinicalTrials.gov) | December 2013 | 18/3/2014 | Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis. | A Phase II, Open-label, Multicenter Study to Assess the Tolerance, Safety, Efficacy and Pharmacokinetics/Pharmacodynamics (PK/PD) of POL7080 in the Treatment of Patients With Acute Exacerbation of Non-cystic Fibrosis Bronchiectasis Due to Pseudomonas Aeruginosa Infection Requiring Intravenous Treatment | Bronchiectasis;Lower Respiratory Infection | Drug: POL7080 | Polyphor Ltd. | NULL | Terminated | 18 Years | 79 Years | All | 20 | Phase 2 | Spain;United Kingdom |
| 843 | EUCTR2013-002819-10-HU (EUCTR) | 29/11/2013 | 14/10/2013 | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON N 25000 INN or Proposed INN: not applicable Other descriptive name: PANCREATIN Trade Name: Creon 25000 INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | Abbott Laboratories GmbH | NULL | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | |||
| 844 | EUCTR2013-000604-41-DK (EUCTR) | 19/11/2013 | 19/11/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden | ||
| 845 | NCT00924547 (ClinicalTrials.gov) | November 2013 | 17/6/2009 | Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis | Oral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in Plasma | Cystic Fibrosis | Dietary Supplement: Docosahexanoic Acid Supplement;Dietary Supplement: Placebo | Vanderbilt University | NULL | Completed | 6 Years | N/A | Both | 17 | Phase 2 | United States |
| 846 | EUCTR2013-000604-41-AT (EUCTR) | 23/10/2013 | 16/09/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 847 | EUCTR2013-000604-41-GB (EUCTR) | 10/10/2013 | 17/09/2013 | A study in people with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term efficacy and safety of a combination of two experimental drugs | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 1000 | Phase 3 | United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden | ||
| 848 | NCT01880346 (ClinicalTrials.gov) | October 2013 | 12/6/2013 | Comparison of Absorption of Vitamin D in Cystic Fibrosis | Vehicles for the Absorption of Vitamin D in Cystic Fibrosis: Comparison of Powder vs Oil | Cystic Fibrosis | Dietary Supplement: Vitamin D Powder;Dietary Supplement: Vitamin D Oil | Emory University | NULL | Completed | 18 Years | 59 Years | Both | 17 | Phase 4 | United States |
| 849 | NCT01702415 (ClinicalTrials.gov) | October 2013 | 4/10/2012 | Zoledronic Acid in Cystic Fibrosis | Randomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Zoledronic acid;Drug: Placebo | Papworth Hospital NHS Foundation Trust | Novartis Pharmaceuticals | Withdrawn | 18 Years | N/A | Both | 0 | Phase 4 | United Kingdom |
| 850 | NCT02035488 (ClinicalTrials.gov) | October 2013 | 27/12/2013 | Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis | Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Tobramycin | University Medical Centre Groningen | NULL | Completed | 18 Years | N/A | Both | 8 | Phase 1/Phase 2 | Netherlands |
| 851 | NCT01931839 (ClinicalTrials.gov) | October 2013 | 26/8/2013 | A Phase 3 Rollover Study of Lumacaftor in Combination With Ivacaftor in Subjects 12 Years and Older With Cystic Fibrosis | A Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Drug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 1164 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 852 | NCT01784419 (ClinicalTrials.gov) | October 2013 | 3/2/2013 | Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients | Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis Patients | Cystic Fibrosis | Drug: ivacaftor;Drug: Placebo | University of California, San Francisco | NULL | Completed | 6 Years | N/A | All | 10 | N/A | United States |
| 853 | EUCTR2013-002202-31-ES (EUCTR) | 24/09/2013 | 01/08/2013 | Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment. | A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 | Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: POL7080 Product Code: POL7080 INN or Proposed INN: POL7080 Other descriptive name: POL7080 | Polyphor Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Spain;Germany;United Kingdom | ||
| 854 | EUCTR2013-001258-82-IT (EUCTR) | 12/09/2013 | 29/07/2013 | Phase II clinical study for the therapy of cystic fibrosis patients with aspecific mutation | A phase II pilot clinical study of experimental research to evaluate thefunctional rescue of CFTR protein through proteostasis regulators - Proteostasis regulators effect in cystic fibrosis therapy | Cystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II mutations;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Cystagon Product Name: Cysteamine bitartrate (Cystagon) Product Code: EMEA/H/C/000125 | European Institute for Cystic Fibrosis Research (IERFC) | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | |||
| 855 | EUCTR2013-002202-31-GB (EUCTR) | 11/09/2013 | 19/06/2013 | Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment. | A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 | Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: POL7080 Product Code: POL7080 INN or Proposed INN: POL7080 Other descriptive name: POL7080 | Polyphor Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | United Kingdom;Germany;Spain | ||
| 856 | NCT01953367 (ClinicalTrials.gov) | September 2013 | 4/9/2013 | Bioequivalence and Safety of Vantobra and TOBI in Healthy Subjects | Bioequivalence and Safety Study of Vantobra and TOBI Nebulizer Solutions in Healthy Subjects | Cystic Fibrosis | Drug: Vantobra (tobramycin);Drug: TOBI (tobramycin) | Pari Pharma GmbH | NULL | Completed | 18 Years | 50 Years | Both | 72 | Phase 1 | Germany |
| 857 | NCT01944735 (ClinicalTrials.gov) | September 2013 | 6/9/2013 | Phase 1 Study Assessing the Safety and Tolerability of CTX-4430 in Cystic Fibrosis Patients | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Ascending Multiple-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CTX-4430 When Administered Orally to Cystic Fibrosis Patients for Fifteen Days | Cystic Fibrosis | Drug: CTX-4430;Drug: Placebo | Celtaxsys, Inc. | Celerion | Completed | 18 Years | 55 Years | Both | 17 | Phase 1 | United Kingdom |
| 858 | NCT02048592 (ClinicalTrials.gov) | September 2013 | 16/12/2013 | Impact of Immunonutrition on the Patients With Cystic Fibrosis | Impact of Immunonutrition on the Patients With Cystic Fibrosis | Cystic Fibrosis;Malnutrition;Oxidative Stress | Dietary Supplement: Impact-Nutridrink;Dietary Supplement: Nutridrink-Impact | University Hospital, Motol | NULL | Recruiting | 18 Years | 40 Years | Both | 30 | Phase 4 | Czech Republic |
| 859 | NCT02288429 (ClinicalTrials.gov) | September 2013 | 15/9/2014 | Evaluation of Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium | Evaluation of Steady-state Pharmacokinetic and Pharmacodynamic Properties of Intravenous Colistimethate Sodium in Cystic Fibrosis and Critically Ill Patients | Colistin | Drug: colistimethate sodium | University of Colorado, Denver | NULL | Completed | 18 Years | 89 Years | All | 16 | United States | |
| 860 | EUCTR2012-003990-24-AT (EUCTR) | 26/08/2013 | 03/04/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Australia;Austria;Germany;United Kingdom | ||
| 861 | EUCTR2012-003989-40-NL (EUCTR) | 21/08/2013 | 17/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 862 | EUCTR2012-003990-24-ES (EUCTR) | 09/08/2013 | 16/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 501 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom | ||
| 863 | NCT01916577 (ClinicalTrials.gov) | August 2013 | 29/7/2013 | Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation | Autologous CD117+ Progenitor Cell Mobilization for Lung Transplantation | COPD;Cystic Fibrosis;Pulmonary Fibrosis | Drug: Plerixafor mobilization of autologous CD117 stem cells | University of Colorado, Denver | Sanofi | Completed | 18 Years | 70 Years | All | 15 | Phase 1 | United States |
| 864 | NCT01885169 (ClinicalTrials.gov) | August 2013 | 20/6/2013 | LAIV (Flumist®) Administration in CF Patients | Safety of Live-attenuated Influenza Vaccine (LAIV, Flumist®) in Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Biological: Flumist® | McGill University Health Center | Ministere de la Sante et des Services Sociaux;Canadian Cystic Fibrosis Foundation;PHAC/CIHR Influenza Research Network | Active, not recruiting | 2 Years | 18 Years | Both | 170 | N/A | Canada |
| 865 | NCT01844778 (ClinicalTrials.gov) | August 2013 | 29/4/2013 | Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI) | An Open-label, Crossover, Interventional Phase IV Study to Compare the Ease of Use of TIP With Nebulized TIS and Nebulized COLI for the Treatment of Pulmonary Pseudomonas Aeruginosa (P.a) in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder;Drug: Tobramycin inhalation solution;Drug: Colistimethate | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 60 | Phase 4 | Germany;Ireland;Spain;Switzerland;United Kingdom |
| 866 | EUCTR2012-000386-20-GB (EUCTR) | 31/07/2013 | 26/04/2013 | A Roll-over study in children with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term safety and pharmacodynamics of ivacaftor | A Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation | cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;United Kingdom | ||
| 867 | EUCTR2013-000219-25-IT (EUCTR) | 18/07/2013 | 12/04/2018 | MRSA study. | Early eradication of S. Aureus (MRSA) in patients with cystic fibrosis: a randomized multicenter study. | Patients affected by cystic fibrosis and who present an initial infection of MRSA.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: Rifampin INN or Proposed INN: RIFAMPICIN Product Name: Trimethoprim-sulfamethoxazole INN or Proposed INN: SULFAMETHOXAZOLE Other descriptive name: TRIMETHOPRIM Product Name: minocycline Other descriptive name: MINOCYCLINE HYDROCHLORIDE | AOU Meyer | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 3 | Italy | ||
| 868 | EUCTR2012-001565-33-ES (EUCTR) | 04/07/2013 | 16/05/2013 | An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin | An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 16.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN Trade Name: TOBI 300 mg/5 ml solución para inhalación por nebulizador INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN Trade Name: Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE | Novartis Farmaceutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 67 | Phase 4 | Spain;Ireland;Germany;United Kingdom;Switzerland | ||
| 869 | NCT01155752 (ClinicalTrials.gov) | July 2013 | 25/6/2010 | Pulmozyme in Cystic Fibrosis With Sinusitis | Z4770s, Use of Recombinant Human DNASE in Cystic Fibrosis Patients With Chronic Sinusitis to Prevent Acute Sinusitis Exacerbations and Improve Symptoms and Outcomes - A Pilot Study | Sinusitis;Cystic Fibrosis | Drug: Pulmozyme single use ampule;Drug: placebo | Milton S. Hershey Medical Center | Genentech, Inc. | Withdrawn | 12 Years | 65 Years | All | 0 | Phase 3 | United States |
| 870 | NCT01897233 (ClinicalTrials.gov) | July 2013 | 8/7/2013 | Study of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: Lumacaftor;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 6 Years | 11 Years | All | 62 | Phase 3 | United States;Canada |
| 871 | NCT01899105 (ClinicalTrials.gov) | July 2013 | 10/7/2013 | A Phase 1 Study to Investigate the Food Effect of Lumacaftor in Combination With Ivacaftor | A Phase 1, Randomized, Single-Dose, Open-Label Crossover Study to Investigate the Effect of Food on the Relative Bioavailability of 2 Fixed-Dose Combinations of Lumacaftor and Ivacaftor Tablet Formulations in Healthy Adult Subjects | Cystic Fibrosis | Drug: lumacaftor;Drug: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 28 | Phase 1 | United States |
| 872 | EUCTR2012-000204-15-GB (EUCTR) | 28/06/2013 | 26/04/2013 | A study in children aged 2 to 5 with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the safety, pharmacokinetics and pharmacodynamics of ivacaftor | A Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who are 2 Through 5 Years of Age and Have a CFTR Gating Mutation | cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;United Kingdom | ||
| 873 | EUCTR2012-003990-24-DK (EUCTR) | 27/06/2013 | 17/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Austria;Australia;Denmark;Germany;United Kingdom | ||
| 874 | EUCTR2009-012842-21-HU (EUCTR) | 27/06/2013 | 10/05/2013 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;Italy;United Kingdom | |||
| 875 | EUCTR2012-003989-40-CZ (EUCTR) | 26/06/2013 | 26/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 876 | EUCTR2012-003990-24-BE (EUCTR) | 25/06/2013 | 26/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom | ||
| 877 | EUCTR2012-001565-33-GB (EUCTR) | 21/06/2013 | 16/04/2013 | An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin | An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 17.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 67 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | Spain;Ireland;Germany;Switzerland;United Kingdom | ||
| 878 | EUCTR2012-003990-24-DE (EUCTR) | 20/06/2013 | 26/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom | ||
| 879 | EUCTR2012-003532-23-DE (EUCTR) | 20/06/2013 | 05/02/2013 | An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 15.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 15.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | ||
| 880 | EUCTR2012-002699-14-BE (EUCTR) | 18/06/2013 | 15/02/2013 | Trial of inhaled mannitol in children with cystic fibrosis | A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years | Cystic fibrosis in children aged 6 to 17 years MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A | Pharmaxis Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | France;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom;Switzerland | |||
| 881 | EUCTR2012-003990-24-GB (EUCTR) | 10/06/2013 | 13/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom | ||
| 882 | EUCTR2012-003989-40-GB (EUCTR) | 10/06/2013 | 13/05/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 883 | EUCTR2012-003989-40-IE (EUCTR) | 07/06/2013 | 11/04/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 884 | EUCTR2012-001565-33-DE (EUCTR) | 05/06/2013 | 18/04/2013 | An open-label clinical trial that compares how long it takes in total for a patient with cystic fibrosis to take a daily dose of tobramycin dry power versus nebulised forms of tobramycin or colistin | An open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 18.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN INN or Proposed INN: Colistimethate Other descriptive name: COLISTIMETHATE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 67 | Phase 4 | Spain;Ireland;Germany;United Kingdom;Switzerland | ||
| 885 | NCT01910415 (ClinicalTrials.gov) | June 2013 | 19/7/2013 | Phase 1, QT/QTC Interval Study in Healthy Subjects | A Phase 1, Randomized, Placebo and Active Controlled, Double-Blind, Parallel, Electrocardiogram Study to Evaluate the Effect of Lumacaftor in Combination With Ivacaftor on the QT/QTc Interval in Healthy Subjects | Cystic Fibrosis | Drug: Lumacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor;Drug: Ivacaftor Placebo;Drug: moxifloxacin hydrochloride | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 200 | Phase 1 | Netherlands |
| 886 | NCT01887197 (ClinicalTrials.gov) | June 2013 | 24/6/2013 | Repeatability and Response Study of Absorptive Clearance Scans | Repeatability and Response Study of Absorptive Clearance Scans | Cystic Fibrosis | Other: Absorptive clearance scan;Drug: inhaled hypertonic saline (7%);Drug: mannitol inhalation powder | Tim Corcoran | NULL | Completed | 18 Years | N/A | All | 24 | Phase 1 | United States |
| 887 | NCT01879228 (ClinicalTrials.gov) | June 2013 | 12/6/2013 | Effect of Chronic Incretin-based Therapy in Cystic Fibrosis | A Randomized, Double-blind, Placebo Controlled Study of the Effectiveness of Chronic Incretin-based Therapy on Insulin Secretion in Cystic Fibrosis | Cystic Fibrosis;Pancreatic Insufficiency | Drug: Sitagliptin | University of Pennsylvania | Children's Hospital of Philadelphia | Completed | 18 Years | N/A | All | 26 | N/A | United States |
| 888 | NCT01859390 (ClinicalTrials.gov) | June 2013 | 17/5/2013 | Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis | A Multi-Center, Randomized, Controlled, Double-Blind Study of the Effects of an Antioxidant-Enriched Multivitamin Supplement on Inflammation and Oxidative Stress in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: AquADEKs-2;Dietary Supplement: control multivitamin | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Yasoo Health | Completed | 10 Years | N/A | All | 73 | Phase 2 | United States |
| 889 | NCT01883037 (ClinicalTrials.gov) | June 2013 | 13/6/2013 | Comparing Laboratory Blood Glucose Results With HemoCue Glucose 201 RT | To Compare the Clinical Accuracy of Glucose Measurement During Oral Glucose Tolerance Test Using Two Methods: i) Laboratory Standard Technique, ii) HemoCue Glucose 201 RT System | Cystic Fibrosis | Other: Blood glucose results | Royal Brompton & Harefield NHS Foundation Trust | NULL | Completed | 16 Years | N/A | Both | 70 | N/A | United Kingdom |
| 890 | NCT01883531 (ClinicalTrials.gov) | June 2013 | 17/6/2013 | Crossover Trial Determining the Efficacy of Dry Powder Mannitol to Improve Lung Function in Subjects Aged 6-17 Years | A Randomised, Multicentre, Double-blind, Placebo-controlled, Crossover Trial Determining the Efficacy of Dry Powder Mannitol in Improving Lung Function in Subjects With Cystic Fibrosis Aged Six to Seventeen Years | Cystic Fibrosis | Drug: Inhaled Mannitol;Drug: Inhaled Placebo | Pharmaxis | NULL | Completed | 6 Years | 17 Years | Both | 95 | Phase 2 | United Kingdom |
| 891 | EUCTR2011-004208-39-GB (EUCTR) | 30/05/2013 | 11/12/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 892 | EUCTR2012-003989-40-IT (EUCTR) | 22/05/2013 | 21/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 893 | EUCTR2012-003989-40-DE (EUCTR) | 17/05/2013 | 26/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 894 | EUCTR2012-004437-16-NL (EUCTR) | 15/05/2013 | 19/03/2013 | Pharmacokinetic evaluation and local tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis | Pharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis - Tobra-02 | BronchiectasisLung infections;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Dry powder tobramycin Product Code: J01GB01 INN or Proposed INN: Tobramycin dry powder Other descriptive name: TOBRAMYCIN | University Medical Center Groningen | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 895 | EUCTR2012-004491-18-IT (EUCTR) | 07/05/2013 | 21/07/2016 | Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs. | A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BAY 85-8501 Product Code: BAY 85-8501 Other descriptive name: BAY 85-8501 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom;Italy | ||
| 896 | EUCTR2011-000801-39-IE (EUCTR) | 07/05/2013 | 12/02/2013 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 897 | EUCTR2012-003989-40-SE (EUCTR) | 07/05/2013 | 18/03/2013 | A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: lumacaftor/ivacaftor 200mg/83mg tablet INN or Proposed INN: lumacaftor INN or Proposed INN: IVACAFTOR Product Name: ivacaftor 125mg tablet INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 898 | NCT01764841 (ClinicalTrials.gov) | May 2, 2013 | 8/1/2013 | Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) | Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis. | Bronchiectasis | Drug: Ciprofloxacin DPI (BAYQ3939);Drug: Placebo | Bayer | Novartis | Completed | 18 Years | N/A | All | 416 | Phase 3 | United States;Argentina;Australia;Denmark;France;Germany;Israel;Italy;Japan;Latvia;New Zealand;Slovakia;Spain;United Kingdom |
| 899 | NCT01852448 (ClinicalTrials.gov) | May 2013 | 9/5/2013 | Genetics of Insulin and Incretins in Cystic Fibrosis | Evaluation of the Enteroinsular Axis in Cystic Fibrosis | Cystic Fibrosis | Genetic: Blood or Saliva Sample Collection;Other: Glucose -potentiated arginine (GPA) stimulation tests | Children's Hospital of Philadelphia | University of Pennsylvania | Active, not recruiting | 2 Years | N/A | All | 550 | United States | |
| 900 | NCT01851694 (ClinicalTrials.gov) | May 2013 | 8/5/2013 | Beta-cell Response to Incretin Hormones in Cystic Fibrosis | Determination of Beta-cell Responsiveness to the Incretin Hormones GLP-1 and GIP in Cystic Fibrosis | Cystic Fibrosis;Pancreatic Insufficiency | Drug: GLP-1;Drug: GIP | University of Pennsylvania | Children's Hospital of Philadelphia | Recruiting | 18 Years | N/A | All | 45 | N/A | United States |
| 901 | NCT01710644 (ClinicalTrials.gov) | May 2013 | 17/10/2012 | Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Randomized, Double-blind, Multicenter, Two-period Crossover Study to Assess the Efficacy and Tolerability of NM-BL (Burlulipase) in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | Pancreatic Insufficiency;Cystic Fibrosis;Digestive System Diseases;Lung Diseases;Respiratory Tract Diseases | Drug: Burlulipase;Drug: Placebo (Caramel in sterile water) | Nordmark Arzneimittel GmbH & Co. KG | Parexel | Completed | 12 Years | N/A | Both | 35 | Phase 1/Phase 2 | United States |
| 902 | NCT01807923 (ClinicalTrials.gov) | May 2013 | 4/3/2013 | A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Drug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 559 | Phase 3 | United States;Australia;Canada;Czech Republic;France;Germany;Ireland;Italy;Netherlands;Sweden;United Kingdom |
| 903 | NCT01863238 (ClinicalTrials.gov) | May 2013 | 22/5/2013 | An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis | An Ocular Safety Study of Ivacaftor-Treated Pediatric Patients 11 Years of Age or Younger With Cystic Fibrosis | Cystic Fibrosis | Other: Ophthalmologic examinations;Drug: Ivacaftor Exposed | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | 11 Years | Both | 95 | N/A | United States |
| 904 | NCT01840735 (ClinicalTrials.gov) | May 2013 | 15/4/2013 | Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF | A Phase 1b, Randomized, Double-Blind, Placebo-Controlled, Single Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of GS-5737 in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: GS-5737;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 8 | Phase 1 | United States |
| 905 | EUCTR2011-000443-24-NL (EUCTR) | 25/04/2013 | 06/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 906 | NCT01818544 (ClinicalTrials.gov) | April 2013 | 8/3/2013 | Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis | A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: BAY85-8501;Drug: Placebo | Bayer | NULL | Completed | 18 Years | N/A | Both | 94 | Phase 2 | France;Germany;Italy;Spain;United Kingdom |
| 907 | NCT01807949 (ClinicalTrials.gov) | April 2013 | 4/3/2013 | A Study of Lumacaftor in Combination With Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Who Are Homozygous for the F508del-CFTR Mutation | A Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Drug: Placebo;Drug: Lumacaftor Plus Ivacaftor Combination;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | 65 Years | All | 563 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Spain;United Kingdom |
| 908 | EUCTR2011-004208-39-FR (EUCTR) | 22/03/2013 | 27/06/2013 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 16.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Spain;Israel;United Kingdom;Italy;France;United States;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 909 | EUCTR2011-003821-93-DE (EUCTR) | 13/03/2013 | 23/12/2011 | A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United States;Canada;Germany;United Kingdom | ||
| 910 | EUCTR2011-004208-39-DK (EUCTR) | 12/03/2013 | 17/12/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 17.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Denmark;Australia;Latvia;Germany;New Zealand;Japan | |||
| 911 | NCT01837355 (ClinicalTrials.gov) | March 2013 | 10/4/2013 | Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Diet Supplementation in Pediatric Cystic Fibrosis | Modulation of Intestinal and Pulmonary Inflammation by Lactobacillus Rhamnosus Diet Supplementation in Pediatric Cystic Fibrosis (MoHuM-1) | Pulmonary Inflammation;Cystic Fibrosis;Microbiota | Dietary Supplement: Lactobacillus rhamnosus;Dietary Supplement: Placebo | Cantonal Hospital of St. Gallen | Swiss Federal Institute of Technology;University Hospital Inselspital, Berne | Unknown status | 6 Years | 20 Years | All | 68 | N/A | Switzerland |
| 912 | NCT01746095 (ClinicalTrials.gov) | March 2013 | 6/12/2012 | Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients | A Phase 2, Randomized, Double Blind, Placebo-controlled Study of AeroVanc for the Treatment of Persistent Methicillin-resistant Staphylococcus Aureus Lung Infection in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Vancomycin hydrochloride inhalation powder;Drug: Placebo inhalation powder | Savara Inc. | Synteract, Inc.;Cystic Fibrosis Foundation | Completed | 12 Years | N/A | All | 87 | Phase 2 | United States |
| 913 | EUCTR2012-004491-18-ES (EUCTR) | 19/02/2013 | 21/12/2012 | Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs. | A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BAY 85-8501 Product Code: BAY 85-8501 INN or Proposed INN: - Other descriptive name: BAY 85-8501 | Bayer HealthCare AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 90 | Phase 2 | Spain;United Kingdom | ||
| 914 | NCT01707290 (ClinicalTrials.gov) | February 2013 | 9/10/2012 | Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation | A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long Term Ivacaftor Treatment in Subjects 6 Years of Age and Older With Cystic Fibrosis and a Non-G551D CFTR Mutation | Cystic Fibrosis | Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | N/A | All | 125 | Phase 3 | United States;Belgium;France;United Kingdom;Ireland |
| 915 | NCT01775137 (ClinicalTrials.gov) | February 2013 | 22/1/2013 | Ext. Long-term Safety Study in CF Patients: Single Arm TIP | A 48 Week Extension to CTBM100C2401, a Single Arm, Open-label, Multicenter, Phase IV Extension Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis Who Completed Participation in CTBM100C2401. | Long-term Safety of TIP | Drug: TBM100 | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 45 | Phase 4 | United States;Argentina;Australia;Canada;Germany;Hungary;Italy;Mexico;Spain |
| 916 | EUCTR2012-004491-18-GB (EUCTR) | 30/01/2013 | 18/12/2012 | Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs. | A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis MedDRA version: 15.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: BAY 85-8501 Product Code: BAY 85-8501 INN or Proposed INN: N/A Other descriptive name: BAY 85-8501 | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Italy;United Kingdom | ||
| 917 | EUCTR2012-003532-23-ES (EUCTR) | 29/01/2013 | 29/11/2012 | An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Farmaceutica, S.A. | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | ||
| 918 | EUCTR2011-004208-39-ES (EUCTR) | 29/01/2013 | 26/11/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non-CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 919 | EUCTR2012-002699-14-GB (EUCTR) | 28/01/2013 | 03/07/2012 | Trial of inhaled mannitol in children with cystic fibrosis | A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years | Cystic fibrosis in children aged 6 to 17 years MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A | Pharmaxis Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Canada;Argentina;Belgium;Netherlands;Italy;United Kingdom | ||
| 920 | EUCTR2012-002880-86-GB (EUCTR) | 25/01/2013 | 09/11/2012 | Resting the pancreas in Cystic Fibrosis | PRESERVING ?ETA-CELLS: ‘RESTING THE PANCREAS’ IN CYSTIC FIBROSIS | Cystic Fibrosis Related Diabetes (CFRD) MedDRA version: 14.1;Level: LLT;Classification code 10022468;Term: Insulin;System Organ Class: 100000004848;Therapeutic area: Body processes [G] - Physiological processes [G07] | Trade Name: Levemir FlexPen Product Name: Levemir FlexPen | Liverpool Heart and Chest Hospital NHS Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | United Kingdom | ||||
| 921 | NCT00928135 (ClinicalTrials.gov) | January 22, 2013 | 18/6/2009 | Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Cystic Fibrosis (CF) Subjects | Randomized Controlled Study of Aerosolized Hypertonic Xylitol Versus Hypertonic Saline in Hospitalized Patients With Exacerbation of Cystic Fibrosis | Cystic Fibrosis | Drug: Xylitol;Drug: Saline | Joseph Zabner | NULL | Completed | 12 Years | N/A | All | 63 | Phase 1/Phase 2 | United States |
| 922 | EUCTR2011-004208-39-DE (EUCTR) | 21/01/2013 | 23/10/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Other descriptive name: CIPROFLOXACIN | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 400 | Phase 3 | Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 923 | EUCTR2012-003532-23-IT (EUCTR) | 18/01/2013 | 21/12/2012 | An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;Level: HLT;Classification code 10037132;Term: Pseudomonal infections;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI PODHALER*448CPS 28MG+10IN INN or Proposed INN: Tobramycin | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | ||
| 924 | EUCTR2011-004208-39-IT (EUCTR) | 11/01/2013 | 11/12/2012 | Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE) | Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 | bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | Product Name: Ciprofloxacin DPI Product Code: BAYq3939 INN or Proposed INN: CIPROFLOXACIN | BAYER HEALTHCARE AG | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan | ||
| 925 | NCT01768663 (ClinicalTrials.gov) | January 2013 | 11/1/2013 | A Phase 1 Study to Examine the Drug-Drug Interaction of Ciprofloxacin, Itraconazole, and Rifampin on the Combination of Lumacaftor With Ivacaftor in Healthy Adult Subjects | A Phase 1, Open-Label Study to Examine the Effect of Ciprofloxacin, Itraconazole, and Rifampin on the Pharmacokinetics of Lumacaftor in Combination With Ivacaftor in Healthy Adult Subjects | Cystic Fibrosis | Drug: Lumacaftor;Drug: Ivacaftor;Drug: Ciprofloxacin;Drug: Itraconazole;Drug: Rifampin | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 80 | Phase 1 | United States |
| 926 | NCT01705145 (ClinicalTrials.gov) | January 2013 | 8/10/2012 | Study of Ivacaftor in Cystic Fibrosis Subjects 2 Through 5 Years of Age With a CFTR Gating Mutation | A Phase 3, 2-Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are 2 Through 5 Years of Age and Have a CFTR Gating Mutation | Cystic Fibrosis | Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 2 Years | 5 Years | All | 35 | Phase 3 | United States;Canada;United Kingdom |
| 927 | EUCTR2012-002503-17-NL (EUCTR) | 21/12/2012 | 14/08/2012 | Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety | Tobramycin nebulisation with I-neb (TONI) study in children with cystic fibrosis: pharmacokinetics and safety - TONI study in children with CF | Cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bramitob Product Name: Bramitob Product Code: 033841 INN or Proposed INN: TOBRAMYCIN | Erasmus University Medical Centre | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Netherlands | ||||
| 928 | EUCTR2012-003532-23-HU (EUCTR) | 19/12/2012 | 31/10/2012 | An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TOBI Podhaler Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | ||
| 929 | EUCTR2011-000443-24-DK (EUCTR) | 14/12/2012 | 22/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 930 | NCT01695343 (ClinicalTrials.gov) | December 2012 | 25/9/2012 | Study to Evaluate the Effect of KB001-A on Time-to-Need for Antibiotic Treatment | A Phase 2, Randomized, Double-blind, Placebo-controlled, Repeat-dose Study of KB001-A in Subjects With Cystic Fibrosis Infected With Pseudomonas Aeruginosa | Cystic Fibrosis | Biological: KB001-A;Drug: Placebo Comparator | KaloBios Pharmaceuticals | NULL | Completed | 12 Years | 50 Years | Both | 182 | Phase 2 | United States;Australia;Israel;New Zealand |
| 931 | NCT01712334 (ClinicalTrials.gov) | December 2012 | 19/10/2012 | A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis | A Phase IV Multicenter, Randomized, Open Label, Two-Period, Crossover Study in Patients With Cystic Fibrosis to Evaluate the Comparable Efficacy and Safety of Pulmozyme Delivered by the eRapid Nebulizer System | Cystic Fibrosis | Drug: dornase alfa [Pulmozyme®] | Genentech, Inc. | NULL | Completed | 6 Years | N/A | All | 99 | Phase 4 | United States |
| 932 | NCT01641822 (ClinicalTrials.gov) | December 2012 | 13/7/2012 | Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas Aeruginosa Infection in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: AZLI;Drug: Placebo to match AZLI;Drug: Tobramycin inhalation solution | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 107 | Phase 3 | United States |
| 933 | EUCTR2009-012842-21-BE (EUCTR) | 19/11/2012 | 14/05/2012 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREASLIPASE | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Phase 3 | Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom | ||
| 934 | NCT01684683 (ClinicalTrials.gov) | November 2012 | 11/9/2012 | The Effect of Theophylline in the Treatment of Bronchiectasis | Clinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) Bronchiectasis | Bronchiectasis | Drug: Theophylline;Drug: Placebo(for Theophylline) | The First Affiliated Hospital of Guangzhou Medical University | NULL | Completed | 18 Years | 70 Years | Both | 100 | Phase 4 | China |
| 935 | NCT01721382 (ClinicalTrials.gov) | November 2012 | 26/10/2012 | Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis | Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis. | Cystic Fibrosis | Drug: Sitagliptin | Nemours Children's Clinic | NULL | Completed | 13 Years | 20 Years | Both | 6 | Phase 1 | United States |
| 936 | EUCTR2012-003140-68-GB (EUCTR) | 29/10/2012 | 28/09/2012 | A Study to Look at the Way the Body Absorbs and Distributes Posaconazole in the Blood and Lungs of Lung Transplant Recipients (PAPAL Study) | A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients | Invasive fungal infection (IFI) in lung transplant patients with and without cystic fibrosis. MedDRA version: 15.0;Level: PT;Classification code 10049085;Term: Antifungal prophylaxis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Noxafil Product Name: Noxafil INN or Proposed INN: Posaconazole | MSD | NULL | Not Recruiting | Female: yes Male: yes | 40 | United Kingdom | |||
| 937 | EUCTR2012-000389-39-GB (EUCTR) | 25/10/2012 | 20/04/2012 | Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR Mutation | A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation | cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Belgium;United Kingdom | ||
| 938 | NCT01316276 (ClinicalTrials.gov) | October 5, 2012 | 14/3/2011 | Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (ARIKACE™) in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Liposomal amikacin for inhalation | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 206 | Phase 3 | Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;United Kingdom |
| 939 | EUCTR2011-005799-41-GB (EUCTR) | 04/10/2012 | 21/08/2012 | Azole Therapy in Cystic Fibrosis (ATCF) | Azole Therapy in Cystic Fibrosis (ATCF) : Efficacy of itraconazole and ofvoriconazole in patients with cystic fibrosis and presenting withpersistent positive sputums for Aspergillus - Azole Therapy in Cystic Fibrosis (ATCF) | Cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: HLT;Classification code 10003486;Term: Aspergillus infections;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: SPORANOX Product Name: Sporanox 10 mg/ml Oral Solution INN or Proposed INN: ITRACONAZOLE Other descriptive name: SPORANOX Trade Name: V-Fend Product Name: VFEND 40 mg/ml powder for oral suspension INN or Proposed INN: voriconazole Other descriptive name: Vfend | CHU de Rennes (Rennes University Hospital Centre) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | United Kingdom | |||
| 940 | NCT01793649 (ClinicalTrials.gov) | October 2012 | 14/2/2013 | A Phase 1 Study to Characterize the Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) in Healthy Subjects | A Phase 1, Randomized, Double-Blind, Cross-Over, Vehicle-Controlled, Single-Dose Study To Characterize The Effect of GS-5737 Enhancement of Mucociliary Clearance (MCC) In Healthy Subjects | Cystic Fibrosis;Chronic Obstructive Pulmonary Disease | Drug: GS-5737 | Gilead Sciences | NULL | Terminated | 18 Years | 45 Years | Both | 7 | Phase 1 | United States |
| 941 | NCT01594827 (ClinicalTrials.gov) | October 2012 | 7/5/2012 | Persistent Methicillin Resistant Staphylococcus Aureus Eradication Protocol (PMEP) | Persistent MRSA Eradication Protocol (PMEP) | Cystic Fibrosis | Drug: Inhaled Vancomycin;Drug: Placebo (Sterile Water);Drug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole (TMP/SMX);Drug: Doxycycline;Drug: Mupirocin Intranasal Creme;Drug: 4% chlorhexidine gluconate liquid skin cleanser | Johns Hopkins University | Case Western Reserve University;Cystic Fibrosis Foundation | Completed | 12 Years | N/A | All | 29 | Phase 2 | United States |
| 942 | NCT01586728 (ClinicalTrials.gov) | October 2012 | 18/1/2012 | Oxygen Therapy in Cystic Fibrosis | Indication and Benefits of Nocturnal Oxygen Therapy in Cystic Fibrosis | Cystic Fibrosis | Other: Air - oxygen;Other: Oxygen - Air | Assistance Publique - Hôpitaux de Paris | Vaincre la Mucoviscidose | Terminated | 6 Years | N/A | Both | 8 | N/A | France |
| 943 | ChiCTR-TRC-12002470 | 2012-09-15 | 2012-08-02 | The effect of theophylline in the treatment of bronchiectasis, a random, double blind study | The effect of theophylline in the treatment of bronchiectasis, a random, double blind study. | bronchiectasis not due to cystic fibrosis | 1:theophylline;2:theophylline; | The first affiliated hospital of Guangzhou Medical University | NULL | Completed | 15 | 65 | Both | 1:46;2:46; | China | |
| 944 | EUCTR2011-000441-20-NL (EUCTR) | 11/09/2012 | 06/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom | |||
| 945 | EUCTR2012-000389-39-BE (EUCTR) | 03/09/2012 | 26/04/2012 | Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR Mutation | A Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-TermIvacaftor Treatment in Subjects 6 Years of Age and Older with CysticFibrosis and a Non-G551D CFTR Mutation | Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | France;United States;Belgium;United Kingdom | ||
| 946 | NCT02201082 (ClinicalTrials.gov) | September 2012 | 20/2/2014 | Evaluation of the Timing of the Nebulization Related to the Physiotherapy Session | Cystic Fibrosis | Procedure: Airway clearance technique;Drug: Amikacin nebulization | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Completed | 16 Years | 50 Years | Both | 15 | N/A | Belgium | |
| 947 | NCT01685801 (ClinicalTrials.gov) | September 2012 | 6/9/2012 | Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function | A Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 =40% Predicted | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo-matched-to-ivacaftor tablet | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 24 | Phase 2 | United States |
| 948 | NCT01667094 (ClinicalTrials.gov) | September 2012 | 13/8/2012 | A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic Fibrosis | Continuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis | Cystic Fibrosis | Drug: Intermittent, short infusion Ceftazidime;Drug: Continuous infusion Ceftazidime;Drug: Intermittent, short infusion Meropenem;Drug: Continuous infusion Meropenem;Drug: Intermittent, short infusion Ticarcillin-clavulanate;Drug: Continuous infusion Ticarcillin-clavulanate;Drug: Intermittent, short infusion Cefepime;Drug: Continuous infusion Cefepime;Drug: Continuous infusion Piperacillin tazobactam;Drug: Intermittent, short infusion Piperacillin tazobactam | The Alfred | NULL | Active, not recruiting | 18 Years | N/A | All | 50 | Phase 4 | Australia |
| 949 | NCT01694069 (ClinicalTrials.gov) | September 2012 | 19/9/2012 | Continuous Infusion Piperacillin-tazobactam for the Treatment of Cystic Fibrosis | Continuous Infusion Piperacillin-Tazobactam for the Treatment of Pulmonary Exacerbations in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Piperacillin-tazobactam combination product | West Virginia University | NULL | Terminated | 8 Years | N/A | All | 6 | Phase 4 | United States |
| 950 | NCT01684410 (ClinicalTrials.gov) | August 2012 | 6/9/2012 | Safety and Tolerability Trial of Inhaled Alpha1-Proteinase Inhibitor (Human), Hydrophobic Chromatography Process (Alpha-1 HC) in Subjects With Cystic Fibrosis | A Three Week Dose Escalation, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of 100 mg or 200 mg of Inhaled Alpha-1 HC, Once a Day in Subjects With Cystic Fibrosis. | Cystic Fibrosis | Biological: Alpha-1 HC 100 mg;Biological: Placebo;Biological: Alpha-1 HC 200 mg | Grifols Therapeutics Inc. | NULL | Completed | 18 Years | N/A | All | 30 | Phase 2 | United States |
| 951 | NCT01194232 (ClinicalTrials.gov) | August 2012 | 1/9/2010 | Sildenafil Trial in Children and Young Adults With CF | Randomized Controlled Study of Sildenafil in Children and Young Adults With Mild to Moderate Cystic Fibrosis Lung Disease | Cystic Fibrosis With Mild to Moderate Lung Disease;CMRI of Lung Perfusion;Lung Perfusion;Lung Vascularization | Drug: Sildenafil | Children's Hospital Medical Center, Cincinnati | NULL | Withdrawn | 8 Years | 21 Years | Both | 0 | Phase 1/Phase 2 | United States |
| 952 | NCT01652157 (ClinicalTrials.gov) | July 31, 2012 | 25/7/2012 | Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy) | A Long-Term Prospective Observational Safety Study of the Incidence of and Risk Factors for Fibrosing Colonopathy in US Patients With Cystic Fibrosis Treated With Pancreatic Enzyme Replacement Therapy: A Harmonized Protocol Across Sponsors(The CF-FC Study) | Fibrosing Colonopathy | Biological: ULTRESA;Biological: PANCREAZE;Biological: CREON;Biological: ZENPEP;Biological: other non-sponsor pancreatic enzyme replacement therapy;Biological: PERTZYE;Other: No pancreatic enzyme replacement therapy | AbbVie | Cystic Fibrosis Foundation;Digestive Care, Inc.;Nestle Health Science;VIVUS, Inc. | Terminated | N/A | 99 Years | All | 17 | United States | |
| 953 | NCT02190604 (ClinicalTrials.gov) | July 31, 2012 | 11/7/2014 | Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients | A Randomized, Double Blind Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of Single and Multiple Ascending Doses of QBW251 in Healthy Subjects and Multiple Doses in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Placebo;Drug: QBW251 | Novartis Pharmaceuticals | NULL | Terminated | 18 Years | 65 Years | All | 153 | Phase 1/Phase 2 | United States;Belgium;France;Germany;Ireland;Romania;United Kingdom;Netherlands |
| 954 | EUCTR2012-000388-26-BE (EUCTR) | 23/07/2012 | 20/04/2012 | Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation | A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation | Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;United States;Belgium | ||
| 955 | EUCTR2011-005085-37-GB (EUCTR) | 20/07/2012 | 24/05/2012 | Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients. | A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients. | cystic fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: QBW251 INN or Proposed INN: Not assigned Product Code: QBW251 INN or Proposed INN: Not assigned | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 1;Phase 2 | United States;France;Belgium;Ireland;Romania;Netherlands;Germany;United Kingdom | ||
| 956 | EUCTR2011-005790-23-GB (EUCTR) | 17/07/2012 | 06/06/2012 | Comparison of recovery of adrenal gland function following short and long term steroid treatment | Comparison of adrenal recovery following short and long-term glucocorticoid therapy. - Adrenal recovery following short and long-term glucocorticoid therapy | Adrenal recovery following long and short term steroid treatment. MedDRA version: 14.1;Level: LLT;Classification code 10066550;Term: Chronic arthritis;System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 14.1;Classification code 10000842;Term: Acute lymphatic leukaemia;System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1;Classification code 10008953;Term: Chronic liver disease;System Organ Class: 10019805 - Hepatobiliary disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Physiological processes [G07] | Product Name: Prednisolone INN or Proposed INN: Prednisolone Product Name: Hydrocortisone INN or Proposed INN: Hydrocortisone | Birmingham Children's Hospital NHS Foundation Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 60 | United Kingdom | |||
| 957 | NCT02014181 (ClinicalTrials.gov) | July 2012 | 27/11/2013 | Flaxseed Modulates Inflammation and Oxidative Stress in CF | Flaxseed Modulates Oxidative Stress and Inflammatory Biomarkers in Stable Patients With Cystic Fibrosis and Healthy Controls | Cystic Fibrosis;Oxidative Stress;Inflammation | Dietary Supplement: finely ground flaxseed powder | University of Pennsylvania | NULL | Completed | 18 Years | 64 Years | Both | 10 | Phase 1 | United States |
| 958 | NCT01614470 (ClinicalTrials.gov) | July 2012 | 5/6/2012 | Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation | A Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | N/A | All | 39 | Phase 3 | United States;Belgium;France |
| 959 | NCT01614457 (ClinicalTrials.gov) | July 2012 | 5/6/2012 | Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have the R117H-CF Transmembrane Conductance Regulator (CFTR) Mutation (KONDUCT) | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR Mutation | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | N/A | All | 70 | Phase 3 | United States;United Kingdom;Ireland |
| 960 | EUCTR2011-001255-36-AT (EUCTR) | 25/06/2012 | 18/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | ||
| 961 | EUCTR2011-000801-39-IT (EUCTR) | 20/06/2012 | 21/06/2012 | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially effects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbility and mortality. PA infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | MUKOVISZIDOSE E.V. | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 962 | EUCTR2011-000441-20-BG (EUCTR) | 13/06/2012 | 03/05/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 963 | EUCTR2012-000387-19-GB (EUCTR) | 11/06/2012 | 20/04/2012 | Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR Mutation | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR Mutation | cystic fibrosis MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;United Kingdom | ||
| 964 | NCT01747330 (ClinicalTrials.gov) | June 2012 | 23/11/2012 | Evaluation of Safety and Tolerability of Creon Micro in Children Younger Than Four Years With Pancreatic Exocrine Insufficiency | An Open Label, Multicenter Study Evaluating Safety and Tolerability of Creon Micro in Pediatric Subjects From at Least One Month to Less Than Four Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Pancreatic Exocrine Insufficiency | Drug: Pancreatin | Abbott Products | NULL | Completed | N/A | 4 Years | All | 40 | Phase 3 | Russian Federation |
| 965 | NCT01641393 (ClinicalTrials.gov) | June 2012 | 10/7/2012 | Safety and Efficacy Study of 2 Pancreatic Enzymes for Treatment of Exocrine Pancreatic Insufficiency in Cystic Fibrosis. | A Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in the Treatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine Pancreatic Insufficiency: Cystic Fibrosis | Drug: EUR-1008 25,000 Units;Drug: Kreon 25,000 Units | Aptalis Pharma | NULL | Completed | 12 Years | N/A | Both | 96 | Phase 3 | Belgium;Bulgaria;France;Germany;Italy;Poland;United Kingdom |
| 966 | NCT01619657 (ClinicalTrials.gov) | June 2012 | 12/6/2012 | Preventive Inhalation of Hypertonic Saline in Infants With Cystic Fibrosis | Randomized, Double-blind, Controlled Pilot Study on Safety of Hypertonic Saline as Preventive Inhalation Therapy in Newborns and Infants With Cystic Fibrosis | Cystic Fibrosis Lung Disease | Drug: 6% Hypertonic Saline (HS), 4mL;Drug: 0.9% Isotonic Saline (IS), 4mL | Heidelberg University | German Center for Lung Research | Completed | N/A | 4 Months | All | 42 | Phase 2 | Germany |
| 967 | EUCTR2011-000443-24-SE (EUCTR) | 24/05/2012 | 07/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 968 | EUCTR2011-001916-69-NL (EUCTR) | 22/05/2012 | 07/02/2012 | treatment with insulin in patients with cystic fibrosis without diabetes | insulin therapy in non-diabetic adults with cystic fibrosis - insulin in CF without CFRD | cystic fibrosis patients without cystic fibrosis related diabetes;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | Trade Name: Lantus 100 units/ml solution for injection in a cartridge | HagaZiekenhuis, pulmonary department | NULL | Not Recruiting | Female: yes Male: yes | 40 | Netherlands | |||
| 969 | EUCTR2011-000441-20-IE (EUCTR) | 02/05/2012 | 26/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Code: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 970 | EUCTR2011-003821-93-GB (EUCTR) | 01/05/2012 | 19/04/2012 | A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | A Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Product Name: VX-661 Product Code: VX-661, VRT-893661 INN or Proposed INN: Not yet assigned Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 220 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Germany;United Kingdom | ||
| 971 | NCT01621867 (ClinicalTrials.gov) | May 2012 | 14/6/2012 | Repeated Application of Gene Therapy in CF Patients | A Randomised, Double-blind, Placebo-controlled Phase 2B Clinical Trial of Repeated Application of Gene Therapy in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: pGM169/GL67A;Drug: Placebo | Imperial College London | University of Edinburgh;University of Oxford;Royal Brompton & Harefield NHS Foundation Trust | Completed | 12 Years | N/A | Both | 130 | Phase 2 | United Kingdom |
| 972 | EUCTR2011-000801-39-BE (EUCTR) | 26/04/2012 | 09/01/2012 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 973 | EUCTR2011-000443-24-IT (EUCTR) | 10/04/2012 | 19/03/2012 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin Product Code: NA INN or Proposed INN: AMIKACIN SULFATE | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 250 | Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 974 | NCT01572194 (ClinicalTrials.gov) | April 2012 | 28/3/2012 | Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation (MUCO-IRC) | Predictive Value of PIIINP Urinary for the Development of Chronic Renal Failure in Patients With Cystic Fibrosis After Lung Transplantation. | Lung Transplantation;Cystic Fibrosis;Renal Failure | Biological: Urinary levels of PIIINP as a marker of changes in renal function | Nantes University Hospital | NULL | Terminated | 18 Years | N/A | All | 45 | N/A | France |
| 975 | NCT01270074 (ClinicalTrials.gov) | April 2012 | 23/12/2010 | Prevention of Bronchiectasis in Infants With Cystic Fibrosis | A Phase 3 Multi-centre Randomised Placebo-controlled Study of Azithromycin in the Primary Prevention of Radiologically-defined Bronchiectasis in Infants With Cystic Fibrosis. | Cystic Fibrosis;Bronchiectasis | Drug: Azithromycin;Drug: Placebo control | The University of Queensland | Telethon Kids Institute | Completed | 6 Weeks | 6 Months | All | 130 | Phase 3 | Australia;New Zealand |
| 976 | EUCTR2011-000441-20-DK (EUCTR) | 29/03/2012 | 22/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 977 | EUCTR2011-001362-18-DE (EUCTR) | 19/03/2012 | 20/12/2011 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;United States;Spain;Poland;Germany;Italy | ||
| 978 | EUCTR2011-001255-36-NL (EUCTR) | 13/03/2012 | 19/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;France;Spain;Poland;Belgium;Ireland;Austria;Germany;Netherlands;Italy | ||
| 979 | EUCTR2011-004761-33-GB (EUCTR) | 08/03/2012 | 14/12/2011 | Repeated application of gene therapy in patients with cystic fibrosis | A randomised double-blind placebo-controlled Phase 2B clinical trial of repeated application of gene therapy in patients with cystic fibrosis - Repeated application of gene therapy in patients with CF v01-010204 | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: pGM169/GL67A Other descriptive name: pGM169/GL67A | Imperial College | NULL | Not Recruiting | Female: yes Male: yes | 130 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 980 | NCT01417481 (ClinicalTrials.gov) | March 2012 | 15/8/2011 | Effect of Glycine in Cystic Fibrosis | Evaluation of the Capability of a Glycine Oral Supplement for Diminishing Bronchial Inflammation in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Glycine;Dietary Supplement: Placebo | Instituto Nacional de Enfermedades Respiratorias | Hospital Infantil de Mexico Federico Gomez;Instituto Mexicano del Seguro Social | Terminated | 5 Years | 15 Years | All | 13 | Phase 2 | Mexico |
| 981 | NCT03045198 (ClinicalTrials.gov) | March 2012 | 2/2/2017 | Effect of Azithromycin on Fatty Acids in CF | Effect of Azithromycin on Lipoproteins and Docosahexaenoic Acid in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Azithromycin | University Childrens' Hospital (Zentrum für Kinderheilkunde des Universitätsklinikum Bonn) | University of Bonn;University Hospital, Frankfurt | Unknown status | 10 Years | 60 Years | All | 20 | Phase 4 | NULL |
| 982 | NCT01315691 (ClinicalTrials.gov) | February 29, 2012 | 14/3/2011 | Study to Evaluate Arikace™ in CF Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikace™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Liposomal amikacin for inhalation;Drug: Placebo for liposomal amikacin for inhalation | Insmed Incorporated | NULL | Withdrawn | 6 Years | N/A | All | 0 | Phase 3 | NULL |
| 983 | NCT01315678 (ClinicalTrials.gov) | February 29, 2012 | 14/3/2011 | Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections | Randomized, Open-Label, Active-Controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Pseudomonas Aeruginosa Infection | Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer.;Drug: Tobramycin inhalation solution using a PARI LC® Plus nebulizer. | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 302 | Phase 3 | Austria;Belgium;Bulgaria;Canada;Denmark;France;Germany;Greece;Hungary;Ireland;Italy;Netherlands;Poland;Serbia;Slovakia;Spain;Sweden;United Kingdom |
| 984 | EUCTR2011-002000-32-IT (EUCTR) | 09/02/2012 | 06/03/2012 | A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A single arm, open-label, multicenter, Phase IV trial to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Tobramycin inhalation powder Product Code: TBM100C INN or Proposed INN: TOBRAMYCIN Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;Hungary;Mexico;Canada;Argentina;Spain;Brazil;Australia;Germany;Italy | ||
| 985 | EUCTR2011-001362-18-IT (EUCTR) | 08/02/2012 | 22/02/2012 | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) | Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa. MedDRA version: 14.1;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM Other descriptive name: NA | GILEAD SCIENCES INC. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | France;United States;Spain;Germany;Italy | ||
| 986 | EUCTR2011-000801-39-SE (EUCTR) | 08/02/2012 | 13/12/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 14.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 987 | EUCTR2011-001255-36-BE (EUCTR) | 07/02/2012 | 13/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | France;United States;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy | ||
| 988 | EUCTR2011-001255-36-IE (EUCTR) | 06/02/2012 | 24/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | ||
| 989 | NCT01531673 (ClinicalTrials.gov) | February 2012 | 1/2/2012 | Study of VX-661 Alone and in Combination With Ivacaftor in Subjects Homozygous or Heterozygous to the F508del-Cystic Fibrosis Transmembrane Conductance Regulator(CFTR) Mutation | A Phase 2, Multicenter, Double-Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: VX-661;Drug: Ivacaftor;Drug: Placebo matched to VX-661;Drug: Placebo matched to ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Completed | 12 Years | N/A | All | 194 | Phase 2 | United States;Canada;Germany;United Kingdom |
| 990 | NCT01429259 (ClinicalTrials.gov) | February 2012 | 2/9/2011 | Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children | An Open Label Study to Assess the Population Pharmacokinetics, Safety, and Practicality of Administering Meropenem as a Prolonged Infusion to Cystic Fibrosis Children Admitted With an Acute Pulmonary Exacerbation | Cystic Fibrosis;Pneumonia;Pseudomonas Aeruginosa Infection | Drug: meropenem | Joseph Kuti | Thrasher Research Fund | Completed | 6 Years | 17 Years | All | 30 | Phase 4 | United States |
| 991 | NCT01543191 (ClinicalTrials.gov) | February 2012 | 27/2/2012 | A Safety and Tolerability Study OF PUR118 In Subjects With Cystic Fibrosis | A Phase 1 Dose-escalation Study TO Evaluate the Safety and Tolerability of PUR118 and Placebo in Subjects With CF | Cystic Fibrosis | Drug: PUR118 | Pulmatrix Inc. | Celerion | Completed | 18 Years | 55 Years | Both | 10 | Phase 1 | United Kingdom |
| 992 | EUCTR2011-000443-24-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 993 | EUCTR2011-000441-20-BE (EUCTR) | 30/01/2012 | 25/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: N/A INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI Product Code: N/A INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany | ||
| 994 | EUCTR2011-001255-36-IT (EUCTR) | 27/01/2012 | 28/09/2012 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas aeruginosa (PA) Aztreonam Lysine for Pseudomonas Infection Eradication (ALPINE)study - ALPINE | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 15.0;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations MedDRA version: 15.0;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Aztreonam 75 mg powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM | GILEAD SCIENCES INC. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;Spain;Ireland;Austria;Netherlands;Germany;Italy | ||
| 995 | EUCTR2011-001362-18-ES (EUCTR) | 25/01/2012 | 21/12/2011 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mgPowder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | Cystic fibrosis and chronic infection of lower respiratory tract withPseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam solución para inhalación Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 3 | United States;France;Poland;Spain;Germany;Italy | ||
| 996 | EUCTR2011-000443-24-PL (EUCTR) | 20/01/2012 | 06/10/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 997 | EUCTR2011-001255-36-DE (EUCTR) | 16/01/2012 | 11/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;France;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy | ||
| 998 | NCT01608555 (ClinicalTrials.gov) | January 2012 | 28/5/2012 | Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis | Tobramycin 300 mg o.d. Aerosol in in Adult Patients With Cystic Fibrosis: Pilot Study on Antimicrobial Activity | Cystic Fibrosis | Drug: tobramycin | University of Milan | Chiesi Farmaceutici S.p.A. | Completed | 18 Years | 45 Years | Both | 10 | Phase 4 | Italy |
| 999 | NCT02128984 (ClinicalTrials.gov) | January 2012 | 28/3/2014 | Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children | Clinical Study With an Enteral Formula With Symbiotic and DHA for Malnourished Children | Cystic Fibrosis;Failure to Thrive;Malnutrition | Dietary Supplement: Symbiotic Formula with DHA and antioxidants;Dietary Supplement: Standard Formula | Laboratorios Ordesa | Quantum Experimental;Peruvian Clinical Research | Completed | 1 Year | N/A | All | 109 | N/A | Peru;Spain |
| 1000 | NCT01519661 (ClinicalTrials.gov) | January 2012 | 24/1/2012 | Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis | A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis | Pulmonary Infections;Pseudomonas Aeruginosa in Cystic Fibrosis | Drug: TBM100 | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 157 | Phase 4 | United States;Argentina;Australia;Canada;France;Germany;Hungary;Italy;Mexico;Spain;Brazil |
| 1001 | NCT01509339 (ClinicalTrials.gov) | January 2012 | 9/1/2012 | Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis | Pharmacokinetics of Vancomycin for Inhalation in Cystic Fibrosis | Cystic Fibrosis;Methicillin-resistant Staphylococcus Aureus | Drug: Vancomycin | Case Western Reserve University | Cystic Fibrosis Foundation Therapeutics | Active, not recruiting | 18 Years | N/A | Both | 10 | Phase 1 | United States |
| 1002 | NCT01731015 (ClinicalTrials.gov) | January 2012 | 16/11/2012 | Imaging Lung Function Using Oxygen Enhanced MRI | A Pilot Study for Evaluation of Regional Lung Function in Normal Subjects and Subjects With Airway and Lung Disorders Using 1H Magnetic Resonance Imaging With Oxygen as a Contrast Agent | COPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways Disease | Drug: Medical Grade Oxygen | Hal C Charles | NULL | Completed | 18 Years | 90 Years | Both | 15 | Phase 1 | United States |
| 1003 | EUCTR2011-002719-27-IT (EUCTR) | 30/12/2011 | 13/03/2012 | EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUS | GLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSIS | PATIENTS WITH CYSTIC FIBROSIS MedDRA version: 14.1;Level: PT;Classification code 10011766;Term: Cystic fibrosis pancreatic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19] | Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML INN or Proposed INN: MECASERMIN | AZIENDA OSPEDALIERA DI PARMA | NULL | Not Recruiting | Female: yes Male: yes | 20 | Italy | |||
| 1004 | EUCTR2011-002000-32-DE (EUCTR) | 13/12/2011 | 31/10/2011 | A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation Product Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy | ||
| 1005 | NCT01404234 (ClinicalTrials.gov) | December 2011 | 26/7/2011 | Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa (PA) in the Lower Airways | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: AZLI | Gilead Sciences | NULL | Completed | N/A | 12 Years | All | 61 | Phase 3 | United States;France;Germany;Italy;Poland;Spain |
| 1006 | EUCTR2011-002000-32-HU (EUCTR) | 25/11/2011 | 05/09/2011 | A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler 28 mg inhalációs por, kemény kapszula Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy | ||
| 1007 | EUCTR2011-001255-36-ES (EUCTR) | 23/11/2011 | 18/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for P.aeruginosa. MedDRA version: 14.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | United States;France;Poland;Belgium;Spain;Ireland;Austria;Netherlands;Germany;Italy | ||
| 1008 | EUCTR2011-002000-32-ES (EUCTR) | 17/11/2011 | 28/09/2011 | A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis - not available | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI PODHALER Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Farmaceutica S. A | NULL | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy | ||
| 1009 | NCT00889434 (ClinicalTrials.gov) | November 1, 2011 | 20/4/2009 | Efficacy and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated Cystic Fibrosis (CF) | Single-site, Open-label, Dose-ranging, Efficacy, and Safety Study of EGCG/Tocotrienol in 18 Patients With Splicing-mutation-mediated CF | Cystic Fibrosis | Dietary Supplement: ECGC;Dietary Supplement: Tocotrienol;Dietary Supplement: EGCG + Tocotrienol | Hadassah Medical Organization | NULL | Completed | 18 Years | N/A | All | 7 | N/A | Israel |
| 1010 | NCT02276898 (ClinicalTrials.gov) | November 2011 | 22/10/2014 | A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index | A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance Index as a Short-term Pharmacodynamic Biomarker in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo) | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 24 | Phase 2 | Canada |
| 1011 | NCT01537666 (ClinicalTrials.gov) | November 2011 | 17/2/2012 | Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics | Phase I, Reference-controlled, Dose Escalating Study to Examine the Pharmacokinetics and Safety of AeroVanc Inhalation Powder. | Healthy;Cystic Fibrosis | Drug: AeroVanc;Drug: IV vancomycin hydrochloride | Savara Inc. | INC Research Limited | Completed | 18 Years | 50 Years | All | 25 | Phase 1 | Australia |
| 1012 | EUCTR2011-006171-19-IT (EUCTR) | 27/10/2011 | 13/01/2012 | Multicentric and randomized study to evaluate the effectiveness of the association of the 2 different treatments in the early P.aerugionsa infection in patient with cystic fibrosis disease. The study will enlist pazients over 5 years old. | randomized multicentric clinical trial upon efficacy of two different drugs combination to eradication of early p.aeruginosa infection in cystic fibrosis patients over 5 years old. | Cystic fibrosis patients with early P.aeruginosa infection. MedDRA version: 14.1;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: CIPROXIN*6CPR RIV 500MG INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML INN or Proposed INN: TOBRAMYCIN Trade Name: CIPROXIN*6CPR RIV 500MG INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI INN or Proposed INN: COLISTIN MESILATE SODIUM | AZIENDA OSPEDALIERA MEYER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1013 | EUCTR2011-001821-26-IT (EUCTR) | 18/10/2011 | 20/03/2012 | Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis | Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis: pilot study of antimicrobial activity | Adult patient with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: BRAMITOB*NEBUL 28F 300MG/4ML INN or Proposed INN: TOBRAMYCIN | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1014 | EUCTR2011-000443-24-DE (EUCTR) | 11/10/2011 | 30/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 1015 | EUCTR2011-000442-38-BG (EUCTR) | 03/10/2011 | 05/07/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
| 1016 | EUCTR2011-000443-24-BG (EUCTR) | 03/10/2011 | 28/07/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 1017 | EUCTR2011-000441-20-IT (EUCTR) | 01/10/2011 | 08/03/2012 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE Trade Name: Tobi INN or Proposed INN: TOBRAMYCIN | INSMED INCORPORATED | NULL | Not Recruiting | Female: yes Male: yes | 300 | Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy | |||
| 1018 | NCT01002534 (ClinicalTrials.gov) | October 2011 | 26/10/2009 | Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients? | Does a Nasal Instillation of Vardenafil Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind, Placebo-controlled Study. | Cystic Fibrosis | Drug: Vardenafil;Drug: Placebo | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Terminated | 14 Years | N/A | All | 5 | Phase 2 | Belgium |
| 1019 | NCT01537614 (ClinicalTrials.gov) | October 2011 | 17/2/2012 | Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis | Cystic Fibrosis | Drug: COLIMYCINE inhalation;Drug: COLIMYCINE injectable | Poitiers University Hospital | NULL | Completed | 18 Years | N/A | Both | 7 | Phase 1 | France | |
| 1020 | NCT01426256 (ClinicalTrials.gov) | October 2011 | 29/8/2011 | Vitamin D for Enhancing the Immune System in Cystic Fibrosis (DISC Study) | Vitamin D for Enhancing the Immune System in Cystic Fibrosis | Cystic Fibrosis;Respiratory Tract Infections | Dietary Supplement: Cholecalciferol | Emory University | Cystic Fibrosis Foundation Therapeutics | Completed | 16 Years | N/A | All | 91 | Phase 3 | United States |
| 1021 | NCT01455675 (ClinicalTrials.gov) | October 2011 | 18/10/2011 | Efficacy Study of IgY (Antibody Against Pseudomonas) in Cystic Fibrosis Patients | Phase III Study to Evaluate Clinical Efficacy and Safety of Avian Polyclonal Anti-Pseudomonas Antibodies (IgY) in Prevention of Recurrence of Pseudomonas Aeruginosa Infection in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: IgY;Drug: Placebo | Mukoviszidose Institut gGmbH | NULL | Completed | 5 Years | N/A | All | 164 | Phase 3 | Austria;Belgium;Germany;Hungary;Ireland;Italy;Poland;Spain;Sweden |
| 1022 | NCT01783613 (ClinicalTrials.gov) | October 2011 | 31/1/2013 | Eficacy of Long-term Suplementation With Docosahexaenoic Acid in Patients With Cystic Fibrosis | Study of the Eficacy of Long-term Suplementation With Docosahexaenoic Acid on Pulmonary, Sistemic and Intestinal Inflammation in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Docosahexaenoic acid administration: 50 mg/kg/day during 12 months;Dietary Supplement: Placebo: 50 mg/kg/day during 12 months | Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal | NULL | Completed | 2 Months | 100 Years | All | 96 | N/A | Spain |
| 1023 | EUCTR2011-000443-24-ES (EUCTR) | 22/09/2011 | 03/11/2011 | Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta Arikace en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa | Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta de amicacina liposomal para inhalación (Arikace) en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa - NCT0131627 | Infeccion pulmonar por Pseudomonas Aeruginosa/ colonizacion en pacientes con fibrosis quistica MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace TM) INN or Proposed INN: Sulfato de amikacina | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 1024 | EUCTR2011-000441-20-ES (EUCTR) | 21/09/2011 | 11/11/2011 | ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | ESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108 | Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Amikacina liposomal (Arikace?) INN or Proposed INN: Sulfato de amikacina Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador INN or Proposed INN: tobramicina | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands | ||
| 1025 | EUCTR2011-000442-38-ES (EUCTR) | 21/09/2011 | 11/11/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;Sweden;New Zealand | |||
| 1026 | EUCTR2011-000441-20-DE (EUCTR) | 19/09/2011 | 30/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution Product Name: TOBI INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 1027 | EUCTR2010-019692-30-ES (EUCTR) | 07/09/2011 | 29/07/2011 | Extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Spain;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 1028 | EUCTR2011-000801-39-DE (EUCTR) | 31/08/2011 | 04/04/2011 | Placebo controlled clinical study to evaluate efficacy and safety of an antibody derived from hens’ eggs building a barrier in the respiratory tract against the Pseudomonas germ in order to prevent infection with Pseudomonas in patients suffering from cystic fibrosis | Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY | Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients. MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: avian polyclonal IgY antibody against PA Product Code: PsAer IgY INN or Proposed INN: IgY | Mukoviszidose Institute gGmbH | NULL | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | ||
| 1029 | EUCTR2010-019692-30-GB (EUCTR) | 22/08/2011 | 23/08/2011 | Extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 1030 | EUCTR2010-019634-26-GB (EUCTR) | 18/08/2011 | 07/02/2011 | Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: Tobi 300 mg/5 ml Nebuliser Solution INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Ireland;Israel;Germany;United Kingdom | ||
| 1031 | EUCTR2011-000443-24-GR (EUCTR) | 09/08/2011 | 23/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 1032 | EUCTR2011-000443-24-IE (EUCTR) | 05/08/2011 | 26/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 1033 | EUCTR2011-000443-24-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 1034 | EUCTR2011-000441-20-GB (EUCTR) | 03/08/2011 | 24/05/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 1035 | NCT01375049 (ClinicalTrials.gov) | August 2011 | 15/6/2011 | Aztreonam Lysine for Pseudomonas Infection Eradication Study | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients With Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas Aeruginosa (PA) | Cystic Fibrosis | Drug: Aztreonam for Inhalation Solution (AZLI) | Gilead Sciences | NULL | Completed | 3 Months | 17 Years | All | 105 | Phase 2 | Italy;Netherlands;Poland;Spain;Austria;Belgium;France;Germany;United States;Ireland |
| 1036 | NCT01772758 (ClinicalTrials.gov) | August 2011 | 16/10/2012 | Cystic Fibrosis and Endothelial Function: At Rest and During Exercise | Influence of Cystic Fibrosis on Vascular Endothelial Function at Rest and During Exercise | Cystic Fibrosis | Drug: BH4 5mg;Drug: BH4 20mg;Dietary Supplement: Antioxidant Cocktail | Augusta University | NULL | Completed | 7 Years | N/A | All | 64 | Phase 2 | United States |
| 1037 | EUCTR2011-000443-24-FR (EUCTR) | 28/07/2011 | 31/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) Product Code: NA INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden | ||
| 1038 | EUCTR2005-003772-37-IE (EUCTR) | 26/07/2011 | 08/07/2008 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom | ||
| 1039 | EUCTR2011-000130-11-IT (EUCTR) | 25/07/2011 | 05/03/2012 | Clinical trials in rare diseases: therapeutic alternative to the use of oral corticosteroids in patients with cystic fibrosis underwent double lung transplantation. | Clinical trials in rare diseases: therapeutic alternative to the use of oral corticosteroids in patients with cystic fibrosis underwent double lung transplantation. | Double lung transplantation in patients with Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10025127;Term: Lung transplant;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Dexamethasone sodium phosphate 250 mg/10 ml solution Product Code: NA INN or Proposed INN: Dexamethasone | AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1040 | EUCTR2011-000443-24-AT (EUCTR) | 22/07/2011 | 27/06/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden | |||
| 1041 | EUCTR2011-000441-20-AT (EUCTR) | 19/07/2011 | 21/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 1042 | EUCTR2011-000441-20-GR (EUCTR) | 15/07/2011 | 22/06/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 1043 | EUCTR2011-000192-13-PL (EUCTR) | 08/07/2011 | 31/05/2011 | A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosis | A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study | systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Colobreathe Product Code: N/A INN or Proposed INN: Colistimethate sodium Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate | Forest Laboratories UK Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 28 | Poland;Ukraine;Germany;United Kingdom | |||
| 1044 | EUCTR2011-000441-20-SK (EUCTR) | 04/07/2011 | 25/11/2014 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany | |||
| 1045 | EUCTR2011-000443-24-SK (EUCTR) | 04/07/2011 | 20/02/2014 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands | ||
| 1046 | EUCTR2009-016590-15-IT (EUCTR) | 01/07/2011 | 14/03/2012 | Evaluation of the efficacy and safety of tobramycin for the treatment of early infections of P. aeruginosa in cystic fibrosis subjects aged from 3 months to less than 7 years. | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients. MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: TOBRAMYCIN Other descriptive name: NA | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 72 | France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Switzerland;Italy | |||
| 1047 | EUCTR2011-000443-24-HU (EUCTR) | 29/06/2011 | 11/05/2011 | Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Long Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden | |||
| 1048 | EUCTR2011-000441-20-HU (EUCTR) | 29/06/2011 | 20/04/2011 | Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Randomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE Trade Name: TOBI 300mg/5ml Nebuliser solution INN or Proposed INN: TOBRAMYCIN | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands | |||
| 1049 | NCT01755455 (ClinicalTrials.gov) | June 2011 | 19/12/2012 | Does a Daily Iron Tablet Improve Anemia in Cystic Fibrosis | Iron Supplementation for the Hypoferremic Anemia of Cystic Fibrosis | Cystic Fibrosis;Anemia, Iron-Deficiency | Drug: Ferrous sulfate 325mg;Drug: Placebo | Dartmouth-Hitchcock Medical Center | NULL | Completed | 18 Years | 70 Years | All | 22 | N/A | United States |
| 1050 | NCT02782312 (ClinicalTrials.gov) | June 2011 | 17/5/2016 | Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis | Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective Study | Bronchiectasis | Drug: ICS+LABA;Other: routine therapy | Shanghai Pulmonary Hospital, Shanghai, China | NULL | Completed | 18 Years | N/A | Both | 120 | Phase 4 | China |
| 1051 | NCT01381289 (ClinicalTrials.gov) | June 2011 | 22/6/2011 | VX-770 Expanded Access Program | VX-770 Expanded Access Program (EAP) | Cystic Fibrosis | Drug: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | NULL | |
| 1052 | EUCTR2010-019634-26-DE (EUCTR) | 24/05/2011 | 25/01/2011 | Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI 300 mg/5 ml Lösung für einen INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | France;United States;Canada;Ireland;Israel;Germany;United Kingdom | ||
| 1053 | EUCTR2010-019692-30-DE (EUCTR) | 11/05/2011 | 13/04/2011 | Extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden | ||
| 1054 | EUCTR2011-000192-13-DE (EUCTR) | 05/05/2011 | 05/04/2011 | A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosis | A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study | systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Colobreathe Product Code: N/A INN or Proposed INN: Colistimethate sodium Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate | Forest Laboratories UK Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Poland;Ukraine;Germany;United Kingdom | |||
| 1055 | EUCTR2010-019634-26-IE (EUCTR) | 03/05/2011 | 15/02/2011 | Trial of Aeroquin versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 330 | Phase 3 | France;United States;Canada;Ireland;Israel;Germany;United Kingdom | ||
| 1056 | NCT01207245 (ClinicalTrials.gov) | May 2011 | 21/9/2010 | Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis | Circadian Rhythm In Tobramycin Elimination In Cystic Fibrosis (CRITIC) A Randomized Pharmacokinetic Comparison of Tobramycin in Cystic Fibrosis | Cystic Fibrosis | Other: Tobramycin time of administration | University of Nottingham | NULL | Completed | 5 Years | N/A | Both | 18 | Phase 4 | United Kingdom |
| 1057 | NCT02295566 (ClinicalTrials.gov) | May 2011 | 20/8/2014 | RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot Study | RATNO (Reducing Antibiotic Tolerance Using NO) Reducing Antibiotic Tolerance Using Low Dose Nitric Oxide in Cystic Fibrosis - a Phase 2 Pilot Study | Cystic Fibrosis | Drug: Nitric Oxide;Drug: Control | University Hospital Southampton NHS Foundation Trust. | University of Southampton | Completed | 12 Years | N/A | Both | 12 | Phase 2 | United Kingdom |
| 1058 | NCT01465529 (ClinicalTrials.gov) | May 2011 | 31/10/2011 | A Cross-over Study of OligoG in Subjects With Cystic Fibrosis. Fibrosis | A Double-blind, Randomized, Placebo-controlled, Cross-over Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of Alginate Oligosaccharide (OligoG) Administered for 28 Days in Subjects With Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: OligoG CF-5/20;Drug: Saline | AlgiPharma AS | NULL | Completed | 18 Years | N/A | Both | 26 | Phase 1/Phase 2 | Ireland;United Kingdom |
| 1059 | NCT01355796 (ClinicalTrials.gov) | May 2011 | 16/5/2011 | Inhaled Xylitol Versus Saline in Stable Subjects With Cystic Fibrosis | Randomized Cross Over Study of Inhaled Hypertonic Xylitol Versus Hypertonic Saline in Stable Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Xylitol;Drug: Hypertonic saline | Joseph Zabner | Ann & Robert H Lurie Children's Hospital of Chicago;Northwestern University | Completed | 16 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
| 1060 | EUCTR2011-000192-13-GB (EUCTR) | 28/04/2011 | 17/03/2011 | A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study | A 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study | cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Colobreathe Product Code: N/A INN or Proposed INN: Colistimethate sodium Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate | Forest Laboratories UK Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 28 | Germany;United Kingdom;Poland | |||
| 1061 | EUCTR2010-023090-19-IE (EUCTR) | 08/04/2011 | 15/02/2011 | A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa | A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis | Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: OligoG (60 mg/ml) Product Code: OligoG INN or Proposed INN: Sodium alginate Other descriptive name: SODIUM ALGINATE | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Ireland;United Kingdom | ||
| 1062 | NCT01314716 (ClinicalTrials.gov) | April 2011 | 11/3/2011 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection (AIR-BX2) | Bronchiectasis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 274 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom |
| 1063 | NCT01347190 (ClinicalTrials.gov) | April 2011 | 3/5/2011 | Safety and Tolerability Study of Liquid Alpha1 Proteinase Inhibitor (API) in Subjects With Cystic Fibrosis | A Double Blind, Randomized, Placebo Controlled, Single Dose, Phase I Study of the Safety and Tolerability of Alpha1 Proteinase Inhibitor (Human) Inhalation Solution (CR002) in Subjects With Cystic Fibrosis | Cystic Fibrosis | Biological: CR002 Liquid API;Biological: Placebo | CSL Behring | NULL | Completed | 18 Years | 65 Years | Both | 25 | Phase 1 | Bulgaria;Hungary;Poland;United Kingdom |
| 1064 | NCT01327703 (ClinicalTrials.gov) | April 2011 | 28/3/2011 | Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | An Open-label, Multicenter, Randomized, Cross-over Study to Compare the Safety and Efficacy of PANZYTRAT® 25,000 to KREON® 25,000 in the Control of Steatorrhea in Subjects Aged 7 Years and Older With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (EPI) | Exocrine Pancreatic Insufficiency;Cystic Fibrosis | Drug: Panzytrat® 25,000;Drug: Kreon® 25,000 | Forest Laboratories | NULL | Completed | 7 Years | N/A | All | 87 | Phase 4 | Germany;Poland |
| 1065 | NCT01349192 (ClinicalTrials.gov) | April 2011 | 4/5/2011 | Early Methicillin-resistant Staphylococcus Aureus (MRSA) Therapy in Cystic Fibrosis (CF) | Early MRSA Therapy in CF - Culture Based vs. Observant Therapy (Treat or Observe) (Star-TOO - STaph Aureus Resistance - Treat or Observe) | Cystic Fibrosis;Methicillin-resistant Staphylococcus Aureus | Drug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole;Drug: Minocycline;Drug: Mupirocin;Drug: chlorhexidine gluconate oral rinse;Drug: 2% Chlorhexidine solution wipes;Behavioral: Environmental Decontamination | University of North Carolina, Chapel Hill | CF Therapeutics Development Network Coordinating Center;Seattle Children's Hospital;Washington University School of Medicine;University of Washington;University of Colorado, Denver;Baylor College of Medicine;University of Alabama at Birmingham;Cook Children's Medical Center;University of Michigan;University of Florida;University of Texas Southwestern Medical Center;Children's Hospital Medical Center, Cincinnati;St. Louis Children's Hospital | Terminated | 4 Years | 45 Years | All | 47 | Phase 2 | United States |
| 1066 | NCT01313624 (ClinicalTrials.gov) | April 2011 | 10/3/2011 | Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution in Subjects With Non-CF Bronchiectasis and Gram-Negative Endobronchial Infection | Bronchiectasis | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | N/A | All | 266 | Phase 3 | United States;Australia;Canada |
| 1067 | NCT01315665 (ClinicalTrials.gov) | April 2011 | 14/3/2011 | Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation | Evaluation of the Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation, Measures of Oxidative Stress, and Neutrophil Migration to Mucosal Surfaces in Healthy and CF Subjects | Cystic Fibrosis | Dietary Supplement: Broccoli sprouts | University Hospitals Cleveland Medical Center | Cystic Fibrosis Foundation | Completed | 18 Years | 49 Years | All | 15 | N/A | United States |
| 1068 | NCT01337219 (ClinicalTrials.gov) | April 2011 | 13/4/2011 | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaide® in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Tobramycin | Erempharma | University of Lyon;Epidemiologie Pharmacologie Investigation Clinique Information medicale Mere Enfant (EPICIME);Clininfo;Hospices Civils de Lyon | Recruiting | 16 Years | N/A | Both | 36 | Phase 1/Phase 2 | France |
| 1069 | NCT03644199 (ClinicalTrials.gov) | March 30, 2011 | 10/5/2016 | Development of Diabetes in Adults With Cystic Fibrosis (CF) | Factors Responsible for the Development of Diabetes in Adults With Cystic Fibrosis | Cystic Fibrosis | Other: Oral Glucose Tolerance Test (OGTT) assessment arm;Other: Mixed meal test evaluation test arm | Liverpool Heart and Chest Hospital NHS Foundation Trust | NULL | Withdrawn | 18 Years | 50 Years | All | 0 | N/A | United Kingdom |
| 1070 | EUCTR2010-023090-19-GB (EUCTR) | 29/03/2011 | 11/02/2011 | A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa | A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: OligoG (60 mg/ml) Product Code: OligoG INN or Proposed INN: OligoG Other descriptive name: OligoG-CF5/20, Alginate oligosaccharide (G-block) fragment | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Ireland;United Kingdom | ||
| 1071 | NCT02029521 (ClinicalTrials.gov) | March 2011 | 30/12/2013 | Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis Patients | Supplementation of Oral Reduced Glutathione in Pediatric Cystic Fibrosis for Growth Failure | Cystic Fibrosis | Dietary Supplement: Oral reduced l-glutathione;Dietary Supplement: Placebo | Clark Bishop | NULL | Completed | 18 Months | 10 Years | All | 47 | N/A | Italy |
| 1072 | EUCTR2009-012842-21-BG (EUCTR) | 24/02/2011 | 28/09/2010 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy | |||
| 1073 | EUCTR2010-023529-39-GB (EUCTR) | 18/02/2011 | 31/12/2010 | Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0 | Reducing antibiotic tolerance using low dose nitric oxide in cystic fibrosis – a phase 2 pilot study - RATNO (Reducing Antibiotic Tolerance using Nitric Oxide in CF) v 1.0 | Cystic Fibrosis | Trade Name: INOmax 400ppm mol/mol inhalation gas Product Name: Nitric Oxide Product Code: NO | Southampton University Hopsitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom | |||
| 1074 | EUCTR2010-020413-90-BE (EUCTR) | 08/02/2011 | 15/10/2010 | Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 293 | Phase 2 | United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand | ||
| 1075 | EUCTR2009-012842-21-DE (EUCTR) | 13/01/2011 | 13/07/2010 | Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;Italy;United Kingdom | |||
| 1076 | EUCTR2010-020413-90-DE (EUCTR) | 06/01/2011 | 15/10/2010 | Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-809 Product Code: VX-809, VRT-826809 INN or Proposed INN: lumacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 293 | Phase 2 | New Zealand;United Kingdom;Germany;Australia;Belgium;United States | ||
| 1077 | NCT02163681 (ClinicalTrials.gov) | January 1, 2011 | 10/6/2014 | MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and Children | Healthy;Cystic Fibrosis (CF);Asthma;Bronchopulmonary Dysplasia (BPD) | Drug: Hyperpolarized Helium-3 MRI of the chest | University of Virginia | Xemed LLC | Completed | 4 Months | 65 Years | All | 77 | N/A | United States | |
| 1078 | NCT01262352 (ClinicalTrials.gov) | January 2011 | 15/12/2010 | Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | N/A | All | 21 | Phase 2 | United States;Canada;United Kingdom;Ireland |
| 1079 | NCT01229553 (ClinicalTrials.gov) | January 2011 | 26/10/2010 | Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients | Effect of Topical and Systemic Decolonization of Staphylococcus Aureus (SA) in Pediatric Cystic Fibrosis (CF) Patients at the CF Center at SUNY Upstate Medical University, Syracuse, NY. | Cystic Fibrosis | Drug: decolonization | State University of New York - Upstate Medical University | NULL | Withdrawn | 2 Months | 23 Months | Both | 0 | N/A | United States |
| 1080 | NCT01270347 (ClinicalTrials.gov) | January 2011 | 3/1/2011 | Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) Patients | Phase 3, Open-label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin) vs. Tobramycin Inhalation Solution (TIS) in Stable CF Patients | Cystic Fibrosis | Drug: MP-376 (Levofloxacin Solution for Inhalation);Drug: TIS (Tobramycin Inhalation Solution) | Horizon Pharma USA, Inc. | Forest Laboratories | Completed | 12 Years | N/A | All | 267 | Phase 3 | United States;France;Germany;Ireland;Israel;United Kingdom |
| 1081 | NCT01494909 (ClinicalTrials.gov) | January 2011 | 15/12/2011 | Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function | Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and Function | Cystic Fibrosis | Dietary Supplement: Ensure plus | Texas A&M University | Arkansas Children's Hospital Research Institute;University of Arkansas | Active, not recruiting | 10 Years | N/A | All | 31 | N/A | United States |
| 1082 | EUCTR2010-023030-23-GB (EUCTR) | 24/12/2010 | 23/11/2010 | Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1 | Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1 | Cystic fibrosis | Trade Name: Nebcin (tobramycin) Product Name: Tobramycin injection 40mg/1ml INN or Proposed INN: Tobramcyin | The Univeristy of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 20 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1083 | EUCTR2010-022042-24-GB (EUCTR) | 24/12/2010 | 25/10/2010 | A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with Pseudomonas | A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with Pseudomonas | The aim of this randomized double blind controlled study is to evaluate the efficacy of a 3 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis. MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Lipitor Product Name: Atorvastatin INN or Proposed INN: Atorvastatin Other descriptive name: Lipitor | NHS Lothian | University of Edinburgh | Not Recruiting | Female: yes Male: yes | 32 | Phase 4 | United Kingdom | ||
| 1084 | EUCTR2010-022040-20-GB (EUCTR) | 17/12/2010 | 21/10/2010 | A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in Bronchiectasis | A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in Bronchiectasis | The aim of this randomised double blind controlled study to evaluate the efficacy of 6 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders | Trade Name: Lipitor Product Name: Atorvastatin INN or Proposed INN: Atorvastatin Other descriptive name: Lipitor | NHS Lothian | University of Edinburgh | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1085 | EUCTR2010-019692-30-SE (EUCTR) | 16/12/2010 | 11/10/2010 | Extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 1086 | EUCTR2010-019802-17-IE (EUCTR) | 15/12/2010 | 09/09/2010 | Tiotropium-bromide in cystic fibrosis | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - | Cystic Fibrosis MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 440 | Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;United Kingdom;Slovakia;Russian Federation;Czech Republic;Canada;Belgium;Spain;United States;Poland | |||
| 1087 | NCT00625703 (ClinicalTrials.gov) | December 2010 | 19/2/2008 | Pharmacokinetics of Linezolid in Children With Cystic Fibrosis | Pharmacokinetics of Linezolid in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Linezolid | University of Texas Southwestern Medical Center | Cystic Fibrosis Foundation | Completed | N/A | 18 Years | All | 45 | Phase 2 | United States |
| 1088 | NCT01100892 (ClinicalTrials.gov) | December 2010 | 31/3/2010 | Cystic Fibrosis - Insulin Deficiency, Early Action | Cystic Fibrosis - Insulin Deficiency, Early Action | Cystic Fibrosis;Diabetes | Drug: Once-daily insulin detemir | Sydney Children's Hospitals Network | John Hunter Children's Hospital;Lady Cilento Children's Hospital, Brisbane;Women's and Children's Hospital, Adelaide;Children's Hospital Colorado | Recruiting | 5 Years | 19 Years | All | 100 | Phase 3 | United States;Australia |
| 1089 | EUCTR2010-019802-17-ES (EUCTR) | 29/11/2010 | 22/09/2010 | Ensayo clínico aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para confirmar eficacia y seguridad del tratamiento durante 12 semanas con tiotropio 5mcg una vez al día inhalado via Respimat® en pacientes con fibrosis quística.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 mcg administered once daily via the Respimat® device in patients with cystic fibrosis. - | Fibrosis QuísticaCystic Fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim España, S.A | NULL | Not Recruiting | Female: yes Male: yes | 360 | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Ireland;Spain;Italy;Austria | ||||
| 1090 | EUCTR2010-019802-17-DE (EUCTR) | 25/11/2010 | 04/08/2010 | Clinical trial to confirm the efficacy and safety of tiotropium 5 microgram administered via Respimat device, in patients with cystic fibrosis. | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. | Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat INN or Proposed INN: Tiotropium Bromide (monohydrate) | Boehringer Ingelheim Pharma GmbH & Co. KG | NULL | Not Recruiting | Female: yes Male: yes | 372 | Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany | |||
| 1091 | EUCTR2010-019802-17-BE (EUCTR) | 23/11/2010 | 11/08/2010 | Tiotropium-bromide in cystic fibrosic | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. | Cystic Fibrosis MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;South Africa;Germany | ||
| 1092 | EUCTR2010-019692-30-NL (EUCTR) | 04/11/2010 | 24/06/2010 | Extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 1093 | NCT01299194 (ClinicalTrials.gov) | November 2010 | 21/10/2010 | Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa | A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in Patients With Pseudomonas Aeruginosa | BRONCHIECTASIS | Drug: ATORVASTATIN | University of Edinburgh | NHS Lothian | Completed | 18 Years | 80 Years | All | 32 | Phase 4 | United Kingdom |
| 1094 | NCT01299181 (ClinicalTrials.gov) | November 2010 | 21/10/2010 | A Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis | A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Atorvastatin | University of Edinburgh | NHS Lothian | Completed | 18 Years | 75 Years | Both | 60 | Phase 4 | United Kingdom |
| 1095 | NCT01180634 (ClinicalTrials.gov) | November 2010 | 10/8/2010 | MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic Fibrosis | A Phase 3, Multi-Center, Multinational, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Efficacy And Safety Of MP-376 (Levofloxacin Inhalation Solution; Aeroquin™) In Stable Cystic Fibrosis Patients | Cystic Fibrosis | Drug: MP-376 (Levofloxacin solution for Inhalation);Drug: Placebo | Horizon Pharma USA, Inc. | Forest Laboratories | Completed | 12 Years | N/A | All | 330 | Phase 3 | United States;Australia;Canada;Israel;New Zealand |
| 1096 | EUCTR2010-018454-13-DK (EUCTR) | 27/10/2010 | 13/08/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | ||
| 1097 | EUCTR2010-019802-17-GB (EUCTR) | 22/10/2010 | 10/08/2010 | Tiotropium-bromide in cystic fibrosis | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - | Cystic Fibrosis MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 471 | Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;Slovakia;Russian Federation;United Kingdom;Czech Republic;Canada;Belgium;Spain;United States;Poland | |||
| 1098 | EUCTR2010-019802-17-AT (EUCTR) | 20/10/2010 | 09/09/2010 | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - | Cystic Fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 12.1;Level: PT;Term: Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim RCV GmbH & Co KG | ,NULL | Not Recruiting | Female: yes Male: yes | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | |||||
| 1099 | EUCTR2010-020546-96-GB (EUCTR) | 08/10/2010 | 17/08/2010 | Study of the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects with Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted - | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | United Kingdom;Canada;United States | ||
| 1100 | EUCTR2010-019692-30-IT (EUCTR) | 06/10/2010 | 02/11/2010 | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009e-CF | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009e-CF | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762 | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC THERAPEUTICS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 1101 | EUCTR2010-019692-30-FR (EUCTR) | 05/10/2010 | 17/06/2010 | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 1102 | EUCTR2010-019802-17-CZ (EUCTR) | 01/10/2010 | 16/08/2010 | Tiotropium-bromide in cystic fibrosic | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. | Cystic Fibrosis MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 360 | Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany | |||
| 1103 | NCT01216046 (ClinicalTrials.gov) | October 2010 | 29/9/2010 | Drug-Drug Interaction Study of VX-770 and VX-809 in Healthy Subjects | A Phase 1, Randomized, Double-Blind, Placebo Controlled, Multiple-Dose, Dose-Escalation, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects | Cystic Fibrosis | Drug: VX-809;Drug: VX-770;Drug: VX-809 placebo;Drug: VX-770 placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 48 | Phase 1 | United States |
| 1104 | NCT01225211 (ClinicalTrials.gov) | October 2010 | 15/10/2010 | Study of VX-809 Alone and in Combination With VX-770 in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR Mutation | A Phase 2, Multicenter, Double-Blinded, Placebo-Controlled, Multiple-Dose Study to Evaluate Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: Lumacaftor;Drug: Ivacaftor;Drug: Lumacaftor Placebo;Drug: Ivacaftor Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 312 | Phase 2 | United States;Australia;Belgium;France;Germany;New Zealand;United Kingdom;Ireland |
| 1105 | NCT01956916 (ClinicalTrials.gov) | October 2010 | 23/9/2013 | Probiotics in Cystic Fibrosis | Effects of LGG Administration in Children With Cystic Fibrosis: A Randomized Controlled Trial | Cystic Fibrosis | Dietary Supplement: Lactobacillus rhamnosus GG;Dietary Supplement: placebo | Federico II University | NULL | Completed | 2 Years | 18 Years | Both | 110 | Phase 3 | Italy |
| 1106 | NCT01161537 (ClinicalTrials.gov) | October 2010 | 9/7/2010 | Study of the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects With Cystic Fibrosis and the G551D Mutation | A Phase 2, Single-Blind, Placebo-Controlled Study to Evaluate the Effect of VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging in Subjects With Cystic Fibrosis, the G551D Mutation, and FEV1 =40% Predicted | Cystic Fibrosis | Drug: VX-770;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 12 Years | N/A | All | 13 | Phase 2 | United States |
| 1107 | NCT01201434 (ClinicalTrials.gov) | October 2010 | 31/8/2010 | Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis | The Effect of Probiotics on Sputum Bacteria, Sputum Inflammation, and Pulmonary Infections in Patients With Cystic Fibrosis: A Double-blind Placebo-controlled Trial | Cystic Fibrosis | Dietary Supplement: Bio-25 probiotic | Sheba Medical Center | NULL | Terminated | 5 Years | 40 Years | Both | 12 | N/A | NULL |
| 1108 | EUCTR2010-019802-17-HU (EUCTR) | 30/09/2010 | 23/07/2010 | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - | Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 microgram Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim RCV GmbH & Co KG | NULL | Not Recruiting | Female: yes Male: yes | 360 | Portugal;Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | ||||
| 1109 | EUCTR2009-012997-11-DE (EUCTR) | 27/09/2010 | 25/06/2010 | Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and Older | An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST | Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 217 | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom | |||
| 1110 | EUCTR2009-012842-21-GB (EUCTR) | 20/09/2010 | 17/06/2010 | Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis | Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis | Exocrine pancreatic insufficiency associated with cystic fibrosis MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Kreon 25 000 Product Name: KREON 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREASLIPASE | Aptalis Pharma US Inc. | NULL | Not Recruiting | Female: yes Male: yes | 86 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom | ||
| 1111 | EUCTR2010-020516-11-IT (EUCTR) | 16/09/2010 | 28/09/2010 | EXPERIMENTAL STUDY, RANDOMIZED, OPEN LABEL, TO EVALUATE THE EFFECT OF DOCOSAHEXAENOIC ACID (DHA) SUPPLEMENTATION VERSUS 5-METHYLTETHRAHYDROFOLATE + B12 VITAMIN AND DHA, IN CYSTIC FIBROSIS PATIENTS AND PANCREATIC INSUFFICIENCY - ND | EXPERIMENTAL STUDY, RANDOMIZED, OPEN LABEL, TO EVALUATE THE EFFECT OF DOCOSAHEXAENOIC ACID (DHA) SUPPLEMENTATION VERSUS 5-METHYLTETHRAHYDROFOLATE + B12 VITAMIN AND DHA, IN CYSTIC FIBROSIS PATIENTS AND PANCREATIC INSUFFICIENCY - ND | CYSTIC FIBROSIS AND PANCREATIC INSUFFICIENCY MedDRA version: 9.1;Level: PT;Classification code 10033628 MedDRA version: 9.1;Classification code 10011762 | Trade Name: PREFOLIC*30CPR GASTROR 15MG INN or Proposed INN: Detoxifying agents for antineoplastic treatment Trade Name: INDUSIL*OS GTT FL 30MG+FL 15ML INN or Proposed INN: Cobamamide | AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1112 | EUCTR2010-019802-17-FR (EUCTR) | 14/09/2010 | 23/07/2010 | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. | Cystic Fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | Ireland;Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Germany;Italy;United Kingdom | ||
| 1113 | EUCTR2010-019802-17-PT (EUCTR) | 13/09/2010 | 07/07/2010 | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - | Cystic Fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 360 | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | ||||
| 1114 | EUCTR2010-019802-17-SK (EUCTR) | 13/09/2010 | 03/08/2010 | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. | Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Product Name: Spiriva Respimat 2.5 mcg Product Code: Tiotropium Respimat Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE | Boehringer Ingelheim RCV GmbH&Co KG | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom | ||
| 1115 | EUCTR2010-018454-13-ES (EUCTR) | 06/09/2010 | 31/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado | Cystic fibrosisFibrosis quistica MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine- N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine- N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Belgium;Spain;Denmark;Germany;United Kingdom;Italy | ||
| 1116 | EUCTR2010-018454-13-GB (EUCTR) | 01/09/2010 | 18/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;Germany;United Kingdom;France;Spain;Italy | ||
| 1117 | NCT01208285 (ClinicalTrials.gov) | September 2010 | 22/9/2010 | Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects | A Phase 1 Non-Randomized, Open-Label Study to Assess the Safety and Pharmacokinetics of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy Subjects | In Development for Cystic Fibrosis | Drug: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 65 Years | Both | 24 | Phase 1 | Czech Republic;Slovakia |
| 1118 | NCT01179347 (ClinicalTrials.gov) | September 2010 | 10/8/2010 | Tiotropium Bromide in Cystic Fibrosis | A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: tiotropium Respimat® inhaler;Drug: Placebo Respimat® inhaler | Boehringer Ingelheim | NULL | Completed | N/A | N/A | All | 464 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czech Republic;France;Germany;Hungary;Ireland;Israel;Italy;Poland;Portugal;Russian Federation;Slovakia;South Africa;Spain;Switzerland;United Kingdom |
| 1119 | NCT01257464 (ClinicalTrials.gov) | September 2010 | 2/12/2010 | Sitagliptin in Cystic Fibrosis-Related Diabetes | The Effects of the DPPIV Inhibitor Sitagliptin in Cystic Fibrosis-related Diabetes | Cystic Fibrosis | Drug: Sitagliptin;Drug: Placebo | University of British Columbia | NULL | Terminated | 19 Years | N/A | Both | 3 | Phase 2 | Canada |
| 1120 | NCT01090908 (ClinicalTrials.gov) | September 2010 | 11/3/2010 | Evaluation of Ciprofloxacin for Inhalation to Cystic Fibrosis Patients With P. Aeruginosa | A Multi-Center, Open Label Study To Evaluate The Safety, Tolerability And Pharmacokinetics Of Ciprofloxacin For Inhalation (CFI) Given Daily For 14 Days To Stable Cystic Fibrosis Patients Ages 6 To 17 With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Antibiotic | Aradigm Corporation | NULL | Withdrawn | 6 Years | 18 Years | Both | 0 | N/A | NULL |
| 1121 | NCT01222273 (ClinicalTrials.gov) | September 2010 | 14/10/2010 | Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis | Open-label Vitamin D Trial for Patients With Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis | Cystic Fibrosis;Allergic Bronchopulmonary Aspergillosis | Dietary Supplement: cholecalciferol (Vitamin D3) | University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 12 Years | N/A | All | 7 | N/A | United States |
| 1122 | NCT01223183 (ClinicalTrials.gov) | September 2010 | 14/10/2010 | Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis | Absorptive Clearance After Inhaled Osmotics in Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic saline (7%);Drug: isotonic saline | University of Pittsburgh | NULL | Completed | 18 Years | N/A | All | 20 | Phase 1 | United States |
| 1123 | EUCTR2010-018454-13-DE (EUCTR) | 31/08/2010 | 21/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 1124 | EUCTR2010-018454-13-CZ (EUCTR) | 27/08/2010 | 21/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;United Kingdom;Germany;Czech Republic;France;Spain;Italy | ||
| 1125 | EUCTR2009-012997-11-FR (EUCTR) | 25/08/2010 | 27/04/2010 | An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST | An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST | Cystic Fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: VX-770 Product Code: VX-770, VRT-8130077 Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 217 | Phase 3 | France;Czech Republic;Ireland;Germany;United Kingdom | ||
| 1126 | EUCTR2010-018454-13-HU (EUCTR) | 17/08/2010 | 17/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 1127 | NCT01140451 (ClinicalTrials.gov) | August 12, 2010 | 7/6/2010 | Extension Study of Ataluren (PTC124) in Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124®) in Subjects With Nonsense-Mutation-Mediated Cystic Fibrosis | Cystic Fibrosis | Drug: Ataluren | PTC Therapeutics | Cystic Fibrosis Foundation | Completed | 6 Years | N/A | All | 191 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 1128 | EUCTR2010-018454-13-FR (EUCTR) | 10/08/2010 | 28/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetylcysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | ||
| 1129 | EUCTR2010-019692-30-BE (EUCTR) | 10/08/2010 | 25/05/2010 | Extension study of ataluren in patients with Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden | ||
| 1130 | EUCTR2009-012842-21-IT (EUCTR) | 10/08/2010 | 23/08/2010 | A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND | A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND | exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF) MedDRA version: 9.1;Level: HLGT;Classification code 10015674 MedDRA version: 9.1;Level: LLT;Classification code 10011762 | Trade Name: ZENPEP INN or Proposed INN: Multienzymes (lipase, protease etc.) Trade Name: CREON 10000 Capsules INN or Proposed INN: Multienzymes (lipase, protease etc.) | EURAND SPA | NULL | Not Recruiting | Female: yes Male: yes | 86 | Hungary;Bulgaria;Germany;United Kingdom;Italy | |||
| 1131 | NCT01181622 (ClinicalTrials.gov) | August 2010 | 12/8/2010 | A Safety and Tolerability Study of Denufosol in 2-4 Year Olds | A Phase 2, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 7-Day Safety and Tolerability Study of Denufosol Tetrasodium Inhalation Solution Administered Via PARI LC® Star in Patients 2 to 4 Years of Age With Cystic Fibrosis | Cystic Fibrosis | Drug: denufosol tetrasodium Inhalation Solution;Drug: 0.9% w/v sodium chloride solution | Merck Sharp & Dohme Corp. | NULL | Completed | 2 Years | 4 Years | Both | 25 | Phase 2 | United States |
| 1132 | NCT00782288 (ClinicalTrials.gov) | August 2010 | 29/10/2008 | Phase II Study of Digitoxin to Treat Cystic Fibrosis | Phase II Study of Digitoxin to Treat Cystic Fibrosis | Cystic Fibrosis | Drug: digitoxin;Other: placebo | National Jewish Health | NULL | Completed | 18 Years | 45 Years | All | 24 | Phase 2 | United States |
| 1133 | EUCTR2010-019802-17-IT (EUCTR) | 27/07/2010 | 20/08/2010 | A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 micrograms administered once daily via the Respimat device in patients with cystic fibrosis. - ND | Patients with cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762 | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: Tiotropium bromide | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 440 | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | ||||
| 1134 | EUCTR2009-016590-15-DE (EUCTR) | 19/07/2010 | 15/04/2010 | A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI 300 mg/5 ml Lösung für einen Vernebler Product Name: TOBI Product Code: TBM100 INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | France;Egypt;Hungary;Greece;Canada;Argentina;Poland;Romania;Russian Federation;Germany;Switzerland;Italy | |||
| 1135 | EUCTR2010-018454-13-IT (EUCTR) | 15/07/2010 | 15/06/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011762 | Product Name: Nacystelyn Product Code: NAL INN or Proposed INN: L-Lysine N acetylcysteinate Product Name: Nacystelyn Product Code: NAL INN or Proposed INN: L-Lysine N-acetylcysteinate | LABORATOIRES SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | ||
| 1136 | EUCTR2008-005045-34-IE (EUCTR) | 09/07/2010 | 18/05/2010 | A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis | A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis | non-CF bronchiectasis (CF = cystic fibrosis) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis | Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution Other descriptive name: colistimethate sodium | Profile Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 260 | United Kingdom;Ireland | |||
| 1137 | EUCTR2009-012997-11-GB (EUCTR) | 08/07/2010 | 21/06/2010 | Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6 and Older | An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST | Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 217 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom | ||
| 1138 | EUCTR2009-012997-11-IE (EUCTR) | 06/07/2010 | 05/05/2010 | Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and Older | An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST | Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 217 | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom | |||
| 1139 | EUCTR2009-016734-26-BG (EUCTR) | 01/07/2010 | 15/06/2010 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Lithuania;Bulgaria;Latvia | ||
| 1140 | NCT01116089 (ClinicalTrials.gov) | July 2010 | 29/4/2010 | Pharmacokinetic Study of Bramitob® Administered for Inhalation by PARI eFlow® vs PARI LC® PLUS Nebulizer | PHARMACOKINETIC STUDY OF BRAMITOB® ADMINISTERED FOR INHALATION BY PARI eFLOW® RAPID ELECTRONIC NEBULIZER VS PARI LC® PLUS NEBULIZER COUPLED WITH THE PARI TURBO BOY® N COMPRESSOR IN CYSTIC FIBROSIS PATIENTS INFECTED WITH PSEUDOMONAS AERUGINOSA | Cystic Fibrosis | Drug: Bramitob® administered by PARI LC® PLUS nebulizer;Drug: Bramitob® administered by PARI eFlow® rapid electronic nebulizer | Chiesi Farmaceutici S.p.A. | NULL | Completed | 18 Years | N/A | All | 25 | Phase 1 | Czechia;Moldova, Republic of;Slovakia;Czech Republic;Russian Federation |
| 1141 | NCT01117012 (ClinicalTrials.gov) | July 2010 | 3/5/2010 | Rollover Study of VX-770 in Cystic Fibrosis Subjects | An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | N/A | All | 192 | Phase 3 | United States;Australia;Canada;Czech Republic;France;Germany;Ireland;United Kingdom |
| 1142 | NCT01131507 (ClinicalTrials.gov) | July 2010 | 25/5/2010 | PR-018: An Open-Label, Safety Extension of Study PR-011 | A Multicenter, Open-Label, Safety Extension of Study PR-011 Titled: A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF) | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: EUR-1008 (APT-1008) | Forest Laboratories | NULL | Completed | N/A | 12 Months | All | 15 | Phase 4 | United States |
| 1143 | EUCTR2009-012997-11-CZ (EUCTR) | 22/06/2010 | 12/05/2010 | Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and Older | An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects with Cystic Fibrosis - PERSIST | Cystic Fibrosis MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 217 | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom | |||
| 1144 | EUCTR2009-016590-15-GR (EUCTR) | 15/06/2010 | 31/12/2009 | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization | Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | France;Hungary;Greece;Poland;Germany;Italy | |||
| 1145 | EUCTR2010-018738-27-DE (EUCTR) | 02/06/2010 | 16/03/2010 | A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic Fibrosis | A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic Fibrosis | Cystic fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: SB-656933 Tablets Product Code: SB-656933-AAA Product Name: SB-656933 Tablets Product Code: SB-656933-AAA | GlaxoSmithKline Research & Development Limited | NULL | Not Recruiting | Female: yes Male: yes | 100 | Germany | |||
| 1146 | NCT01100606 (ClinicalTrials.gov) | June 2010 | 31/3/2010 | A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age | A Multicenter, Randomized, Open-Label, Crossover Study to Evaluate the Mode of Administration and Safety of EUR-1008 in Infants 1 to 12 Months of Age With Exocrine Pancreatic Insufficiency (EPI) Associated With Cystic Fibrosis (CF) | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: EUR-1008 (APT-1008) | Forest Laboratories | NULL | Completed | 1 Month | 12 Months | All | 15 | Phase 4 | United States |
| 1147 | NCT01149005 (ClinicalTrials.gov) | June 2010 | 9/6/2010 | Cystic Fibrosis (CF) Exacerbation and Insulin Treatment | Evaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary Exacerbation | Cystic Fibrosis;Impaired Glucose Tolerance;Pulmonary Exacerbation | Drug: novorapid / humalog short acting insulin;Drug: Novo Rapid Insulin (Novonordisk) | Hadassah Medical Organization | NULL | Not yet recruiting | 10 Years | N/A | Both | 30 | N/A | Israel |
| 1148 | NCT01450267 (ClinicalTrials.gov) | June 2010 | 30/9/2011 | Inhaled Glutathione (GSH) Versus Placebo in Cystic Fibrosis | Randomized, Single Blind, Controlled Trial of Inhaled Glutathione Versus Placebo in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Inhaled Reduced Glutathione;Drug: Physiological solution | Serafino A. Marsico | Federico II University | Recruiting | 6 Years | 45 Years | Both | 150 | Phase 3 | Italy |
| 1149 | NCT01153542 (ClinicalTrials.gov) | June 2010 | 28/6/2010 | Study of VX-770 on Desipramine | An Open-Label Phase 1 Study to Examine the Effect of VX 770 on Desipramine in Healthy Subjects | In Development for Cystic Fibrosis | Drug: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 24 | Phase 1 | United States |
| 1150 | EUCTR2007-001401-15-DK (EUCTR) | 21/05/2010 | 14/04/2010 | Treatment of patients with cystic fibrosis with N-acetylcysteine | Treatment of patients with cystic fibrosis with N-acetylcysteine | Patients with cystic fibrosis and chronic Pseudomonas lung infection MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: ACC600Tabs Product Name: N-acetylcystein Product Code: R05C B01 INN or Proposed INN: ACETYLCYSTEINE | Rigshospitalet | NULL | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | |||
| 1151 | EUCTR2007-006276-11-IT (EUCTR) | 18/05/2010 | 07/05/2010 | A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - ND | A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - ND | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763 | Product Name: heparin 25mg inhalation powder, hard capsule Product Code: VR496 | VECTURA LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1/2 | Ireland;Italy | ||
| 1152 | EUCTR2010-019194-15-IT (EUCTR) | 12/05/2010 | 13/05/2010 | Esplorative study to evaluate the tolerability of Amphotericin B lipid complex (Abelcet) by aerosol in patients with Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA) - ND | Esplorative study to evaluate the tolerability of Amphotericin B lipid complex (Abelcet) by aerosol in patients with Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA) - ND | Cystic Fibrosis and Allergic Bronchopulmonary Aspergillosis (ABPA) MedDRA version: 9.1;Level: SOC;Classification code 10021881 MedDRA version: 9.1;Level: PT;Classification code 10011762 | Trade Name: ABELCET INN or Proposed INN: Amphotericin B | AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1153 | NCT01092572 (ClinicalTrials.gov) | May 2010 | 23/3/2010 | Statins To Treat Adult Cystic Fibrosis | The Effect of Simvastatin on Systemic Inflammation in Adult Cystic Fibrosis Subjects: A Pilot Study | Cystic Fibrosis;Systemic Inflammation | Drug: Simvastatin;Drug: placebo | University of British Columbia | NULL | Withdrawn | 18 Years | N/A | Both | 0 | Phase 1/Phase 2 | Canada |
| 1154 | NCT01158937 (ClinicalTrials.gov) | May 2010 | 7/7/2010 | Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patients | Pharmacokinetic Study of Extended Infusion Meropenem in Adult Cystic Fibrosis Patient With Exacerbation of Pulmonary Infection | Cystic Fibrosis Pulmonary Exacerbation | Drug: Meropenem Infusion | St. Michael's Hospital, Toronto | Sunnybrook Health Sciences Centre;University of Toronto | Terminated | 18 Years | N/A | Both | 2 | N/A | Canada |
| 1155 | NCT00967798 (ClinicalTrials.gov) | May 2010 | 27/8/2009 | Prevention of Cystic Fibrosis Diabetes | A Randomized, Double-blind, Placebo-controlled Study to Determine Whether Chronic Treatment of Cystic Fibrosis Subjects With Impaired Glucose Tolerance Using Sitagliptin (Januvia) Prevents the Development of Diabetes | Cystic Fibrosis;Prediabetes | Drug: Sitagliptin | Emory University | NULL | Terminated | 13 Years | N/A | All | 33 | Phase 3 | United States;Canada |
| 1156 | NCT02690857 (ClinicalTrials.gov) | May 2010 | 16/2/2016 | Study of Docosahexanoic Acid in Patients With Cystic Fibrosis (CF) | Efficacy of Docosahexanoic Acid on Lipid Peroxidation in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Docosahexaenoic acid;Drug: Sunflower Oil | Hospices Civils de Lyon | NULL | Completed | 6 Years | 30 Years | Male | 10 | Phase 2 | NULL |
| 1157 | EUCTR2009-016590-15-FR (EUCTR) | 15/04/2010 | 14/12/2009 | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization | Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin Trade Name: TOBI 300mg/5mL nebuliser solution Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 72 | Phase 3 | France;Hungary;Greece;Poland;Germany;Italy | ||
| 1158 | NCT01321905 (ClinicalTrials.gov) | April 2010 | 23/3/2011 | Prospective Intervention Study on Vitamin D in Patients With Cystic Fibrosis | 5-month Pilot Intervention Study on Vitamin D in Patients With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Supplementation with vitamin D2/D3 | Karolinska Institutet | Stockholm County Council, Sweden;Swedish Cystic Fibrosis Association | Recruiting | 6 Years | N/A | Both | 15 | Phase 2 | Sweden |
| 1159 | NCT01093521 (ClinicalTrials.gov) | April 2010 | 24/3/2010 | A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients | A Pharmacokinetic and Safety Study of IV Gallium Nitrate (Ganite) in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: 100 mg/m2 dose;Drug: 200 mg/m2 dose | University of Washington | Cystic Fibrosis Foundation | Completed | 18 Years | 55 Years | All | 20 | Phase 1 | United States |
| 1160 | NCT00763477 (ClinicalTrials.gov) | April 2010 | 30/9/2008 | Ghrelin in Cystic Fibrosis | The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis | Cystic Fibrosis | Biological: ghrelin | Papworth Hospital | NULL | Recruiting | 18 Years | 80 Years | Both | 20 | N/A | United Kingdom |
| 1161 | NCT01082367 (ClinicalTrials.gov) | April 2010 | 5/3/2010 | Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. Aeruginosa in Cystic Fibrosis Subjects Aged From 3 Months to Less Than 7 Years | Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients | Drug: TOBI;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 3 Months | 6 Years | All | 50 | Phase 3 | Canada;Egypt;France;Germany;Greece;Hungary;Italy;Romania;Russian Federation;Switzerland;Poland;United States |
| 1162 | NCT01460836 (ClinicalTrials.gov) | April 2010 | 25/10/2011 | Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis | Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalation | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | Both | N/A | NULL | |
| 1163 | EUCTR2009-016734-26-LT (EUCTR) | 23/03/2010 | 20/01/2010 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Lithuania;Bulgaria;Latvia | ||
| 1164 | NCT01086839 (ClinicalTrials.gov) | March 2010 | 12/3/2010 | Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Sino-nasal Inhalation of Sodium Chloride 6,0% in Patients With Cystic Fibrosis and Chronic Rhinosinusitis. A Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Clinical Trial | Cystic Fibrosis;Rhinosinusitis | Drug: sodium chloride 6%;Drug: sodium chloride 0,9% | University of Jena | NULL | Completed | 8 Years | N/A | Both | 69 | N/A | Germany |
| 1165 | NCT01348204 (ClinicalTrials.gov) | March 2010 | 1/6/2010 | Nasal Potential Studies Utilizing Cystic Fibrosis Transmembrane Regulator (CFTR) Modulators | Nasal Potential Studies Utilizing CFTR Modulators (UAB Center for Clinical and Translational Science) | Cystic Fibrosis | Other: quercetin | University of Alabama at Birmingham | National Institutes of Health (NIH) | Completed | 8 Years | 65 Years | Both | 32 | Phase 2 | United States |
| 1166 | NCT02198079 (ClinicalTrials.gov) | March 2010 | 21/2/2014 | A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida | A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in Florida | Cystic Fibrosis;Pediatrics | Biological: Sputum | University of Miami | University of Florida | Completed | N/A | 18 Years | Both | 85 | N/A | United States |
| 1167 | EUCTR2009-014412-35-GB (EUCTR) | 23/02/2010 | 01/10/2009 | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | Non-cystic fibrosis bronchiectasis MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS | Product Name: Ciprofloxacin for Inhalation Product Code: None assigned INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Germany;United Kingdom | |||
| 1168 | EUCTR2009-016734-26-LV (EUCTR) | 17/02/2010 | 11/01/2010 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 1169 | NCT01051999 (ClinicalTrials.gov) | February 2010 | 15/1/2010 | Glutamine Supplementation in Cystic Fibrosis | Glutamine Supplementation and Immunity in Adults With Cystic Fibrosis | Cystic Fibrosis;Immune Function | Dietary Supplement: Glutamine;Dietary Supplement: L-alanine | Emory University | Emmaus Medical, Inc. | Completed | 18 Years | N/A | Both | 17 | Phase 2 | United States |
| 1170 | NCT01059565 (ClinicalTrials.gov) | February 2010 | 28/1/2010 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis and Chronic Burkholderia Species Infection | Phase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects With Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection | Cystic Fibrosis;Burkholderia Infections | Drug: AZLI;Drug: Placebo | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 102 | Phase 3 | United States;Canada |
| 1171 | NCT01288170 (ClinicalTrials.gov) | February 2010 | 1/2/2011 | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® | Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® | Cystic Fibrosis | Drug: Nebcinal Tobi;Drug: Tobi Nebcinal | Erempharma | Hopitaux de Lyon;University of Lyon | Recruiting | 6 Years | N/A | Both | 12 | N/A | France |
| 1172 | NCT01060566 (ClinicalTrials.gov) | February 2010 | 29/1/2010 | Study of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770 | An Open-Label Phase 1 Study to Examine the Effect of VX-770 on Midazolam and Rosiglitazone and the Effect of Fluconazole on VX-770 in Healthy Subjects | Cystic Fibrosis | Drug: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 24 | Phase 1 | United States |
| 1173 | NCT01069705 (ClinicalTrials.gov) | February 2010 | 15/2/2010 | Second Open Label Extension to Bridging Study CTBM100C2303 | A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Completed Participation in Study CTBM100C2303E1. | Pulmonary Infections;Pseudomonas Aeruginosa | Drug: Tobramycin inhalation powder | Novartis Pharmaceuticals | NULL | Completed | 6 Years | 21 Years | All | 49 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania;Romania;Russian Federation;South Africa |
| 1174 | NCT00889967 (ClinicalTrials.gov) | February 2010 | 27/4/2009 | Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis ORBIT-1 | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared With Placebo for Inhalation in the Management of Pseudomonas Aeruginosa in Patients With Non Cystic Fibrosis Bronchiectasis | Non-Cystic Fibrosis Bronchiectasis | Drug: Ciprofloxacin for Inhalation;Drug: Placebo | Aradigm Corporation | NULL | Completed | 18 Years | 80 Years | All | 95 | Phase 2 | United States;Canada;Germany;United Kingdom |
| 1175 | EUCTR2009-014412-35-DE (EUCTR) | 27/01/2010 | 09/10/2009 | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | An International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A | Non-cystic fibrosis bronchiectasis MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS | Product Name: Ciprofloxacin for Inhalation Product Code: None assigned INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE | Aradigm Corporation | NULL | Not Recruiting | Female: yes Male: yes | 96 | Phase 2 | Germany;United Kingdom | ||
| 1176 | EUCTR2009-013340-36-IT (EUCTR) | 25/01/2010 | 31/12/2009 | PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - ND | PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - ND | cystic fibrosis MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: reparixin INN or Proposed INN: Reparixin | IST. DI RICERCHE FARMACOLOG. M. NEGRI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1177 | EUCTR2007-004277-26-AT (EUCTR) | 21/01/2010 | 21/04/2009 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 1178 | EUCTR2009-016734-26-EE (EUCTR) | 08/01/2010 | 15/12/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Lithuania;Bulgaria;Latvia | ||
| 1179 | NCT00996424 (ClinicalTrials.gov) | January 2010 | 15/10/2009 | The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function | The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function. | Cystic Fibrosis | Drug: Acetylcysteine;Drug: normal saline | University Hospital, Ghent | BVSM | Terminated | 6 Years | 64 Years | Both | 19 | Phase 4 | Belgium |
| 1180 | NCT01044719 (ClinicalTrials.gov) | January 2010 | 14/12/2009 | Duration of Antibiotics in Infective Exacerbations of Cystic Fibrosis | What Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Ceftazidime;Drug: Tobramycin;Drug: Meropenem | Imperial College London | NULL | Not yet recruiting | 16 Years | N/A | Both | 240 | Phase 4 | United Kingdom |
| 1181 | NCT01155115 (ClinicalTrials.gov) | January 2010 | 29/6/2010 | Inflammatory and Microbiologic Markers in Sputum: Comparing Cystic Fibrosis With Primary Ciliary Dyskinesia | Inflammatory and Microbiologic Markers in Sputum in Response to Pulmonary Exacerbation: Comparing Cystic Fibrosis With Primary Ciliary Dyskinesia | Cystic Fibrosis;Primary Ciliary Dyskinesia | Procedure: Sputum Collection;Procedure: Pulmonary Function Testing;Procedure: Exhaled Nitric Oxide | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 46 | N/A | Canada |
| 1182 | EUCTR2009-016590-15-HU (EUCTR) | 29/12/2009 | 25/11/2009 | A clinical trial to assess the treatment with nebulised tobramycin in terms of safety and ability to kill Pseudomonas bacteria in the lungs of cystic fibrosis patients aged 3 months to 6 years included | A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. | Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862 MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI 300 mg / 5 mL nebuliser solution Product Name: TOBI Product Code: TBM100 INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 50 | France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland | |||
| 1183 | EUCTR2007-006648-23-IE (EUCTR) | 11/12/2009 | 15/04/2009 | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA | Trade Name: Xolair | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 4 | Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom | ||
| 1184 | NCT01035853 (ClinicalTrials.gov) | December 2009 | 17/12/2009 | Sino-nasal Inhalation of Colistin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization | Sino-nasal Inhalation of Colistin Via the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Colonization of the Upper Airways With Pseudomonas Aeruginosa | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: Colistin | University of Jena | NULL | Completed | 6 Years | N/A | Both | 10 | Phase 2 | Germany |
| 1185 | NCT01025713 (ClinicalTrials.gov) | December 2009 | 1/12/2009 | A Phase 1 Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS 9411 in Subjects With Cystic Fibrosis (CF) | A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS 9411 in Subjects With Cystic Fibrosis (CF) | Cystic Fibrosis;Mucociliary Clearance | Drug: GS-9411;Drug: Placebo | Gilead Sciences | NULL | Withdrawn | 18 Years | 65 Years | Both | 0 | Phase 1 | Australia |
| 1186 | NCT01658449 (ClinicalTrials.gov) | December 2009 | 13/7/2012 | Comparison of the Tolerability of Two Formulations of Hypertonic Saline in Cystic Fibrosis Patients | Cystic Fibrosis | Other: Inhalable Hypertonic saline 7% + Hyaluronan 0.1%;Other: Inhalable Hypertonic saline 7% | Ospedale Civile Ca' Foncello | NULL | Completed | 8 Years | N/A | Both | 40 | N/A | Italy | |
| 1187 | NCT00812045 (ClinicalTrials.gov) | December 2009 | 18/12/2008 | Study to Assess Efficacy of AZD1236 in Patients With Cystic Fibrosis | A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II Study to Assess the Efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: AZD1236;Drug: Placebo | AstraZeneca | NULL | Withdrawn | 18 Years | N/A | Both | 44 | Phase 2 | Canada;Netherlands;Poland;Spain |
| 1188 | EUCTR2009-012575-10-GB (EUCTR) | 16/11/2009 | 11/09/2009 | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF | Product Name: Ceftazidime INN or Proposed INN: Ceftazidime Other descriptive name: N/A Product Name: Tobramycin INN or Proposed INN: Tobramycin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A Product Name: Ciprofloxacin INN or Proposed INN: Ciprofloxacin Other descriptive name: N/A | University Hospitals Bristol NHS Foundation Trust | University of Liverpool | Not Recruiting | Female: yes Male: yes | 260 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom;Sweden | |||
| 1189 | EUCTR2008-008317-20-BE (EUCTR) | 13/11/2009 | 21/09/2009 | The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function | The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function | Cystic Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Lysomucil 10 % Product Name: N-acetylcysteine INN or Proposed INN: Acetylcysteine | University Hospital Ghent | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 1190 | EUCTR2009-016662-90-FR (EUCTR) | 03/11/2009 | 23/10/2009 | Etude de cohorte évaluant l'efficacité cliique, la tolérance et l'immunogénicité à la vaccination antigrippale pandémique chez les patients atteints de mucoviscidose et, le cas échéant, l'expression clinique de la grippe A (H1N1) et les facteurs associés à la survenue de formes sévères dans cette population. - Etude MUCOFLU | Etude de cohorte évaluant l'efficacité cliique, la tolérance et l'immunogénicité à la vaccination antigrippale pandémique chez les patients atteints de mucoviscidose et, le cas échéant, l'expression clinique de la grippe A (H1N1) et les facteurs associés à la survenue de formes sévères dans cette population. - Etude MUCOFLU | patients atteints de mucoviscidose MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Oseltamivir Product Name: Vaccin grippal pandémique H1N1 INN or Proposed INN: Vaccin grippal pandémique H1N1 | Inserm | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1191 | NCT01499914 (ClinicalTrials.gov) | November 2009 | 21/11/2011 | Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination | Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1) | Cystic Fibrosis With Gastrointestinal Manifestation | Biological: influenza vaccination | Assistance Publique - Hôpitaux de Paris | NULL | Completed | 6 Months | N/A | Both | 439 | Phase 4 | France |
| 1192 | NCT01018368 (ClinicalTrials.gov) | November 2009 | 19/11/2009 | Study of VX-770 and Rifampin in Healthy Male Subjects | An Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy Subjects | Cystic Fibrosis | Drug: VX-770;Drug: Rifampin | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Male | 24 | Phase 1 | United States |
| 1193 | NCT01094704 (ClinicalTrials.gov) | November 2009 | 19/3/2010 | Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis | Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic Fibrosis | Cystic Fibrosis | Drug: sodium chloride (7%) | University of North Carolina, Chapel Hill | Johns Hopkins University;Novartis Pharmaceuticals | Completed | 18 Years | N/A | All | 16 | Phase 1 | United States |
| 1194 | EUCTR2009-014042-28-GB (EUCTR) | 16/10/2009 | 14/10/2010 | What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis | What duration of intravenous antibiotic therapy should be used in the treatment of infective exacerbations of cystic fibrosis in patients chronically colonised with Pseudomonas aeruginosa? - Duration of antibiotics in infective exacerbations of cystic fibrosis | Cystic Fibrosis | Trade Name: Meropenem Product Name: Meropenem INN or Proposed INN: Meropenem Trade Name: Ceftazidime Product Name: Ceftazidime INN or Proposed INN: Ceftazidime Trade Name: Tobramycin Product Name: Tobramycin INN or Proposed INN: Tobramycin | Imperial College, London | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 240 | United Kingdom | |||
| 1195 | EUCTR2009-009869-34-SE (EUCTR) | 12/10/2009 | 29/07/2009 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | United Kingdom;Germany;Spain;Sweden | |||
| 1196 | EUCTR2009-015875-28-IT (EUCTR) | 07/10/2009 | 22/10/2009 | Modulation of intestinal and extraintestinal inflammation in infants with Cystic Fibrosis by early modification of intestinal microflora - Role of intestinal microflora in infants with Cystic Fibrosis | Modulation of intestinal and extraintestinal inflammation in infants with Cystic Fibrosis by early modification of intestinal microflora - Role of intestinal microflora in infants with Cystic Fibrosis | infants with cystic fibrosis MedDRA version: 9.1;Level: SOC;Classification code 10017947 MedDRA version: 9.1;Classification code 10038738 | INN or Proposed INN: Lactic acid producing organisms | UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1197 | EUCTR2008-003924-52-NL (EUCTR) | 06/10/2009 | 05/02/2009 | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | ||
| 1198 | NCT00999531 (ClinicalTrials.gov) | October 2009 | 20/10/2009 | A Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial of GS-9411 in Healthy Volunteers | A Phase 1, Randomized, Double-Blind, Placebo-Controlled Multiple Dose Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Volunteers | Cystic Fibrosis;Mucociliary Clearance;Airway Hydration | Drug: GS-9411;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | 65 Years | Both | 24 | Phase 1 | Australia |
| 1199 | NCT00903201 (ClinicalTrials.gov) | September 28, 2009 | 14/5/2009 | 28 Day Repeat Dose in Cystic Fibrosis Patients | A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: SB656933;Drug: Placebo | GlaxoSmithKline | NULL | Completed | 18 Years | N/A | All | 146 | Phase 2 | United States;Canada;France;Germany;Israel |
| 1200 | EUCTR2008-007479-26-DE (EUCTR) | 25/09/2009 | 26/06/2009 | Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D Mutation | A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;France;Canada;Ireland;Australia;Germany;United Kingdom | ||
| 1201 | EUCTR2006-006215-68-FR (EUCTR) | 21/09/2009 | 06/08/2009 | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | France;Hungary;Czech Republic;Spain;Germany | ||
| 1202 | EUCTR2009-014050-15-BE (EUCTR) | 18/09/2009 | 14/09/2009 | Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XL | Conversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XL | Stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant MedDRA version: 12.0;Level: LLT;Classification code 10025127;Term: Lung transplant | Trade Name: Prograft capsules Product Name: Tacrolimus capsules INN or Proposed INN: TACROLIMUS INN or Proposed INN: TACROLIMUS INN or Proposed INN: TACROLIMUS Trade Name: Advagraf prolonged-release hard capsules Product Name: Tacrolimus prolonged-release hard capsules | Hopital Erasme - Chest service | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Belgium | ||||
| 1203 | EUCTR2008-007416-15-FR (EUCTR) | 14/09/2009 | 04/06/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - REACH | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - REACH | cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: VX-770 Product Code: VX-770, VRT-813077 Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Ireland;Germany;United Kingdom | ||
| 1204 | EUCTR2009-013660-39-FR (EUCTR) | 10/09/2009 | 27/11/2009 | Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® | Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® | Mucoviscidose MedDRA version: 12.0;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Nebcinal INN or Proposed INN: tobramycine Trade Name: Tobi Product Name: Tobi INN or Proposed INN: tobramycine | Erempharma SAS | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1205 | NCT00803205 (ClinicalTrials.gov) | September 8, 2009 | 4/12/2008 | Study of Ataluren (PTC124™) in Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Cystic Fibrosis | Drug: Ataluren;Drug: Placebo | PTC Therapeutics | Cystic Fibrosis Foundation | Completed | 6 Years | N/A | All | 238 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom |
| 1206 | EUCTR2008-007479-26-FR (EUCTR) | 07/09/2009 | 07/07/2009 | A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION | A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION | cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: VX-770 Product Code: VX-770, VRT-813077 Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 3 | France;Ireland;Germany;United Kingdom | ||
| 1207 | EUCTR2008-004764-39-LT (EUCTR) | 07/09/2009 | 22/01/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 13.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 1208 | EUCTR2008-002318-22-LT (EUCTR) | 07/09/2009 | 22/01/2009 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin Other descriptive name: TBM100C | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 1209 | EUCTR2009-009869-34-GB (EUCTR) | 02/09/2009 | 09/04/2009 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Germany;United Kingdom;Spain;Sweden | |||
| 1210 | NCT00989807 (ClinicalTrials.gov) | September 2009 | 2/10/2009 | Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis | Expanded Access for Aztreonam Lysine for Inhalation in Canadian Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: Aztreonam lysine | Gilead Sciences | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | Canada | |
| 1211 | NCT01710449 (ClinicalTrials.gov) | September 2009 | 17/10/2012 | Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen | Evaluation of Regional Ventilation in Normal Subjects and Subjects With Airway and Lung Disorders (COPD, Asthma, Emphysema, Small Airway Disease and Cystic Fibrosis) Using 19F MRI of Inert Perfluorinated Gases Mixed With Oxygen. | COPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways Diseases | Drug: perfluorinated gas/oxygen mixture | Hal C Charles | NULL | Completed | 18 Years | N/A | Both | 44 | Phase 1 | United States |
| 1212 | NCT00975663 (ClinicalTrials.gov) | September 2009 | 10/9/2009 | Bayesian Dose Adjustment of Immunosuppressants After Lung Transplantation | Evaluation of the Interest of Therapeutic Drug Monitoring of Immunosuppressants (Tacrolimus, Mycophenolate Mofetil) Based on Bayesian Estimation During the Three First Years Following Lung Transplantation, in Patients With or Without Cystic Fibrosis | Lung and Heart-lung Transplantation | Drug: Tacrolimus and MMF | University Hospital, Limoges | NULL | Terminated | 18 Years | N/A | Both | 180 | Phase 4 | Belgium;France |
| 1213 | NCT00951522 (ClinicalTrials.gov) | September 2009 | 3/8/2009 | A Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers | A Phase 1 Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety, Tolerability, and Pharmacokinetics of GS-9411 in Healthy Male Volunteers | Cystic Fibrosis;Mucociliary Clearance;Airway Hydration | Drug: GS-9411;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | 45 Years | Male | 15 | Phase 1 | Australia |
| 1214 | NCT01031706 (ClinicalTrials.gov) | September 2009 | 11/12/2009 | Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic Fibrosis | Sustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline;Drug: Placebo | University of North Carolina, Chapel Hill | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 5 Years | 12 Years | All | 23 | N/A | United States |
| 1215 | NCT02723968 (ClinicalTrials.gov) | September 2009 | 21/3/2016 | Cystic Fibrosis Related Diabetes Screening. | Sensitivity and Specificity of Different Methods for Cystic Fibrosis-related Diabetes Screening. | Cystic Fibrosis-related Diabetes | Other: glucose solution at a dose of 1.75 g/kg (up to a maximum of 75 g) for the OGTT and glucose solution at a dose of 0.5 g/kg (up to a maximum of 35 g) was injected in 2.5-3 min for the IGTT;Procedure: HGPIV diagnosis test;Procedure: HOMAR-IR diagnosis test | Hospices Civils de Lyon | NULL | Completed | 10 Years | 18 Years | All | 29 | N/A | NULL |
| 1216 | NCT01111383 (ClinicalTrials.gov) | September 2009 | 13/4/2010 | A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® | A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa) | Cystic Fibrosis | Drug: tobramycin | Chiesi Farmaceutici S.p.A. | NULL | Completed | 6 Years | N/A | All | 209 | Phase 3 | France;Poland;Ukraine |
| 1217 | NCT00970346 (ClinicalTrials.gov) | September 2009 | 1/9/2009 | Safety and Efficacy of Inhaled OligoG CF-5/20 for the Treatment Cystic Fibrosis | A Randomised, Double-blind, Placebo-controlled Dose-escalation Phase I Study to Evaluate the Safety and Tolerability of Inhaled Aerosolised OligoG CF-5/20 (G-block Oligosaccharide Derived From Alginate Polysaccharide) in Healthy Volunteers | Cystic Fibrosis | Drug: OligoG CF-5/20 | AlgiPharma AS | Smerud Medical Research International AS | Completed | 18 Years | 65 Years | Male | 26 | Phase 1 | United Kingdom |
| 1218 | NCT00966602 (ClinicalTrials.gov) | September 2009 | 25/8/2009 | Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects | A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose, Drug-Drug Interaction Study of VX-809 and VX-770 in Healthy Subjects | Cystic Fibrosis | Drug: VX-809;Drug: VX-770;Drug: VX-809 & VX-770;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | 55 Years | Both | 24 | Phase 1 | Netherlands |
| 1219 | NCT00953706 (ClinicalTrials.gov) | September 2009 | 4/8/2009 | Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older Homozygous for the F508del-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Terminated | 12 Years | N/A | All | 140 | Phase 2 | United States |
| 1220 | NCT01961661 (ClinicalTrials.gov) | September 2009 | 9/10/2013 | Probiotics on Intestinal Inflammation in Cystic Fibrosis | Effect of Probiotics on Intestinal Inflammation and Microflora in Cystic Fibrosis: a Pilot Study | Cystic Fibrosis | Dietary Supplement: Lactobacillus rhamnosus GG;Dietary Supplement: placebo | Federico II University | NULL | Completed | 2 Years | 18 Years | Both | 22 | Phase 3 | Italy |
| 1221 | EUCTR2008-003924-52-GB (EUCTR) | 26/08/2009 | 09/04/2009 | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 208 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 1222 | EUCTR2008-006446-25-NL (EUCTR) | 26/08/2009 | 10/03/2009 | A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 | A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS | Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 90 | Germany;Netherlands;Belgium | |||
| 1223 | EUCTR2008-002318-22-BG (EUCTR) | 20/08/2009 | 28/08/2009 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Bulgaria;Latvia;Lithuania | ||
| 1224 | EUCTR2008-004764-39-BG (EUCTR) | 20/08/2009 | 28/08/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 12.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Bulgaria;Latvia;Lithuania | ||
| 1225 | EUCTR2008-003924-52-DE (EUCTR) | 17/08/2009 | 10/07/2009 | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom;Sweden | ||
| 1226 | EUCTR2008-007416-15-IE (EUCTR) | 11/08/2009 | 14/05/2009 | Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D Mutation | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom | ||
| 1227 | EUCTR2008-007479-26-IE (EUCTR) | 11/08/2009 | 14/05/2009 | Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D Mutation | A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Germany;United Kingdom;Canada;France;Ireland;United States;Australia | ||
| 1228 | EUCTR2008-002740-42-NL (EUCTR) | 10/08/2009 | 25/03/2009 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: MTT INN or Proposed INN: Mannitol | Pharmaxis Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;Netherlands;Belgium;France | |||
| 1229 | EUCTR2007-006648-23-IT (EUCTR) | 06/08/2009 | 22/05/2009 | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - ND | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - ND | Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: XOLAIR INN or Proposed INN: Omalizumab | NOVARTIS FARMA | NULL | Not Recruiting | Female: yes Male: yes | 60 | United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy | |||
| 1230 | EUCTR2008-007416-15-CZ (EUCTR) | 05/08/2009 | 04/06/2009 | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE | cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: VX-770 Product Code: VX-770, VRT-813077 Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;Czech Republic;Ireland;Germany;United Kingdom | ||
| 1231 | NCT00982930 (ClinicalTrials.gov) | August 2009 | 21/9/2009 | Open Label Extension to Bridging Study CTBM100C2303 | A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas Aeruginosa;Cystic Fibrosis | Drug: Tobramycin inhalation powder | Novartis Pharmaceuticals | NULL | Completed | 6 Years | 21 Years | Both | 57 | Phase 3 | Estonia;Russian Federation |
| 1232 | NCT00909727 (ClinicalTrials.gov) | August 2009 | 26/5/2009 | Study of Ivacaftor in Cystic Fibrosis Subjects Aged 6 to 11 Years With the G551D Mutation | A Phase 3, 2-Part, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX-770 in Subjects Aged 6 to 11 Years With Cystic Fibrosis and the G551D Mutation | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | 11 Years | All | 52 | Phase 3 | United States;Australia;Canada;France;Germany;Ireland;United Kingdom |
| 1233 | EUCTR2008-004764-39-EE (EUCTR) | 30/07/2009 | 23/07/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 1234 | EUCTR2008-007416-15-GB (EUCTR) | 27/07/2009 | 22/05/2009 | Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D Mutation | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom | ||
| 1235 | EUCTR2008-001156-43-IT (EUCTR) | 27/07/2009 | 28/07/2009 | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis | cystic fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: Tiotropium bromide Product Name: Tiotropium Respimat 1.25 micrograms solution for inhalation Product Code: NA INN or Proposed INN: Tiotropium bromide | BOEHRINGER ING. | NULL | Not Recruiting | Female: yes Male: yes | 600 | Portugal;France;Belgium;Netherlands;Germany;United Kingdom;Italy | |||
| 1236 | EUCTR2008-007479-26-GB (EUCTR) | 27/07/2009 | 22/05/2009 | Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D Mutation | A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;United States;Canada;Ireland;Australia;Germany;United Kingdom | ||
| 1237 | EUCTR2008-006446-25-BE (EUCTR) | 08/07/2009 | 12/05/2009 | A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 | A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS | Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809 Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 90 | Germany;Netherlands;Belgium | |||
| 1238 | EUCTR2009-009869-34-ES (EUCTR) | 03/07/2009 | 06/05/2009 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística. | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística. | Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of greater than or equal to 35 % and less than or equal to 80 percent of predicted) Bronquiectasias idiopática y post-neumónica no debidas a fibrosis quística en pacientes en situación pulmonar estable (definida como mayor o igual al 35% y menor o igual al 80%) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 120 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Spain;Germany;United Kingdom;Sweden | ||
| 1239 | NCT00945347 (ClinicalTrials.gov) | July 2009 | 23/7/2009 | Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients ? | Does a Nasal Instillation of Miglustat Normalize the Nasal Potential Difference in Cystic Fibrosis Patients Homozygous for the F508del Mutation? A Randomized, Double Blind Placebo-controlled Study. | Cystic Fibrosis | Drug: Miglustat;Drug: Placebo | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | NULL | Completed | 14 Years | N/A | Both | 10 | Phase 2 | Belgium |
| 1240 | NCT00910351 (ClinicalTrials.gov) | July 2009 | 28/5/2009 | Cipro Inhaler for Cystic Fibrosis Children Ages 6-12 | A Study to Evaluate the Safety and Pharmacokinetics of Ciprofloxacin in Adults and Children Aged 6 - 12 Years With Cystic Fibrosis Following Inhalation of Ciprofloxacin Dry Powder | Pseudomonas Infection | Drug: Ciprofloxacin (Cipro, BAYQ3939) | Bayer | NULL | Completed | 6 Years | 12 Years | Both | 19 | Phase 1 | United States |
| 1241 | EUCTR2008-003924-52-IT (EUCTR) | 26/06/2009 | 22/06/2009 | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009-CF | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009-CF | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: PTC124 Product Name: PTC124 Product Name: PTC124 | PTC THERAPEUTICS, INC. | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | ||
| 1242 | EUCTR2008-001156-43-PT (EUCTR) | 23/06/2009 | 05/05/2009 | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: Tiotropium Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation INN or Proposed INN: Tiotropium | Boehringer Ingelheim Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy | |||
| 1243 | EUCTR2008-008314-40-DE (EUCTR) | 22/06/2009 | 03/03/2009 | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 276 | Denmark;Germany;United Kingdom;Sweden | |||
| 1244 | EUCTR2008-004764-39-LV (EUCTR) | 19/06/2009 | 08/05/2009 | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 1245 | EUCTR2008-007877-19-DE (EUCTR) | 15/06/2009 | 28/05/2009 | Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot | Nasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot | subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Colistin CF Product Name: Colistin CF INN or Proposed INN: Colistimethat-Natrium | University of Jena | NULL | Not Recruiting | Female: yes Male: yes | 14 | Germany | |||
| 1246 | EUCTR2008-003924-52-FR (EUCTR) | 12/06/2009 | 17/03/2009 | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: not assigned Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 1247 | EUCTR2007-006648-23-NL (EUCTR) | 08/06/2009 | 03/09/2008 | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA | Trade Name: Xolair INN or Proposed INN: omalizumab Other descriptive name: Recombinant humanized monoclonal antibody omalizumab to IgE | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy | |||
| 1248 | EUCTR2009-009869-34-DE (EUCTR) | 08/06/2009 | 17/03/2009 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 | Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted) MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis MedDRA version: 9.1;Level: PT;Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 122 | Spain;Germany;United Kingdom;Sweden | |||
| 1249 | EUCTR2006-003275-12-NO (EUCTR) | 03/06/2009 | 27/03/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: Zitromax Product Code: Zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | ||
| 1250 | EUCTR2008-008314-40-DK (EUCTR) | 02/06/2009 | 16/04/2009 | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 276 | United Kingdom;Germany;Denmark;Sweden | |||
| 1251 | NCT00918957 (ClinicalTrials.gov) | June 2009 | 4/6/2009 | A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew). | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 6 Years | 21 Years | All | 62 | Phase 3 | Bulgaria;Egypt;Estonia;India;Latvia;Lithuania;Romania;Russian Federation;South Africa |
| 1252 | NCT00909532 (ClinicalTrials.gov) | June 2009 | 26/5/2009 | Study of Ivacaftor in Cystic Fibrosis Subjects Aged 12 Years and Older With the G551D Mutation | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-770 in Subjects With Cystic Fibrosis and the G551D Mutation | Cystic Fibrosis | Drug: Ivacaftor;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 12 Years | N/A | All | 167 | Phase 3 | United States;Australia;Canada;Czech Republic;France;Germany;Ireland;United Kingdom |
| 1253 | NCT00930982 (ClinicalTrials.gov) | June 2009 | 30/6/2009 | Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis Bronchiectasis | Randomized, Placebo-controlled, Double-blind, Multi-center Study to Evaluate the Safety and Efficacy of Ciprofloxacin Inhale Compared to Placebo in Patients With Non-cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Ciprofloxacin (Cipro, BAYQ3939);Drug: Placebo | Bayer | Novartis | Completed | 18 Years | N/A | All | 124 | Phase 2 | United States;Australia;Germany;Spain;Sweden;United Kingdom |
| 1254 | EUCTR2008-003924-52-ES (EUCTR) | 18/05/2009 | 09/03/2009 | Estudio de fase 3 sobre la eficacia y la seguridad de PTC124 como tratamiento oral para la fibrosis quística mediada por mutación terminadora | Estudio de fase 3 sobre la eficacia y la seguridad de PTC124 como tratamiento oral para la fibrosis quística mediada por mutación terminadora | Fibrosis quística mediada por mutación terminadora MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: no asignado Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: no asignado Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: no asignado Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 | PTC Therapeutics, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 208 | Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden | |||
| 1255 | EUCTR2008-008314-40-GB (EUCTR) | 18/05/2009 | 09/04/2009 | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer Healthcare AG | NULL | Not Recruiting | Female: yes Male: yes | 276 | Germany;United Kingdom;Denmark;Sweden | |||
| 1256 | EUCTR2008-008314-40-SE (EUCTR) | 15/05/2009 | 25/03/2009 | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis | Cystic fibrosis MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin Product Name: Ciprofloxacin Inhale Product Code: BAYq3939 INN or Proposed INN: Ciprofloxacin | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 276 | United Kingdom;Germany;Denmark;Sweden | |||
| 1257 | EUCTR2008-006446-25-DE (EUCTR) | 14/05/2009 | 14/04/2009 | A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 | A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS | Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809 Product Name: VX-809 Product Code: VX-809 Other descriptive name: VRT-826809 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 90 | Belgium;Netherlands;Germany | |||
| 1258 | EUCTR2008-002318-22-LV (EUCTR) | 13/05/2009 | 28/01/2009 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 1259 | ChiCTR-TRC-13003979 | 2009-05-07 | 2013-10-28 | Application of roxithromycin in patients with bronchiectasis in stable condition | Effect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis | Bronchietasis | Roxithromycin group:The patients received oral roxithromycin in roxithromycin group;Control group:The patients received no drug in control group; | First Affiliated Hospital of Guangxi Medical University | NULL | Completed | 18 | 70 | Both | Roxithromycin group:26;Control group:26; | China | |
| 1260 | EUCTR2008-002318-22-EE (EUCTR) | 06/05/2009 | 27/02/2009 | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100C INN or Proposed INN: tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | ||
| 1261 | NCT01309178 (ClinicalTrials.gov) | May 2009 | 4/3/2011 | Anti-inflammatory Pulmonal Therapy of Cystic Fibrosis (CF) Patients With Amitriptyline and Placebo | Anti-inflammatory Pulmonal Therapy of CF Patients With Amitriptyline and Placebo - a Randomised, Double-blind, Placebo-controlled, Multicenter, Cohort - Study | Cystic Fibrosis;Pneumonia | Drug: Amitriptyline;Drug: Mannite | University Children’s Hospital Tuebingen | Universität Duisburg-Essen;University of Ulm | Recruiting | 14 Years | 65 Years | Both | 30 | Phase 2 | Germany |
| 1262 | NCT01880723 (ClinicalTrials.gov) | May 2009 | 15/6/2013 | Utilizing Exhaled Breathe Condensate Collection to Study Ion Regulation in Cystic Fibrosis | Modifying Genes in Cystic Fibrosis: The Beta-2 Adrenergic Receptors and Epithelial Na+ Channels | Cystic Fibrosis;Healthy | Drug: Albuterol;Drug: Placebo saline | University of Arizona | National Heart, Lung, and Blood Institute (NHLBI) | Completed | 15 Years | 55 Years | All | 32 | N/A | United States |
| 1263 | NCT01737983 (ClinicalTrials.gov) | May 2009 | 12/7/2012 | Effect of Lactobacillus Reuteri in Cystic Fibrosis | Lactobacillus Reuteri Reduces Pulmonary Exacerbations and Upper Respiratory Tract Infections in CF Patients With Mild-to-moderate Lung Disease. LR Administration Might Have a Beneficial Effect on the Disease Course of Cystic Fibrosis. | CYSTIC FIBROSIS | Dietary Supplement: Lactobacillus reuteri;Dietary Supplement: placebo | Azienda Policlinico Umberto I | NULL | Completed | 6 Years | 42 Years | Both | 61 | Phase 4 | Italy |
| 1264 | EUCTR2009-011289-27-IT (EUCTR) | 22/04/2009 | 27/04/2009 | Probiotics in Cystic Fibrosis - ND | Probiotics in Cystic Fibrosis - ND | Cystic Fibrosis Patients MedDRA version: 9.1;Level: SOC;Classification code 10017947 | INN or Proposed INN: Lactic acid producing organisms | UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1265 | EUCTR2008-003924-52-SE (EUCTR) | 08/04/2009 | 17/12/2008 | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Product Name: PTC124 Product Code: PTC124 INN or Proposed INN: ataluren Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 1266 | EUCTR2008-003924-52-BE (EUCTR) | 08/04/2009 | 20/02/2009 | Study of ataluren in patients with Cystic Fibrosis | A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Nonsense-Mutation-Mediated Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren Product Name: ataluren Product Code: PTC124 INN or Proposed INN: ataluren | PTC Therapeutics, Inc | NULL | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom;Sweden | ||
| 1267 | NCT00840333 (ClinicalTrials.gov) | April 2009 | 5/2/2009 | Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients | A Phase 1B, Multi-Center, Open Label Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MP-376 Inhalation Solution Given Daily for 14 Days to Stable Pediatric Cystic Fibrosis Patients. | Cystic Fibrosis | Drug: MP-376 (Levofloxacin solution for Inhalation) | Horizon Pharma USA, Inc. | NULL | Completed | 6 Years | 16 Years | All | 27 | Phase 1 | United States |
| 1268 | NCT00775528 (ClinicalTrials.gov) | April 2009 | 17/10/2008 | Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | An Open Label, Multi-center, Study to Assess the Safety and Tolerability of Pancrelipase Delayed Release Capsules in Infants and Children Less Than 7 Years of Age With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis;Pancreatic Exocrine Insufficiency | Drug: Pancrelipase Delayed Release | Solvay Pharmaceuticals | NULL | Completed | 1 Month | 6 Years | All | 19 | Phase 3 | United States |
| 1269 | NCT00843817 (ClinicalTrials.gov) | April 2009 | 12/2/2009 | RhDNase and Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | RhDNase Effect on Biodistribution of PMN Serine Proteases in Cystic Fibrosis Sputum | Cystic Fibrosis | Drug: Pulmozyme | University Hospital, Tours | NULL | Completed | 18 Years | N/A | All | 15 | Phase 4 | France |
| 1270 | NCT00880100 (ClinicalTrials.gov) | April 2009 | 9/4/2009 | Use of Ultrase® MT12 in Young Cystic Fibrosis Children (CF) | Efficacy and Safety of Ultrase MT12 in the Control of Steatorrhea in Cystic Fibrosis (CF) and Pancreatic Insufficient (PI) Children Aged 2 to 6 Years Old | Cystic Fibrosis;Pancreatic Insufficiency | Drug: Ultrase® MT12 | Forest Laboratories | NULL | Completed | 2 Years | 6 Years | All | 49 | Phase 3 | United States |
| 1271 | NCT00885365 (ClinicalTrials.gov) | April 2009 | 20/4/2009 | A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® | A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: tobramycin / Bramitob;Drug: tobramycin / TOBI | Chiesi Farmaceutici S.p.A. | NULL | Completed | 6 Years | N/A | All | 324 | Phase 3 | Czechia;France;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine;Czech Republic |
| 1272 | NCT00709280 (ClinicalTrials.gov) | April 2009 | 1/7/2008 | Infant Study of Inhaled Saline in Cystic Fibrosis | Infant Study of Inhaled Saline in Cystic Fibrosis | Cystic Fibrosis | Drug: 7% Hypertonic Saline (HS);Drug: 0.9% Isotonic Saline (IS) | CF Therapeutics Development Network Coordinating Center | Cystic Fibrosis Foundation Therapeutics;National Heart, Lung, and Blood Institute (NHLBI) | Completed | 4 Months | 59 Months | Both | 321 | N/A | United States;Canada |
| 1273 | EUCTR2007-004277-26-GB (EUCTR) | 12/03/2009 | 08/02/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 1274 | EUCTR2009-009875-37-NL (EUCTR) | 11/03/2009 | 21/01/2009 | A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRD | A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRD | Cystic fibrosis-related diabetes MedDRA version: 9.1;Level: HLT;Classification code 10012602;Term: Diabetes mellitus (incl subtypes) MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Metformine HCL 500 PCH | Staf Longziekten | NULL | Not Recruiting | Female: yes Male: yes | 25 | Netherlands | |||
| 1275 | EUCTR2008-002740-42-FR (EUCTR) | 11/03/2009 | 12/03/2009 | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: MTT INN or Proposed INN: Mannitol | Pharmaxis Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;Belgium;Netherlands;Germany | ||
| 1276 | EUCTR2008-001530-27-GB (EUCTR) | 11/03/2009 | 18/04/2008 | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom;Denmark;Sweden | ||
| 1277 | NCT01377792 (ClinicalTrials.gov) | March 2009 | 9/5/2011 | Study of Long-term Treatment With Hypertonic Saline in Patients With Cystic Fibrosis | Phase 4 Study of the Efficacy of Long-term Treatment With Hypertonic Saline on Pulmonary Exacerbations in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic saline | Adelaida Lamas Ferreiro | NULL | Completed | 6 Years | N/A | Both | 71 | Phase 4 | Spain |
| 1278 | NCT01091025 (ClinicalTrials.gov) | March 2009 | 18/3/2010 | Comparing Two Different Approaches in the Screening of Cystic Fibrosis Related Diabetes | A Comparative Analysis of the Clinical Efficacy of Two Approaches in the Screening for Cystic Fibrosis Related Diabetes in Adult With Cystic Fibrosis: i) a Selective Approach; ii) an Unselected Annual Oral Glucose Tolerance Test | Screening of Cystic Fibrosis Related Diabetes | Other: Glucose profile for 2 weeks | Imperial College London | Royal Brompton & Harefield NHS Foundation Trust | Completed | 16 Years | N/A | All | 100 | N/A | United Kingdom |
| 1279 | NCT00865904 (ClinicalTrials.gov) | March 2009 | 18/3/2009 | Study of VX-809 in Cystic Fibrosis Subjects With the ?F508-CFTR Gene Mutation | A Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study of VX-809 to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of VX-809 in Cystic Fibrosis Subjects Homozygous for the ?F508-CFTR Gene Mutation | Cystic Fibrosis | Drug: VX-809;Drug: Placebo | Vertex Pharmaceuticals Incorporated | NULL | Completed | 18 Years | N/A | All | 93 | Phase 2 | United States;Belgium;Canada;Germany;Netherlands |
| 1280 | EUCTR2007-006648-23-GB (EUCTR) | 27/02/2009 | 09/10/2008 | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA | Trade Name: Xolair INN or Proposed INN: Omalizumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany;United Kingdom;Netherlands;Belgium;Ireland;Italy | |||
| 1281 | EUCTR2008-002740-42-BE (EUCTR) | 13/02/2009 | 17/11/2008 | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: MTT INN or Proposed INN: Mannitol | Pharmaxis Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;Netherlands;Belgium;France | |||
| 1282 | EUCTR2008-005080-33-IT (EUCTR) | 05/02/2009 | 19/01/2009 | RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS | RANDOMIZED, SINGLE BLIND, CONTROLLED TRIAL OF INHALED GLUTATHIONE VERSUS PLACEBO IN PATIENTS WITH CYSTIC FIBROSIS. - INHALED GSH VS PLACEBO IN CYSTIC FIBROSIS | Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: TAD 600 INN or Proposed INN: Glutathione | AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1283 | EUCTR2008-001530-27-DK (EUCTR) | 02/02/2009 | 20/11/2008 | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom;Denmark;Sweden | ||
| 1284 | NCT00846781 (ClinicalTrials.gov) | February 2009 | 18/2/2009 | Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642) | Cystic Fibrosis | Drug: Denufosol tetrasodium Inhalation Solution | Merck Sharp & Dohme Corp. | NULL | Terminated | 5 Years | N/A | Both | 308 | Phase 3 | United States;Australia;Canada;New Zealand | |
| 1285 | NCT00663975 (ClinicalTrials.gov) | February 2009 | 17/4/2008 | Open Label Safety Study of DCI-1020 in Pediatric Cystic Fibrosis (CF) Patients | An Open-Label, Multi-Center Safety and Efficacy Study of DCI-1020 in Pediatric Cystic Fibrosis Patients With Exocrine Pancreatic Insufficiency | Digestive System Diseases;Pancreatic Disease;Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: DCI 1020 | Digestive Care, Inc. | NULL | Withdrawn | N/A | 2 Years | Both | 24 | N/A | United States |
| 1286 | EUCTR2008-008228-34-GB (EUCTR) | 28/01/2009 | 29/07/2010 | Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients | Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients | Cystic Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: IDPM: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: MANNITOL | Pharmaxis Ltd | NULL | Not Recruiting | Female: yes Male: yes | 18 | United Kingdom | |||
| 1287 | EUCTR2008-001284-11-ES (EUCTR) | 19/01/2009 | 27/01/2009 | Estudio de la eficacia del tratamiento a largo plazo con suero salino hipertónico sobre las exacerbaciones pulmonares en pacientes con Fibrosis Quística | Estudio de la eficacia del tratamiento a largo plazo con suero salino hipertónico sobre las exacerbaciones pulmonares en pacientes con Fibrosis Quística | Fibrosis Quística MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: CLORURO SODICO 7% Product Name: CLORURO SODICO 7% INN or Proposed INN: CLORURO SODICO 7% Trade Name: CLORURO SODICO 7% Product Name: CLORURO SODICO 7% INN or Proposed INN: CLORURO SODICO 7% | ADELAIDA LAMAS FERREIRO | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Spain | ||||
| 1288 | EUCTR2008-001156-43-NL (EUCTR) | 15/01/2009 | 15/09/2008 | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CF | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CF | Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Other descriptive name: TIOTROPIUM Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Other descriptive name: TIOTROPIUM | Boehringer Ingelheim bv | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy | |||
| 1289 | EUCTR2007-001412-23-GB (EUCTR) | 09/01/2009 | 19/02/2008 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Cystic Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: IDPM: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: MANNITOL | Pharmaxis Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 340 | United Kingdom;Ireland | |||
| 1290 | NCT03905642 (ClinicalTrials.gov) | January 8, 2009 | 2/4/2019 | Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) - Extension Phase | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) in Cystic Fibrosis Patients With Chronic Infections Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Arikayce™ | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 49 | Phase 2 | Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Macedonia, The Former Yugoslav Republic of |
| 1291 | EUCTR2008-004699-34-ES (EUCTR) | 16/12/2008 | 25/09/2008 | A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBER | A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBER | Cystic FibrosisFibrosis quística MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Code: AZD1236 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Netherlands;Spain | ||
| 1292 | EUCTR2008-005045-34-GB (EUCTR) | 15/12/2008 | 17/10/2008 | A clinical study to investigate the effect and safety of up to 6 months of treatment with inhaled Promixin in the treatment of chest infections causeed by Pseudomonas in people with a lung disease called bronchiectasis | A double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis | non-CF bronchiectasis (CF = cystic fibrosis) MedDRA version: 14.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution Other descriptive name: colistimethate sodium | Profile Pharma Ltd | NULL | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Ukraine;Ireland;Russian Federation;United Kingdom | ||
| 1293 | EUCTR2007-004277-26-PT (EUCTR) | 12/12/2008 | 17/10/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 1294 | NCT00685971 (ClinicalTrials.gov) | December 2008 | 27/5/2008 | Cholecalciferol for Vitamin D in Adult Cystic Fibrosis (CF) Patients | Randomized Placebo-Controlled Trial of Cholecalciferol for Vitamin D Deficiency in Adults With Cystic Fibrosis | Cystic Fibrosis;Vitamin D Deficiency | Dietary Supplement: 5000 IU of cholecalciferol;Dietary Supplement: placebo | St. Michael's Hospital, Toronto | NULL | Completed | 18 Years | N/A | Both | 200 | N/A | Canada |
| 1295 | NCT00792714 (ClinicalTrials.gov) | December 2008 | 16/11/2008 | Pharmacokinetics of Inhaled Mannitol in Cystic Fibrosis Patients | Determination of the Pharmacokinetics of Inhaled Mannitol After Single and Multiple Dosing in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Mannitol | Pharmaxis | NULL | Completed | 6 Years | N/A | Both | 18 | Phase 1 | Australia;United Kingdom |
| 1296 | EUCTR2008-002740-42-DE (EUCTR) | 13/11/2008 | 31/07/2008 | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: MTT INN or Proposed INN: Mannitol | Pharmaxis Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 300 | Germany;Netherlands;Belgium;France | |||
| 1297 | EUCTR2007-006648-23-DE (EUCTR) | 12/11/2008 | 15/08/2008 | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA | Trade Name: Xolair 150 mg Pulver und Injektionslösung zur Herstellung einer Injektionslösung Product Name: Xolair Product Code: IGE025 INN or Proposed INN: Omalizumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy | |||
| 1298 | EUCTR2007-006276-11-IE (EUCTR) | 11/11/2008 | 11/02/2008 | A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in adults with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in adults with Cystic Fibrosis | A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in adults with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in adults with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Heparin 25mg inhalation powder, hard capsule INN or Proposed INN: HEPARIN SODIUM | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1/2 | Ireland;Italy | ||
| 1299 | NCT00800579 (ClinicalTrials.gov) | November 2008 | 21/11/2008 | Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers | A Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male Volunteers | Cystic Fibrosis | Drug: GS-9411;Drug: Placebo | Gilead Sciences | NULL | Completed | 18 Years | 45 Years | Male | 12 | Phase 1 | Australia |
| 1300 | NCT00846573 (ClinicalTrials.gov) | November 2008 | 16/2/2009 | Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders | Hyperpolarized Noble Gas MR Imaging for Pulmonary Disorders | COPD;Cystic Fibrosis;Asthma;Healthy | Drug: Hyperpolarized Helium-3 | University of Massachusetts, Worcester | NULL | Terminated | 5 Years | N/A | All | 14 | N/A | United States |
| 1301 | NCT00809094 (ClinicalTrials.gov) | November 2008 | 15/12/2008 | NAC Phase IIB: A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients | A Multi-Center, Phase IIB, Randomized, Placebo-controlled, Double-Blind Study Of The Effects Of N-Acetylcysteine On Redox Changes and Lung Inflammation In Cystic Fibrosis Patients | Cystic Fibrosis | Drug: N-acetylcysteine (NAC);Drug: Placebo | Stanford University | Cystic Fibrosis Foundation Therapeutics | Completed | 7 Years | N/A | All | 70 | Phase 2 | United States |
| 1302 | NCT00787917 (ClinicalTrials.gov) | November 2008 | 7/11/2008 | An Exploratory Study to Assess Multiple Doses of Omalizumab in Patients With Cystic Fibrosis Complicated by Acute Bronchopulmonary Aspergillosis (ABPA) | An Exploratory, Randomized, Double-blind, Placebo Controlled Study to Assess the Efficacy of Multiple Doses of Omalizumab in Cystic Fibrosis Complicated by Allergic Bronchopulmonary Aspergillosis (ABPA) | Cystic Fibrosis;Allergic Bronchopulmonary Aspergillosis | Drug: Omalizumab;Drug: Placebo;Drug: Itraconazole | Novartis Pharmaceuticals | NULL | Terminated | 12 Years | N/A | All | 14 | Phase 4 | Belgium;Germany;Italy;Netherlands;United Kingdom |
| 1303 | NCT00794586 (ClinicalTrials.gov) | November 2008 | 18/11/2008 | Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection | A Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: FTI, AZLI;Drug: Placebo, AZLI | Gilead Sciences | NULL | Completed | 18 Years | N/A | Both | 120 | Phase 2 | United States |
| 1304 | NCT00789867 (ClinicalTrials.gov) | November 2008 | 11/11/2008 | Single Dose of pGM169/GL67A in CF Patients | Evaluation of Safety and Gene Expression With a Single Dose of pGM169/GL67A Administered to the Nose and Lung of Individuals With Cystic Fibrosis | Cystic Fibrosis | Drug: pGM169/GL67A | Imperial College London | Royal Brompton & Harefield NHS Foundation Trust;University of Oxford;University of Edinburgh;Cystic Fibrosis Trust;University of Pennsylvania | Completed | 16 Years | 70 Years | All | 35 | Phase 1/Phase 2 | United Kingdom |
| 1305 | NCT00803179 (ClinicalTrials.gov) | November 2008 | 4/12/2008 | Growth Hormone Therapy for Wasting in Cystic Fibrosis | Growth Hormone Therapy for Wasting in Cystic Fibrosis | Cystic Fibrosis | Drug: Nutropin AQ | University of Massachusetts, Worcester | NULL | Terminated | 18 Years | N/A | All | 5 | Phase 1 | United States |
| 1306 | NCT01112059 (ClinicalTrials.gov) | November 2008 | 20/4/2010 | Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) Patients | A Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary Exacerbations | Cystic Fibrosis | Drug: Doxycycline;Other: placebo | University of Alabama at Birmingham | Cystic Fibrosis Foundation Therapeutics | Completed | 19 Years | N/A | All | 40 | N/A | United States |
| 1307 | EUCTR2008-004699-34-NL (EUCTR) | 28/10/2008 | 29/08/2008 | A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis. - CYBER | A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis. - CYBER | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Code: AZD1236 | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Netherlands;Spain | ||
| 1308 | EUCTR2006-004155-38-BE (EUCTR) | 21/10/2008 | 23/09/2008 | Biochemical effects of a long-term supplementation with omega-3 polyunsaturated fatty acids in cystic fibrosis - Omega 3 study | Biochemical effects of a long-term supplementation with omega-3 polyunsaturated fatty acids in cystic fibrosis - Omega 3 study | cystic fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Omega 3 Premium Other descriptive name: OMEGA-3-ACID TRIGLYCERIDES | Hôpital Universitaire Des Enfants Reine Fabiola (H.U.D.E.R.F.) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 80 | Belgium | |||
| 1309 | EUCTR2008-001156-43-DE (EUCTR) | 15/10/2008 | 18/07/2008 | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation INN or Proposed INN: tiotropium bromide monohydrate Product Name: Tiotropium Respimat 1.25 microgram, solution for inhalation Product Code: N/A INN or Proposed INN: tiotropium bromide monohydrate | Boehringer Ingelheim Pharma GmbH & Co.KG | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom | |||
| 1310 | EUCTR2007-004277-26-DE (EUCTR) | 14/10/2008 | 29/05/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Cayston Product Name: AZLI Product Code: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 1311 | NCT00757848 (ClinicalTrials.gov) | October 2008 | 22/9/2008 | A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Cystic Fibrosis | A Phase II, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: AZD9668;Drug: AZD9668 Placebo equivalent | AstraZeneca | NULL | Completed | 16 Years | N/A | All | 56 | Phase 2 | Denmark;Germany;Poland;Russian Federation;Sweden;United Kingdom |
| 1312 | NCT00934362 (ClinicalTrials.gov) | October 2008 | 6/7/2009 | Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung Disease | A Double Blind, Cross-Over Study Comparing Aerosolized Lucinactant and Vehicle on Mucociliary Clearance for Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: Lucinactant first;Drug: Placebo first | University of North Carolina, Chapel Hill | Cystic Fibrosis Foundation Therapeutics;Windtree Therapeutics | Completed | 14 Years | N/A | All | 16 | Phase 2 | United States |
| 1313 | NCT00959010 (ClinicalTrials.gov) | October 2008 | 13/8/2009 | Omega 3 Supplementation in Cystic Fibrosis Patients | Biochemical Effects of a Long-term Supplementation With Omega-3 Polyunsaturated Fatty Acids in Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: omega-3 triglycerides;Dietary Supplement: Placebo | Queen Fabiola Children's University Hospital | NULL | Completed | 6 Years | 60 Years | Both | 15 | Phase 3 | Belgium |
| 1314 | NCT00774072 (ClinicalTrials.gov) | October 2008 | 16/10/2008 | Nasal Inhalation of Tobramycin in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization | Nasal Inhalation of Tobramycin by the Pari Sinus Nebulizer in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Colonization in the Upper Airways | Cystic Fibrosis;Pseudomonas Aeruginosa | Drug: Tobramycin (Gernebcin®) | University of Jena | NULL | Completed | 8 Years | N/A | Both | 9 | Phase 2 | Germany |
| 1315 | NCT00788138 (ClinicalTrials.gov) | October 2008 | 7/11/2008 | Effects of Vitamin D Supplementation on Lung Function in an Acute Pulmonary Exacerbation of Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Vitamin D3;Dietary Supplement: Placebo | Emory University | NULL | Completed | 18 Years | 70 Years | Both | 30 | N/A | United States | |
| 1316 | EUCTR2007-006648-23-BE (EUCTR) | 30/09/2008 | 28/08/2008 | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis | Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis. MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10000244;Term: ABPA | Trade Name: Xolair INN or Proposed INN: omalizumab | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 60 | United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy | |||
| 1317 | EUCTR2008-001769-27-GB (EUCTR) | 29/09/2008 | 09/10/2008 | Microbiological assessment of prophylactic ciprofloxacin therapy for children with cystic fibrosis during viral respiratory viral infection to prevent Pseudomonas aeruginosa colonisation – a randomised control study (Prevent Pseudomonas Aeruginosa Colonisation- PREPAC) - PREPAC | Microbiological assessment of prophylactic ciprofloxacin therapy for children with cystic fibrosis during viral respiratory viral infection to prevent Pseudomonas aeruginosa colonisation – a randomised control study (Prevent Pseudomonas Aeruginosa Colonisation- PREPAC) - PREPAC | Cystic FibrosisSpecifically the trial will include children aged 2-14 years with a diagnosis of cystic fibrosis and not chronically infected with pseudomonas aeruginosa in their lungs. | Trade Name: Ciproxin Suspension Product Name: Ciproxin Product Code: PL 0010/0211 | Southampton University Hospital Trust | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 45 | United Kingdom | |||
| 1318 | EUCTR2008-001156-43-FR (EUCTR) | 19/09/2008 | 13/06/2008 | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Other descriptive name: TIOTROPIUM Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Other descriptive name: TIOTROPIUM | Boehringer Ingelheim France | NULL | Not Recruiting | Female: yes Male: yes | 596 | Phase 2 | Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom | ||
| 1319 | EUCTR2007-004050-85-GB (EUCTR) | 15/09/2008 | 13/10/2008 | Evaluation of safety and gene expression with a single dose of pGM169/GL67A administered to the nose and lung of individuals with cystic fibrosis - Single dose of pGM169/GL67A in CF patients | Evaluation of safety and gene expression with a single dose of pGM169/GL67A administered to the nose and lung of individuals with cystic fibrosis - Single dose of pGM169/GL67A in CF patients | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: pGM169/GL67A Product Code: pGM169/GL67A | Imperial College | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 1320 | EUCTR2008-001156-43-GB (EUCTR) | 11/09/2008 | 14/10/2008 | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Other descriptive name: TIOTROPIUM Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Other descriptive name: TIOTROPIUM | Boehringer Ingelheim Limited | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Italy | |||
| 1321 | EUCTR2007-006276-11-GB (EUCTR) | 01/09/2008 | 26/11/2007 | A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis | A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Heparin 25mg inhalation powder, hard capsule INN or Proposed INN: HEPARIN SODIUM | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 1/2 | Ireland;Italy;United Kingdom | ||
| 1322 | NCT00737100 (ClinicalTrials.gov) | September 2008 | 15/8/2008 | Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis | A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Placebo Respimat;Drug: Tiotropium bromide 5 mcg;Drug: tiotropium bromide-low dose-2.5mcg | Boehringer Ingelheim | NULL | Completed | N/A | N/A | All | 510 | Phase 2 | United States;Australia;Belgium;France;Germany;Italy;Netherlands;New Zealand;Portugal;Russian Federation;United Kingdom |
| 1323 | NCT00630812 (ClinicalTrials.gov) | September 2008 | 27/2/2008 | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis | Long Term Administration of Inhaled Mannitol in Cystic Fibrosis- A Safety and Efficacy Study | Cystic Fibrosis | Drug: inhaled mannitol;Drug: Placebo comparator | Pharmaxis | ethica Clinical Research Inc.;Europe: KasaConsult bvba, Hoegaarden, Belgium;Argentina: Resolution Latin America; Buenos Aires, Argentina | Completed | 6 Years | N/A | All | 318 | Phase 3 | United States;Argentina;Belgium;Canada;France;Germany;Netherlands |
| 1324 | EUCTR2007-004956-35-GB (EUCTR) | 27/08/2008 | 26/11/2007 | The effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards | The effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards | Acute exacerbations of chronic obstructive pulmonary disease. Stress hyperglycaemia. Insulin-induced hypoglycaemia. Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10010953;Term: COPD exacerbation MedDRA version: 9.1;Classification code 10060439;Term: Stress induced hyperglycaemia MedDRA version: 9.1;Classification code 10022484;Term: Insulin hypoglycaemia MedDRA version: 9.1;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Actrapid 100 IU/ml, Solution for injection in a vial Trade Name: Levemir 100 U/ml solution for injection in a cartridge, Levemir 100 U/ml solution for injection in a pre-filled pen Trade Name: NovoRapid 100 U/ml, solution for injection in a vial. NovoRapid Penfill 100 U/ml, solution for injection in a cartridge. NovoRapid FlexPen 100 U/ml, solution for injection in a pre-filled pen. Trade Name: Lantus® 100 Units/ml solution for injection in a vial. Lantus® 100 Units/ml solution for injection in a cartridge. Lantus® 100 Units/ml solution for injection in a pre-filled pen | St George's, University of London | NULL | Not Recruiting | Female: yes Male: yes | United Kingdom | ||||
| 1325 | EUCTR2008-001728-30-DE (EUCTR) | 26/08/2008 | 07/05/2008 | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: MP-376 Product Code: MP-376 INN or Proposed INN: levofloxacin | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | Netherlands;Germany | ||
| 1326 | EUCTR2007-004277-26-ES (EUCTR) | 25/08/2008 | 24/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA). MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;France;Belgium;Spain;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 1327 | EUCTR2006-006215-68-ES (EUCTR) | 22/08/2008 | 27/06/2008 | ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA | Infección pulmonar crónica por P. aeruginosa en pacientes con fibrosis quística MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramicina Trade Name: Tobi 300mg/5ml Solución para inhalación por nebulizador. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | France;Hungary;Czech Republic;Spain;Germany | ||
| 1328 | EUCTR2007-004507-36-DE (EUCTR) | 19/08/2008 | 19/10/2007 | A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects. | A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects. | patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: Tobi Product Code: TBM100 INN or Proposed INN: Tobramycin | Novartis Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | Germany | ||||
| 1329 | EUCTR2008-001728-30-NL (EUCTR) | 18/08/2008 | 30/05/2008 | A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients - | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: MP-376 Product Code: MP-376 INN or Proposed INN: levofloxacin | Mpex Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | Germany;Netherlands | |||
| 1330 | EUCTR2006-006215-68-DE (EUCTR) | 14/08/2008 | 18/12/2008 | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | France;Hungary;Czech Republic;Spain;Germany | |||
| 1331 | EUCTR2008-000164-17-DE (EUCTR) | 13/08/2008 | 26/05/2008 | Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot | Nasale Inhalation von Tobramycin mit dem Pari Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of tobramycin by the Pari Sinus nebulizer in patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - tobra nasal CF pilot | subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways | Trade Name: Gernebcin 80 mg Product Name: Gernebcin 80 mg INN or Proposed INN: tobramycin | University of Jena | NULL | Not Recruiting | Female: yes Male: yes | 14 | Germany | |||
| 1332 | EUCTR2006-006215-68-HU (EUCTR) | 13/08/2008 | 25/06/2008 | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | Hungary;Germany;Czech Republic;France;Spain | |||
| 1333 | EUCTR2008-002352-20-BE (EUCTR) | 11/08/2008 | 17/07/2008 | Single center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic fibrosis homozygous for the F508del mutation | Single center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic fibrosis homozygous for the F508del mutation | Cystic fibrosis homozygous for the F508del mutation MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Zavesca INN or Proposed INN: miglustat | Actelion Pharmaceuticals Ltd | NULL | Not Recruiting | Female: yes Male: yes | Belgium | ||||
| 1334 | EUCTR2008-001530-27-SE (EUCTR) | 06/08/2008 | 17/06/2008 | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom;Denmark;Sweden | ||
| 1335 | NCT00742092 (ClinicalTrials.gov) | August 2008 | 26/8/2008 | Miglustat in Cystic Fibrosis | Single Center, Double-blind, Randomized, Placebo-controlled, Two-period/Two-treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the F508del Mutation | Cystic Fibrosis | Drug: miglustat;Drug: placebo | Actelion | NULL | Completed | 12 Years | N/A | Both | 11 | Phase 2 | Belgium |
| 1336 | NCT00639626 (ClinicalTrials.gov) | August 2008 | 14/3/2008 | Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD) | Use of Levemir® Improves Metabolic and Clinical Status in CFRD | Cystic Fibrosis Related Diabetes | Drug: insulin detemir [rDNA origin] injection | Nationwide Children's Hospital | Novo Nordisk A/S | Terminated | 16 Years | 45 Years | All | 6 | Phase 2/Phase 3 | United States |
| 1337 | NCT00743483 (ClinicalTrials.gov) | August 2008 | 26/8/2008 | Efficacy of Bucelipase Alfa (BSSL) in Patients With Cystic Fibrosis and Pancreatic Insufficiency | An Open Label, Exploratory Study on the Effect of rhBSSL on the Fat Absorption in Patients With Cystic Fibrosis and Pancreatic Insufficiency | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: rhBSSL | Swedish Orphan Biovitrum | NULL | Completed | 18 Years | N/A | All | 15 | Phase 2 | Netherlands;Poland |
| 1338 | NCT00659529 (ClinicalTrials.gov) | August 2008 | 14/4/2008 | Safety and Efficacy of Sildenafil in Cystic Fibrosis (CF) Lung Disease | The Role of Phosphodiesterase Inhibitors in CF Lung Disease | Cystic Fibrosis | Drug: sildenafil | National Jewish Health | Cystic Fibrosis Foundation | Completed | 14 Years | N/A | All | 36 | Phase 1/Phase 2 | United States |
| 1339 | NCT00662675 (ClinicalTrials.gov) | August 2008 | 17/4/2008 | A Study of the Efficacy and Tolerability of Pancrelipase Microtablet (MT) Capsules for the Treatment of Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency | A Randomized Double-blind (Withdrawal) Phase 3 Study to Evaluate the Efficacy and Tolerability of Pancrelipase MT Capsules Compared With Placebo in the Treatment of Subjects With Cystic Fibrosis-dependent Exocrine Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Steatorrhea;Malabsorption Syndromes;Cystic Fibrosis | Drug: Pancrease MT 10.5, or MT 21;Drug: Placebo for Pancrease MT 10.5 or MT 21 | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | NULL | Completed | 7 Years | 60 Years | All | 40 | Phase 3 | United States;Canada |
| 1340 | NCT00744250 (ClinicalTrials.gov) | August 2008 | 28/8/2008 | Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control | Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic Insufficiency | Exocrine Pancreatic Insufficiency;Chronic Pancreatitis;Cystic Fibrosis | Drug: Pancrelipase | Digestive Care, Inc. | University of North Carolina, Chapel Hill | Terminated | 18 Years | N/A | Both | 3 | Phase 4 | United States |
| 1341 | NCT00757237 (ClinicalTrials.gov) | August 2008 | 22/9/2008 | Aztreonam for Inhalation Solution vs Tobramycin Inhalation Solution in Patients With Cystic Fibrosis & Pseudomonas Aeruginosa | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam for Inhalation Solution (AZLI) Versus Tobramycin Inhalation Solution (TIS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects With Cystic Fibrosis Followed by an Open-Label, Single Arm Extension (European Union [EU] Only) | Cystic Fibrosis | Drug: Aztreonam for Inhalation Solution (AZLI);Drug: Tobramycin Inhalation Solution (TIS) | Gilead Sciences | Chiltern International Inc.;ClinPhone, Inc.;Covance | Completed | 6 Years | N/A | All | 274 | Phase 3 | United States;Austria;Belgium;Denmark;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom;Poland |
| 1342 | EUCTR2006-006215-68-CZ (EUCTR) | 29/07/2008 | 16/06/2008 | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | A MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA | cystic fibrosis and P. aeruginosa chronic infection MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob INN or Proposed INN: tobramycin Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi INN or Proposed INN: tobramycin | Chiesi Farmaceutici S.p.A | NULL | Not Recruiting | Female: yes Male: yes | 320 | Phase 3 | France;Hungary;Czech Republic;Spain;Germany | ||
| 1343 | EUCTR2007-004063-21-NL (EUCTR) | 24/07/2008 | 31/10/2007 | An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency. - N/A | An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency. - N/A | Cystic fibrosis and pancreatic insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: rhBSSL Product Code: rhBSSL INN or Proposed INN: Bucelipase alfa Trade Name: Nexium 20 Product Name: Nexium INN or Proposed INN: Esomeprazole | Biovitrum AB | NULL | Not Recruiting | Female: yes Male: yes | 18 | Netherlands | |||
| 1344 | EUCTR2008-001156-43-BE (EUCTR) | 22/07/2008 | 16/06/2008 | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. | Cystic fibrosis. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation Other descriptive name: TIOTROPIUM Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Other descriptive name: TIOTROPIUM | SCS Boehringer Ingelheim Comm.V | NULL | Not Recruiting | Female: yes Male: yes | 596 | Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy | |||
| 1345 | EUCTR2006-006693-24-CZ (EUCTR) | 16/07/2008 | 09/05/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 1346 | EUCTR2008-001530-27-DE (EUCTR) | 08/07/2008 | 26/05/2008 | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | A Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZD9668 Product Code: AZD9668 INN or Proposed INN: none | AstraZeneca AB | NULL | Not Recruiting | Female: yes Male: yes | 65 | Phase 2 | United Kingdom;Germany;Denmark;Sweden | ||
| 1347 | EUCTR2007-006204-37-GB (EUCTR) | 03/07/2008 | 09/05/2008 | Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CF | Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CF | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Glutamine Product Code: none Other descriptive name: L-Glutamine | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 44 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1348 | NCT00706004 (ClinicalTrials.gov) | July 2008 | 25/6/2008 | Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis | Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis | Constipation;Cystic Fibrosis | Drug: lubiprostone | University of Arkansas | Takeda Pharmaceuticals North America, Inc. | Completed | 18 Years | N/A | All | 9 | N/A | United States |
| 1349 | NCT01172301 (ClinicalTrials.gov) | July 2008 | 27/7/2010 | Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis | Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Essential amino acid intake + Leucine vs total AA supplement | Texas A&M University | Arkansas Children's Hospital Research Institute | Completed | 10 Years | 21 Years | Both | 14 | N/A | United States |
| 1350 | EUCTR2007-004277-26-IE (EUCTR) | 19/06/2008 | 27/02/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria | ||
| 1351 | EUCTR2007-004277-26-NL (EUCTR) | 10/06/2008 | 29/05/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 1352 | EUCTR2005-003772-37-GR (EUCTR) | 03/06/2008 | 21/01/2008 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE II | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE II | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom | ||
| 1353 | NCT00566241 (ClinicalTrials.gov) | June 2008 | 30/11/2007 | IGF-1 Therapy in Patients With Cystic Fibrosis | An Investigation Into the Use of IGF-1 Therapy in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: recombinant human IGF-1;Drug: Placebo | Stony Brook University | NULL | Terminated | 18 Years | N/A | Both | 15 | Phase 1 | United States |
| 1354 | NCT00690820 (ClinicalTrials.gov) | June 2008 | 3/6/2008 | Study Investigating a Delayed-Release Pancrelipase in Patients With Pancreatic Exocrine Insufficiency (PEI) Due to Cystic Fibrosis (CF) | A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 12,000 Unit Capsules in Subjects Aged 7 - 11 With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis;Pancreatic Exocrine Insufficiency | Drug: Pancrelipase Delayed Release;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 7 Years | 11 Years | All | 17 | Phase 3 | United States |
| 1355 | NCT00680316 (ClinicalTrials.gov) | June 2008 | 16/5/2008 | A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis | A Phase IV, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme® in 3- to 5-Year-Old Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Dornase alfa;Drug: Placebo | Genentech, Inc. | NULL | Terminated | 3 Years | 5 Years | All | 3 | Phase 4 | United States |
| 1356 | NCT00677365 (ClinicalTrials.gov) | June 2008 | 12/5/2008 | Safety, Tolerability and Efficacy of MP-376 Given for 28 Days to Cystic Fibrosis (CF) Patients | Phase II, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Evaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable CF Patients | Cystic Fibrosis (CF) | Drug: MP-376;Drug: Placebo | Horizon Pharma USA, Inc. | NULL | Completed | 16 Years | N/A | All | 151 | Phase 2 | United States;Germany;Netherlands |
| 1357 | NCT00712166 (ClinicalTrials.gov) | May 2008 | 7/7/2008 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa | A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine For Inhalation in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa (AIR-CF4) | Cystic Fibrosis;Lung Infection;Pseudomonas Aeruginosa | Drug: AZLI 75 mg three times daily (TID);Drug: Placebo three times daily (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 160 | Phase 3 | United States;Australia;Canada |
| 1358 | NCT00645788 (ClinicalTrials.gov) | May 2008 | 26/3/2008 | Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic Fibrosis | Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Ciprofloxacin (Cipro Inhale, BAYQ3939);Drug: Placebo | Bayer | Novartis | Completed | 12 Years | N/A | All | 288 | Phase 2 | United States;Australia;Canada;Denmark;Germany;Israel;Norway;Sweden;United Kingdom |
| 1359 | NCT00411736 (ClinicalTrials.gov) | May 2008 | 14/12/2006 | Scandinavian Cystic Fibrosis Azithromycin Study | Supplementary Oral Azithromycin in Treatment of Intermittent Pseudomonas Aeruginosa Colonization in CF-patients With Inhaled Colistin and Oral Ciprofloxacin; Postponing Next Isolate of Pseudomonas and Prevention of Chronic Infection. A Prospective, Double-blinded, Placebo-controlled Scandinavian Multi-centre Study. | Cystic Fibrosis | Drug: Study medication, azithromycin or placebo;Drug: Azithromycin or placebo tablets | Rigshospitalet, Denmark | Cystic Fibrosis Foundation Therapeutics | Completed | 1 Year | N/A | Both | 45 | Phase 4 | Denmark;Norway;Sweden |
| 1360 | EUCTR2007-004277-26-FR (EUCTR) | 30/04/2008 | 21/01/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 1361 | EUCTR2007-004277-26-BE (EUCTR) | 29/04/2008 | 20/12/2007 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 1362 | EUCTR2007-004277-26-IT (EUCTR) | 23/04/2008 | 17/06/2008 | An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND | An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: aztreonan lysine Product Code: AZLI INN or Proposed INN: Aztreonam Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | ||
| 1363 | EUCTR2008-006502-42-IT (EUCTR) | 22/04/2008 | 07/04/2010 | Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 | Early antibiotic treatment in pseudomonas aeruginosa eradication in cystic fibrosis patients: a randomised policentric study on two different protocols - #FFC17/2007 | Cystic fibrosis MedDRA version: 9.1;Level: SOC;Classification code 10038738 | Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML INN or Proposed INN: Tobramycin INN or Proposed INN: Colistin INN or Proposed INN: Ciprofloxacin | AZIENDA OSPEDALIERA MEYER | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1364 | EUCTR2007-004277-26-DK (EUCTR) | 16/04/2008 | 12/03/2008 | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: AZLI INN or Proposed INN: aztreonam lysine Trade Name: TOBI INN or Proposed INN: tobramycin | Gilead Sciences Inc | NULL | Not Recruiting | Female: yes Male: yes | 273 | Phase 3 | Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom | ||
| 1365 | EUCTR2007-001782-15-IT (EUCTR) | 09/04/2008 | 04/07/2007 | Efficacy and safety of Intra-erythrocytes dexamethasone in cystic fibrosis - ND | Efficacy and safety of Intra-erythrocytes dexamethasone in cystic fibrosis - ND | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: dexamethasone INN or Proposed INN: Dexamethasone | ISTITUTO GIANNINA GASLINI | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | Italy | ||||
| 1366 | NCT00700050 (ClinicalTrials.gov) | April 2008 | 16/6/2008 | Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways | Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot Study | Cystic Fibrosis | Drug: Hypertonic saline | The Hospital for Sick Children | Unity Health Toronto | Active, not recruiting | 14 Years | 28 Years | All | 80 | Canada | |
| 1367 | NCT01323101 (ClinicalTrials.gov) | April 2008 | 15/2/2011 | Doxycycline Effects on Inflammation in Cystic Fibrosis | Effect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis. | Cystic Fibrosis | Drug: Doxycycline;Other: No doxycycline | University of Southern California | NULL | Completed | 18 Years | N/A | All | 21 | Phase 4 | United States |
| 1368 | NCT00476281 (ClinicalTrials.gov) | April 2008 | 18/5/2007 | Nutritional, Metabolic and Respiratory Status in Cystic Fibrosis | Multicenter Prospective Study of Abnormalies Tolerance Glucose by the Continuous Measurement of Glucose of Nutritional Status and Breathing in the Patient With Cystic Fibrosis | Cystic Fibrosis;Diabetes | Procedure: Urinary collect;Procedure: Continuous Glucose Monitoring System (CGMS) | University Hospital, Strasbourg, France | Association d'Aide aux Insuffisants Respiratoires d'Alsace Lorraine | Completed | 10 Years | N/A | All | 114 | N/A | France |
| 1369 | NCT01759342 (ClinicalTrials.gov) | April 2008 | 21/12/2012 | Comprehensive Exercise Training Program During Hospitalization for an Acute CF Exacerbation | The Efficacy of a Standardized Exercise Protocol in Inpatient Care of Patients With Cystic Fibrosis | Cystic Fibrosis | Behavioral: Aerobic exercise;Behavioral: Resistance exercise;Behavioral: Flexibility and postural exercise;Behavioral: Balance exercise | University of Alabama at Birmingham | NULL | Completed | 6 Years | 21 Years | Both | 23 | N/A | United States |
| 1370 | EUCTR2007-003868-22-FR (EUCTR) | 19/03/2008 | 20/12/2007 | ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION. - NEBCINAL 01-07 | ASSESMENT OG EFFICACY AND TOLERABILITY OF INHABLED TOBRAMYCIN VS PLACEBO IN CYSTIC FIBROSIS PATIENTS REVEIVING ANTIBIOTHERAPY FOR 28 DAYS FOR PSEUDOMONAS AERUGINOSA PRIMO COLONISATION. - NEBCINAL 01-07 | Assessment of microbiological efficacy and tolerability of inhaled tobramycin vs placebo in cystic fibrosis patients, primo colonised by Pseudomonas aeruginosa justified inhaled antiobiotherapeutical treatment during 28 days. | Product Code: NEB/01-07 | Laboratoire Erempharma | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1371 | NCT00638365 (ClinicalTrials.gov) | March 2008 | 12/3/2008 | Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa | A Phase I/II Randomized, Double-Blind, Placebo-Controlled, Single-Dose, Dose Escalation Study of KB001 in Cystic Fibrosis Patients Infected With Pseudomonas Aeruginosa | Cystic Fibrosis | Biological: KB001;Other: Placebo | KaloBios Pharmaceuticals | NULL | Completed | 12 Years | N/A | All | 27 | Phase 1/Phase 2 | United States |
| 1372 | NCT00762918 (ClinicalTrials.gov) | March 2008 | 26/9/2008 | Vitamin D3 for the Treatment of Low Vitamin D in Cystic Fibrosis | Vitamin D and Its Non-Classic Roles in Cystic Fibrosis | Cystic Fibrosis;Vitamin D Deficiency | Dietary Supplement: cholecalciferol | Children's Hospital of Philadelphia | NULL | Withdrawn | 10 Years | 25 Years | Both | 0 | Phase 3 | United States |
| 1373 | NCT00635141 (ClinicalTrials.gov) | March 2008 | 4/3/2008 | The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic Fibrosis | The Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic saline (7 %) and isotonic saline (0.9%) | The Hospital for Sick Children | Canadian Cystic Fibrosis Foundation | Completed | 6 Years | 18 Years | Both | 20 | Phase 3 | Canada |
| 1374 | NCT00628134 (ClinicalTrials.gov) | March 2008 | 22/2/2008 | Self-dispersing Liquids as Aerosol Drug Carriers | Self-dispersing Liquids as Aerosol Drug Carriers | Cystic Fibrosis | Drug: calfactant;Drug: isotonic saline | University of Pittsburgh | Cystic Fibrosis Foundation Therapeutics | Completed | 18 Years | N/A | All | 8 | N/A | United States |
| 1375 | EUCTR2007-004004-12-BG (EUCTR) | 28/02/2008 | 05/02/2008 | A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY | A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY | Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc. MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy | Trade Name: Creon 10000 Product Name: Pancrelipase Delayed Release Capsule Other descriptive name: Pancrelipase/Pancreas Powder Trade Name: Creon 25000 Product Name: Pancrelipase Delayed Release Capsule Other descriptive name: Pancrelipase/Pancreas Powder | Solvay Pharmaceuticals GmbH | NULL | Not Recruiting | Female: yes Male: yes | 52 | Bulgaria | |||
| 1376 | NCT01983774 (ClinicalTrials.gov) | February 2008 | 6/11/2013 | Effect of Proton Pump Inhibitors on CF Pulmonary Exacerbations | Effect of Proton Pump Inhibitors on CF Exacerbations | Cystic Fibrosis | Drug: Esomeprazole;Drug: Placebo | Columbia University | NULL | Terminated | 18 Years | 65 Years | Both | 13 | Phase 2 | United States |
| 1377 | NCT00625612 (ClinicalTrials.gov) | February 2008 | 12/2/2008 | Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease | A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted | Cystic Fibrosis | Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution;Drug: Placebo | Merck Sharp & Dohme Corp. | NULL | Completed | 5 Years | N/A | Both | 466 | Phase 3 | United States;Australia;Canada;New Zealand |
| 1378 | NCT00605761 (ClinicalTrials.gov) | February 2008 | 18/1/2008 | SD Cystic Fibrosis Study | An Open Label Dose Ascending, Single Dose Study to Investigate the Pharmacokinetics of SB-656933 in Subjects With Cystic Fibrosis. | Cystic Fibrosis | Drug: SB656933 | GlaxoSmithKline | NULL | Completed | 16 Years | N/A | Both | 9 | Phase 1 | United States |
| 1379 | NCT00634192 (ClinicalTrials.gov) | February 2008 | 4/3/2008 | Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled Tobramycin | A Multicenter, Open Label, 2 Period Cross-over Study to Evaluate the PK of a 8 Week Continuous Treatment With 1x300mg/d and 2x300mg/d Tobramycin Inhaled With a 'Soft Mist' Nebulizer in Cystic Fibrosis (CF) Subjects | Pseudomonas Infections | Drug: tobramycin | Novartis | NULL | Completed | 6 Years | N/A | All | 50 | Phase 3 | Germany |
| 1380 | EUCTR2006-006693-24-IT (EUCTR) | 31/01/2008 | 12/11/2007 | A randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND | A randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND | Cystic fibrosis MedDRA version: 6.1;Level: PT;Classification code 10011763 | Product Name: DURAMYCIN Product Code: MOLI 1901 | AOP ORPHAN PHARMACEUTICALS | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 1381 | EUCTR2006-006693-24-ES (EUCTR) | 21/01/2008 | 14/09/2007 | Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y la seguridad de Moli1901 aerosol en adolescentes (12 años de edad o más) y adultos con fibrosis quística - MOLI | Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y la seguridad de Moli1901 aerosol en adolescentes (12 años de edad o más) y adultos con fibrosis quística - MOLI | La FQ es la enfermedad hereditaria mortal más frecuente en la población caucásica, afectando a unos 4 de cada 10.000 niños. En la fibrosis quística, el transporte de cloro a través del epitelio respiratorio es deficiente, de manera que la mucosidad contiene menos agua y su viscosidad está aumentada de manera anormal. Se puede suponer que Moli1901 corrige el transporte anormal de cloro y agua en los pulmones y de ese modo reduce la formación de tapones de mucosidad y aumenta el aclaramiento. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2;Phase 3 | France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden | ||
| 1382 | NCT00719381 (ClinicalTrials.gov) | January 2008 | 17/7/2008 | Effect of Pioglitazone on Inflammation in Cystic Fibrosis | Effect of Pioglitazone on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Cystic Fibrosis | Cystic Fibrosis | Drug: Pioglitazone | Paul Beringer | NULL | Completed | 18 Years | N/A | Both | 24 | Phase 1 | United States |
| 1383 | NCT00558844 (ClinicalTrials.gov) | January 2008 | 13/11/2007 | Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa | Phase 1b/2a Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikayce™) in Cystic Fibrosis Patient With Chronic Infections Due to Pseudomonas Aeruginosa. | Cystic Fibrosis | Drug: Arikayce™ 560 mg;Drug: Placebo for 560 mg;Drug: Arikayce™ 70 mg;Drug: Arikayce™ 140 mg;Drug: Placebo for 70 mg / 140 mg | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 41 | Phase 1/Phase 2 | United States |
| 1384 | NCT00557089 (ClinicalTrials.gov) | January 2008 | 9/11/2007 | The Effect of rhDNase on Ventilation Inhomogeneity in Patients With Cystic Fibrosis | Randomized, Placebo-controlled Trial on the Effect of rhDNase on Ventilation Inhomogeneity in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: rhDNAse;Other: Placebo | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 17 | Phase 4 | Canada |
| 1385 | EUCTR2007-000178-21-IT (EUCTR) | 31/12/2007 | 07/01/2008 | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) | ALTUS PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 200 | Italy | |||
| 1386 | EUCTR2007-000171-41-IT (EUCTR) | 31/12/2007 | 07/01/2008 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTUS-135 Product Code: ALTUS-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: Multienzymes (lipase, protease etc.) | ALTUS PHARMACEUTICALS INC | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | Italy | ||
| 1387 | EUCTR2007-005346-20-GB (EUCTR) | 04/12/2007 | 28/11/2007 | Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF | Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF | Children with cystic fibrosis | Trade Name: Tobi 300 mg/5 ml Nebuliser Solution Product Name: TOBI INN or Proposed INN: tobramycin | Leeds Teaching Hospitals NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 30 | United Kingdom | |||
| 1388 | NCT00484263 (ClinicalTrials.gov) | December 2007 | 7/6/2007 | The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis | The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis. | Bronchiectasis | Drug: Hypertonic saline 6% - | The Alfred | NULL | Completed | 18 Years | N/A | Both | 40 | Phase 3 | Australia |
| 1389 | EUCTR2007-003628-39-IT (EUCTR) | 22/11/2007 | 08/04/2008 | Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND | Pilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND | Rhinosinusal infection by Pseudomonas a. e/o Staphylococcus a. in patients with Cystic Fibrosis MedDRA version: 9.1;Level: HLGT;Classification code 10024970;Term: Respiratory tract infections | Product Code: TNSE INN or Proposed INN: TOBRAMYCIN | ECUPHARMA S.R.L. | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1390 | EUCTR2005-003772-37-HU (EUCTR) | 08/11/2007 | 03/07/2007 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Germany;United Kingdom;Spain;Italy;Greece | ||
| 1391 | NCT00510484 (ClinicalTrials.gov) | November 2007 | 1/8/2007 | Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis | A Double-blind, Randomized, Multi-center, Placebo-controlled, Cross-over Study to Assess the Efficacy and Safety of Pancrelipase Delayed Release 24,000 Unit Capsules in Subjects With Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase Delayed Release;Drug: Placebo Comparator | Solvay Pharmaceuticals | NULL | Completed | 12 Years | N/A | All | 35 | Phase 3 | United States;Hungary;Israel;South Africa;Spain |
| 1392 | NCT00537602 (ClinicalTrials.gov) | November 2007 | 28/9/2007 | Miglustat / OGT 918 in the Treatment of Cystic Fibrosis | Single Center, Double-blind, Randomized, Placebo-controlled, 2-period/2-treatment Crossover Study Investigating the Effect of Miglustat on the Nasal Potential Difference in Patients With Cystic Fibrosis Homozygous for the ?F508 Mutation | Cystic Fibrosis | Drug: miglustat;Drug: placebo | Actelion | NULL | Terminated | 12 Years | N/A | Both | 6 | Phase 2 | Spain |
| 1393 | EUCTR2007-002912-24-DE (EUCTR) | 30/10/2007 | 05/09/2007 | Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years | Study to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years | long term treatment of chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Ciprofloxacin Product Code: BAY q 3939 INN or Proposed INN: CIPROFLOXACIN Other descriptive name: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[1-piperazinyl]-3-quinoline carboxylic acid | Bayer HealthCare AG | NULL | Not Recruiting | Female: yes Male: yes | 16 | Germany | |||
| 1394 | EUCTR2007-002657-23-DE (EUCTR) | 01/10/2007 | 09/07/2007 | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects with Genotype G551D | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects with Genotype G551D | cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: NA Other descriptive name: VRT-813077 Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: NA Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | Germany | ||
| 1395 | NCT00686361 (ClinicalTrials.gov) | October 2007 | 26/5/2008 | Choline Nutrition in Children With Cystic Fibrosis (CF) | To Investigate Whether Choline Supplementation in Children With CF Will Correct Biochemical Markers of Choline Deficiency and Improve Plasma Indices of Methylation Capacity and Redox Status and Result in Decreased Pro-inflammatory Cytokines | Cystic Fibrosis | Drug: Choline supplementation | University of British Columbia | Cystic Fibrosis Foundation Therapeutics | Completed | 5 Years | 17 Years | Both | 34 | N/A | Canada |
| 1396 | NCT00528190 (ClinicalTrials.gov) | October 2007 | 10/9/2007 | Treatment of Aspergillus Fumigatus (a Fungal Infection) in Patients With Cystic Fibrosis | Treatment of Aspergillus Fumigatus in Patients With Cystic Fibrosis: A Randomized, Double-blind, Placebo-Controlled Trial | Cystic Fibrosis | Drug: Itraconazole | Ottawa Hospital Research Institute | The Hospital for Sick Children;Canadian Cystic Fibrosis Foundation;The Physicians' Services Incorporated Foundation | Completed | 6 Years | N/A | All | 35 | Phase 4 | Canada |
| 1397 | NCT00541190 (ClinicalTrials.gov) | October 2007 | 5/10/2007 | Absorptive Clearance in the Cystic Fibrosis Airway | Absorptive Clearance in the Cystic Fibrosis Airway | Cystic Fibrosis | Other: Technetium [Tc-99m] sulfur colloid and Indium [In-111] DTPA | University of Pittsburgh | NULL | Completed | 18 Years | N/A | All | 21 | N/A | United States |
| 1398 | NCT01070446 (ClinicalTrials.gov) | October 2007 | 10/2/2010 | Choline Nutrition in Children With Cystic Fibrosis | Choline Nutrition in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: Vitamin: Choline Bitartrate (2-hydroxyethyl) trimethylammonium salt 1:1 | University of British Columbia | Cystic Fibrosis Foundation (US) | Completed | 5 Years | 17 Years | Both | 34 | N/A | Canada |
| 1399 | NCT00671736 (ClinicalTrials.gov) | October 2007 | 30/4/2008 | Lancovutide (Moli1901) Inhalation Solution Study in Adolescents and Adults With Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults With Cystic Fibrosis | Cystic Fibrosis | Drug: Moli1901;Drug: Moli1901 placebo | AOP Orphan Pharmaceuticals AG | NULL | Completed | 12 Years | N/A | Both | 160 | Phase 2 | Austria |
| 1400 | EUCTR2007-000724-40-BE (EUCTR) | 27/09/2007 | 27/04/2007 | A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Code: PTC124 | PTC Therapeutics, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Belgium | ||
| 1401 | EUCTR2007-001412-23-IE (EUCTR) | 27/09/2007 | 11/07/2007 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol | Pharmaxis Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Ireland | |||
| 1402 | NCT00221546 (ClinicalTrials.gov) | September 2007 | 12/9/2005 | Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis | Influence of DHA-rich Supplement on DHA-status and Health Evolution of Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Giving DHA-rich supplement | University Hospital, Ghent | Belgian Society against Cystic Fibrosis | Completed | 6 Years | N/A | Both | 17 | Phase 2 | Belgium |
| 1403 | NCT00499837 (ClinicalTrials.gov) | September 2007 | 11/7/2007 | Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients | Double-Blind, Randomized, Placebo-Controlled, Phase II Study of the Safety and Efficacy of Inhaled Alpha-1 Antitrypsin (AAT ) in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Aerosolized, human, plasma-derived Alpha-1 Antitrypsin | Kamada, Ltd. | NULL | Completed | 5 Years | N/A | Both | 21 | Phase 2 | Israel |
| 1404 | NCT00531882 (ClinicalTrials.gov) | September 2007 | 18/9/2007 | Pilot Mouthwash Study of Pioglitazone and Simvastatin in Healthy Volunteers | A Pilot Study Evaluating the Effect of Pioglitazone, Simvastatin, and Ibuprofen on Neutrophil Migration in Vivo in Healthy Subjects | Cystic Fibrosis | Drug: Pioglitazone;Drug: Simvastatin;Drug: Ibuprofen | University Hospitals Cleveland Medical Center | NULL | Completed | 18 Years | 50 Years | All | 25 | N/A | United States |
| 1405 | NCT01851642 (ClinicalTrials.gov) | September 2007 | 25/4/2013 | Lung Disease and Its Affect on the Work of White Blood Cells in the Lungs | The Role of Conformational Diseases on Macrophage Function | Alpha-1 Antitrypsin Deficiency;AAT Deficiency;AATD;Cystic Fibrosis (CF) | Procedure: History and physical exam.;Procedure: Blood draw.;Procedure: Pulmonary function testing.;Drug: Albuterol inhaler. | University of Florida | NULL | Recruiting | 18 Years | N/A | All | 220 | United States | |
| 1406 | NCT00546663 (ClinicalTrials.gov) | September 2007 | 17/10/2007 | Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis | A Pilot Study to Evaluate the Tolerability of Inhaled 7% Hypertonic Saline in Infants With Cystic Fibrosis | Cystic Fibrosis | Drug: inhaled 7% hypertonic saline (HS) | CF Therapeutics Development Network Coordinating Center | Cystic Fibrosis Foundation Therapeutics | Completed | 12 Months | 30 Months | Both | 19 | N/A | United States;Canada |
| 1407 | NCT00534079 (ClinicalTrials.gov) | September 2007 | 21/9/2007 | Nasal Inhalation of Pulmozyme in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis - a Double Blind Placebo-controlled Cross-over, Bicenter, Prospective Clinical Study | Cystic Fibrosis;Rhinosinusitis | Drug: Dornase alfa (Pulmozyme);Drug: isotonic saline | University of Jena | NULL | Completed | 5 Years | N/A | Both | 23 | Phase 3 | Germany |
| 1408 | EUCTR2006-006693-24-DE (EUCTR) | 29/08/2007 | 29/05/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2;Phase 3 | France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden | ||
| 1409 | EUCTR2006-006693-24-FR (EUCTR) | 23/08/2007 | 16/05/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In Cystic Fibrosis chloride transport accross the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli 1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. | Product Name: Moli 1901 (2622U90, duramycin) Product Code: Moli 1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Phase 2;Phase 3 | France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden | ||
| 1410 | EUCTR2006-006693-24-SE (EUCTR) | 16/08/2007 | 02/07/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 1411 | EUCTR2007-000959-33-DE (EUCTR) | 16/08/2007 | 04/04/2007 | Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF | Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CF | Cystic Fibrosis with Pseudomonas aeruginosa infection | Product Name: Tobramycin 100 PARI Product Code: T100 PARI INN or Proposed INN: Tobramycin Trade Name: TOBI® INN or Proposed INN: Tobramycin | PARI GmbH | NULL | Not Recruiting | Female: yes Male: yes | 25 | Germany | |||
| 1412 | NCT01018303 (ClinicalTrials.gov) | August 2007 | 19/11/2009 | Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic Fibrosis | Safety and Efficacy of a Novel Antioxidant-rich Multivitamin Supplement for Persons With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: AquADEK | University of Colorado, Denver | Cystic Fibrosis Foundation Therapeutics;Yasoo Health;National Institutes of Health (NIH) | Completed | 10 Years | 40 Years | Both | 17 | Phase 1/Phase 2 | United States |
| 1413 | EUCTR2006-006693-24-HU (EUCTR) | 27/07/2007 | 18/06/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 1414 | EUCTR2006-002049-35-ES (EUCTR) | 22/07/2007 | 28/05/2007 | Estudio unicéntrico, a doble ciego, aleatorizado y controlado con placebo, cruzado de 2 brazos, para investigar el efecto de miglustat sobre la diferencia de potencial nasal en pacientes con fibrosis quística homocigotos para la mutación ?F508 | Estudio unicéntrico, a doble ciego, aleatorizado y controlado con placebo, cruzado de 2 brazos, para investigar el efecto de miglustat sobre la diferencia de potencial nasal en pacientes con fibrosis quística homocigotos para la mutación ?F508 | fibrosis quística MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Zavesca Product Name: miglustat Product Code: OGT 918 INN or Proposed INN: Miglustat Other descriptive name: 1,5 (Butylimino)-1,5-dideoxy-D-glucitol | Actelion Pharmaceuticals Ltd | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 25 | Spain | |||
| 1415 | EUCTR2007-000171-41-SK (EUCTR) | 16/07/2007 | 10/04/2008 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease | Altus Pharmaceuticals Inc | NULL | Not Recruiting | Female: yes Male: yes | 176 | Phase 3 | Slovakia;Italy | ||
| 1416 | EUCTR2007-000178-21-SK (EUCTR) | 16/07/2007 | 10/04/2008 | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease | Altus Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Italy | ||
| 1417 | NCT00506688 (ClinicalTrials.gov) | July 2007 | 24/7/2007 | Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis Patients | Randomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: reduced glutathione sodium salt;Drug: 0.9% normal saline (control) | Mukoviszidose Institut gGmbH | Cystic Fibrosis Foundation Therapeutics | Completed | 8 Years | N/A | Both | 153 | Phase 2 | Germany |
| 1418 | NCT00506792 (ClinicalTrials.gov) | July 2007 | 22/7/2007 | Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic Fibrosis | A Two-part, Randomized, Double-blind, Placebo-controlled, Ascending Single-dose, Adaptive Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QAU145 Administered Via a Nasal Spray Pump to Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: QAU145;Drug: Placebo | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 50 Years | Both | 9 | Phase 2 | United States |
| 1419 | NCT00513682 (ClinicalTrials.gov) | July 2007 | 7/8/2007 | Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI) | Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA%) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI) | Cystic Fibrosis;Pancreatic Insufficiency | Drug: Ultrase® MT20 | Forest Laboratories | NULL | Completed | 7 Years | 11 Years | All | 9 | Phase 3 | United States |
| 1420 | NCT00425165 (ClinicalTrials.gov) | July 2007 | 19/1/2007 | Study of Denufosol Inhalation Solution in Patients With Mild to Moderate Cystic Fibrosis Lung Disease | A Randomized, Double-Blind, Two Way Crossover Evaluation of the Effects of a Single Dose of Denufosol Tetrasodium (INS37217) Inhalation Solution Versus Placebo (0.9% Sodium Chloride Solution) on Mucociliary Clearance in Patients With Mild to Moderate Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) Inhalation Solution | Merck Sharp & Dohme Corp. | NULL | Terminated | 10 Years | N/A | Both | 6 | Phase 2 | United States |
| 1421 | NCT01293084 (ClinicalTrials.gov) | July 2007 | 9/2/2011 | Hypertonic Saline and Mucociliary Clearance in Children | Acute Inhalation of Hypertonic Saline Does Not Improve Mucociliary Clearance in All Children With Cystic Fibrosis | Cystic Fibrosis | Drug: 0.12% saline;Drug: 7% saline | Johns Hopkins University | Cystic Fibrosis Foundation Therapeutics | Completed | 7 Years | 12 Years | All | 17 | Phase 2 | NULL |
| 1422 | EUCTR2007-002707-40-BE (EUCTR) | 28/06/2007 | 04/06/2007 | The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients | The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients | Mucoviscidose MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Hypertonic saline solution INN or Proposed INN: Sodium Chloride Product Name: Normal saline solution INN or Proposed INN: Sodium Chloride | University Hospital Ghent | NULL | Not Recruiting | Female: yes Male: yes | 60 | Belgium | |||
| 1423 | EUCTR2006-006980-22-BE (EUCTR) | 27/06/2007 | 19/07/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin sulfate | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Belgium | |||
| 1424 | EUCTR2006-006980-22-HU (EUCTR) | 14/06/2007 | 03/04/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Belgium | |||
| 1425 | NCT00449904 (ClinicalTrials.gov) | June 2007 | 19/3/2007 | Open-Label Phase III Long-Term Safety Trial of Liprotamase | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: Liprotamase | Anthera Pharmaceuticals | NULL | Completed | 7 Years | N/A | Both | 214 | Phase 3 | United States |
| 1426 | NCT00503490 (ClinicalTrials.gov) | June 2007 | 16/7/2007 | Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis | Phase I, Single and Multi-dose, Placebo Controlled, Randomized, Dose-Escalation Study to Evaluate the Safety, Tolerability and PK Profile of MP-376 Using the PARI eFlow Nebulizer for 14 Days to CF Patients | Cystic Fibrosis | Drug: MP-376 (Levofloxacin solution for Inhalation);Drug: placebo | Horizon Pharma USA, Inc. | NULL | Completed | 16 Years | N/A | All | 40 | Phase 1 | United States |
| 1427 | EUCTR2006-003275-12-DK (EUCTR) | 23/05/2007 | 17/04/2007 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Denmark | ||
| 1428 | EUCTR2006-006980-22-SK (EUCTR) | 17/05/2007 | 23/04/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Hungary;Slovakia;Poland;Belgium | ||
| 1429 | EUCTR2006-006693-24-AT (EUCTR) | 09/05/2007 | 11/01/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | |||
| 1430 | NCT00449878 (ClinicalTrials.gov) | May 2007 | 19/3/2007 | Liprotamase Efficacy Trial in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients With Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: Liprotamase;Drug: Placebo | Anthera Pharmaceuticals | NULL | Completed | 7 Years | N/A | Both | 163 | Phase 3 | United States |
| 1431 | NCT00457821 (ClinicalTrials.gov) | May 2007 | 5/4/2007 | Safety Study of Ivacaftor in Subjects With Cystic Fibrosis | A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects With Genotype G551D | Cystic Fibrosis | Drug: Ivacaftor 25 mg/75 mg;Drug: Ivacaftor 75 mg/150 mg;Drug: Ivacaftor 150 mg or 250 mg;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Cystic Fibrosis Foundation Therapeutics | Completed | 18 Years | N/A | All | 39 | Phase 2 | United States;Canada;Germany |
| 1432 | EUCTR2007-001007-38-FR (EUCTR) | 25/04/2007 | 26/03/2007 | STUDY OF THE LONG TERM BIOLOGICAL EFFICACY AND TOLERABILITY OF VEDROP (VITAMIN E-TPGS FORMULATION) AFTER DAILY ORAL ADMINISTRATION IN 30 PAEDIATRIC PATIENTS WITH CYSTIC FIBROSIS - 1ORP2 | STUDY OF THE LONG TERM BIOLOGICAL EFFICACY AND TOLERABILITY OF VEDROP (VITAMIN E-TPGS FORMULATION) AFTER DAILY ORAL ADMINISTRATION IN 30 PAEDIATRIC PATIENTS WITH CYSTIC FIBROSIS - 1ORP2 | Paediatric patient who present a cystic fibrosis | Product Name: VEDROP Product Code: VITAMIN E - TGPS INN or Proposed INN: d-a-tocopheryl PEG 1000 succinate | ORPHAN | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1433 | EUCTR2006-006362-41-GB (EUCTR) | 05/04/2007 | 28/03/2007 | An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CF | An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CF | Adult patients with cystic fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Vfend Product Name: Vfend INN or Proposed INN: VORICONAZOLE | Leeds Teaching Hospital NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 12 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1434 | NCT00458341 (ClinicalTrials.gov) | March 23, 2007 | 6/4/2007 | A Study of Ataluren in Pediatric Participants With Cystic Fibrosis | A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Cystic Fibrosis | Drug: Ataluren | PTC Therapeutics | NULL | Completed | 6 Years | 18 Years | All | 30 | Phase 2 | Belgium;France;Israel |
| 1435 | EUCTR2006-004078-28-GB (EUCTR) | 14/03/2007 | 15/02/2012 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Cystic Fibrosis MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: IDPM: Inhaled Dry Powder Mannitol Product Code: IDPM INN or Proposed INN: MANNITOL | Pharmaxis UK Limited | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United Kingdom | ||
| 1436 | NCT00434278 (ClinicalTrials.gov) | March 2007 | 11/2/2007 | A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC) | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease | Cystic Fibrosis | Drug: Dornase alfa;Drug: placebo | Genentech, Inc. | NULL | Terminated | 14 Years | N/A | All | 27 | Phase 4 | United States |
| 1437 | NCT00446680 (ClinicalTrials.gov) | March 2007 | 12/3/2007 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis - A Safety and Efficacy Study | Cystic Fibrosis | Drug: Mannitol;Drug: placebo | Pharmaxis | NULL | Completed | 6 Years | N/A | Both | 340 | Phase 3 | Australia;Ireland;United Kingdom |
| 1438 | NCT00777296 (ClinicalTrials.gov) | February 22, 2007 | 15/10/2008 | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) | Phase 2a Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) In Cystic Fibrosis Patients With Chronic Infections Due To Pseudomonas Aeruginosa. | Cystic Fibrosis | Drug: ARIKACE™;Drug: Placebo | Insmed Incorporated | NULL | Completed | 6 Years | N/A | All | 66 | Phase 1/Phase 2 | Belgium;Hungary;North Macedonia;Poland;Serbia;Slovakia;Ukraine;Bulgaria;Macedonia, The Former Yugoslav Republic of |
| 1439 | NCT00431964 (ClinicalTrials.gov) | February 2007 | 2/2/2007 | Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. Aeruginosa | Multi-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: azithromycin 250 mg tablets;Drug: placebo tablets | CF Therapeutics Development Network Coordinating Center | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | 18 Years | All | 263 | Phase 4 | United States;Canada |
| 1440 | NCT00432861 (ClinicalTrials.gov) | January 2007 | 7/2/2007 | Evaluation of the Safety and Efficacy of Pancrecarb® MS-16 in Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Crossover Study to Evaluate the Effectiveness and Safety of PANCRECARB® MS-16 (Pancrelipase) in Reducing Steatorrhea in Children and Adults With Cystic Fibrosis | Cystic Fibrosis;Pancreatic Insufficiency | Drug: PANCRECARB® (pancrelipase);Drug: Placebo | Digestive Care, Inc. | NULL | Completed | 7 Years | N/A | Both | 29 | Phase 3 | United States |
| 1441 | NCT00406536 (ClinicalTrials.gov) | January 2007 | 29/11/2006 | Study of LYM-X-SORB™ to Improve Fatty Acid and Choline Status in Children With CF and PI | Phase II Study: LYM-X-SORB™, an Organized Lipid Matrix: Fatty Acids and Choline in CF | Cystic Fibrosis;Pancreatic Insufficiency | Dietary Supplement: Lym-X-Sorb powder;Dietary Supplement: Placebo powder | Avanti Polar Lipids, Inc. | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 6 Years | 17 Years | Both | 110 | Phase 2 | United States |
| 1442 | EUCTR2006-005180-25-DE (EUCTR) | 15/12/2006 | 31/10/2006 | A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design | A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design | Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study. MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Code: LU 70274 | Nordmark Arzneimittel GmbH | NULL | Not Recruiting | Female: no Male: yes | 20 | Germany | |||
| 1443 | NCT00416182 (ClinicalTrials.gov) | December 2006 | 26/12/2006 | Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis | The Use of Nasally Delivered Pulmozyme in the Treatment of Sinusitis in Cystic Fibrosis Patients: A Pilot Study | Sinusitis;Cystic Fibrosis | Drug: Pulmozyme (dornase alfa);Drug: Placebo | University of Vermont | Genentech, Inc. | Completed | 5 Years | N/A | All | 16 | Phase 2 | United States |
| 1444 | NCT00547053 (ClinicalTrials.gov) | December 2006 | 17/10/2007 | Amiloride Solution and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis | A Six Month Open Label Study of Amiloride Solution for Inhalation and Tobramycin Solution for Inhalation for the Eradication of Burkholderia Dolosa in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Amiloride Solution for Inhalation | Children's Hospital Boston | Cystic Fibrosis Foundation Therapeutics | Completed | 6 Years | N/A | Both | 25 | Phase 1 | United States |
| 1445 | NCT00721071 (ClinicalTrials.gov) | December 2006 | 21/7/2008 | Utility of Induced Sputum Using Hypertonic Saline to Evaluate Infection and Inflammation in Cystic Fibrosis | Diagnostic Utility of Induced Sputum Using Hypertonic Saline to Evaluate Airway Infection and Inflammation in Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline | The Hospital for Sick Children | NULL | Completed | 6 Years | 18 Years | Both | 95 | Phase 2 | Canada |
| 1446 | NCT00351078 (ClinicalTrials.gov) | December 2006 | 11/7/2006 | PTC124 for the Treatment of Cystic Fibrosis | A Phase 2b Extension Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Cystic Fibrosis | Drug: PTC124 | PTC Therapeutics | NULL | Completed | 18 Years | N/A | All | 19 | Phase 2 | Israel |
| 1447 | EUCTR2006-001254-27-FR (EUCTR) | 30/11/2006 | 25/08/2006 | Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus | Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus | Patients atteints de mucoviscidose, chez lesquels un diagnostic de diabète a été fait par hyperglycémie provoquée orale (HGPO) MedDRA version: 8.1;Level: PT;Classification code 10012594;Term: DIABETES | Trade Name: NovoNorm 0.5 mg Product Name: NovoNorm 0.5 mg INN or Proposed INN: Répaglinide Trade Name: Actrapid Penfill 100UI/ml Product Name: Actrapid Penfill 100UI/ml INN or Proposed INN: Insuline humaine recombinante Trade Name: NovoNorm 1 mg Product Name: NovoNorm 1 mg INN or Proposed INN: Répaglinide Trade Name: NovoNorm 2 mg Product Name: NovoNorm 2 mg INN or Proposed INN: Répaglinide | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | France | ||||
| 1448 | NCT00408317 (ClinicalTrials.gov) | November 2006 | 4/12/2006 | Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI) | A Multicenter, Randomized, Double-Blind, Crossover Study to Compare the Safety and Efficacy of Ultrase® MT20 to Placebo for the Correction of Steatorrhea in Patients With Cystic Fibrosis (CF) | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: Ultrase® MT20;Drug: Placebo | Forest Laboratories | NULL | Completed | 7 Years | N/A | All | 36 | Phase 3 | United States |
| 1449 | NCT00763412 (ClinicalTrials.gov) | November 2006 | 29/9/2008 | Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis | Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic Fibrosis | Cystic Fibrosis Related Diabetes;Pancreatic Insufficiency | Drug: placebo;Drug: repaglinide | Arbelaez, Ana Maria | Washington University School of Medicine;National Institutes of Health (NIH);Novo Nordisk A/S;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 12 Years | 24 Years | All | 31 | N/A | United States |
| 1450 | NCT00405665 (ClinicalTrials.gov) | November 2006 | 28/11/2006 | The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis | Pilot Study of the Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: L-arginine | The Hospital for Sick Children | NULL | Completed | 14 Years | N/A | Both | 20 | Phase 2 | Canada |
| 1451 | NCT00450073 (ClinicalTrials.gov) | November 2006 | 19/3/2007 | Improving Vitamin D Status In Cystic Fibrosis | Desktop Tanning Unit to Improve Vitamin D Status in Patients With Cystic Fibrosis and Short Bowel Syndrome: A Pilot Study | Cystic Fibrosis | Drug: ergocalciferol (vitamin D2);Device: Sperti Del Sol Lamp;Drug: Vitamin D3 | Atlanta VA Medical Center | Emory University | Completed | 18 Years | 60 Years | All | 30 | N/A | United States |
| 1452 | EUCTR2005-005594-29-HU (EUCTR) | 31/10/2006 | 19/06/2006 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic Fibrosis | Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Hungary;Czech Republic | |||
| 1453 | EUCTR2005-003870-88-DE (EUCTR) | 20/10/2006 | 28/08/2006 | Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4 | Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4 | Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction. | Product Name: GSH (Glutathione) Product Code: TAD 600 INN or Proposed INN: Glutathione Other descriptive name: reduced glutathione | Mukoviszidose Institut gGmbH i. G. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Germany | |||
| 1454 | EUCTR2006-002259-33-DE (EUCTR) | 10/10/2006 | 11/07/2006 | Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study - | Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study - | CF-patients develop a chronic pulmonary infection with Pseudomonas aeruginosa (P. aeruginosa). At present it is unknown why CF-patients are highly sensitive to P. aeruginosa infections and, most important, no curative treatment for cystic fibrosis is available. This Study should provide a novel anti-inflammatory treatment for cystic fibrosis, which reduces pulmonary complications, progression of the disease and may possibly increase the life-expectance of the patients. | Trade Name: Amitriptylin-ct Tabletten Product Name: Amitriptyline INN or Proposed INN: AMITRIPTYLINE Trade Name: Amitriptylin-ct Tabletten Product Name: Amitriptyline INN or Proposed INN: AMITRIPTYLINE Trade Name: Amitriptylin-ct Tabletten Product Name: Amitriptyline INN or Proposed INN: AMITRIPTYLINE | Paediatrisches Sekretariat fuer Klinische Studien | NULL | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | ||
| 1455 | EUCTR2005-005594-29-CZ (EUCTR) | 04/10/2006 | 02/08/2006 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic Fibrosis | Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 360 | Hungary;Czech Republic | |||
| 1456 | NCT00671723 (ClinicalTrials.gov) | October 2006 | 30/4/2008 | Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis Patients | Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis | Atelectasis | Drug: Normal saline:;Drug: Hypertonic Saline;Drug: Dornase alpha | University of Oklahoma | NULL | Completed | 18 Years | 90 Years | All | 33 | N/A | United States |
| 1457 | NCT00515229 (ClinicalTrials.gov) | October 2006 | 9/8/2007 | Anti-Inflammatory Pulmonal Therapy of CF-Patients With Amitriptyline and Placebo | Protocol for a Phase II-Study Anti-Inflammatory Pulmonal Therapy of CF-Patients With Amitriptyline and Placebo - Randomised, Double-Blinded, Placebo-Controlled, Cross Over - Study - | Cystic Fibrosis;Infection;Pseudomonas Aeruginosa | Drug: amitriptyline | University Hospital Tuebingen | NULL | Completed | 18 Years | 50 Years | Both | 18 | Phase 2 | Germany |
| 1458 | NCT01463371 (ClinicalTrials.gov) | October 2006 | 28/10/2011 | Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis | Effects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: Azithromycin | Instituto de Investigacion Sanitaria La Fe | Sociedad Valenciana de Neumología | Completed | 16 Years | 80 Years | Both | 30 | N/A | Spain |
| 1459 | EUCTR2005-005594-29-SK (EUCTR) | 14/09/2006 | 11/08/2006 | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic Fibrosis | Product Name: Moli1901 Product Code: Moli1901 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 360 | Phase 2;Phase 3 | Czech Republic;Hungary;Slovakia | ||
| 1460 | NCT02172534 (ClinicalTrials.gov) | September 2006 | 20/6/2014 | Safety, Tolerability and Pharmacokinetics of Tiotropium in Cystic Fibrosis Patients | A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single and Multiple Doses (28-day Dosing) of Tiotropium Bromide Administered Once Daily Via the Respimat® Device in Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Tiotropium bromide low;Drug: Tiotropium bromide medium;Drug: Tiotropium bromide high;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | N/A | N/A | Both | 113 | Phase 1 | NULL |
| 1461 | EUCTR2006-000945-20-GB (EUCTR) | 22/08/2006 | 18/09/2006 | To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis - Vitamin K supplementation in Cystic Fibrosis | To investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis - Vitamin K supplementation in Cystic Fibrosis | Cystic Fibrosis MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Trade Name: Menadiol Diphosphate Product Name: Menadiol Diphosphate Product Code: Menadiol Diphosphate INN or Proposed INN: Menadiol sodium diphosphate | Barts and the London NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom | ||
| 1462 | EUCTR2005-002997-31-GB (EUCTR) | 10/08/2006 | 09/11/2005 | A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes | A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetes | Individuals with cystic fibrosis develop diabetes. They exhibit abnormal glucose handling (impaired glucose tolerance), poor growth and a decline in lung function before overt diabetes develops. Early treatment with insulin before diabetes develops may improve weight gain and lung function and delay progression to overt diabetes. | Product Name: Levemir Penfill | Sheffield Children's NHS Trust | NULL | Not Recruiting | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1463 | NCT00572975 (ClinicalTrials.gov) | August 2006 | 11/12/2007 | Malabsorption Blood Test:Toward a Novel Approach to Quantify Steatorrhea | MALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify Steatorrhea | Cystic Fibrosis;Pancreatic Insufficiency | Other: Pentadecanoic acid (PA) and Triheptadecanoin (THA) | Children's Hospital of Philadelphia | Solvay Pharmaceuticals | Completed | 8 Years | N/A | Both | 9 | Phase 4 | United States |
| 1464 | NCT00357279 (ClinicalTrials.gov) | July 2006 | 25/7/2006 | Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease | A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) Inhalation Solution;Drug: Placebo - 0.9% w/v sodium chloride solution | Merck Sharp & Dohme Corp. | NULL | Completed | 5 Years | N/A | Both | 352 | Phase 3 | United States;Canada |
| 1465 | NCT00458614 (ClinicalTrials.gov) | June 2006 | 9/4/2007 | Pharmacokinetic Study of Lansoprazole in Cystic Fibrosis | Lansoprazole Disposition in Young Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Lansoprazole | Arkansas Children's Hospital Research Institute | NULL | Completed | 2 Years | 10 Years | Both | 18 | Phase 1 | United States |
| 1466 | EUCTR2005-004344-30-HU (EUCTR) | 10/05/2006 | 23/12/2005 | An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease | An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance. | Product Name: Moli1901 (2622U90, duramycin) Product Code: EU Orphan Designation Number EU/3/02/120 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 18 | Hungary | |||
| 1467 | EUCTR2005-004103-10-DE (EUCTR) | 03/05/2006 | 30/01/2006 | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Cystic Fibrosis with Pseudomoas aeuriginosa infection MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Tobramycin 100 PARI Product Code: T100 PARI INN or Proposed INN: Tobramycin Trade Name: Tobi Product Name: TOBI® INN or Proposed INN: Tobramycin | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Germany | |||
| 1468 | NCT00297167 (ClinicalTrials.gov) | May 2006 | 27/2/2006 | Study to Evaluate the Safety and Efficacy of EUR-1008 (APT-1008) Pancreatic Enzyme Product in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | A Randomized, Double-Blind, Placebo-Controlled, Two-Treatment, Crossover Study to Evaluate the Safety and Efficacy of Eurand Pancreatic Enzyme Product (PEP) in Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: EUR-1008 (APT-1008);Drug: Placebo | Forest Laboratories | NULL | Completed | 7 Years | N/A | All | 34 | Phase 3 | United States |
| 1469 | NCT00981214 (ClinicalTrials.gov) | May 2006 | 21/9/2009 | Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | An Open-Label Study to Evaluate the Efficacy and Safety of Pancreatic Enzyme Product (PEP) Microtabs in Pediatric Patients With Cystic Fibrosis and Exocrine Pancreatic Insufficiency | Cystic Fibrosis;Exocrine Pancreatic Insufficiency | Drug: EUR-1008 (APT-1008) | Forest Laboratories | NULL | Completed | N/A | 7 Years | All | 19 | Phase 3 | United States |
| 1470 | NCT00399945 (ClinicalTrials.gov) | May 2006 | 14/11/2006 | Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy Study | A Phase 1, Single-Dose, Open-Label, Two-Way Crossover, Pharmacoscintigraphy Study of Aerosol Delivery Characteristics (Measured by In Vivo Lung Deposition, Nebulization Time, Serum Tobramycin Concentrations, and Pharmacokinetic Parameters) and Safety of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (No Compressor) vs. PARI LC PLUS (TM) Jet Nebulizer (With Compressor) in Healthy Subjects and in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin | Novartis | NULL | Completed | 18 Years | 65 Years | Both | 12 | Phase 1 | United Kingdom |
| 1471 | NCT00322868 (ClinicalTrials.gov) | April 2006 | 4/5/2006 | Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease | A Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: pioglitazone | University Hospitals Cleveland Medical Center | Cystic Fibrosis Foundation | Completed | 18 Years | N/A | All | 21 | N/A | United States |
| 1472 | NCT00420836 (ClinicalTrials.gov) | April 2006 | 10/1/2007 | Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study | Crossover Pharmacokinetic Study of Tobramycin Administered for Inhalation by PARI eFlow® Rapid Electronic Nebulizer (no Compressor) vs. PARI LC PLUSTM Jet Nebulizer (With Compressor) in Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: Tobramycin | Novartis | NULL | Completed | 6 Years | N/A | Both | 20 | Phase 1 | NULL |
| 1473 | NCT00311883 (ClinicalTrials.gov) | March 2006 | 4/4/2006 | Hydroxychloroquine in Cystic Fibrosis | Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis | Cystic Fibrosis | Drug: hydroxychloroquine | Vanderbilt University | NULL | Completed | 16 Years | N/A | Both | 20 | Phase 1 | United States |
| 1474 | NCT00308243 (ClinicalTrials.gov) | March 2006 | 27/3/2006 | Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. | Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. Stage 1) | Cystic Fibrosis | Drug: Sodium Pyruvate in 0.9% Sodium Chloride Solution | Emphycorp | Cellular Sciences | Completed | 18 Years | N/A | Both | 15 | Phase 1 | United States |
| 1475 | NCT00753987 (ClinicalTrials.gov) | March 2006 | 15/9/2008 | Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis | Tolerability of Hypertonic Saline in Infants With Cystic Fibrosis | Cystic Fibrosis | Drug: Hypertonic Saline | The Hospital for Sick Children | NULL | Completed | 2 Months | 2 Years | Both | 13 | Phase 1 | Canada |
| 1476 | EUCTR2005-003772-37-IT (EUCTR) | 28/02/2006 | 23/06/2006 | A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003 | A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003 | Cystic Fibrosis with presence of Pseudomonas aeruginosa infection MedDRA version: 6.1;Level: PT;Classification code 10011763 | INN or Proposed INN: Tobramycin Product Name: Tobramycin Inhalation Powder TIP delivered by the T-326 Inhaler Product Code: T-326 INN or Proposed INN: Tobramycin | CHIRON CORPORATION LIMITED | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Germany;United Kingdom;Spain;Italy;Greece | ||
| 1477 | EUCTR2005-003772-37-ES (EUCTR) | 09/02/2006 | 20/01/2006 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística. | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística. | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycin Trade Name: TOBI 300mg/5mL Nebuliser Solution Product Name: TOBI INN or Proposed INN: Tobramycin | Chiron Corporation Ltd | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Germany;Italy;United Kingdom | ||
| 1478 | NCT00287456 (ClinicalTrials.gov) | February 2, 2006 | 2/2/2006 | Use of the Insulin Pump in Cystic Fibrosis Patients With Impaired Glucose Tolerance or CFRD and in Type 1 Diabetes Patients. | Cystic Fibrosis Related Diabetes | Device: Insulin Pump;Drug: Insulin;Procedure: Oral Glucose Tolerance Test;Procedure: Whole body Protein Turnover | University of Texas Southwestern Medical Center | NULL | Withdrawn | 12 Years | 32 Years | All | 0 | N/A | United States | |
| 1479 | NCT00287443 (ClinicalTrials.gov) | February 2, 2006 | 2/2/2006 | Metabolic Abnormalities in Hispanic Children With Cystic Fibrosis | Cystic Fibrosis | Procedure: Oral Glucose tolerance test;Procedure: Whole body protein turnover;Procedure: IV glucose tolerance test;Procedure: Indirect Calorimetry;Procedure: Dual Energy X-ray Absorptiometry (DEXA);Procedure: Growth Hormone Stimulation Test | University of Texas Southwestern Medical Center | Genentech, Inc. | Withdrawn | 7 Years | 17 Years | All | 0 | N/A | United States | |
| 1480 | NCT00298922 (ClinicalTrials.gov) | February 2006 | 2/3/2006 | Azithromycin in Patients With CF, Infected With Burkholderia Cepacia Complex | Phase II, Randomized, Double Blind, Placebo-Controlled Trial of Azithromycin in Patients With CF, Chronically Infected With Burkholderia Cepacia Complex | Cystic Fibrosis | Drug: Azithromycin;Drug: Placebo | St. Michael's Hospital, Toronto | Cystic Fibrosis Foundation Therapeutics;Pfizer | Active, not recruiting | 19 Years | N/A | Both | 45 | Phase 2 | Canada |
| 1481 | NCT00483769 (ClinicalTrials.gov) | February 2006 | 6/6/2007 | One Year Glargine Treatment in CFRD Children and Adolescents | One-Year Glargine-Treatment Can Ameliorate Clinical Features in Cystic Fibrosis Children and Adolescents With Glucose Derangements | Cystic Fibrosis;Glucose Metabolism Disorders | Drug: Glargine | Federico II University | NULL | Completed | 3 Years | 20 Years | Both | 20 | Phase 4 | Italy |
| 1482 | NCT00332215 (ClinicalTrials.gov) | February 2006 | 30/5/2006 | A Phase I Study of Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. | Inhaled Sodium Pyruvate for the Treatment of Cystic Fibrosis. A Phase I, Double Blind, Placebo Controlled, Safety Study. | Cystic Fibrosis | Drug: Inhaled Sodium Pyruvate | University of Minnesota - Clinical and Translational Science Institute | Cellular Sciences | Terminated | 18 Years | N/A | Both | 70 | Phase 1 | United States |
| 1483 | NCT00388505 (ClinicalTrials.gov) | February 2006 | 16/10/2006 | Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis | A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for Inhalation | Novartis Pharmaceuticals | NULL | Completed | 6 Years | N/A | All | 517 | Phase 3 | United States;Australia;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom |
| 1484 | EUCTR2005-003772-37-GB (EUCTR) | 06/01/2006 | 09/11/2005 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder (TIP) Product Code: TBM100C INN or Proposed INN: Tobramycin Trade Name: TOBI Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Germany;Italy;United Kingdom | ||
| 1485 | NCT00274313 (ClinicalTrials.gov) | January 2006 | 6/1/2006 | Safety Study of Inhaled 552-02 in Cystic Fibrosis Patients | A Study of the Safety and Pharmacokinetics of 552-02 Following 14 Days of Dosing By Inhalation in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: 552-02 | Parion Sciences | NULL | Completed | 14 Years | N/A | Both | 40 | Phase 1/Phase 2 | United States |
| 1486 | NCT00287430 (ClinicalTrials.gov) | January 2006 | 2/2/2006 | Growth Hormone Use in Adolescents and Adults With Cystic Fibrosis | Cystic Fibrosis | Drug: Growth Hormone;Procedure: Whole body Protein Turnover Study;Procedure: Dual Energy X-ray Absorptiometry (DEXA) | University of Texas Southwestern Medical Center | Dana S Hardin | Withdrawn | 6 Years | 40 Years | All | 0 | N/A | NULL | |
| 1487 | EUCTR2005-004389-17-HU (EUCTR) | 28/12/2005 | 24/10/2005 | SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA | SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSA | Cystic Fibrosis with mild to moderate obstructive lung disease and chronic infection with Pseudomonas aeruginosa | Product Name: SLIT Amikacin Product Code: TR02 INN or Proposed INN: amikacin Other descriptive name: amikin, amiklin, amicacin, BB-K8, Biklin, Fabianol, Kaminax, Mikavir, Novamin, Pierami | Transave, Inc | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 15 | Hungary | |||
| 1488 | EUCTR2005-004899-21-BE (EUCTR) | 22/12/2005 | 12/01/2006 | Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA | Safety and tolerability study of SLIT(TM) Amikacin 500 mg once daily for 14 days by inhalation in cystic fibrosis study subjects chronically infected with Pseudomonas aeruginosa. - NA | Cystic Fibrosis | Product Name: SLIT(TM) Amikacin Product Code: TR02 INN or Proposed INN: Amikacin Other descriptive name: amikin®, amiklin, amicacin, BB-K8, Biklin®, Fabianol®, Kaminax, Mikavir, Novamin®, Pierami | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 15 | Belgium | |||
| 1489 | NCT00265434 (ClinicalTrials.gov) | December 2005 | 13/12/2005 | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Nasal Inhalation of Dornase Alfa (Pulmozyme) in Patients With Cystic Fibrosis and Chronic Rhinosinusitis | Cystic Fibrosis;Chronic Rhinosinusitis | Drug: Pulmozyme | University of Jena | PD Dr. Joachim Riethmöller, Tübingen;PD Dr. Assen Koitschev, Tübingen;Dr. Gerlind Schneider | Completed | 5 Years | N/A | Both | 5 | Phase 3 | Germany |
| 1490 | NCT00237380 (ClinicalTrials.gov) | November 30, 2005 | 7/10/2005 | Safety and Efficacy of Ataluren (PTC124) for Cystic Fibrosis | A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Cystic Fibrosis | Drug: Ataluren | PTC Therapeutics | NULL | Completed | 18 Years | N/A | All | 24 | Phase 2 | Israel |
| 1491 | EUCTR2005-000311-98-GB (EUCTR) | 09/11/2005 | 14/09/2005 | A randomised controlled trial (pilot study) of the use of macerated garlic oil in patients with cystic fibrosis who have pulmonary infection with Pseudomonas aeruginosa - GAP pilot study | A randomised controlled trial (pilot study) of the use of macerated garlic oil in patients with cystic fibrosis who have pulmonary infection with Pseudomonas aeruginosa - GAP pilot study | Chronic pulmonary infection with Pseudomonas aeruginosa in patients with cystic fibrosis | Product Name: Boots High Strength Garlic Odour Controlled Product Code: SE10599 | University of Nottingham | NULL | Not Recruiting | Female: yes Male: yes | 30 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1492 | NCT00117208 (ClinicalTrials.gov) | November 2005 | 30/6/2005 | Comparison of Inhaled Mannitol and rhDNase in Children With Cystic Fibrosis | A Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: mannitol;Drug: mannitol + pulmozyme;Drug: Dornase alpha | Pharmaxis | NULL | Completed | 8 Years | 18 Years | Both | 20 | Phase 2 | United Kingdom |
| 1493 | EUCTR2005-004344-30-AT (EUCTR) | 31/10/2005 | 26/09/2005 | An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease | An Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance. | Product Name: Moli1901 (2622U90, duramycin) Product Code: EU Orphan Designation Number EU/3/02/120 Other descriptive name: Duramycin, 2622U90 | AOP Orphan Pharmaceuticals AG | NULL | Not Recruiting | Female: yes Male: yes | 18 | Hungary;Austria | |||
| 1494 | EUCTR2004-003675-36-BE (EUCTR) | 27/10/2005 | 13/10/2005 | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis. | Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Trade Name: TOBI 300 mg/5 ml Nebuliser Solution Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI® | Forest Laboratories UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 360 | Denmark;Belgium | |||
| 1495 | NCT00231192 (ClinicalTrials.gov) | October 2005 | 3/10/2005 | Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes | Repaglinide for Adolescents With Cystic Fibrosis-Related Diabetes | Diabetes | Drug: Repaglinide and Insulin | Children's Hospital of Philadelphia | NULL | Withdrawn | 12 Years | 20 Years | Both | 0 | N/A | United States |
| 1496 | NCT00251056 (ClinicalTrials.gov) | October 2005 | 30/6/2005 | Mannitol Dose Response Study in Cystic Fibrosis | A Phase IIa Randomised, Open Label, Dose Response Study to Determine the Optimum Dose of Dry Powder Mannitol Required to Generate Clinical Improvement In Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: mannitol | Pharmaxis | NULL | Completed | 7 Years | N/A | Both | 48 | Phase 2 | Argentina;Canada |
| 1497 | EUCTR2005-003837-42-GB (EUCTR) | 26/09/2005 | 24/08/2005 | CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis | CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis | infection - ciprofloxacin is used to treat various infections, for example respiratory tract infections, ear, nose and throat infections, eye infections, urinary tract infections. The main indication that is relevant to this application is its use in the treatment of chest infections in patients with cystic fibrosis. I have included the ICD classification for chest infection below. | Trade Name: Ciprofloxacin (ciproxin) Product Name: N/A Product Code: N/A | Belfast City Hospital Trust | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1498 | EUCTR2005-002035-28-LT (EUCTR) | 19/09/2005 | 24/08/2005 | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects | pulmonary P aeruginosa infection in patient with cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycine | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Lithuania | ||
| 1499 | NCT00125346 (ClinicalTrials.gov) | September 2005 | 28/7/2005 | Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis Subjects | A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects | Cystic Fibrosis | Drug: Tobramycin Inhalation Powder | Novartis | NULL | Terminated | 6 Years | 21 Years | Both | 98 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Lithuania;Mexico;Former Serbia and Montenegro |
| 1500 | NCT00234663 (ClinicalTrials.gov) | September 2005 | 5/10/2005 | PTC124 for Cystic Fibrosis | A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Cystic Fibrosis | Drug: PTC124 | PTC Therapeutics | Cystic Fibrosis Foundation Therapeutics;FDA Office of Orphan Products Development | Completed | 18 Years | N/A | Both | 24 | Phase 2 | United States |
| 1501 | EUCTR2004-002341-12-BE (EUCTR) | 05/08/2005 | 25/08/2005 | Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients | Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients | Cystic fibrosis MedDRA version: 7.0;Level: PT;Classification code 10011762 | Product Name: Depelestat Product Code: EPI-hNE4 DX-890 INN or Proposed INN: Depelestat Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase INN or Proposed INN: Depelestat Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase | Debiopharm SA | NULL | Not Recruiting | Female: yes Male: yes | 90 | United Kingdom;Germany;Belgium;Italy | |||
| 1502 | NCT00687466 (ClinicalTrials.gov) | August 2005 | 27/5/2008 | Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay | Phase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay | Cystic Fibrosis;Glucose Intolerance | Drug: Insulin | Fondazione per la ricerca sulla Fibrosi Cistica | NULL | Active, not recruiting | 10 Years | 70 Years | Both | 70 | Phase 3 | Italy |
| 1503 | NCT00130182 (ClinicalTrials.gov) | August 2005 | 11/8/2005 | A Study in Pediatric Patients With Cystic Fibrosis Lung Disease | A Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Pediatric Patients With Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) | Merck Sharp & Dohme Corp. | NULL | Completed | 5 Years | 7 Years | Both | 13 | Phase 2 | United States |
| 1504 | NCT00128492 (ClinicalTrials.gov) | August 2005 | 8/8/2005 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA) | A Phase 3, Open-label, Follow-On Study of Multiple Courses of Aztreonam Lysinate for Inhalation (AI) in Cystic Fibrosis Patients (AIR-CF3) | Cystic Fibrosis | Drug: AZLI 75 mg two times a day (BID)/ three times a day (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 274 | Phase 3 | United States;Australia;Canada;New Zealand |
| 1505 | EUCTR2005-002135-27-IT (EUCTR) | 06/07/2005 | 28/06/2005 | Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration | Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration | Cystic Fibrosis patients with glucose intolerance MedDRA version: 6.1;Level: PT;Classification code 10011762 | Trade Name: LANTUS*SC 5CAR3ML100UI/ML Product Name: NA Product Code: NA INN or Proposed INN: Insulin glargine | ISTITUTO GIANNINA GASLINI | NULL | Not Recruiting | Female: yes Male: yes | Italy | ||||
| 1506 | NCT00217204 (ClinicalTrials.gov) | July 2005 | 13/9/2005 | An Effectiveness, Safety, and Palatability Study of Pancrelipase Microtablets in Infants and Toddlers With Cystic Fibrosis and Fat Malabsorption | A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Effectiveness of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers With Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | Cystic Fibrosis;Steatorrhea | Drug: Pancrelipase microtablets | McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc. | NULL | Completed | 6 Months | 30 Months | Both | 18 | Phase 2 | Belgium;Netherlands |
| 1507 | EUCTR2004-005019-28-GB (EUCTR) | 09/05/2005 | 19/04/2005 | Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose | Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose | Cystic fibrosis related diabetes mellitus | Trade Name: NovoRapid Aspartate INN or Proposed INN: Novo Rapid Trade Name: Rapeglinide INN or Proposed INN: Rapeglinide | Papworth Hospital NHS Foundation Trust | NULL | Not Recruiting | Female: yes Male: yes | 6 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | United Kingdom | ||
| 1508 | NCT00112359 (ClinicalTrials.gov) | May 2005 | 1/6/2005 | International Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa | A Phase 3, Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary Pseudomonas Aeruginosa (AIR-CF1) | Cystic Fibrosis | Drug: AZLI 75 mg three times a day (TID);Drug: Placebo three times a day (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 166 | Phase 3 | United States;Australia;Canada;New Zealand |
| 1509 | EUCTR2004-003675-36-DK (EUCTR) | 28/04/2005 | 06/12/2004 | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis. | Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI® | Forest Laboratories UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 360 | Belgium;Denmark | |||
| 1510 | EUCTR2004-003675-36-AT (EUCTR) | 19/04/2005 | 15/03/2005 | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | A randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection | Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis. | Product Name: Colobreathe INN or Proposed INN: Colistimethate sodium Other descriptive name: Colomycin Trade Name: TOBI 300 mg/5 ml Nebuliser Solution Product Name: TOBI® INN or Proposed INN: Tobramycin Other descriptive name: TOBI® | Forest Laboratories UK Ltd | NULL | Not Recruiting | Female: yes Male: yes | 360 | Belgium;Denmark;Austria | |||
| 1511 | EUCTR2004-002341-12-GB (EUCTR) | 15/04/2005 | 10/02/2005 | Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients | Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients | Cystic fibrosis MedDRA version: 7.0;Level: PT;Classification code 10011762 | Product Name: Depelestat Product Code: EPI-hNE4 DX-890 INN or Proposed INN: Depelestat Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase INN or Proposed INN: Depelestat Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase | Debiopharm SA | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 2 | Belgium;Germany;Italy;United Kingdom | ||
| 1512 | EUCTR2005-000313-35-GB (EUCTR) | 13/04/2005 | 17/03/2005 | A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study | A Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study | Cystic Fibrosis MedDRA version: 7.1;Level: LLT;Classification code 10011762 | Product Name: Recombinant truncated SPINT2 protease inhibitor Product Code: AER002 | Aerovance Inc | NULL | Not Recruiting | Female: yes Male: yes | 106 | Phase 1;Phase 2 | United Kingdom | ||
| 1513 | EUCTR2004-004334-13-IE (EUCTR) | 08/04/2005 | 06/12/2004 | A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Talniflumate in Cystic Fibrosis Subjects | A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Talniflumate in Cystic Fibrosis Subjects | Cystic Fibrosis | Trade Name: Somalgen Product Name: Talniflumate Product Code: MSI-1995 INN or Proposed INN: Talniflumate | Genaera Corporation | NULL | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | Ireland | ||
| 1514 | NCT00219882 (ClinicalTrials.gov) | April 2005 | 16/9/2005 | Safety Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis | A Phase I Safety and Dose Finding Study of Orally Administered Curcuminoids in Adult Subjects With Cystic Fibrosis Who Are Homozygous for Delta F508 Cystic Fibrosis Transmembrane Conductance Regulator (?F508 CFTR) Mutation | Cystic Fibrosis | Drug: standardized turmeric root extract | Ramsey, Bonnie, MD | Seer Pharmaceuticals;CF Therapeutics Development Network Coordinating Center;Cystic Fibrosis Foundation Therapeutics | Completed | 18 Years | 40 Years | Both | 11 | Phase 1 | United States |
| 1515 | NCT00198289 (ClinicalTrials.gov) | April 2005 | 9/9/2005 | Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs | A Phase IIa Dose Escalation Study to Assess Safety and Pharmacokinetics of Aurexis® in Cystic Fibrosis Subjects Chronically Colonized With Staphylococcus Aureus in Their Lungs | Staphylococcus Aureus | Drug: Aurexis® (tefibazumab) | Bristol-Myers Squibb | NULL | Completed | 7 Years | N/A | Both | 30 | Phase 2 | United States |
| 1516 | EUCTR2004-002341-12-DE (EUCTR) | 14/02/2005 | 24/09/2004 | Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients | Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients | Cystic fibrosis MedDRA version: 7.0;Level: PT;Classification code 10011762 | Product Name: Depelestat Product Code: EPI-hNE4 DX-890 INN or Proposed INN: Depelestat Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase INN or Proposed INN: Depelestat Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase | Debiopharm SA | NULL | Not Recruiting | Female: yes Male: yes | 90 | United Kingdom;Germany;Belgium;Italy | |||
| 1517 | NCT00104520 (ClinicalTrials.gov) | February 2005 | 1/3/2005 | Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa | A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam Lysinate for Inhalation in Cystic Fibrosis Patients With Pulmonary P. Aeruginosa Requiring Frequent Antibiotics (AIR-CF2) | Cystic Fibrosis | Drug: AZLI 75 mg two times a day (BID)/three times a day (TID);Drug: Placebo two times a day (BID)/three times a day (TID) | Gilead Sciences | NULL | Completed | 6 Years | N/A | All | 211 | Phase 3 | United States |
| 1518 | EUCTR2004-002341-12-IT (EUCTR) | 12/01/2005 | 16/03/2005 | Multicenter, 8-week, Randomised,Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients | Multicenter, 8-week, Randomised,Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients | cystic fibrosis MedDRA version: 6.1;Level: PT;Classification code 10011762 | Product Name: DEPELESTAT Product Code: DX-890 INN or Proposed INN: Other respiratory system products Product Name: DEPELESTAT Product Code: DX-890 INN or Proposed INN: Other respiratory system products | DEBIOPHARM S.A. | NULL | Not Recruiting | Female: yes Male: yes | 90 | United Kingdom;Germany;Belgium;Italy | |||
| 1519 | NCT00105183 (ClinicalTrials.gov) | January 2005 | 8/3/2005 | EZ-2053 in the Prophylaxis of Acute Pulmonary Allograft Rejection | A Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study of an Anti-human-T-lymphocyte Immune Globulin (EZ-2053) in the Prophylaxis of Acute Pulmonary Allograft Rejection in Adult Recipients of Primary Pulmonary Allograft(s) | Chronic Obstructive Pulmonary;Idiopathic Pulmonary Fibrosis;Cystic Fibrosis;Bronchiectasis;Pulmonary Vascular Disease | Biological: Placebo;Biological: EZ-2053;Biological: EZ-2053 5mg/kg | Neovii Biotech | NULL | Completed | 18 Years | N/A | All | 223 | Phase 3 | United States;Australia;Austria;Canada |
| 1520 | NCT00103714 (ClinicalTrials.gov) | January 2005 | 14/2/2005 | Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease | A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) | Merck Sharp & Dohme Corp. | NULL | Completed | 8 Years | 50 Years | Both | 72 | Phase 2 | United States |
| 1521 | NCT00179998 (ClinicalTrials.gov) | January 2005 | 10/9/2005 | Effectiveness of Pulmozyme in Infants With Cystic Fibrosis | Efficacy of Pulmozyme in Infants and Young Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Recombinant Human DNase (Pulmozyme);Drug: Placebos | Nationwide Children's Hospital | Genentech, Inc. | Completed | 1 Month | 30 Months | All | 24 | Phase 2 | United States |
| 1522 | EUCTR2004-001888-21-GB (EUCTR) | 03/12/2004 | 22/02/2005 | A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis | A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis | Cystic fibrosis (CF) | Product Name: DP Mannitol INN or Proposed INN: Mannitol Trade Name: Pulmozyme (dornase alfa) Product Name: Pulmozyme (dornase alfa) INN or Proposed INN: Dornase alfa Other descriptive name: rhDNAse | Pharmaxis Ltd | NULL | Not Recruiting | Female: yes Male: yes | 42 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 1523 | NCT00377741 (ClinicalTrials.gov) | December 2004 | 15/9/2006 | A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis. | Relative Bioavailability Study of Ganciclovir From the Pro-drug, Valganciclovir, in Lung Transplant Recipients With or Without Cystic Fibrosis | Cytomegalovirus Infections | Drug: valganciclovir [Valcyte] | Hoffmann-La Roche | NULL | Completed | 14 Years | N/A | All | 31 | Phase 1 | United States |
| 1524 | NCT00221559 (ClinicalTrials.gov) | September 2004 | 12/9/2005 | Serum Zn Status of Patients With Cystic Fibrosis at Diagnosis and One Year Later, Compared to a Healthy Control Group | Serum Zn Status of Patients With Cystic Fibrosis at Diagnosis and One Year Later, Compared to a Healthy Control Group | Cystic Fibrosis | Procedure: Blood sampling for determination of serum Zn | University Hospital, Ghent | Scientific research fund Bruges | Completed | N/A | N/A | All | 0 | Belgium | |
| 1525 | NCT00097773 (ClinicalTrials.gov) | September 2004 | 30/11/2004 | Comparison of Two Treatment Regimens to Reduce PA Infection in Children With Cystic Fibrosis | Effectiveness and Safety of Intermittent Antimicrobial Therapy for the Treatment of New Onset Pseudomonas Aeruginosa Airway Infection in Young Patients With Cystic Fibrosis | Cystic Fibrosis;Pulmonary Disease, Chronic Obstructive | Drug: Tobramycin solution for inhalation (TOBI);Drug: Oral placebo;Drug: Oral ciprofloxacin | Seattle Children's Hospital | National Heart, Lung, and Blood Institute (NHLBI);Cystic Fibrosis Foundation Therapeutics;CF Therapeutics Development Network Coordinating Center | Completed | 1 Year | 12 Years | All | 304 | Phase 2 | United States |
| 1526 | NCT00219895 (ClinicalTrials.gov) | August 2004 | 16/9/2005 | Assessment of Inflammatory Mediators (AIM) | Assessment of Induced Sputum as a Tool to Evaluate Anti-Inflammatory Agents in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Ibuprofen | Ramsey, Bonnie, MD | Cystic Fibrosis Foundation Therapeutics | Completed | 10 Years | N/A | Both | 120 | N/A | United States |
| 1527 | NCT00823238 (ClinicalTrials.gov) | July 2004 | 29/12/2008 | Comparison of Antibiotics for Pseudomonas in Early CF | Comparison of Antibiotics for Pseudomonas in Early CF | Cystic Fibrosis | Drug: ceftazidime and tobramycin;Drug: inhaled tobramycin | University of North Carolina, Chapel Hill | Cystic Fibrosis Foundation Therapeutics | Completed | 3 Months | 16 Years | Both | 21 | Phase 1 | United States |
| 1528 | NCT00255242 (ClinicalTrials.gov) | July 2004 | 16/11/2005 | Effect of Simvastatin on CF Airway Inflammation | Effect of Simvastatin on CF Airway Inflammation | Cystic Fibrosis | Drug: Simvastatin treatment for 28 days | Akron Children's Hospital | Cystic Fibrosis Foundation Therapeutics | Completed | 10 Years | N/A | Both | 40 | Phase 1 | United States |
| 1529 | NCT00570349 (ClinicalTrials.gov) | July 2004 | 6/12/2007 | Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis | Safety and Tolerability of Inhaled Nitric Oxide in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Nitric Oxide for Inhalation;Drug: Nitrogen | Mallinckrodt | NULL | Completed | 12 Years | N/A | All | 18 | Phase 1/Phase 2 | United States |
| 1530 | NCT00095732 (ClinicalTrials.gov) | June 2004 | 9/11/2004 | Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency | A Phase 2, Randomized, Double Blind, Parallel Dose Ranging Study of Oral TheraCLEC™ - Total in Cystic Fibrosis Subjects With Exocrine Pancreatic Insufficiency | Cystic Fibrosis;Pancreatic Insufficiency | Drug: Liprotamase;Drug: Placebo | Anthera Pharmaceuticals | Cystic Fibrosis Foundation Therapeutics | Completed | 7 Years | N/A | Both | 129 | Phase 2 | United States |
| 1531 | NCT02010411 (ClinicalTrials.gov) | June 2004 | 9/12/2013 | Alpha1 Antitrypsin Aerosol Therapy in Cystic Fibrosis | Effects of Prolastin Aerosol Therapy on Bacterial Density in the Airways of Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Prolastin (drug) | Université de Sherbrooke | NULL | Terminated | 14 Years | N/A | Both | 17 | Phase 2 | Canada |
| 1532 | NCT00104494 (ClinicalTrials.gov) | May 2004 | 1/3/2005 | Zinc Homeostasis and Kinetics in Children With Cystic Fibrosis (CF) | Zinc Homeostasis and Kinetics in Children With CF | Cystic Fibrosis | Drug: Zinc acetate (20mg/d) | Cystic Fibrosis Foundation Therapeutics | NULL | Completed | 8 Years | 14 Years | Both | 30 | N/A | United States |
| 1533 | NCT00730509 (ClinicalTrials.gov) | April 2004 | 4/8/2008 | Effects of 5-Methyltetrahydrofolate and Vitamin B12 Supplemetation on Red Cell Membrane in Children With Cystic Fibrosis | Preliminary Evidences of Active Form of Folic Acid and Vitamin B12 Supplementation to Ameliorate Cell Membrane in Children With Cystic Fibrosis | Cystic Fibrosis | Dietary Supplement: 5-methyltetrahydrofolate and vitamin B12 | Universita di Verona | NULL | Completed | 3 Years | 8 Years | Both | 31 | N/A | Italy |
| 1534 | NCT00455130 (ClinicalTrials.gov) | March 2004 | 2/4/2007 | A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis | Cystic Fibrosis | Drug: Inhaled mannitol | Pharmaxis | NULL | Completed | 8 Years | N/A | Both | Phase 2 | Australia;New Zealand | ||
| 1535 | NCT00153634 (ClinicalTrials.gov) | March 2004 | 8/9/2005 | Standard vs. Biofilm Susceptibility Testing in Cystic Fibrosis (CF) | Standard vs. Biofilm Susceptibility Testing in CF | Cystic Fibrosis;Chronic Bronchitis | Drug: IV amikacin;Drug: PO azithromycin;Drug: IV ceftazidime;Drug: PO ciprofloxacin;Drug: IV meropenem;Drug: IV piperacillin-tazobactam;Drug: IV ticarcillin-clavulanate;Drug: IV tobramycin | Seattle Children's Hospital | Cystic Fibrosis Foundation Therapeutics | Completed | 14 Years | N/A | Both | 75 | N/A | United States |
| 1536 | NCT00163852 (ClinicalTrials.gov) | February 2004 | 12/9/2005 | Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis | Salt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic Fibrosis | Cystic Fibrosis | Drug: Normal saline IV, salt tablets | Bayside Health | National Health and Medical Research Council, Australia;Monash University;Cystic Fibrosis Australia | Recruiting | 18 Years | 75 Years | Both | 40 | Phase 2/Phase 3 | Australia |
| 1537 | NCT00728715 (ClinicalTrials.gov) | January 2004 | 31/7/2008 | Efficacy of Budesonide-Formoterol in Bronchiectasis | Clinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis Bronchiectasis | Bronchiectasis | Drug: budesonide-formoterol single inhaler;Drug: High dose of budesonide;Drug: A;Drug: B | Hospital General de Requena | Esteve Labs (Grant) | Completed | 18 Years | 80 Years | Both | 40 | N/A | Spain |
| 1538 | NCT00486837 (ClinicalTrials.gov) | December 2003 | 13/6/2007 | Deposition of Inhaled Prolastin in Cystic Fibrosis Patients | Multicenter, Randomized, Parallel Group Study to Investigate the Optimal Deposition Site for Inhaled Prolastin® in Patients With Cystic Fibrosis (CF) | Cystic Fibrosis | Drug: Alpha1-Proteinase Inhibitor (Human) | Grifols Therapeutics Inc. | NULL | Completed | 8 Years | N/A | All | 72 | Phase 2 | NULL |
| 1539 | NCT00157690 (ClinicalTrials.gov) | December 2003 | 8/9/2005 | Study of Alendronate to Prevent and Treat Osteoporosis in Cystic Fibrosis Patients | A Multicentre, Double-Blind, Randomized Placebo-Controlled Study of 70mg Alendronate Once Weekly for the Prevention and Treatment of Osteoporosis in Canadian Adult Cystic Fibrosis Patients | Cystic Fibrosis;Osteoporosis;Bone Diseases, Metabolic | Drug: Alendronate;Drug: Placebo | McMaster University | Centre hospitalier de l'Université de Montréal (CHUM);London Health Sciences Centre;University of Calgary;McGill University;Laval University;Merck Frosst Canada Ltd. | Completed | 18 Years | N/A | Both | 56 | Phase 4 | Canada |
| 1540 | NCT00633191 (ClinicalTrials.gov) | November 2003 | 4/3/2008 | Anti-pseudomonas IgY to Prevent Infections in Cystic Fibrosis | Post Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) Patients | Cystic Fibrosis;Infection;Pseudomonas Aeruginosa | Drug: Anti-pseudomonas IgY gargle | Immunsystem AB | NULL | Completed | N/A | N/A | Both | 14 | Phase 1/Phase 2 | Sweden |
| 1541 | NCT00391976 (ClinicalTrials.gov) | November 2003 | 19/10/2006 | Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic Fibrosis | The Microbiologic Efficacy and Safety of Two Treatment Regimens of Inhaled Tobramycin Nebuliser Solution (TNS) for the Treatment of Early Onset Pseudomonas Aeruginosa Lower Respiratory Tract Infection in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin solution for inhalation 300 mg | Novartis | NULL | Completed | 6 Months | N/A | All | 123 | Phase 3 | NULL |
| 1542 | NCT00499720 (ClinicalTrials.gov) | October 2003 | 9/7/2007 | Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection | Expanded Access Program for Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection Who Have Limited Treatment Options and Are at Risk for Disease Progression | Cystic Fibrosis;Pseudomonas Aeruginosa Airway Infection | Drug: Aztreonam Lysine for Inhalation | Gilead Sciences | NULL | Approved for marketing | 6 Years | N/A | Both | N/A | United States;Puerto Rico | |
| 1543 | NCT00079742 (ClinicalTrials.gov) | September 2003 | 11/3/2004 | A Study to Evaluate Nutropin AQ for the Treatment of Growth Restriction in Children With Cystic Fibrosis | A Phase II, Multicenter, Randomized, Controlled, Open-Label Study of the Safety and Efficacy of Nutropin AQ [Somatropin (DNA Origin) Injection] for the Treatment of Growth Restriction in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Nutropin AQ [somatropin (DNA origin) injection] | Genentech, Inc. | NULL | Completed | 5 Years | 13 Years | Both | 68 | Phase 2 | United States |
| 1544 | NCT01055847 (ClinicalTrials.gov) | June 2003 | 23/1/2010 | Aztreonam for Inhalation (AI) in Patients With Cystic Fibrosis & P. Aeruginosa Infection | A Blinded, Multicenter, Randomized, Placebo-Controlled Trial With Aztreonam for Inhalation (AI) in Cystic Fibrosis Patient With Lung Disease Due to P. Aeruginosa Infection | Cystic Fibrosis;CF;Lung Infection;Pseudomonas Aeruginosa | Drug: Aztreonam for Inhalation (AI);Drug: Placebo | Gilead Sciences | Conducted under Salus Pharma, Inc. | Completed | 13 Years | N/A | Both | 105 | Phase 2 | United States |
| 1545 | NCT00060801 (ClinicalTrials.gov) | May 2003 | 13/5/2003 | Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult and Pediatric Patients | A Randomized, Double-blind, Placebo-controlled Study to Investigate the Efficacy and Safety of 24 Weeks of Oral Treatment With BIIL 284 BS in Adult (75 mg, 150 mg) and Pediatric (75 mg) Cystic Fibrosis Patients | Cystic Fibrosis | Drug: BIIL 283 BS (Amelubent) | Boehringer Ingelheim | NULL | Terminated | 6 Years | N/A | Both | 420 | Phase 2 | United States |
| 1546 | NCT00222521 (ClinicalTrials.gov) | April 2003 | 14/9/2005 | Insulin Glargine Vs Standard Insulin Therapy | Comparison of Insulin Glargine Vs Standard Insulin Therapy in CFRD Without Fasting Hyperglycemia | Cystic Fibrosis Related Diabetes | Drug: Glargine insulin | University of Minnesota - Clinical and Translational Science Institute | Sanofi;Moran, Antoinette, M.D. | Completed | 12 Years | N/A | Both | 20 | Phase 3 | United States |
| 1547 | NCT00056147 (ClinicalTrials.gov) | April 2003 | 6/3/2003 | Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease | Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of INS37217 Inhalation Solution in Subjects With Mild to Moderate Cystic Fibrosis Lung Disease | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) | Merck Sharp & Dohme Corp. | Cystic Fibrosis Foundation Therapeutics | Completed | 8 Years | 50 Years | Both | 90 | Phase 2 | United States |
| 1548 | NCT00157183 (ClinicalTrials.gov) | March 2003 | 9/9/2005 | Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation | Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen Desaturation | Cystic Fibrosis | Device: Nocturnal oxygen , nocturnal bi-level positive pressure ventilation | Bayside Health | National Health and Medical Research Council, Australia;Monash University;Cystic Fibrosis Australia | Completed | 18 Years | 75 Years | Both | 59 | Phase 1/Phase 2 | Australia |
| 1549 | NCT00530244 (ClinicalTrials.gov) | March 2003 | 13/9/2007 | Use of Formula Fortified With DHA in Infants With Cystic Fibrosis | The Effect of Formula Fortified With Docosahexaenoic Acid (DHA) on Infants With Cystic Fibrosis (CF) | Cystic Fibrosis | Dietary Supplement: Docosahexaenoic acid (DHA);Dietary Supplement: Standard formula (Enfamil) | University of Massachusetts, Worcester | Cystic Fibrosis Foundation | Completed | N/A | 56 Days | All | 76 | N/A | United States |
| 1550 | NCT00590538 (ClinicalTrials.gov) | February 2003 | 27/12/2007 | Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygotes (for Cystic Fibrosis) | A Pilot Trial of Phenylbutyrate/Genistein Duotherapy in Delta F508-Heterozygous Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Sodium 4-Phenylbutyrate;Drug: Genistein (Unconjugated Isoflavones 100);Drug: Placebo | Children's Hospital of Philadelphia | Cystic Fibrosis Foundation Therapeutics | Terminated | 18 Years | N/A | All | 9 | Phase 1/Phase 2 | United States |
| 1551 | NCT00376428 (ClinicalTrials.gov) | January 2003 | 13/9/2006 | Interest of Gentamicin-induced Readthrough in Cystic Fibrosis Patients | Application of Functional Electrophysiological Tests to Evaluate Pharmacological Treatments in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Gentamicin | Assistance Publique - Hôpitaux de Paris | NULL | Terminated | N/A | N/A | Both | 20 | Phase 2 | France |
| 1552 | NCT01812551 (ClinicalTrials.gov) | October 2002 | 14/3/2013 | Treatment of Low Bone Density in Cystic Fibrosis. | Osteoporosis in Cystic Fibrosis: Study of Bone Mass and Bone Metabolism, and Prospective Randomized Therapeutic Trial. | Osteoporosis;Cystic Fibrosis | Drug: Alendronate;Drug: Placebo | Istituto Auxologico Italiano | Fondazione Telethon | Completed | 5 Years | 30 Years | Both | 171 | Phase 3 | Holy See (Vatican City State);Italy |
| 1553 | NCT02269189 (ClinicalTrials.gov) | April 2002 | 16/10/2014 | Safety, Tolerability and Pharmacokinetics of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients | A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Repeated Oral Doses (15-day Dosing) of BIIL 284 BS in Adult (300 mg) and Pediatric (150 mg) Cystic Fibrosis Patients | Cystic Fibrosis | Drug: BIIL 284 BS, high dose;Drug: BIIL 284 BS, low dose;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 6 Years | N/A | Both | 36 | Phase 1 | NULL |
| 1554 | NCT00043342 (ClinicalTrials.gov) | April 2002 | 7/8/2002 | Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis | A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: interferon gamma-1b | InterMune | NULL | Completed | 6 Years | N/A | Both | 51 | Phase 1/Phase 2 | United States |
| 1555 | NCT00177645 (ClinicalTrials.gov) | March 2002 | 13/9/2005 | Inhaled Bicarbonate Therapy in Cystic Fibrosis | Inhaled Bicarbonate Therapy in Cystic Fibrosis | Cystic Fibrosis | Procedure: sodium bicarbonate | University of Pittsburgh | Cystic Fibrosis Foundation Therapeutics;Children's Hospital of Pittsburgh | Completed | 12 Years | N/A | Both | 16 | Phase 1 | United States |
| 1556 | NCT00333385 (ClinicalTrials.gov) | October 2001 | 2/6/2006 | Continuous Versus Short Infusions of Ceftazidime in Cystic Fibrosis | Cystic Fibrosis;Pseudomonas Aeruginosa;Pulmonary Exacerbation | Drug: ceftazidime | Association Nationale pour le Traitement à Domicile de l'Insuffisance Respiratoire | Vaincre la Mucoviscidose;GlaxoSmithKline;Baxter Healthcare Corporation;Roche Pharma AG | Terminated | 8 Years | N/A | Both | 120 | Phase 4 | France | |
| 1557 | NCT02265679 (ClinicalTrials.gov) | October 2001 | 15/10/2014 | Safety, Tolerability and Pharmacokinetics of Increasing Doses of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis (CF) Patients | A Randomized, Double-blind Within Dose, Placebo-controlled Study to Investigate the Safety, Tolerability and Pharmacokinetics of Increasing Single Oral Doses of BIIL 284 BS in Adult and Pediatric Cystic Fibrosis Patients | Cystic Fibrosis | Drug: BIIL 284 BS, low dose, pediatric patients;Drug: BIIL 284 BS, medium dose, pediatric patients;Drug: BIIL 284 BS, high dose, pediatric patients;Drug: BIIL 284 BS, low dose, adult patients;Drug: BIIL 284 BS, medium dose, adult patients;Drug: BIIL 284 BS, high dose, adult patients;Drug: Placebo | Boehringer Ingelheim | NULL | Completed | 6 Years | N/A | Both | 45 | Phase 1 | NULL |
| 1558 | NCT00016744 (ClinicalTrials.gov) | September 2001 | 31/5/2001 | Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous(for Cystic Fibrosis) | A Pilot Trial of Phenylbutyrate/Genistein Duotherapy in Delta F508-Homozygous Cystic Fibrosis Patients | Cystic Fibrosis | Drug: Sodium 4-Phenylbutyrate (4PBA);Drug: Unconjugated Isoflavones 100 (PTI G-4660, 87% Genistein);Drug: Placebo | Children's Hospital of Philadelphia | Cystic Fibrosis Foundation Therapeutics;National Center for Research Resources (NCRR) | Completed | 18 Years | N/A | Both | 12 | Phase 1/Phase 2 | United States |
| 1559 | NCT00662714 (ClinicalTrials.gov) | September 2001 | 17/4/2008 | Early Diagnosis of Diabetes Mellitus in Patients With Cystic Fibrosis | Open Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes Mellitus | Cystic Fibrosis;Diabetes Mellitus | Drug: Repaglinide;Drug: short-acting Insulin (Actrapid) | Mukoviszidose Institut gGmbH | Novo Nordisk A/S;Mucoviscidose-ABCF2;Assistance Publique - Hôpitaux de Paris | Completed | 10 Years | N/A | Both | 73 | Phase 3 | Austria;France;Germany;Italy |
| 1560 | NCT01400750 (ClinicalTrials.gov) | August 2001 | 18/7/2011 | Comparison of 2 Treatment Regimens for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis | Prospective Randomized Trial Comparing Oral Ciproxin Plus Inhaled Colistin With Tobramycin for Inhalation for Eradication of P Aeruginosa Infection in Children With Cystic Fibrosis. | Cystic Fibrosis | Drug: oral ciprofloxacin plus inhaled colistin;Drug: TOBI | Universitaire Ziekenhuizen Leuven | NULL | Completed | N/A | 18 Years | Both | 61 | Phase 4 | Belgium |
| 1561 | NCT00274391 (ClinicalTrials.gov) | July 2001 | 9/1/2006 | Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis | Efficacy of Amiloride and Hypertonic Saline in Cystic Fibrosis | Cystic Fibrosis | Drug: 7% NaCl;Drug: Amiloride HCl | University of North Carolina | Cystic Fibrosis Foundation Therapeutics | Completed | 14 Years | N/A | Both | 24 | Phase 2 | United States |
| 1562 | NCT00023465 (ClinicalTrials.gov) | June 2001 | 6/9/2001 | Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging | Quantification of Pulmonary Neutrophil Activity in Cystic Fibrosis Using Radiolabeled Fluorodeoxyglucose and PET Imaging | Cystic Fibrosis | Procedure: FDG-PET;Procedure: spirometry;Procedure: bronchoscopy with BAL | National Center for Research Resources (NCRR) | NULL | Recruiting | 18 Years | N/A | Female | 10 | N/A | United States |
| 1563 | NCT00072904 (ClinicalTrials.gov) | June 2001 | 12/11/2003 | Diabetes Therapy to Improve BMI and Lung Function in CF | Diabetes Therapy to Improve BMI and Lung Function in CF | Cystic Fibrosis;Diabetes Mellitus | Drug: Insulin Asparte;Drug: Repaglinide | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Cystic Fibrosis Foundation Therapeutics;Novo Nordisk A/S | Completed | 16 Years | N/A | Both | 108 | Phase 3 | United States;Canada |
| 1564 | NCT00034515 (ClinicalTrials.gov) | June 2001 | 29/4/2002 | A Study in Adult and Pediatric Patients With Cystic Fibrosis | Ph 1b/2a Study to Assess Levels of INS37217 and Placebo Treatment With Maximum Tolerated Dose Administered by Inhalation Via the Pari LC Star Nebulizer in Adult and Pediatric CF Patients | Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) Inhalation Solution | Merck Sharp & Dohme Corp. | NULL | Completed | 5 Years | N/A | Both | 63 | Phase 1/Phase 2 | United States |
| 1565 | NCT01882400 (ClinicalTrials.gov) | May 2001 | 17/6/2013 | Assessment of Response to Treatment of Osteoporosis With Oral Bisphosphonates in Patients With Muscular Dystrophy | Évaluation Multidimensionnelle de la réponse au Traitement de l'ostéoporose spontanée et Induite Par Les corticostéroïdes à l'Aide d'un Bisphosphonate à Administration Orale Chez Des Malades Porteurs d'Une Dystrophie Musculaire sévère. | Osteoporosis;Muscular Dystrophy;Cystic Fibrosis | Drug: Bisphosphonate treatment | Gilles Boire | Procter and Gamble | Completed | 5 Years | 18 Years | All | 11 | Phase 4 | Canada |
| 1566 | NCT00220259 (ClinicalTrials.gov) | May 2001 | 20/9/2005 | Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study) | Cystic Fibrosis Withdrawal of Inhaled Steroids Evaluation Study (CF WISE Study) | Cystic Fibrosis | Drug: Fluticasone or placebo | Royal Brompton & Harefield NHS Foundation Trust | Cystic Fibrosis Trust;GlaxoSmithKline | Completed | 6 Years | N/A | Both | 240 | N/A | United Kingdom |
| 1567 | NCT00043316 (ClinicalTrials.gov) | February 2001 | 7/8/2002 | Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis | A Phase I/II Study of Interferon Gamma-1b by Inhalation for the Treatment of Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: interferon gamma-1b | InterMune | NULL | Completed | 12 Years | N/A | Both | 66 | Phase 1/Phase 2 | United States |
| 1568 | NCT00164021 (ClinicalTrials.gov) | February 2001 | 13/9/2005 | The Prevalence and Significance of Gastro-oesophageal Reflux in Cystic Fibrosis Before and After Lung Transplantation | The Prevalence and Significance of Gastro-oesophageal Reflux in Adults With Cystic Fibrosis Before and After Lung Transplantation, Together With the Effects of Physiotherapy Airway Clearance Techniques on Gastro-oesophageal Function | Cystic Fibrosis | Procedure: Physiotherapy, exercise, percutaneous gastrostomy feeds;Drug: Anti-reflux pharmacotherapy | Bayside Health | The Alfred;Monash University | Recruiting | 16 Years | 70 Years | Both | 180 | N/A | Australia |
| 1569 | NCT00014768 (ClinicalTrials.gov) | February 2001 | 10/4/2001 | Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis | Cystic Fibrosis | Drug: glucose;Drug: insulin;Drug: leucine | National Center for Research Resources (NCRR) | University of Utah | Terminated | N/A | N/A | Female | 36 | N/A | United States | |
| 1570 | NCT00016445 (ClinicalTrials.gov) | February 2001 | 6/5/2001 | Phase II Study of Growth Hormone in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: growth hormone | University of Utah | NULL | Completed | 5 Years | 12 Years | Both | 40 | Phase 2 | United States | |
| 1571 | NCT00205634 (ClinicalTrials.gov) | December 2000 | 12/9/2005 | Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis | Macrolide Antibiotic Therapy for Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Biaxin ( clarithromycin) | Wake Forest University | Abbott | Completed | 6 Years | 50 Years | All | 50 | Phase 2 | United States |
| 1572 | NCT00271310 (ClinicalTrials.gov) | September 2000 | 29/12/2005 | The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis | The Effects of Long Term Inhalation of Hypertonic Saline in Subjects With Cystic Fibrosis | Cystic Fibrosis | Drug: hypertonic saline | Royal Prince Alfred Hospital, Sydney, Australia | Cystic Fibrosis Foundation Therapeutics;National Health and Medical Research Council, Australia;Cystic Fibrosis Trust | Completed | 6 Years | N/A | Both | 164 | Phase 3 | NULL |
| 1573 | NCT00005110 (ClinicalTrials.gov) | April 2000 | 13/4/2000 | A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis | Cystic Fibrosis | Drug: Salmeterol;Drug: Albuterol | National Center for Research Resources (NCRR) | NULL | Suspended | 5 Years | 45 Years | Both | N/A | United States | ||
| 1574 | NCT00005112 (ClinicalTrials.gov) | April 2000 | 15/4/2000 | Growth Hormone Use in Cystic Fibrosis - a Multicenter Study | Cystic Fibrosis | Drug: Human recombinant growth hormone | National Center for Research Resources (NCRR) | Genentech, Inc. | Completed | 5 Years | 12 Years | Both | Phase 3 | United States | ||
| 1575 | NCT00256555 (ClinicalTrials.gov) | February 2000 | 17/11/2005 | Growth Hormone Treatment Study in Children With Cystic Fibrosis | GROWTH HORMONE USE IN CYSTIC FIBROSIS - A MULTICENTER STUDY | Cystic Fibrosis | Drug: Nutropin AQ | University of Texas Southwestern Medical Center | Genentech, Inc. | Withdrawn | 5 Years | 12 Years | All | 0 | Phase 2/Phase 3 | NULL |
| 1576 | NCT00006280 (ClinicalTrials.gov) | February 2000 | 11/9/2000 | A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis | A Phase II Multicenter Randomized Trial of Tobramycin for Inhalation in Young Children With Cystic Fibrosis | Cystic Fibrosis | Drug: Tobramycin for Inhalation | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | National Center for Research Resources (NCRR) | Completed | 6 Months | 5 Years | Both | 98 | Phase 2 | United States |
| 1577 | NCT00004533 (ClinicalTrials.gov) | August 1999 | 28/1/2000 | Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients With Cystic Fibrosis | Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Adeno-associated virus-CFTR vector | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | University of Florida | Completed | 15 Years | N/A | All | 19 | Phase 1 | NULL |
| 1578 | NCT00006063 (ClinicalTrials.gov) | July 1999 | 5/7/2000 | Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: pancrelipase with bicarbonate | National Center for Research Resources (NCRR) | Indiana University School of Medicine | Completed | N/A | N/A | Both | 24 | N/A | NULL | |
| 1579 | NCT00004489 (ClinicalTrials.gov) | October 1998 | 18/10/1999 | Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis | Osteoporosis;Cystic Fibrosis | Drug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferol | University of North Carolina | NULL | Completed | 18 Years | 45 Years | Both | 60 | N/A | United States | |
| 1580 | NCT00004441 (ClinicalTrials.gov) | September 1997 | 18/10/1999 | Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis | Cystic Fibrosis | Drug: tauroursodeoxycholic acid;Drug: ursodiol | Children's Hospital Medical Center, Cincinnati | NULL | Completed | N/A | N/A | Both | 39 | N/A | United States;Italy | |
| 1581 | NCT00004428 (ClinicalTrials.gov) | September 1997 | 18/10/1999 | Phase I Randomized Study of CPX for the Treatment of Adult Patients With Mild Cystic Fibrosis | Cystic Fibrosis | Drug: CPX | FDA Office of Orphan Products Development | SciClone Pharmaceuticals | Completed | 18 Years | N/A | Both | 35 | Phase 1 | NULL | |
| 1582 | NCT00004705 (ClinicalTrials.gov) | September 1996 | 24/2/2000 | Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis | Cystic Fibrosis | Drug: amiloride;Drug: uridine | FDA Office of Orphan Products Development | University of North Carolina | Completed | 4 Years | N/A | Both | N/A | NULL | ||
| 1583 | NCT00004440 (ClinicalTrials.gov) | August 1996 | 18/10/1999 | Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: ibuprofen | FDA Office of Orphan Products Development | Case Western Reserve University | Completed | 5 Years | N/A | Both | 75 | N/A | NULL | |
| 1584 | NCT00004315 (ClinicalTrials.gov) | November 1995 | 18/10/1999 | Phase II Pilot Study to Compare the Bioavailability of Buffered, Enteric-Coated Ursodiol With Unmodified Ursodiol for Chronic Cholestatic Liver Disease and Cystic Fibrosis-Associated Liver Disease | Cystic Fibrosis;Gastrointestinal Diseases;Cholestasis | Drug: ursodiol | National Center for Research Resources (NCRR) | Children's Hospital Medical Center, Cincinnati | Active, not recruiting | 4 Months | N/A | Both | 20 | Phase 2 | United States | |
| 1585 | NCT00004747 (ClinicalTrials.gov) | July 1995 | 24/2/2000 | Phase II Randomized, Double-Blind, Placebo-Controlled Study of Intravenous Mucoid Exopolysaccharide Pseudomonas Aeruginosa Immune Globulin for Cystic Fibrosis | Cystic Fibrosis;Bacterial Infections | Drug: mucoid exopolysaccharide P. aeruginosa immune globulin IV | National Center for Research Resources (NCRR) | Vanderbilt University | Completed | 6 Years | N/A | Both | 170 | Phase 2 | NULL | |
| 1586 | NCT00004829 (ClinicalTrials.gov) | June 1995 | 24/2/2000 | Phase III Randomized Study of the Inhalation of Tobramycin in Patients With Cystic Fibrosis | Cystic Fibrosis;Bacterial Infection | Drug: tobramycin | FDA Office of Orphan Products Development | NULL | Completed | 6 Years | N/A | Both | 200 | Phase 3 | NULL | |
| 1587 | EUCTR2020-002239-31-DE (EUCTR) | 20/12/2021 | Evaluation of Long-term Safety and Efficacy of ELX/TEZ/IVA in Cystic Fibrosis Subjects 2 Years and Older | A Phase 3 Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Years and Older | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 80mg ELX / 40mg TEZ / 60mg IVA Product Code: ELX/TEZ/IVA INN or Proposed INN: Ivacaftor Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: IVACAFTOR 59.5mg Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 100g ELX / 50mg TEZ / 75mg IVA Product Code: ELX/TEZ/IVA INN or Proposed INN: Ivacaftor Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Trade Name: Kalydeco Product Name: IVACAFTOR 75mg Product Code: VX-77 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 70 | Phase 3 | United States;Canada;Australia;Germany;United Kingdom | |||
| 1588 | EUCTR2014-003882-10-FR (EUCTR) | 29/07/2015 | Evaluation of the efficacy of antibiotic treatments associated with the Nebcine® as intravenous injection only and / or monitoring of aerosols of Tobi® in order to optimize the therapeutic management of exacerbations in patients with cystic fibrosis . | Evaluation of the effectiveness of a treatment involving one (or several ) antibiotic (s) with 14-day tobramycin ( Nebcine® ) by intravenous injection versus the same antibiotic treatment (s ) associated with only 5 days of tobramycin ( Nebcine® ) by intravenous injection followed tobramycin aerosol ( Tobi® ) for 9 days in the context of cystic fibrosis | mucoviscidosis or cystic fibrosis MedDRA version: 18.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: NEBCINE Product Name: NEBCINE Other descriptive name: TOBRAMYCIN Trade Name: TOBI Product Name: TOBI Other descriptive name: TOBRAMYCIN | CHRU de Lille | NULL | NA | Female: yes Male: yes | Phase 2 | France | ||||
| 1589 | EUCTR2017-002968-40-DE (EUCTR) | 05/04/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Symdeko Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symkevi Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Symdeko Product Name: Ivacaftor 75 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor 150 mg Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 1590 | EUCTR2020-004885-21-NL (EUCTR) | 22/09/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 143 | Phase 3 | Czechia;Spain;Belgium;Netherlands | |||
| 1591 | EUCTR2007-001412-23-DE (EUCTR) | 26/01/2009 | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Product Name: Inhaled dry powder mannitol Product Code: IDPM INN or Proposed INN: Mannitol Trade Name: Aridol or Osmohale INN or Proposed INN: Mannitol | Pharmaxis Pharmaceuticals Limited | NULL | Not Recruiting | Female: yes Male: yes | 340 | Phase 3 | Ireland;Germany;United Kingdom | |||
| 1592 | EUCTR2018-004652-38-DE (EUCTR) | 24/06/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100 mg VX-445 /50 mg TEZ/75 mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Trikafta Product Name: 100 mg ELX (VX-445) / 50 mg TEZ / 75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Ivacaftor Other descriptive name: IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ | Vertex Pharmaceuticals Incorporated | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 481 | Phase 3 | Switzerland;United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom | |||
| 1593 | EUCTR2021-000694-85-BE (EUCTR) | 21/10/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 1594 | EUCTR2017-003723-29-FR (EUCTR) | 14/03/2018 | A study of safety and efficacy of lenabasum in Cystic Fibrosis | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis | Cystic Fibrosis (CF) MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 415 | Phase 2 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden | |||
| 1595 | EUCTR2015-000396-26-Outside-EU/EEA (EUCTR) | 02/02/2015 | Program to Give the Drug Aztreonam Lysine for Inhalation to Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease Progression | Expanded Access Program for Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 603 | United States | ||||
| 1596 | EUCTR2017-004133-82-DE (EUCTR) | 08/03/2018 | A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Product Name: Tezacaftor/Ivacaftor/100mg/150mg Product Code: VX-661/VX-770 (TEZ/IVA) INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | United States;Spain;Ireland;Australia;Germany;United Kingdom | |||
| 1597 | EUCTR2012-002699-14-FR (EUCTR) | 20/09/2012 | Trial of inhaled mannitol in children with cystic fibrosis | A randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years | Cystic fibrosis in children aged 6 to 17 years MedDRA version: 15.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Bronchitol Product Name: Bronchitol Product Code: N/A INN or Proposed INN: mannitol Other descriptive name: N/A | Pharmaxis Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 160 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | France;Canada;Argentina;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom | |||
| 1598 | EUCTR2015-004841-13-FR (EUCTR) | 23/06/2016 | A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR Mutation | A Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Code: VX-371 in hypertonic saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Product Code: VX-371 in saline INN or Proposed INN: Not yet assigned Other descriptive name: VX-371 Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809/VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Ivacaftor INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR Product Name: Hypertonic saline INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 150 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;France;Czech Republic;Ireland;United Kingdom | |||
| 1599 | EUCTR2005-003772-37-DE (EUCTR) | 05/12/2005 | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects | A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects | Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis Classification code 10011762 | Product Name: Tobramycin Inhalation Powder Product Code: TIP INN or Proposed INN: Tobramycin Product Name: TOBI INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;United Kingdom;Germany;Spain;Italy;Greece | |||
| 1600 | EUCTR2019-004511-31-GB (EUCTR) | 06/10/2020 | Prospective validation and clinical evaluation of a new posaconazole dosingregimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus Infection MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: Noxafil - oral suspension 40 mg/ml Product Name: Noxafil - oral suspension 40 mg/ml Trade Name: Noxafil 100 mg Product Name: Noxafil 100 mg | Bambino Gesù Children's Hospital | NULL | NA | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden | |||
| 1601 | EUCTR2011-001362-18-FR (EUCTR) | 05/01/2012 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States;France;Spain;Poland;Germany;Italy | |||
| 1602 | EUCTR2005-001438-34-BE (EUCTR) | 15/07/2005 | A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | A Phase II, Randomized, Investigator-Blinded, Parallel-Group, Pilot Study Evaluating the Safety, Palatability and Efficacy of Four Doses of Pancrelipase Microtablets in the Treatment of Infants and Toddlers with Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | Cystic Fibrosis-Related Pancreatic Insufficiency and Fat Malabsorption | Trade Name: Panzytrat® ok Product Name: Pancrelipase Microtablets Product Code: N/A INN or Proposed INN: Pancreatin | McNeil Consumer and Specialty Pharmaceuticals | NULL | NA | Female: yes Male: yes | 20 | Phase 2 | Belgium | |||
| 1603 | EUCTR2018-000183-28-FR (EUCTR) | 12/12/2018 | A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 360 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 1604 | EUCTR2009-011740-19-Outside-EU/EEA (EUCTR) | 02/02/2015 | Clinical Trial to Assess the Safety and Efficacy of Aztreonam for Inhalation Solution (AZLI) in patients with Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection | Phase 3b Randomized, Double-Blind, Placebo-Controlled Two-Part Trial to Assess the Safety and Efficacy of Continuous Aztreonam for Inhalation Solution (AZLI) in Subjects with Cystic Fibrosis (CF) and Chronic Burkholderia Species Infection | Cystic Fibrosis subjects with chronic Burkholderia spp. infection of the airways. MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | United States;Canada | |||
| 1605 | EUCTR2015-003537-99-Outside-EU/EEA (EUCTR) | 05/07/2016 | A Study of the Comparable Efficacy and Safety of Pulmozyme (Dornase Alfa) Delivered by the eRapid Nebulizer System in Patients With Cystic Fibrosis | A PHASE IV MULTICENTER, RANDOMIZED, OPEN LABEL, TWO-PERIOD CROSSOVER STUDY IN PATIENTS WITH CYSTIC FIBROSIS TO EVALUATE THE COMPARABLE EFFICACY AND SAFETY OF PULMOZYME® DELIVERED BY THE ERAPID™ NEBULIZER SYSTEM | Cystic Fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05] | Trade Name: Pulmozyme Product Name: Pulmozyme INN or Proposed INN: DORNASE ALFA | F. Hoffmann-La Roche AG | NULL | NA | Female: yes Male: yes | 80 | Phase 4 | United States | |||
| 1606 | EUCTR2017-000672-28-Outside-EU/EEA (EUCTR) | 27/03/2017 | Study of the Effect of VX-770 on Hyperpolarized Helium-3 MagneticResonance Imaging in Subjects With Cystic Fibrosis and the G551DMutation | A Phase 2, Single-Blind, Placebo-Controlled Study to Evaluate the Effectof VX-770 on Hyperpolarized Helium-3 Magnetic Resonance Imaging inSubjects With Cystic Fibrosis, the G551D Mutation, and FEV1 =40%Predicted | cystic fibrosis MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 17 | Phase 2 | United States | |||
| 1607 | EUCTR2015-000543-16-FR (EUCTR) | 07/07/2015 | A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugs | A Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation | Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | |||
| 1608 | EUCTR2021-005320-38-BE (EUCTR) | 05/01/2022 | Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy | |||
| 1609 | EUCTR2021-005320-38-PT (EUCTR) | 02/02/2022 | Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy | |||
| 1610 | EUCTR2020-001404-42-DE (EUCTR) | 01/10/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 108 | Phase 3 | Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;France | |||
| 1611 | EUCTR2008-007416-15-DE (EUCTR) | 29/05/2009 | Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D Mutation | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE | Cystic Fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770, VRT-813077 INN or Proposed INN: ivacaftor Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom | |||
| 1612 | EUCTR2016-005014-21-NL (EUCTR) | 31/10/2020 | Pharmacokinetic evaluation and tolerability of dry powder tobramycin viathe Cyclops® in children with cystic fibrosis | Pharmacokinetic evaluation and tolerability of dry powder tobramycin via the Cyclops® in children with cystic fibrosis - DPI-tobra-child | Cystic FibrosisLung infections;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Dry powder tobramycin Product Code: J01GB01 INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN Product Name: Nebulization tobramycin INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | University Medical Center Groningen | NULL | NA | Female: yes Male: yes | 10 | Phase 2 | Netherlands | |||
| 1613 | EUCTR2011-001255-36-Outside-EU/EEA (EUCTR) | 02/02/2015 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 105 | Phase 2 | United States | |||
| 1614 | EUCTR2015-001267-39-FR (EUCTR) | 04/12/2015 | A study to assess the efficacy and safety of ivacaftor in children aged 3 to 5 with Cystic Fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation | Cystic Fibrosis MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 50 | Phase 3 | France;Canada;Australia;United Kingdom | |||
| 1615 | EUCTR2015-004143-39-FR (EUCTR) | 30/03/2017 | Saline hypertonic in preschoolers and lung structure as measured by computed tomography. | A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Hypertonic saline 7% INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE PH. EUR. Product Name: Isotonic saline 0.9% INN or Proposed INN: SODIUM CHLORIDE Other descriptive name: SODIUM CHLORIDE PH. EUR. | Erasmus MC | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;France;Spain;Belgium;Denmark;Australia;Netherlands;Italy | |||
| 1616 | EUCTR2009-012575-10-IT (EUCTR) | 18/01/2022 | Trial of Therapy for the first pulmonary infection by Pseudomonas aeruginosa in Cystic Fibrosis. | Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-FC | First Pseudomonas aeruginosa infection in patients with cystic fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOTTIZIM - 1 G/10 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO ENDOVENOSO 1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 10 ML INN or Proposed INN: CEFTAZIDIMA PENTAIDRATO Other descriptive name: ceftazidime Trade Name: BRAMICIL - 100 MG/ 2 ML SOLUZIONE INIETTABILE 10 FIALE DA 2 ML Product Name: Tobramicina Product Code: tobramicina INN or Proposed INN: TOBRAMICINA SOLFATO Other descriptive name: Tobramicyn Trade Name: CIPROXIN - 500 MG COMPRESSE RIVESTITE 14 COMPRESSE Product Name: Ciprofloxacina INN or Proposed INN: CIPROFLOXACINA CLORIDRATO Other descriptive name: ciprofloxacin | UNIVERSITY OF LIVERPOOL | NULL | NA | Female: yes Male: yes | 286 | Phase 4 | United Kingdom;Italy;Sweden | |||
| 1617 | EUCTR2016-004786-80-DE (EUCTR) | 30/06/2017 | Tolerability and Efficacy of Anakinra in patients with cystic fibrosis. | A phase IIa, randomized, placebo-controlled, double-blind, cross-over study to evaluate safety and efficacy of subcutanous administration of anakinra in patients with cystic fibrosis. - ANAKIN | Cystic fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10028141;Term: Mucoviscidosis;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kineret INN or Proposed INN: ANAKINRA | Ruprecht-Karls-University Heidelberg, Medical Faculty | NULL | NA | Female: yes Male: yes | 52 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Germany | |||
| 1618 | EUCTR2018-003831-31-PL (EUCTR) | 01/12/2020 | MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis. | A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs | Exocrine Pancreatic Insufficiency due to Cystic Fibrosis MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000004856 MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: MS1819-SD INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica Other descriptive name: LIPASE LIP2 | AzurRx SAS | NULL | Not Recruiting | Female: yes Male: yes | 24 | Phase 2 | Hungary;Spain;Poland;Turkey | |||
| 1619 | EUCTR2007-000171-41-PL (EUCTR) | 11/07/2007 | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease | Altus Pharmaceuticals Inc | NULL | NA | Female: yes Male: yes | 176 | Phase 3 | Slovakia;Poland;Italy | |||
| 1620 | EUCTR2008-002673-13-DE (EUCTR) | 27/08/2008 | Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo | Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo | Deficiency of the Cftr-molecule results in accumulation of ceramide in respiratory epithelial cells. Ceramide triggers a pro-inflammatory and -apoptotic status in cystic fibrosis patients. Amitriptyline reduces ceramide levels in the lung tissue, normalises the activity of cytokines and prevents constitutive cell death of epithelial cells. Amitriptyline prevents pulmonary infections of CF-mice with P. aeruginosa. Amitriptyline may result in an improved lung function of cystic fibrosis patients. | Trade Name: Amitriptylin-CT Product Name: Amitriptyline INN or Proposed INN: Amitriptyline | PSKS | NULL | Not Recruiting | Female: yes Male: yes | Phase 2 | Germany | ||||
| 1621 | EUCTR2010-019267-11-DE (EUCTR) | 19/10/2010 | AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI) | AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI) | Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis MedDRA version: 13.1;Level: PT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1;Level: LLT;Classification code 10041968;Term: Steatorrhea;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: PANZYTRAT 25000 Product Name: PANZYTRAT 25000 INN or Proposed INN: Pancreas Powder Other descriptive name: PANCREATIN Trade Name: KREON 25000 Product Name: KREON 25000 Other descriptive name: PANCREATIN | Axcan Pharma Inc. | NULL | Not Recruiting | Female: yes Male: yes | 68 | Germany | ||||
| 1622 | EUCTR2019-004511-31-IE (EUCTR) | 21/05/2021 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - 40 mg/ml oral suspension Product Name: Noxafil INN or Proposed INN: POSACONAZOLE Other descriptive name: POSACONAZOLE Trade Name: Noxafil 100 mg Tablets Gastro-Resistant Product Name: Noxafil INN or Proposed INN: POSACONAZOLE Other descriptive name: POSACONAZOLE | Bambino Gesù Children's Hospital | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 1623 | EUCTR2020-003170-44-NL (EUCTR) | 09/11/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czechia;Spain;Belgium;Australia;Netherlands;Italy | |||
| 1624 | EUCTR2016-002749-42-IE (EUCTR) | 26/07/2017 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Randomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 20.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 140 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | |||
| 1625 | EUCTR2020-001762-11-SE (EUCTR) | 17/07/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | Sweden;Germany;Bulgaria;Romania;Poland;Belgium;Canada;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Austria;Spain;Greece;Slovakia;Portugal;Serbia;United States | |||
| 1626 | EUCTR2017-000571-85-PL (EUCTR) | 08/05/2017 | Study of Oral Liprotamase Therapy Of Non-Porcine Origin | A Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment | Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: liprotamase INN or Proposed INN: not assigned Other descriptive name: LIPASE INN or Proposed INN: not assigned Other descriptive name: PROTEASE INN or Proposed INN: not assigned Other descriptive name: AMYLASE Trade Name: PANCREAZE® Product Name: PANCREAZE® INN or Proposed INN: not assigned Other descriptive name: PANCREATIN | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 192 | Phase 3 | United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom | |||
| 1627 | EUCTR2020-001762-11-AT (EUCTR) | 10/08/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden | |||
| 1628 | EUCTR2018-000185-11-DE (EUCTR) | 03/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Trikafta Product Name: 100-mg ELX (VX-445) / 50-mg TEZ / 75-mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-c | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 1629 | EUCTR2019-001827-11-GB (EUCTR) | 11/12/2019 | Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Trade Name: Kalydeco 150 mg film-coated tablets Product Name: IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445 / TEZ / IVA | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 56 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United Kingdom;Australia;Ireland;Canada;United States | |||
| 1630 | EUCTR2016-001840-20-Outside-EU/EEA (EUCTR) | 18/05/2016 | Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis Patients | A Multi-center, Human Factors Engineering (HFE) Usability Study in Cystic Fibrosis Patients to Validate the Approved Instructions for Use (IFU) of TOBI® Podhaler™ (Tobramycin Inhalation Powder) Using Placebo Capsules. | cystic fibrosis MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler | Novartis Pharmaceuticals Corporation | NULL | NA | Female: yes Male: yes | 45 | Phase 4 | United States | |||
| 1631 | EUCTR2018-000378-30-IE (EUCTR) | 26/06/2019 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 - 17.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 27.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 Product Name: OligoG CF/20 - 37.5 mg INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | Not Recruiting | Female: yes Male: yes | 168 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | |||
| 1632 | EUCTR2010-019634-26-FR (EUCTR) | 08/02/2011 | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | A Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients | Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa | Product Name: Aeroquin Product Code: MP-376 INN or Proposed INN: levofloxacin Other descriptive name: levofloxacin hemihydrate Trade Name: TOBI 300 mg/5 ml, solution pour inhalation par nébuliseur INN or Proposed INN: TOBRAMYCIN | Mpex Pharmaceuticals, Inc. | NULL | NA | Female: yes Male: yes | 330 | Phase 3 | France;Ireland;Germany;United Kingdom | |||
| 1633 | EUCTR2017-001379-21-DE (EUCTR) | 01/08/2017 | A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 75 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | |||
| 1634 | EUCTR2018-000185-11-SE (EUCTR) | 02/07/2018 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Trikafta Product Name: 100 mg ELX /50 mg TEZ /75 mg IVA FDC Product Code: ELX/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 460 | Phase 3 | United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 1635 | EUCTR2010-018454-13-BE (EUCTR) | 25/05/2010 | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® | Cystic fibrosis MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate Other descriptive name: Nacystelyn® Product Name: Nacystelyn® Product Code: NAL INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate Other descriptive name: Nacystelyn® | Laboratoires SMB S.A. | NULL | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy | |||
| 1636 | EUCTR2019-000833-37-BE (EUCTR) | 25/07/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | |||
| 1637 | EUCTR2018-002624-16-FR (EUCTR) | 21/11/2018 | NA | Validation of respiratory epithelial functional assessment to predict clinical efficacy of Orkambi®. Pathway to personalized therapy in Cystic Fibrosis PREDICT-CF - PREDICT-CF | Homozygous F508del patient aged 12 years or older MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Orkambi® Product Name: Orkambi® | ASSISTANC-PUBLIQUE-HOPITAUX DE PARIS (AP-HP) | NULL | NA | Female: yes Male: yes | 104 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yes | France | |||
| 1638 | EUCTR2020-001762-11-DE (EUCTR) | 17/09/2020 | A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial. | An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials | Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum Product Name: Lenabasum Product Code: JBT-101 INN or Proposed INN: Lenabasum Other descriptive name: resunab, ajulemic acid, anabasum | Corbus Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2;Phase 3 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | |||
| 1639 | EUCTR2017-001379-21-IE (EUCTR) | 26/07/2017 | A study to assess the safety and pharmacodynamics of long-term ivacaftor treatment in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Arm, Open-label Study to Evaluate the Safety and Pharmacodynamics of Long-term Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Approved Ivacaftor-Responsive Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: Kalydeco | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 75 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | |||
| 1640 | EUCTR2007-001548-36-DE (EUCTR) | 27/07/2009 | Nasale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cf | Nasale Inhalation von Pulmozyme bei Patienten mit Mukoviszidose und chronischer Rhinosinusitis mit dem Pari Sinus-Vernebler.- bizentrische, randomisierte, doppel-blinde, placebo-kontrollierte, prospektive klinische Studie -Nasal Inhalation of Dornase alfa (Pulmozyme) in Patients with Cystic Fibrosis and Chronic Rhinosinusitis - pulmozyme-nasal-cf | Cystic Fibrosis with chronic rhinosinusitis | Trade Name: Pulmozyme Product Name: Pulmozyme INN or Proposed INN: Dornase alfa Other descriptive name: recombiant human Desoxyribonuclease ( rhDNase) | University of Jena | NULL | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | Germany | |||
| 1641 | EUCTR2019-003052-36-GB (EUCTR) | 28/02/2020 | Magnetic Resonance Imaging (MRI) in Bronchiectasis | Triple Modality Functional Magnetic Resonance Lung Imaging in Cystic Fibrosis and Non-CF Bronchiectasis - MRI in Bronchiectasis | Cystic fibrosis (CF) Non-CF Bronchiectasis MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: hyperpolarized xenon-129 Product Name: hyperpolarized xenon-129 | The University of Nottingham | NULL | NA | Female: yes Male: yes | 40 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | |||
| 1642 | EUCTR2007-000178-21-PL (EUCTR) | 04/09/2007 | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas | Product Name: ALTU-135 Product Code: ALTU-135 INN or Proposed INN: NA Other descriptive name: Lipase CLEC INN or Proposed INN: NA Other descriptive name: Amylase INN or Proposed INN: NA Other descriptive name: Protease | Altus Pharmaceuticals Inc. | NULL | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Poland;Italy | |||
| 1643 | EUCTR2011-001362-18-Outside-EU/EEA (EUCTR) | 02/02/2015 | Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) | cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | United States | |||
| 1644 | EUCTR2015-000397-36-Outside-EU/EEA (EUCTR) | 03/02/2015 | Program to Give the Drug Aztreonamn Lysine for Inhalation to Canadian Patients with Cystic Fibrosis and infection by the Bacteria Pseudomonas aeruginosa Who Have Limited Treatment Options and are at Risk for Disease Progression | Expanded Access Program for Aztreonam Lysine for Inhalation in Canadian Patients with Cystic Fibrosis and Pseudomonas aeruginosa Airway Infection Who Have Limited Treatment Options and are at Risk for Disease Progression | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 45 | Canada | ||||
| 1645 | EUCTR2017-004132-11-PL (EUCTR) | 18/04/2018 | A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic Fibrosis | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-659/Tezacaftor/Ivacaftor Product Code: VX-659/TEZ/IVA INN or Proposed INN: VX-659 Other descriptive name: VX-659 INN or Proposed INN: TEZACAFTOR INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | |||
| 1646 | EUCTR2016-004318-82-Outside-EU/EEA (EUCTR) | 15/05/2017 | A study comparing Tobramycin Inhalation Powder (TIP) administered once daily continuously versus TIP administered BID in 28 day on / 28 day off cycles for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis | Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: TOBI Podhaler INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN | Novartis Pharmaceuticals Corporation | NULL | NA | Female: yes Male: yes | 200 | Phase 4 | United States | |||
| 1647 | EUCTR2015-000395-97-Outside-EU/EEA (EUCTR) | 02/02/2015 | A Clinical Trial to Evaluate the Effects of the drug Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and infection with the bacteria Pseudomonas aeruginosa (AIR-CF4) | A Double-Blind, Multicenter, Multinational, Randomized, Placebo-Controlled Trial Evaluating Aztreonam Lysine for Inhalation in Patients with Cystic Fibrosis, Mild Lung Disease, and P. aeruginosa (AIR-CF4) | Cystic Fibrosis with Mild Lung Disease and P. aeruginosa (AIR-CF4);Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM | Gilead Sciences, Inc. | Gilead Sciences Pty Ltd;Gilead Sciences Canada, Inc. | NA | Female: yes Male: yes | 157 | United States;Australia;Canada | ||||
| 1648 | EUCTR2017-001309-34-Outside-EU/EEA (EUCTR) | 29/03/2017 | Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Advanced Lung Disease | A Phase 3b, Open-Label Study to Evaluate Lumacaftor and Ivacaftor Combination Therapy in Subjects 12 Years and Older With Cystic Fibrosis and Advanced Lung Disease, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: lumacaftor/ivacaftor Product Name: lumacaftor/ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: Lumacaftor Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 46 | Phase 3 | United States | |||
| 1649 | EUCTR2010-023235-41-PL (EUCTR) | 28/01/2011 | A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE | A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE | Cystic fibrosis with bronchopulmonary chronic Pseudomonas aeruginosa infection MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Tobramycin Product Code: T100 INN or Proposed INN: Tobramycin Other descriptive name: Tobramycinum Trade Name: TOBI® INN or Proposed INN: TOBRAMYCIN | PARI Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | Poland | |||
| 1650 | EUCTR2017-002968-40-FR (EUCTR) | 13/06/2018 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic Fibrosis | A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 121 | Phase 3 | Switzerland;United Kingdom;Germany;Australia;Denmark;Ireland;Belgium;Poland;Canada;France;United States | |||
| 1651 | EUCTR2014-003023-22-FR (EUCTR) | 22/06/2015 | Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) | Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP study | bronchiectasis excluding cystic fibrosis in children;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: ZITHOMAX 40 mg/ml ENFANTS Product Name: zithromax INN or Proposed INN: AZITHROMYCIN DIHYDRATE Trade Name: ZITHROMAX 250 mg Product Name: ZITHROMAX INN or Proposed INN: AZITHROMYCIN DIHYDRATE | ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France | |||
| 1652 | EUCTR2015-001997-16-DE (EUCTR) | 24/04/2017 | A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have a CFTR Gating Mutation | Cystic Fibrosis MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 35 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Canada;Ireland;Germany;United Kingdom | |||
| 1653 | EUCTR2021-000694-85-IE (EUCTR) | 29/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 1654 | EUCTR2014-001401-41-IT (EUCTR) | 07/09/2021 | Targeting Antibiotics to Pseudomonas aeruginosa in Small airways study in patients with Cystic Fibrosis | Targeting Antibiotics to Pseudomonas aeruginosa in Small airways (TAPAS) study in patients with Cystic Fibrosis - TAPAS study in patients with CF | Cystic Fibrosis and chronic infection with Pseudomonas aeuroginosa MedDRA version: 22.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: BRAMITOB - 300 MG/4 ML SOLUZIONE DA NEBULIZZARE 56 CONTENITORI MONODOSE 4 ML Product Name: Bramitob INN or Proposed INN: TOBRAMICINA | ERASMUS UNIVERSITY MEDICAL CENTER ROTTERDAM | NULL | NA | Female: yes Male: yes | 26 | Phase 4 | Netherlands;Italy | |||
| 1655 | EUCTR2007-004277-26-Outside-EU/EEA (EUCTR) | 02/02/2015 | A Clinical Trial to Evaluate the Efficacy and Safety of the drug Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) in comparison to the drug Tobramycin Nebulizer Solution (TNS) in patients with Cystic Fibrosis. | An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension. | Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM Trade Name: TOBI INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Gilead Sciences Inc | NULL | NA | Female: yes Male: yes | 268 | Phase 3 | United States | |||
| 1656 | EUCTR2021-005320-38-AT (EUCTR) | 07/01/2022 | Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy | |||
| 1657 | EUCTR2017-000540-18-FR (EUCTR) | 01/08/2017 | Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi | Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 INN or Proposed INN: tezacaftor Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 90 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;France;Germany | |||
| 1658 | EUCTR2020-004885-21-BE (EUCTR) | 15/09/2021 | A Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects With Cystic Fibrosis | A Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kaftrio Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 143 | Phase 3 | Czechia;Czech Republic;Canada;Spain;Belgium;Australia;Netherlands | |||
| 1659 | EUCTR2021-005320-38-DE (EUCTR) | 16/12/2021 | Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy | |||
| 1660 | EUCTR2017-000673-37-Outside-EU/EEA (EUCTR) | 27/03/2017 | Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function | A Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis, Residual CFTR Function, and FEV1 =40% Predicted | cystic fibrosis MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 24 | Phase 2 | United States | |||
| 1661 | EUCTR2011-000442-38-PL (EUCTR) | 01/08/2011 | Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Randomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa | Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: Amikacin Sulfate | Insmed Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden | |||
| 1662 | EUCTR2011-001255-36-FR (EUCTR) | 14/10/2011 | Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteria | Open-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) | Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa MedDRA version: 14.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations MedDRA version: 14.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston Product Name: Aztreonam for Inhalation Solution Product Code: AZLI INN or Proposed INN: AZTREONAM Other descriptive name: N/A | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 80 | Phase 2 | United States;France;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy | |||
| 1663 | EUCTR2018-002835-76-BE (EUCTR) | 25/07/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy | |||
| 1664 | EUCTR2015-001644-11-SE (EUCTR) | 05/11/2015 | Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor. | A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: lumacaftor/ivacaftor 100mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: lumacaftor Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 INN or Proposed INN: Ivacaftor INN or Proposed INN: Lumacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 256 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | |||
| 1665 | EUCTR2018-002835-76-FR (EUCTR) | 12/07/2019 | A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) | Cystic fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States;France;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom | |||
| 1666 | EUCTR2015-001219-11-Outside-EU/EEA (EUCTR) | 31/03/2015 | A study of the efficacy and tolerability of pancrelipase microtablet (MT) capsules for the treatment of cystic fibrosis-dependent exocrine pancreatic insufficiency | A randomized double-blind (withdrawal) phase 3 study to evaluate the efficacy and tolerability of pancrelipase MT capsules compared with placebo in the treatment of subjects with cystic fibrosis-dependent exocrine pancreatic insufficiency | Cystic fibrosis MedDRA version: 17.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: PANCREASE MT Product Name: PANCREASE MT INN or Proposed INN: pancrelipase Other descriptive name: PANCRELIPASE AMYLASE | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | NULL | NA | Female: yes Male: yes | 40 | Phase 3 | United States;Canada | |||
| 1667 | EUCTR2021-005320-38-NL (EUCTR) | 23/02/2022 | Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del Mutation | A Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100mg ELX/50mg TEZ /75mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 75-mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: Ivacaftor Other descriptive name: IVA Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA Product Code: VX-445/TEZ/IVA INN or Proposed INN: Ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 270 | Phase 3 | Portugal;France;Spain;Belgium;Austria;Germany;Netherlands;Switzerland;Italy | |||
| 1668 | EUCTR2018-000378-30-PL (EUCTR) | 01/06/2020 | A dose finding study of OligoG in patients with CF. | A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: OligoG CF-5/20 INN or Proposed INN: OLIGOG CF-5/20 Other descriptive name: OLIGOG CF-5/20 | AlgiPharma AS | NULL | NA | Female: yes Male: yes | 180 | Phase 2 | Poland;Ireland;Austria;Germany;United Kingdom | |||
| 1669 | EUCTR2017-001078-41-Outside-EU/EEA (EUCTR) | 27/03/2017 | A study in people with cystic fibrosis (a rare pulmonary disease) to assess the pharmacokinetics and safety of a combination of two experimental drugs | A Phase 3, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Lumacaftor in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Trade Name: lumacaftor/ivacaftor Product Name: lumacaftor/ivacaftor Product Code: VX-809/VX-770 INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 58 | Phase 3 | United States;Canada | |||
| 1670 | EUCTR2021-000694-85-AT (EUCTR) | 27/10/2021 | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 550 | Phase 3 | United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden | |||
| 1671 | EUCTR2010-023533-34-FR (EUCTR) | 14/12/2010 | Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose. | Etude pharmacocinétique de l’équivalence de la biodisponibilité entre Nebcinal® 150mg/3ml administré par Aeroneb® Idehaler® et Tobi® 300mg/5ml administré par Pari LC Plus ® /Pulmoaid ® chez des patients atteints de mucoviscidose. | Mucoviscidose MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Nebcinal Product Code: Nebcinal Trade Name: Tobi Product Name: Tobi | EREMPHARMA SAS | NULL | NA | Female: yes Male: yes | Phase 1 | France | ||||
| 1672 | EUCTR2020-001404-42-FR (EUCTR) | 16/11/2020 | A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF genotypes | A Phase 3b Open label Study Evaluating the Long term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination Product Code: VX-445 / TEZ / IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 108 | Phase 3 | France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland | |||
| 1673 | EUCTR2006-003275-12-SE (EUCTR) | 07/07/2009 | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa. MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: Azithromycin Product Name: azithromycin Product Code: azithromycin INN or Proposed INN: AZITHROMYCIN Trade Name: Zitromax Product Name: zitromax Product Code: zitromax INN or Proposed INN: AZITHROMYCIN | Copenhagen CF-centre | NULL | NA | Female: yes Male: yes | 250 | Phase 4 | Denmark;Norway;Sweden | |||
| 1674 | EUCTR2007-000935-25-NL (EUCTR) | 02/04/2007 | ‘Peripheral targeting of inhaled rhDNase in stable CF patients.’ | ‘Peripheral targeting of inhaled rhDNase in stable CF patients.’ | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung | Trade Name: Pulmozyme (Dornase alpha) Product Name: Pulmozyme | ErasmusMC - Sophia Children's Hospital | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 50 | Netherlands | ||||
| 1675 | EUCTR2016-002851-92-PL (EUCTR) | 02/08/2016 | NA | An Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years | Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: Liprotamase INN or Proposed INN: NOT ASSIGNED Other descriptive name: LIPASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: PROTEASE INN or Proposed INN: NOT ASSIGNED Other descriptive name: AMYLASE | ANTHERA Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 70 | Phase 3 | United States;Czech Republic;Hungary;Canada;Spain;Poland;Israel | |||
| 1676 | EUCTR2016-004479-35-IE (EUCTR) | 19/02/2018 | A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic Fibrosis | A Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-661/ivacaftor 50 mg/ 75 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: VX-661/ivacaftor 100 mg/ 150 mg INN or Proposed INN: TEZACAFTOR Other descriptive name: VRT-893661 INN or Proposed INN: IVACAFTOR Other descriptive name: VX-770 Product Name: Ivacaftor Product Code: VX-770, VRT-813077 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 65 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
| 1677 | EUCTR2020-003170-44-FR (EUCTR) | 22/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | |||
| 1678 | EUCTR2015-001997-16-GB (EUCTR) | 07/03/2016 | A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs). | A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have an Ivacaftor-responsive CFTR Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 35 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | |||
| 1679 | EUCTR2011-002000-32-FR (EUCTR) | 22/09/2011 | A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis | A single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis | Pseudomonas aeruginosa infection in cystic fibrosis patients MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: TOBI Podhaler Product Name: TIP (Tobramycin inhalation powder) Product Code: TBM100 INN or Proposed INN: Tobramycin | Novartis Pharma Services AG | NULL | NA | Female: yes Male: yes | 150 | Phase 4 | United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy | |||
| 1680 | EUCTR2021-000712-31-CZ (EUCTR) | 23/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Product Name: ivacaftor Product Code: VX-770 INN or Proposed INN: ivacaftor | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 400 | Phase 3 | United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden | |||
| 1681 | EUCTR2020-003170-44-BE (EUCTR) | 16/10/2020 | A study Evaluating the effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism | A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects with Abnormal Glucose Metabolism - A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Subjects With Cystic Fibrosis | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: ELX (VX-445)/TEZ (VX-661)/IVA (VX-770) INN or Proposed INN: Elexacaftor INN or Proposed INN: Tezacaftor INN or Proposed INN: IVACAFTOR Trade Name: Ivacaftor Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 60 | Phase 3 | France;Czech Republic;Spain;Belgium;Australia;Netherlands;Italy | |||
| 1682 | EUCTR2006-006693-24-PL (EUCTR) | 11/10/2007 | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | A Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis | Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance. MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Moli1901 (2622U90, duramycin) Product Code: Moli1901 INN or Proposed INN: Not available Other descriptive name: 2622U90 Duramycin | AOP Orphan Pharmaceuticals AG | NULL | NA | Female: yes Male: yes | 160 | Phase 2 | France;Hungary;Czech Republic;Spain;Poland;Austria;Germany;Italy;Sweden | |||
| 1683 | EUCTR2015-000398-11-Outside-EU/EEA (EUCTR) | 03/02/2015 | A Clinical Trial to Assess the Safety and Efficacy of an Alternating Therapy of Antibiotics with the Drug Aztreonam for Inhalation Solution (AZLI) for the Treatment of Lung Infection by the bacteria Pseudomonas aeruginosa in Patients with Cystic Fibrosis. | A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy (CAT) Regimen of Inhaled Antibiotics for the Treatment of Chronic Pulmonary Pseudomonas aeruginosa Infection in Subjects with Cystic Fibrosis | Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: Cayston INN or Proposed INN: AZTREONAM Trade Name: TOBI® INN or Proposed INN: TOBRAMYCIN Other descriptive name: TOBRAMYCIN | Gilead Sciences, Inc. | NULL | NA | Female: yes Male: yes | 250 | Phase 3 | United States | |||
| 1684 | EUCTR2019-004511-31-FR (EUCTR) | 01/04/2021 | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. | Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF | Cystic Fibrosis and Aspergillus infection. MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | Trade Name: NOXAFIL - oral suspension 40 mg/ml Product Name: Noxafil Trade Name: Noxafil 100 mg Product Name: Noxafil | Bambino Gesù Children's Hospital | NULL | Not Recruiting | Female: yes Male: yes | 135 | Phase 2;Phase 3 | Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden | |||
| 1685 | EUCTR2005-004103-10-PL (EUCTR) | 26/09/2007 | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Randomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in cystic fibrosis patients with Pseudomonas Aeruginosa infections | Cystic Fibrosis with Pseudomonas aeruginosa infections MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Tobramycin 100 PARI Product Code: T 100 PARI Other descriptive name: tobramycinum Trade Name: TOBI Other descriptive name: tobramycinum | PARI GmbH | NULL | NA | Female: yes Male: yes | 60 | Phase 1 | Poland;Germany | |||
| 1686 | EUCTR2018-000185-11-FR (EUCTR) | 24/01/2019 | A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: VX-445 Other descriptive name: VX-445 INN or Proposed INN: Tezacaftor Other descriptive name: VX-661 INN or Proposed INN: Ivacaftor Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 460 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
| 1687 | EUCTR2015-001225-16-Outside-EU/EEA (EUCTR) | 24/04/2015 | A Study to Evaluate the Pharmacokinetics and Safety of Doripenem in Children and Adolescents with Cystic Fibrosis | An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics and Safety of Doripenem in Pediatric Subjects 6 to 17 Years of age, Inclusive, With Cystic Fibrosis | Cystic fibrosis MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Trade Name: DORIBAX Product Name: DORIBAX INN or Proposed INN: DORIPENEM HYDRATE Other descriptive name: DORIPENEM HYDRATE | Johnson & Johnson Pharmaceutical Research & Development L.L.C | NULL | NA | Female: yes Male: yes | 22 | United States | ||||
| 1688 | EUCTR2009-010261-23-Outside-EU/EEA (EUCTR) | 06/06/2011 | Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older Homozygous for the F508del-CFTR Mutation | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of VX-770 in Subjects Aged 12 Years and Older With Cystic Fibrosis who are Homozygous for the F508del-CFTR Mutation - DISCOVER | Cystic Fibrosis MedDRA version: 13.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16] | Product Name: VX-770 Product Code: VX-770; VRT-813077 INN or Proposed INN: ivacaftor (proposed INN) Other descriptive name: VRT-813077 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 140 | Phase 2 | United States | |||
| 1689 | EUCTR2021-003277-55-AT (EUCTR) | 27/07/2021 | COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF | COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF - CAR-CF | COVID-19 vaccine Antibody response from natural infection or after vaccination in patients with Cystic Fibrosis (CF) MedDRA version: 20.0;Level: LLT;Classification code 10021433;Term: Immunization;System Organ Class: 100000004865 MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify | Trade Name: Comirnaty concentrate for dispersion for injection Product Name: Comirnaty INN or Proposed INN: Tozinameran Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified) Trade Name: Vaxzevria suspension for injection COVID-19 Vaccine (ChAdOx1-S Product Name: Vaxzevria INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant]) Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19) Trade Name: COVID-19 Vaccine Moderna dispersion for injection Product Name: COVID-19 Vaccine Moderna INN or Proposed INN: Elasomeran Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414) Trade Name: COVID-19 Vaccine Janssen suspension for injection Product Name: COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant]) INN or Proposed INN: COVID-19 vaccine (Ad26.COV2-S [recombinant]) Other descriptive name: Ad26.COV2-S.02 | Medical University of Innsbruck, University Clinic for Pediatrics III | NULL | NA | Female: yes Male: yes | 5000 | Phase 4 | United States;European Union;Canada;Ireland;Austria;United Kingdom | |||
| 1690 | EUCTR2018-004652-38-PL (EUCTR) | 06/09/2019 | A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | A Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis - A Study Evaluating the Long-term Safety of VX-445 Combination Therapy | Cystic Fibrosis MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 /50-mg TEZ/75-mg Product Code: VX-445 /TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: VX-661 INN or Proposed INN: IVACAFTOR INN or Proposed INN: VX-445 Other descriptive name: VX-445 Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 458 | Phase 3 | United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Germany;United Kingdom;Switzerland | |||
| 1691 | EUCTR2006-006980-22-PL (EUCTR) | 22/08/2007 | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA | Cystic fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis | Product Name: Liposomal Amikacin (Arikace™) INN or Proposed INN: AMIKACIN SULFATE | Transave, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 60 | Phase 2 | Hungary;Slovakia;Belgium;Poland | |||
| 1692 | EUCTR2021-000712-31-IE (EUCTR) | 29/09/2021 | A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF) | A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) | MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-121/tezacaftor/deutivacaftor Product Code: VX-121/TEZ/D-IVA INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: deutivacaftor Other descriptive name: D-IVA INN or Proposed INN: Not yet assigned Other descriptive name: VX-121 Trade Name: Kaftrio Product Name: elexacaftor/tezacaftor/ivacaftor Product Code: ELX/TEZ/IVA INN or Proposed INN: elexacaftor Other descriptive name: ELX INN or Proposed INN: tezacaftor Other descriptive name: TEZ INN or Proposed INN: ivacaftor Other descriptive name: IVA Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 400 | Phase 3 | Portugal;United States;Czechia;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden | |||
| 1693 | EUCTR2019-001735-31-BE (EUCTR) | 08/07/2019 | A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic Fibrosis | A Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: ELEXACAFTOR Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Symkevi 100mg/150mg Film-coated tablets Product Code: VX-661 / VX-770 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 158 | Phase 3 | Belgium;Australia;Germany;United Kingdom | |||
| 1694 | EUCTR2007-006276-11-PL (EUCTR) | 06/05/2009 | A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis | A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis | Cystic Fibrosis MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung | Product Name: Heparin 25mg inhalation powder, hard capsule INN or Proposed INN: HEPARIN SODIUM | Vectura Limited | NULL | Not Recruiting | Female: yes Male: yes | 64 | Phase 2 | Poland;Ireland;Italy;United Kingdom | |||
| 1695 | EUCTR2018-001695-38-IE (EUCTR) | 28/08/2019 | Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 Years | A Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ Trade Name: Kalydeco 150 mg film-coated tablets Product Name: IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Product Name: VX-445 / TEZ / IVA FDC Product Code: VX-445/TEZ/IVA INN or Proposed INN: TEZACAFTOR Other descriptive name: TEZ INN or Proposed INN: IVACAFTOR Other descriptive name: IVA INN or Proposed INN: elexacaftor Other descriptive name: VX-445 Product Name: IVACAFTOR | Vertex Pharmaceuticals Incorporated | NULL | Not Recruiting | Female: yes Male: yes | 56 | Phase 3 | United States;Canada;Ireland;Australia;United Kingdom | |||
| 1696 | EUCTR2021-001628-16-BE (EUCTR) | 06/08/2021 | A Study to Evaluate ELX/TEZ/IVA on Cough and Physical Activity in Subjects with Cystic Fibrosis (CF) | A Phase 3b Open-label Study Evaluating the Effects of Elexacaftor/Tezacaftor/Ivacaftor on Cough and Physical Activity in Cystic Fibrosis Subjects 12 Years of Age and Older Who Are Heterozygous for the F508delMutation and a Minimal Function Mutation (F/MF) | Cystic Fibrosis MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination INN or Proposed INN: Tezacaftor Other descriptive name: TEZ INN or Proposed INN: Elexacaftor Other descriptive name: ELX INN or Proposed INN: IVACAFTOR Other descriptive name: IVA Trade Name: Kalydeco 150 mg film-coated tablets Product Name: 150mg IVACAFTOR Product Code: VX-770 INN or Proposed INN: IVACAFTOR Other descriptive name: IVA | Vertex Pharmaceuticals Incorporated | NULL | NA | Female: yes Male: yes | 100 | Phase 3 | Canada;Spain;Belgium;Australia |