299. 嚢胞性線維症 [臨床試験数:856,薬物数:981(DrugBank:220),標的遺伝子数:84,標的パスウェイ数:158]
Searched query = "Cystic fibrosis"
The queries were searched in Public_title, Scientific_title, and Condition of the data. Export date: 11/21/2019, 11/20/2019. Trials are sorted by Date_enrolment from most recent to oldest in the table.
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
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1 | NCT03931252 | February 2020 | 11 November 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 | Recruiting | 18 Years | N/A | All | 10 | N/A | United States | |
2 | NCT03698448 | December 1, 2019 | 22 October 2019 | 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 | Not recruiting | 12 Years | N/A | All | 120 | Phase 2/Phase 3 | Germany |
3 | NCT02547116 | December 2019 | 9 September 2019 | 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 | Not recruiting | 12 Years | N/A | All | 16 | Phase 4 | United States | |
4 | NCT03058068 | December 2019 | 15 July 2019 | 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 | Not recruiting | 20 Years | 45 Years | All | 18 | Phase 1 | United States | |
5 | NCT03921060 | December 2019 | 7 October 2019 | Markers of Osteoporosis in Cystic Fibrosis | Markers of Osteoporosis in Cystic Fibrosis | Cystic Fibrosis | Drug: Denosumab | University of Texas Southwestern Medical Center | Not recruiting | 12 Years | 64 Years | All | 100 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
6 | NCT04058366 | November 2019 | 30 September 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 | Not recruiting | 12 Years | N/A | All | 250 | Phase 3 | ||
7 | NCT04135495 | October 16, 2019 | 4 November 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 | Eloxx Pharmaceuticals, Inc. | Recruiting | 18 Years | N/A | All | 8 | Phase 2 | United States | |
8 | NCT03435939 | October 15, 2019 | 7 October 2019 | 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 | Not recruiting | 18 Years | N/A | All | 16 | Early Phase 1 | United States | |
9 | NCT04105972 | October 3, 2019 | 11 November 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 | Recruiting | 12 Years | N/A | All | 158 | Phase 3 | Australia;Belgium;Germany;United Kingdom | |
10 | NCT04126473 | October 3, 2019 | 4 November 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 | Genetic Disease;Nonsense Mutation;Cystic Fibrosis With Meconium Ileus | Drug: ELX-02 | Eloxx Pharmaceuticals, Inc. | Recruiting | 16 Years | N/A | All | 16 | Phase 2 | Israel | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
11 | NCT03924947 | October 2, 2019 | 4 November 2019 | A Study to Compare US Marketed Pancrelipase Drug Product With Drug Product Manufactured With a Modernized Process at an Alternate Manufacturing 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, in Subjects With Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis | Cystic Fibrosis | Drug: Pancrelipase | AbbVie | Recruiting | 12 Years | N/A | All | 28 | Phase 4 | United States;Spain | |
12 | NCT03925194 | October 1, 2019 | 6 May 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 | Not recruiting | 12 Years | N/A | All | 52 | Phase 2 | Germany | |
13 | NCT04090294 | October 1, 2019 | 14 October 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 | Not recruiting | 18 Years | 75 Years | All | 35 | Early Phase 1 | ||
14 | NCT04118010 | October 2019 | 22 October 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 | Not recruiting | 18 Years | N/A | All | 40 | Phase 4 | United States | |
15 | NCT04059094 | September 16, 2019 | 11 November 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 | Drug: BI 1265162;Drug: Placebo | Boehringer Ingelheim | Recruiting | 12 Years | N/A | All | 98 | Phase 2 | United States;Belgium;France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
16 | NCT04038710 | September 5, 2019 | 4 November 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 | Recruiting | 12 Years | N/A | All | 7 | Phase 2 | United States | |
17 | NCT04039087 | September 5, 2019 | 4 November 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 |
18 | NCT04056702 | September 5, 2019 | 4 November 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 | 70 | Phase 4 | United States |
19 | NCT03506061 | September 4, 2019 | 30 September 2019 | Symdeko in Cystic Fibrosis Patients | iPS Cell Response to CFTR Modulators: Study of Symdeko in CF Patients Carrying Partial Function Mutations | Cystic Fibrosis | Drug: Symdeko | Emory University | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 12 Years | N/A | All | 22 | Phase 2 | United States |
20 | NCT04006873 | September 3, 2019 | 4 November 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 | Recruiting | 12 Years | 40 Years | All | 12 | Phase 2 | United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
21 | NCT04058353 | August 28, 2019 | 4 November 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 | Recruiting | 12 Years | N/A | All | 250 | Phase 3 | United States | |
22 | NCT03969888 | August 27, 2019 | 11 June 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 | Not recruiting | 18 Years | N/A | All | 189 | Phase 2 | United States | |
23 | NCT04043806 | August 9, 2019 | 11 November 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 | Recruiting | 12 Years | N/A | All | 480 | Phase 3 | United States | |
24 | NCT03587961 | August 1, 2019 | 14 October 2019 | Personalized Theratyping Trial | Personalized Theratyping Trial | Cystic Fibrosis | Drug: Symdeko | University of Alabama at Birmingham | Recruiting | 6 Years | N/A | All | 20 | Early Phase 1 | United States | |
25 | NCT04058340 | July 30, 2019 | 2 September 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 | Recruiting | 6 Years | N/A | All | 30 | N/A | Poland | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
26 | NCT03988816 | July 2019 | 1 July 2019 | Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis 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 | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | Brazil | |
27 | NCT03597347 | June 20, 2019 | 30 September 2019 | 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. | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States | |
28 | NCT03734744 | June 17, 2019 | 26 August 2019 | 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 | Recruiting | 18 Years | N/A | All | 12 | N/A | United States | |
29 | NCT03485456 | May 29, 2019 | 26 August 2019 | 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 | Recruiting | 6 Years | 18 Years | All | 10 | Phase 1/Phase 2 | Netherlands | |
30 | NCT04010799 | May 27, 2019 | 15 July 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. | Recruiting | 18 Years | N/A | All | 48 | Phase 1 | Germany | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
31 | NCT03965832 | May 24, 2019 | 15 July 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 | Recruiting | 18 Years | N/A | All | 20 | N/A | United Kingdom | |
32 | NCT03822455 | May 15, 2019 | 29 July 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. | Recruiting | 18 Years | N/A | All | 33 | Phase 2/Phase 3 | Australia |
33 | NCT02748798 | May 2019 | 23 April 2019 | 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 | Not recruiting | 18 Years | N/A | All | 160 | Early Phase 1 | Canada |
34 | NCT03903913 | May 2019 | 23 April 2019 | Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis | 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 | Cystic Fibrosis | Drug: S-1226 | SolAeroMed Inc. | Recruiting | 14 Years | 50 Years | All | 12 | Phase 2 | Canada | |
35 | NCT03912233 | April 30, 2019 | 22 October 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 | Not recruiting | 18 Years | N/A | All | 87 | Phase 2 | United States;Germany;Netherlands;Portugal;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
36 | NCT03911713 | April 17, 2019 | 4 November 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 | Recruiting | 18 Years | N/A | All | 88 | Phase 2 | United States;Australia;Belgium;Germany;Ireland;United Kingdom | |
37 | NCT03795363 | April 10, 2019 | 7 October 2019 | 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 | Recruiting | 2 Years | 5 Years | All | 32 | Phase 2 | United States |
38 | NCT03870841 | April 3, 2019 | 26 August 2019 | 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 | Recruiting | 18 Years | N/A | All | 18 | Phase 2 | United Kingdom | |
39 | NCT03710538 | April 1, 2019 | 17 June 2019 | 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 | Recruiting | 18 Years | N/A | All | 14 | N/A | Canada | |
40 | NCT03724955 | April 2019 | 29 April 2019 | 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 | Not recruiting | 18 Years | N/A | Female | 0 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
41 | NCT03894657 | April 2019 | 8 April 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 | Not recruiting | 12 Years | N/A | All | 104 | N/A | France | |
42 | EUCTR2018-003831-31-HU | 28/03/2019 | 30 April 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 - 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 Pharmaceutical Form: Capsule, hard | AzurRx | Authorised | Female: yes Male: yes | 24 | Phase 2 | Hungary | |||
43 | NCT03902236 | March 1, 2019 | 15 April 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 | Recruiting | 6 Years | 18 Years | All | 60 | N/A | Turkey | |
44 | NCT03632525 | February 22, 2019 | 29 April 2019 | 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 | Recruiting | 18 Years | N/A | All | 20 | Phase 4 | United Kingdom | |
45 | NCT03783286 | February 6, 2019 | 7 October 2019 | Ivacaftor Treatment in 6 Month to 2 Year Old CF Subjects | Nutritional Impact of Ivacaftor Treatment in 6 Month to 2 Year Old Children With CF Gating Mutations | Cystic Fibrosis | Drug: Ivacaftor | Children's Hospital of Philadelphia | Vertex Pharmaceuticals Incorporated | Recruiting | 1 Year | 2 Years | All | 18 | Phase 4 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
46 | NCT03746483 | January 10, 2019 | 20 May 2019 | 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. | Recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States;Poland | |
47 | NCT03647228 | December 13, 2018 | 2 September 2019 | 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. | Recruiting | 18 Years | 50 Years | All | 88 | Phase 1 | United Kingdom | |
48 | NCT03669614 | December 7, 2018 | 26 August 2019 | SAD and MAD of Inhaled AR-501 in Health Adults and P. Aeruginosa Infected Cystic Fibrosis Subjects | A P1/2a 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 AR-501 placebo | Aridis Pharmaceuticals, Inc. | Recruiting | 18 Years | 49 Years | All | 96 | Phase 1/Phase 2 | United States | |
49 | NCT02323100 | December 2, 2018 | 29 July 2019 | 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 |
50 | NCT03624101 | December 1, 2018 | 27 May 2019 | 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: Tezacaftor/Ivacaftor | University of Alabama at Birmingham | Recruiting | 18 Years | N/A | All | 5 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
51 | NCT03756922 | November 27, 2018 | 26 August 2019 | 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 | Recruiting | 18 Years | 55 Years | All | 78 | Phase 1/Phase 2 | United Kingdom | |
52 | EUCTR2017-003723-29-DE | 19/11/2018 | 26 November 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Lenabasum Product Code: JBT-101 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Corbus Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 415 | Phase 2 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | |||
53 | NCT03748199 | November 8, 2018 | 3 December 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 | Recruiting | 18 Years | 55 Years | All | 40 | Phase 1/Phase 2 | Germany | |
54 | NCT03617718 | November 1, 2018 | 21 January 2019 | 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 |
55 | EUCTR2018-000185-11-CZ | 15/10/2018 | 28 February 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VX-445 CAS Number: 2216712-66-0 Current Sponsor code: VX-445 Other descriptive name: VX-445 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: Tezacaftor CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: Ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
56 | NCT03265288 | October 10, 2018 | 30 September 2019 | 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 | Recruiting | 18 Years | N/A | All | 136 | Phase 2 | United States;Canada |
57 | NCT03525574 | October 9, 2018 | 30 September 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 | Drug: VX-445;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | 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 | |
58 | NCT03691779 | October 2, 2018 | 11 November 2019 | 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 | Recruiting | 6 Years | 11 Years | All | 56 | Phase 3 | United States;Australia | |
59 | NCT03956589 | October 1, 2018 | 3 June 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 | Recruiting | 12 Years | N/A | All | 20 | Phase 4 | Belgium | |
60 | EUCTR2018-002579-16-SE | 26/08/2018 | 3 September 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® Pharmaceutical Form: Tablet | Karolinska University Hospital, Stockholm CF center | Authorised | Female: yes Male: yes | 12 | Phase 2 | Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
61 | NCT03591094 | August 21, 2018 | 29 April 2019 | 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. | Not recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States | |
62 | NCT03551691 | August 7, 2018 | 25 March 2019 | 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 | Recruiting | 12 Years | N/A | All | 24 | Phase 2 | United States |
63 | NCT03525548 | August 3, 2018 | 18 March 2019 | 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;Drug: TEZ;Drug: IVA;Drug: TEZ/IVA | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 113 | Phase 3 | United States;Belgium;Netherlands;United Kingdom | |
64 | NCT03633526 | August 3, 2018 | 2 September 2019 | 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;Drug: TEZ;Drug: IVA | Vertex Pharmaceuticals Incorporated | Not recruiting | 6 Years | 11 Years | All | 18 | Phase 3 | United States | |
65 | NCT03655249 | August 1, 2018 | 30 September 2019 | 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 | Recruiting | 6 Years | N/A | All | 30 | N/A | Belgium | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
66 | NCT03593434 | July 30, 2018 | 20 August 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) | Recruiting | 6 Years | 21 Years | All | 20 | Phase 2 | United States |
67 | NCT03447262 | July 13, 2018 | 18 March 2019 | 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 | Not recruiting | 12 Years | N/A | All | 484 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom | |
68 | NCT03565692 | July 1, 2018 | 18 December 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 | Société Française de la Mucoviscidose | Recruiting | 6 Years | N/A | All | 250 | Phase 1 | France |
69 | EUCTR2017-003761-99-DE | 27/06/2018 | 14 January 2019 | 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 Pharmaceutical Form: Granules INN or Proposed INN: LUMACAFTOR CAS Number: 936727-05-8 Current Sponsor code: VX-809 Other descriptive name: LUMACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use Product Name: lumacaftor / ivacaftor Product Code: VX-809 / VX-770 Pharmaceutical Form: Granules INN or Proposed INN: LUMACAFTOR CAS Number: 936727-05-8 Current Sponsor code: VX-809 Other descriptive name: LUMACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 188- Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use Trade Name: Orkambi 100 mg/125 mg film-coated tablets Product Name: LUM/IVA fixed-dose combination Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LUMACAFTOR CAS Number: 936727-05-8 Current Sponsor code: VX-809 Other descriptive name: LUMACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Other descriptive name: IVACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 50 | Phase 2 | Germany | |||
70 | EUCTR2016-004479-35-BE | 26/06/2018 | 28 February 2019 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: VX-661/ivacaftor 100 mg/ 150 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
71 | EUCTR2017-002968-40-BE | 26/06/2018 | 7 January 2019 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6 to 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Product Name: VX-661/ivacaftor 100 mg/ 150 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
72 | NCT03525444 | June 15, 2018 | 30 September 2019 | 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;Drug: TEZ;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 405 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom | |
73 | EUCTR2018-001573-24-BE | 11/06/2018 | 27 August 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- | Antwerp University Hospital | Authorised | Female: yes Male: yes | 20 | Phase 4 | Belgium | |||
74 | EUCTR2017-003723-29-SE | 07/06/2018 | 28 February 2019 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENABASUM CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Lenabasum Product Code: JBT-101 Pharmaceutical Form: Capsule, hard INN or Proposed INN: LENABASUM CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Corbus Pharmaceuticals, Inc. | Authorised | Female: yes Male: yes | 415 | Phase 2 | Serbia;Portugal;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden | |||
75 | EUCTR2017-003319-21-GB | 04/06/2018 | 30 April 2019 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: None CAS Number: Not assigned Current Sponsor code: PTI-808 Other descriptive name: PTI-808 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 10-150 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: None CAS Number: Not assigned Current Sponsor code: PTI-801 Other descriptive name: PTI-801 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 50-100 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide Product Code: PTI-428 Pharmaceutical Form: Capsule, hard INN or Proposed INN: None CAS Number: Not assigned Current Sponsor code: PTI-428 Other descriptive name: PTI-428 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 5-100 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Proteostasis Therapeutics, Inc. | Authorised | Female: yes Male: yes | 240 | Phase 1;Phase 2 | France;United States;Canada;Belgium;Denmark;Germany;United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
76 | NCT03540524 | May 31, 2018 | 15 April 2019 | 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 | Not recruiting | 18 Years | N/A | All | 10 | Phase 1 | Belgium;Bulgaria;Germany;Greece;Netherlands;Serbia;Sweden;United Kingdom | |
77 | EUCTR2016-001440-18-NL | 30/05/2018 | 11 June 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 Pharmaceutical Form: Film-coated tablet Trade Name: claritromycin 500mg film coated tablets Product Name: Claritromycin Pharmaceutical Form: Film-coated tablet Trade Name: Azithromycin 500 mg film-coated tablet Product Name: azithromycin Pharmaceutical Form: Film-coated tablet Trade Name: Norvir 100 mg film-coated tablets Product Name: Norvir Pharmaceutical Form: Film-coated tablet | university medical center utrecht | Authorised | Female: yes Male: yes | 12 | Phase 4 | Netherlands | |||
78 | NCT03482960 | May 29, 2018 | 22 October 2019 | 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 | Not recruiting | 18 Years | N/A | All | 8 | Early Phase 1 | United States |
79 | NCT03462056 | May 17, 2018 | 15 July 2019 | 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 | Not recruiting | 2 Years | 12 Years | All | 16 | Phase 1/Phase 2 | United States |
80 | NCT03559062 | May 17, 2018 | 11 February 2019 | 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 | Not recruiting | 6 Years | 11 Years | All | 69 | Phase 3 | Australia;Belgium;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
81 | NCT03375047 | May 10, 2018 | 1 April 2019 | 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. | Recruiting | 18 Years | N/A | All | 32 | Phase 1/Phase 2 | United States | |
82 | NCT03428334 | May 10, 2018 | 14 October 2019 | 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 | Not recruiting | 18 Years | N/A | All | 20 | Phase 2 | Hong Kong | |
83 | NCT03460990 | May 1, 2018 | 18 December 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;Drug: TEZ;Drug: IVA;Drug: TEZ/IVA | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 116 | Phase 3 | United States;Australia;Germany;Ireland;Spain;United Kingdom | |
84 | NCT03522831 | May 1, 2018 | 4 November 2019 | 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 | Recruiting | 19 Years | N/A | All | 20 | N/A | Canada | |
85 | EUCTR2017-002968-40-IE | 27/04/2018 | 28 February 2019 | A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6 to 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Product Name: VX-661/ivacaftor 100 mg/ 150 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Trade Name: Kalydeco 150mg Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 121 | Phase 3 | France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
86 | EUCTR2017-004132-11-DE | 25/04/2018 | 28 February 2019 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VX-659 Current Sponsor code: VX-659 Other descriptive name: VX-659 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 120- INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 360 | Phase 3 | United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland | |||
87 | NCT03492567 | April 25, 2018 | 3 December 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 | Not recruiting | 18 Years | N/A | All | 25 | N/A | France |
88 | EUCTR2016-004479-35-DK | 18/04/2018 | 30 April 2019 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: VX-661/ivacaftor 100 mg/ 150 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland | |||
89 | EUCTR2017-003723-29-HU | 16/04/2018 | 27 August 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 Pharmaceutical Form: Capsule INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Name: Lenabasum Product Code: JBT-101 Pharmaceutical Form: Capsule INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Corbus Pharmaceuticals, Inc. | Authorised | 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 | |||
90 | NCT03527095 | April 5, 2018 | 12 November 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 | Not recruiting | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
91 | NCT03489629 | April 3, 2018 | 26 August 2019 | 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;National Jewish Health;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 |
92 | NCT03768089 | March 19, 2018 | 11 June 2019 | 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 | Not recruiting | 18 Years | N/A | All | 114 | Phase 1/Phase 2 | Netherlands;United Kingdom | |
93 | EUCTR2018-000126-55-NL | 15/03/2018 | 21 May 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 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: Not yet assigned Current Sponsor code: VX-121 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 10-720 Pharmaceutical form of the placebo: Powder for oral suspension Route of administration of the placebo: Oral use Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 120 | Phase 1;Phase 2 | Netherlands | |||
94 | NCT03447249 | March 7, 2018 | 18 March 2019 | 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;Drug: TEZ;Drug: IVA;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 385 | Phase 3 | United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom | |
95 | NCT03516331 | March 7, 2018 | 12 November 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 | Not recruiting | 18 Years | 55 Years | All | 16 | Phase 1 | United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
96 | NCT03367494 | March 1, 2018 | 8 April 2019 | 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 | Recruiting | 18 Years | N/A | All | 50 | N/A | United States | |
97 | NCT03589313 | February 12, 2018 | 23 July 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 | Not recruiting | 18 Years | N/A | Male | 6 | Phase 1 | Belgium | |
98 | NCT03421366 | February 5, 2018 | 12 February 2018 | Modified Release Posaconazole in Patients With Cystic Fibrosis | Modified Release Posaconazole in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Posaconazole | Bayside Health | Not recruiting | 18 Years | N/A | All | 20 | N/A | ||
99 | NCT03500263 | January 30, 2018 | 30 September 2019 | 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. | Not recruiting | 18 Years | N/A | All | 12 | Phase 1/Phase 2 | United Kingdom | |
100 | NCT03460704 | January 29, 2018 | 11 June 2018 | Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS-2) | A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 24 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 | Recruiting | 18 Years | 90 Years | All | 374 | Phase 3 | Poland | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
101 | NCT02653027 | January 1, 2018 | 26 August 2019 | 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 | Not recruiting | 18 Years | 65 Years | All | 0 | N/A | ||
102 | EUCTR2018-000185-11-DE | 28 February 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VX-445 CAS Number: 2216712-66-0 Current Sponsor code: VX-445 Other descriptive name: VX-445 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: Tezacaftor CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: Ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Not Available | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||||
103 | EUCTR2018-000185-11-SE | 28 February 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VX-445 CAS Number: 2216712-66-0 Current Sponsor code: VX-445 Other descriptive name: VX-445 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: Tezacaftor CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: Ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Not Available | Female: yes Male: yes | 460 | Phase 3 | United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||||
104 | EUCTR2018-002624-16-FR | 28 February 2019 | 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® Pharmaceutical Form: Tablet | ASSISTANC-PUBLIQUE-HOPITAUX DE PARIS (AP-HP) | Not Available | Female: yes Male: yes | 104 | Phase 4 | France | ||||
105 | NCT03451045 | December 22, 2017 | 26 August 2019 | 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 | Recruiting | 12 Years | N/A | All | 415 | Phase 2 | United States;Austria;Belgium;Bulgaria;Canada;Czechia;France;Germany;Greece;Hungary;Italy;Netherlands;Poland;Portugal;Russian Federation;Serbia;Slovakia;Spain;Sweden;United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
106 | NCT03424252 | December 18, 2017 | 12 November 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 | Not recruiting | 18 Years | 55 Years | All | 11 | Phase 1 | United Kingdom | |
107 | NCT03218917 | December 1, 2017 | 11 June 2019 | 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 | Not recruiting | 18 Years | 85 Years | All | 240 | Phase 2 | United States;Australia;Belgium;Bulgaria;Denmark;Germany;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Singapore;Spain;United Kingdom;Sweden | |
108 | NCT03474042 | November 29, 2017 | 25 June 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 | Not recruiting | 18 Years | N/A | All | 22 | Phase 2 | Germany | |
109 | NCT03219164 | November 28, 2017 | 28 October 2019 | 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 | Recruiting | 3 Months | 18 Years | All | 140 | Phase 3 | United States;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United Kingdom | |
110 | EUCTR2016-005110-22-DE | 20/11/2017 | 25 June 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 Pharmaceutical Form: Nebuliser solution Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Santhera Pharmaceuticals (Switzerland) Ltd | Authorised | Female: yes Male: yes | 40 | Phase 1;Phase 2 | Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
111 | NCT03206788 | November 11, 2017 | 26 August 2019 | 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 | Recruiting | 12 Years | N/A | All | 36 | Phase 2 | United States |
112 | EUCTR2017-002181-42-DE | 27/10/2017 | 23 July 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 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not applicable Current Sponsor code: G1117337 Other descriptive name: GLPG2737 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 18 | Phase 2 | Germany | |||
113 | NCT03278314 | October 9, 2017 | 12 November 2018 | 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 | Not recruiting | 12 Years | N/A | All | Phase 1/Phase 2 | |||
114 | EUCTR2017-000797-11-NL | 06/10/2017 | 30 April 2018 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: VX-445 Current Sponsor code: VX-445 Other descriptive name: VX-445 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: VX-445 Current Sponsor code: VX-445 Other descriptive name: VX-445 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: tezacaftor Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 80 | Phase 2 | Netherlands;Australia;Belgium;United States | |||
115 | NCT03309358 | September 28, 2017 | 11 June 2018 | 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. | Not recruiting | 18 Years | 50 Years | All | 32 | Phase 1 | United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
116 | NCT03181932 | September 26, 2017 | 7 October 2019 | A Study of AeroVanc for the Treatment of MRSA Infection in CF Patients | 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. | Recruiting | 6 Years | N/A | All | 200 | Phase 3 | United States;Canada | |
117 | EUCTR2016-002749-42-DE | 22/09/2017 | 28 February 2019 | 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 Pharmaceutical Form: Powder and solvent for nebuliser solution INN or Proposed INN: AZTREONAM Current Sponsor code: AZLI Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Powder and solvent for nebuliser solution Route of administration of the placebo: Inhalation use | Gilead Sciences, Inc. | Authorised | Female: yes Male: yes | 140 | Phase 3 | United States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands | |||
118 | NCT02769637 | September 7, 2017 | 9 July 2018 | 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 Therapeutics | Not recruiting | 10 Years | 21 Years | All | 2 | Phase 1 | United States |
119 | NCT03771313 | September 1, 2017 | 18 December 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 | Recruiting | 2 Years | 21 Years | All | 24 | Phase 4 | United States | |
120 | EUCTR2016-005230-30-PT | 28/08/2017 | 30 April 2019 | 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 Pharmaceutical Form: Inhalation solution INN or Proposed INN: SPX-101 Current Sponsor code: SPX-101 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use Product Name: SPX-101 Pharmaceutical Form: Inhalation solution INN or Proposed INN: SPX-101 Current Sponsor code: SPX-101 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use | Spyryx Biosciences, Inc. | Authorised | Female: yes Male: yes | 90 | Phase 2 | France;Portugal;Canada;Australia;Italy;United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
121 | EUCTR2017-000797-11-BE | 28/08/2017 | 7 January 2019 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: VX-445 Current Sponsor code: VX-445 Other descriptive name: VX-445 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: VX-445 Current Sponsor code: VX-445 Other descriptive name: VX-445 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: tezacaftor Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Tezacaftor Product Code: VX-661 Pharmaceutical Form: Tablet INN or Proposed INN: Tezacaftor (TEZ) Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) Pharmaceutical Form: Tablet INN or Proposed INN: VX-561 Current Sponsor code: VX-561 Other descriptive name: VX-561 | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 104 | Phase 2 | United States;Belgium;Australia;Netherlands | |||
122 | NCT03093714 | August 23, 2017 | 11 June 2018 | 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 | Not recruiting | 18 Years | 85 Years | All | 27 | Phase 1 | Australia;Czechia;Germany;United Kingdom | |
123 | NCT03277196 | August 16, 2017 | 6 May 2019 | 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 | Recruiting | N/A | 24 Months | All | 75 | Phase 3 | United States;Australia;Canada;Germany;Ireland;United Kingdom | |
124 | EUCTR2016-004558-13-PL | 14/08/2017 | 30 April 2019 | 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: 20.1 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: COLISTIMETHATE SODIUM CAS Number: 8068-28-8 Other descriptive name: Colistimethate Sodium Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1000000- Pharmaceutical form of the placebo: Powder for nebuliser solution Route of administration of the placebo: Inhalation use | Zambon S.p.A. | Authorised | Female: yes Male: yes | 420 | Phase 3 | France;United States;Canada;Argentina;Poland | |||
125 | EUCTR2016-003585-11-GB | 10/08/2017 | 10 September 2018 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: VX-659 Current Sponsor code: VX-659 Other descriptive name: VX-659 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 80- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Tezacaftor/Ivacaftor 100mg/150mg Product Code: VX-661/VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Tezacaftor Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Tezacaftor Product Code: VX-661 Pharmaceutical Form: Tablet INN or Proposed INN: TEZACAFTOR Current Sponsor code: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Deuterated Ivacaftor Product Code: VX-561 (CTP-656) Pharmaceutical Form: Tablet INN or Proposed INN: Deuterated Ivacaftor Other descriptive name: VX-561 (CTP-656) Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 105 | Phase 2 | United States;Ireland;Israel;United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
126 | NCT03172793 | August 8, 2017 | 4 November 2019 | 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. | Not recruiting | 18 Years | N/A | All | 18 | Phase 4 | United States |
127 | NCT03224351 | August 8, 2017 | 11 March 2019 | 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 | Not recruiting | 18 Years | N/A | All | 124 | Phase 2 | United States;Ireland;Israel;United Kingdom | |
128 | NCT03229252 | August 1, 2017 | 3 June 2019 | 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. | Not recruiting | 18 Years | 50 Years | All | 91 | Phase 2 | Canada;France;Italy;Portugal;United Kingdom | |
129 | NCT03258424 | July 28, 2017 | 11 June 2018 | 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 Pharmakinetics of PTI-428 in Subjects With Cystic Fibrosis. | Cystic Fibrosis | Drug: PTI-428;Drug: Placebo | Proteostasis Therapeutics, Inc. | Recruiting | 18 Years | N/A | All | 16 | Phase 1 | United Kingdom | |
130 | EUCTR2016-001214-24-DE | 27/07/2017 | 26 March 2018 | 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 Pharmaceutical Form: Capsule, hard Current Sponsor code: PTI-428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: PTI-428 Pharmaceutical Form: Capsule, hard Current Sponsor code: PTI-428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Proteostasis Therapeutics | Not Recruiting | Female: yes Male: yes | 132 | Phase 1;Phase 2 | France;United States;Czech Republic;Canada;Denmark;Germany;Italy;United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
131 | NCT02819856 | July 21, 2017 | 25 March 2019 | 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 | Recruiting | 18 Years | N/A | All | 80 | Phase 2 | United States |
132 | NCT03068312 | July 18, 2017 | 28 January 2019 | 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 | Not recruiting | 6 Years | N/A | All | 38 | Phase 3 | Israel | |
133 | NCT03251092 | July 17, 2017 | 28 October 2019 | 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 | Drug: PTI-808;Drug: Placebo;Drug: PTI-428;Drug: PTI-801 | Proteostasis Therapeutics, Inc. | Recruiting | 18 Years | 99 Years | All | 180 | Phase 1/Phase 2 | United States;Belgium;Canada;Denmark;France;Germany;New Zealand;United Kingdom | |
134 | EUCTR2016-001214-24-DK | 10/07/2017 | 30 April 2018 | 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 Pharmaceutical Form: Capsule Current Sponsor code: PTI-428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Code: PTI-428 Pharmaceutical Form: Capsule Current Sponsor code: PTI-428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Code: PTI-428 Pharmaceutical Form: Capsule Current Sponsor code: PTI-428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use Product Code: PTI-428 Pharmaceutical Form: Capsule Current Sponsor code: PTI-428 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Proteostasis Therapeutics | Not Recruiting | Female: yes Male: yes | 144 | Phase 1;Phase 2 | France;United States;Czech Republic;Canada;Denmark;Germany;Italy;United Kingdom | |||
135 | NCT03450720 | June 28, 2017 | 11 June 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 | Not recruiting | 18 Years | N/A | Male | 6 | Phase 1 | Belgium | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
136 | NCT03173573 | June 27, 2017 | 17 September 2018 | 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 | Not recruiting | 18 Years | 55 Years | All | 109 | Phase 1 | Australia | |
137 | EUCTR2016-004033-25-ES | 19/06/2017 | 3 July 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 Level: LLT Classification code 10011764 Term: Cystic fibrosis NOS System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Sodium bicarbonate Pharmaceutical Form: Solution for injection INN or Proposed INN: Sodium Bicarbonate CAS Number: 144-55-8 Other descriptive name: SODIUM BICARBONATE BP Concentration unit: mol/l mole(s)/litre Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Inhalation use Product Name: sodium chloride Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Sodium chloride CAS Number: 7647-14-5 Other descriptive name: SODIUM CHLORIDE Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 0.2- Product Name: sodium chloride Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Sodium chloride CAS Number: 7647-14-5 Other descriptive name: SODIUM CHLORIDE Concentration unit: g/ml gram(s)/millilitre Concentration type: equal Concentration number: 0.2- Product Name: Water for injections Pharmaceutical Form: Solvent for parenteral use INN or Proposed INN: water for injections CAS Number: 7789-20-0 Other descriptive name: WATER FOR INJECTIONS, EP Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 10- | Fundació Parc Taulí | Authorised | Female: yes Male: yes | Phase 2 | Spain | ||||
138 | NCT03078088 | June 15, 2017 | 27 August 2018 | Airway Alkalinization and Nasal Colonization | Airway Alkalinization and Nasal Colonization | Healthy Subjects;Cystic Fibrosis | Drug: Tham;Drug: Saline | Lakshmi Durairaj | Recruiting | 16 Years | N/A | All | 64 | Phase 1 | United States | |
139 | NCT03020719 | June 14, 2017 | 27 August 2018 | 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 - Clinical and Translational Science Institute | Cystic Fibrosis Foundation Therapeutics | Not recruiting | 2 Years | 11 Years | All | 60 | Phase 2 | United States |
140 | NCT03066453 | June 13, 2017 | 4 March 2019 | 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 | Recruiting | 8 Years | N/A | All | 97 | Phase 3 | France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
141 | NCT03093974 | June 1, 2017 | 15 October 2018 | 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 | Recruiting | 18 Years | N/A | All | 464 | Phase 3 | Belgium;Germany;Italy;Portugal;Spain;United Kingdom | |
142 | NCT03056989 | May 31, 2017 | 16 December 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. | Not recruiting | 18 Years | 50 Years | All | 5 | Phase 1 | Canada | |
143 | EUCTR2016-004558-13-FR | 30/05/2017 | 2 October 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: COLISTIMETHATE SODIUM CAS Number: 8068-28-8 Other descriptive name: Colistimethate Sodium Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1000000- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Zambon S.p.A. | Authorised | Female: yes Male: yes | 264 | Phase 3 | United States;France;Canada;Poland | |||
144 | NCT02950805 | May 30, 2017 | 23 July 2018 | 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 | Not recruiting | 18 Years | 60 Years | All | 9 | Phase 1 | United States |
145 | EUCTR2015-002743-33-DE | 29/05/2017 | 28 February 2019 | 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: 20.1 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: COLISTIMETHATE SODIUM CAS Number: 8068-28-8 Other descriptive name: Colistimethate Sodium Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1000000- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Zambon S.p.A. | Authorised | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Spain;Israel;Switzerland;United Kingdom;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
146 | EUCTR2016-004477-40-GB | 26/05/2017 | 30 April 2019 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Not applicable Current Sponsor code: G957389 Other descriptive name: GLPG2222 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: GLPG2222 Product Code: G957389 Pharmaceutical Form: Tablet INN or Proposed INN: Not applicable Current Sponsor code: G957389 Other descriptive name: GLPG2222 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: GLPG2222 Product Code: G957389 Pharmaceutical Form: Tablet INN or Proposed INN: Not applicable Current Sponsor code: G957389 Other descriptive name: GLPG2222 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Serbia;United States;Belgium;Spain;Netherlands;United Kingdom | |||
147 | NCT03150719 | May 24, 2017 | 30 September 2019 | 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 | Not recruiting | 12 Years | N/A | All | 98 | Phase 3 | United States;France;Germany | |
148 | NCT03125395 | May 12, 2017 | 26 August 2019 | 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: Lumacaftor;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | Not recruiting | 2 Years | N/A | All | 57 | Phase 3 | United States;Canada | |
149 | EUCTR2016-004996-33-ES | 03/05/2017 | 3 July 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Lumacaftor Current Sponsor code: VX-809; VRT-826809; VRT-0826809 Other descriptive name: LUMACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200 - INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770, VRT-813077 Other descriptive name: IVACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125 - | Vertex Pharmaceuticals Incoporated | Not Recruiting | Female: yes Male: yes | 75 | Phase 4 | United Kingdom;Australia;Spain;Canada;United States | |||
150 | NCT03070522 | May 1, 2017 | 15 July 2019 | 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 |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
151 | NCT03051490 | April 28, 2017 | 11 June 2018 | 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 | Not recruiting | 7 Years | N/A | All | 140 | Phase 3 | United States;Hungary;Israel;Lithuania;Poland;Spain;United Kingdom | |
152 | NCT03140527 | April 10, 2017 | 30 September 2019 | 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. | Recruiting | 18 Years | N/A | All | 180 | Phase 1 | United States;Canada;Denmark;Germany | |
153 | NCT03104855 | April 3, 2017 | 6 May 2019 | 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) | Not recruiting | 18 Years | N/A | All | 10 | Phase 1 | United States |
154 | NCT03584841 | March 31, 2017 | 22 July 2019 | 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 | Recruiting | 18 Years | 100 Years | All | 120 | N/A | Belgium | |
155 | EUCTR2016-001619-19-NL | 27/03/2017 | 8 May 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 Pharmaceutical Form: Capsule INN or Proposed INN: genistein CAS Number: 446-72-0 Other descriptive name: GENISTEIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 48.5- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | UMC Utrecht | Authorised | Female: yes Male: yes | Phase 2 | Netherlands | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
156 | NCT03119649 | March 18, 2017 | 16 December 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 dose 1 for cohort A;Drug: GLPG2222 dose 2 for cohort A;Drug: Placebo 1;Drug: GLPG2222 dose 1 for cohort B;Drug: GLPG2222 dose 2 for cohort B;Drug: Placebo 2 | Galapagos NV | Not recruiting | 18 Years | 99 Years | All | 59 | Phase 2 | United States;Belgium;Netherlands;Serbia;Spain;United Kingdom | |
157 | NCT03256799 | March 17, 2017 | 16 December 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 | University of Alabama at Birmingham | Not recruiting | 19 Years | N/A | All | 1 | Phase 4 | United States | |
158 | NCT02950116 | March 9, 2017 | 16 December 2017 | 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 | Not recruiting | 6 Years | 17 Years | All | 27 | N/A | Belgium | |
159 | NCT02498535 | February 22, 2017 | 2 September 2019 | 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 | Recruiting | 18 Years | N/A | All | 60 | Phase 2 | United States;Canada |
160 | EUCTR2015-002743-33-GB | 21/02/2017 | 28 February 2019 | 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: 20.1 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: COLISTIMETHATE SODIUM CAS Number: 8068-28-8 Other descriptive name: Colistimethate Sodium Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1000000- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Zambon S.p.A. | Authorised | Female: yes Male: yes | 420 | Phase 3 | Portugal;Greece;Spain;Israel;United Kingdom;Switzerland;Italy;France;Belgium;Australia;Germany;Netherlands;New Zealand | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
161 | NCT02888730 | February 16, 2017 | 25 February 2019 | 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 |
162 | NCT02976519 | February 15, 2017 | 17 September 2018 | 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: Placebo;Drug: BI 443651 | Boehringer Ingelheim | Not recruiting | 18 Years | 55 Years | All | 64 | Phase 1 | Germany;United Kingdom | |
163 | NCT02919995 | February 8, 2017 | 20 May 2019 | 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 | Not recruiting | 18 Years | N/A | All | 10 | Phase 2 | United Kingdom |
164 | NCT03256968 | January 27, 2017 | 28 January 2019 | 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 | Not recruiting | 6 Years | N/A | All | 1 | Phase 4 | United States | |
165 | NCT03227471 | January 23, 2017 | 8 April 2019 | 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 | Not recruiting | 18 Years | N/A | All | 230 | Phase 1/Phase 2 | United States;Australia;Belgium;Netherlands | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
166 | EUCTR2015-004986-99-IT | 11/01/2017 | 19 February 2018 | 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 Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | NovaBiotics, Ltd | Authorised | Female: yes Male: yes | 120 | Phase 2 | United States;Netherlands;United Kingdom;Italy | |||
167 | EUCTR2016-000454-36-AT | 03/01/2017 | 9 October 2017 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: VX-440 Other descriptive name: VX-440 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: tezacaftor/ivacaftor 100mg/150mg Product Code: VX-661/VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: tezacaftor Current Sponsor code: VX-661 Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Tezacaftor Product Code: VX-661 Pharmaceutical Form: Tablet INN or Proposed INN: Tezacaftor (TEZ) Other descriptive name: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Trade Name: Kalydeco 150 mg film-coated tablets Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 198 | Phase 2 | United States;Canada;Belgium;Spain;Denmark;Australia;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden | |||
168 | NCT02955888 | January 3, 2017 | 12 March 2018 | 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 | ProMetic Pharma SMT Limited | ProMetic BioSciences Inc. | Not recruiting | 18 Years | N/A | All | 11 | Phase 2 | Canada |
169 | NCT02730793 | January 2017 | 15 July 2019 | 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 | Not recruiting | 7 Years | 100 Years | All | 30 | Phase 2 | United States |
170 | NCT02894684 | January 2017 | 22 October 2019 | 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 | Not recruiting | 16 Years | 65 Years | Male | 16 | Phase 4 | United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
171 | NCT02947126 | January 2017 | 19 November 2018 | 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 | University of Pittsburgh | National Heart, Lung, and Blood Institute (NHLBI) | Recruiting | 12 Years | N/A | All | 62 | N/A | United States |
172 | NCT03045523 | January 2017 | 16 December 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 | Not recruiting | 18 Years | 99 Years | All | 37 | Phase 2 | Australia;Belgium;Czechia;Germany;Ireland;United Kingdom | |
173 | EUCTR2017-001379-21-DE | 30 April 2019 | 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 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- | Vertex Pharmaceuticals Incorporated | Not Available | Female: yes Male: yes | 75 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | ||||
174 | EUCTR2017-001379-21-IE | 29 January 2018 | 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 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- | Vertex Pharmaceuticals Incorporated | Not Available | Female: yes Male: yes | 75 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | ||||
175 | EUCTR2017-003723-29-FR | 28 February 2019 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: Lenabasum Product Code: JBT-101 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Lenabasum CAS Number: 137945-48-3 Current Sponsor code: JBT-101 Other descriptive name: resunab, ajulemic acid, anabasum Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Corbus Pharmaceuticals, Inc. | Not Available | Female: yes Male: yes | 415 | Phase 2 | Serbia;Portugal;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 | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
176 | EUCTR2016-001585-29-NL | 21/12/2016 | 29 January 2018 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LUMACAFTOR Current Sponsor code: VX-809 Other descriptive name: LUMACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 20 | Phase 2 | Netherlands | |||
177 | NCT03205904 | December 12, 2016 | 20 August 2018 | 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 | Recruiting | 10 Years | N/A | All | 38 | N/A | Brazil | |
178 | EUCTR2015-004263-36-GB | 07/12/2016 | 4 September 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. - 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 Pharmaceutical Form: Nebuliser suspension INN or Proposed INN: RPL554 CAS Number: 298680-25-8 Current Sponsor code: RPL554 Other descriptive name: RPL554 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 0.5-6 Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Verona Pharma plc | Authorised | Female: yes Male: yes | 10 | Phase 2 | United Kingdom | |||
179 | EUCTR2016-002837-31-GB | 05/12/2016 | 28 February 2019 | 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 Pharmaceutical Form: Oral suspension INN or Proposed INN: Not Applicable Current Sponsor code: G957389 Other descriptive name: GLPG2222 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use Product Name: GLPG2222 Product Code: G957389 Pharmaceutical Form: Oral suspension INN or Proposed INN: Not Applicable Current Sponsor code: G957389 Other descriptive name: GLPG2222 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use | Galapagos NV | Not Recruiting | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | |||
180 | EUCTR2016-002837-31-IE | 02/12/2016 | 20 August 2018 | 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 Pharmaceutical Form: Oral suspension INN or Proposed INN: Not Applicable Current Sponsor code: G957389 Other descriptive name: GLPG2222 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use Product Name: GLPG2222 Product Code: G957389 Pharmaceutical Form: Oral suspension INN or Proposed INN: Not Applicable Current Sponsor code: G957389 Other descriptive name: GLPG2222 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Oral suspension Route of administration of the placebo: Oral use | Galapagos NV | Authorised | Female: yes Male: yes | 35 | Phase 2 | Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
181 | NCT02971839 | December 2016 | 27 August 2018 | 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: CTP-656, 20 mg (QD);Drug: CTP-656, 100 mg (QD);Drug: CTP-656, 150 mg (QD);Drug: Placebo (QD);Drug: Kalydeco, 150 mg Tablet (BID; open-label) | Vertex Pharmaceuticals Incorporated | Not recruiting | 18 Years | N/A | All | 11 | Phase 2 | United States | |
182 | NCT03000348 | December 2016 | 9 July 2018 | 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. | Not recruiting | 18 Years | N/A | All | 91 | Phase 2 | United States;Italy;United Kingdom |
183 | NCT02759562 | November 4, 2016 | 20 August 2018 | 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 | Not recruiting | 18 Years | N/A | All | 6 | Phase 2 | Australia;France;Germany;Spain;United Kingdom;Belgium;Canada;Ireland;United States | |
184 | NCT02934698 | November 1, 2016 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | Female | 2 | Phase 3 | |
185 | NCT02951195 | November 2016 | 21 January 2019 | 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 | Not recruiting | 18 Years | N/A | All | 80 | Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
186 | NCT03029455 | November 2016 | 16 December 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 | Not recruiting | 18 Years | N/A | All | 163 | Phase 1 | United Kingdom | |
187 | NCT03056326 | November 2016 | 16 December 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. | Not recruiting | 18 Years | 55 Years | Male | 72 | Phase 1 | Belgium | |
188 | EUCTR2015-004986-99-GB | 31/10/2016 | 3 April 2017 | 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 Pharmaceutical Form: Capsule, hard Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | NovaBiotics, Ltd | Authorised | Female: yes Male: yes | 120 | Phase 2 | United States;Netherlands;Italy;United Kingdom | |||
189 | NCT02677701 | October 21, 2016 | 11 June 2019 | Testing the Effect of Adding Chronic Oral Azithromycin to Inhaled Tobramycin in People With 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 | Recruiting | 12 Years | N/A | All | 140 | Phase 4 | United States |
190 | NCT02912637 | October 2016 | 11 February 2019 | 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 | Not recruiting | 18 Years | 70 Years | All | 30 | Phase 3 | United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
191 | NCT02934139 | October 2016 | 16 December 2017 | 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. | Not recruiting | 18 Years | 55 Years | All | 32 | Phase 1 | United States | |
192 | NCT02951182 | October 2016 | 27 August 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 | Drug: Tezacaftor;Drug: Ivacaftor;Drug: VX-440;Drug: Matched Placebos | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 74 | Phase 2 | United States;Australia;Austria;Belgium;Canada;Denmark;Germany;Italy;Spain;United Kingdom | |
193 | NCT02953314 | October 2016 | 15 October 2018 | A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis | 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: VX-661;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | Not recruiting | 6 Years | 11 Years | All | 70 | Phase 3 | United States;Canada | |
194 | EUCTR2015-003040-39-ES | 29/09/2016 | 17 October 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 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: TOBI Podhaler Product Name: Tobramycin inhalation powder Product Code: TBM100 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Novartis Pharma Services AG | Authorised | Female: yes Male: yes | 180 | Phase 2 | France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland | |||
195 | EUCTR2016-002578-11-GB | 16/09/2016 | 3 April 2017 | 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 Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Flucloxacillin CAS Number: 5250-39-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 25-50-mg/ml | Alder Hey Children's NHS Foundation Trust | Authorised | Female: yes Male: yes | 480 | Phase 4 | United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
196 | NCT02730208 | September 2016 | 4 November 2019 | 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 | Not recruiting | 12 Years | N/A | All | 41 | Phase 2 | Australia | |
197 | NCT02823964 | September 2016 | 11 June 2018 | 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 | Not recruiting | 7 Years | N/A | All | 25 | Phase 4 | United States;Czechia;Hungary;Israel;Poland;Spain;Czech Republic | |
198 | NCT02875366 | September 2016 | 16 December 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 | Drug: LUM/IVA;Drug: Placebo | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 70 | Phase 4 | Australia;United Kingdom | |
199 | EUCTR2016-001785-29-IE | 15/08/2016 | 29 August 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 300-300 Trade Name: Ciprofloxacin Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ciprofloxacin CAS Number: 86393-32-0 Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 1500-1500 Product Name: Flucloxicillin Pharmaceutical Form: Powder for injection INN or Proposed INN: FLUCLOXACILLIN SODIUM CAS Number: 1847-24-1 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 4000-8000 Trade Name: Fortum Pharmaceutical Form: INN or Proposed INN: CEFTAZIDIME CAS Number: 72558-82-8 Concentration unit: g gram(s) Concentration type: range Concentration number: 4-8 Product Name: Tobramycin Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: TOBRAMYCIN SULFATE CAS Number: 79645-27-5 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: range Concentration number: 10-20 Trade Name: Meropenem Pharmaceutical Form: INN or Proposed INN: Meropenem CAS Number: 96036-03-2 Other descriptive name: MEROPENEM Concentration unit: g gram(s) Concentration type: range Concentration number: 3-8 Trade Name: Colistin Pharmaceutical Form: INN or Proposed INN: COLISTIMETHATE SODIUM CAS Number: 8068-28-8 Concentration unit: Munit million units Concentration type: range Concentration number: 2-8 | St. Vincent's University Hospital | Authorised | Female: yes Male: yes | Phase 4 | Ireland | ||||
200 | EUCTR2016-000166-35-NL | 08/08/2016 | 22 August 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 Pharmaceutical Form: Inhalation solution Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use | Noordwest Ziekenhuisgroep | Authorised | Female: yes Male: yes | Phase 2;Phase 3 | Netherlands | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
201 | NCT02858843 | August 1, 2016 | 11 June 2018 | 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 | Not recruiting | 18 Years | 65 Years | All | 1 | N/A | ||
202 | NCT02657473 | August 2016 | 16 December 2017 | 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 | Recruiting | 18 Years | N/A | All | 52 | Phase 2/Phase 3 | Netherlands | |
203 | NCT02866721 | August 2016 | 25 February 2019 | 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 | Recruiting | 18 Years | N/A | All | 15 | Phase 1 | United States |
204 | NCT02918409 | August 2016 | 25 March 2019 | 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 | Recruiting | 18 Years | N/A | All | 270 | Phase 4 | United States | |
205 | NCT02950883 | August 2016 | 16 September 2019 | Saline Hypertonic in Preschoolers + CT | Saline Hypertonic in Preschoolers With Cystic Fibrosis and Lung Structure as Measured by Computed Tomography (CT) | Cystic Fibrosis | Drug: Control Group 0.9% Isotonic Saline;Drug: Active Treatment Group 7% Hypertonic Saline | University of Washington, the Collaborative Health Studies Coordinating Center | Cystic Fibrosis Foundation | Recruiting | 3 Years | 5 Years | All | 120 | Phase 2/Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Italy;Netherlands;Spain |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
206 | NCT02750501 | July 20, 2016 | 20 August 2018 | 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 Therapeutics | Not recruiting | 4 Years | N/A | All | 49 | N/A | United States |
207 | NCT03486236 | July 20, 2016 | 11 June 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 | Not recruiting | 18 Years | 55 Years | All | 16 | Phase 1 | United Kingdom | |
208 | NCT02718495 | July 19, 2016 | 1 April 2019 | 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. | Not recruiting | 18 Years | N/A | All | 56 | Phase 1/Phase 2 | United States;Canada;Denmark;France;Germany;Czechia;United Kingdom | |
209 | NCT02555059 | July 15, 2016 | 28 January 2019 | 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 | Not recruiting | N/A | 14 Years | All | 48 | Phase 4 | Japan | |
210 | NCT02992080 | July 12, 2016 | 25 February 2019 | Small Circulating RNA as Molecular Markers of Lung Disease in Cystic Fibrosis | Determination of Circulating miRNAs as Diagnostic Markers of Lung Disease in Cystic Fibrosis | Cystic Fibrosis | Biological: miRNAs isolation from blood samples of patients and control | University Hospital, Montpellier | Recruiting | 12 Months | 65 Years | All | 80 | N/A | France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
211 | NCT02810691 | July 2016 | 20 August 2018 | 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 | Not recruiting | 18 Years | N/A | All | 14 | N/A | Canada |
212 | NCT02807415 | June 1, 2016 | 11 March 2019 | 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 | Recruiting | 6 Years | N/A | All | 100 | N/A | Germany |
213 | NCT02734810 | June 2016 | 11 June 2018 | 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 | Not recruiting | N/A | N/A | All | 15 | Phase 3 | United States | |
214 | NCT02781610 | June 2016 | 17 June 2019 | 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 | Recruiting | 18 Years | N/A | All | 1300 | Phase 4 | United States;Canada |
215 | NCT02823470 | June 2016 | 16 December 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, 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 | Not recruiting | 16 Years | N/A | All | 24 | Phase 4 | United States;Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
216 | EUCTR2016-000354-35-DK | 12/05/2016 | 13 March 2017 | 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 Pharmaceutical Form: Effervescent tablet INN or Proposed INN: ACETYLCYSTEINE SODIUM Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200-6oo Trade Name: AAC Hexal Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLCYSTEINE SODIUM Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200-6oo | Aarhus University Hospital | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | ||||
217 | NCT02722122 | May 2016 | 10 October 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 | Recruiting | 12 Years | N/A | Both | 15 | Phase 2 | Israel | |
218 | NCT02797132 | May 2016 | 16 December 2017 | 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: lumacaftor/ ivacaftor | Vertex Pharmaceuticals Incorporated | Not recruiting | 2 Years | 5 Years | All | 60 | Phase 3 | United States;Canada | |
219 | NCT02850692 | April 18, 2016 | 26 August 2019 | 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 | Recruiting | 18 Years | N/A | All | 60 | N/A | France | |
220 | NCT02724527 | April 2016 | 28 November 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. | Not recruiting | 18 Years | N/A | Both | 19 | Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
221 | NCT02767297 | April 2016 | 31 October 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 | Not recruiting | 18 Years | N/A | Both | 46 | Phase 1/Phase 2 | United Kingdom | |
222 | EUCTR2016-000398-19-BE | 08/03/2016 | 30 April 2018 | 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 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Meropenem Fresenius Kabi Other descriptive name: MEROPENEM TRIHYDRATE Concentration unit: g gram(s) Concentration type: equal Concentration number: 1- Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Ceftazidim Fresenius Kabi Other descriptive name: CEFTAZIDIME PENTAHYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2000- Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM Concentration unit: g gram(s) Concentration type: equal Concentration number: 2- INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.25- Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: PIPERACILLIN SODIUM Concentration unit: g gram(s) Concentration type: equal Concentration number: 4- INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie Other descriptive name: TAZOBACTAM SODIUM Concentration unit: g gram(s) Concentration type: equal Concentration number: 0.5- | Ghent University | Not Recruiting | Female: yes Male: yes | 45 | Phase 4 | Belgium | |||
223 | NCT02354859 | March 2016 | 1 April 2019 | 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 | Not recruiting | 18 Years | N/A | All | 119 | Phase 2 | United States |
224 | NCT02725567 | March 2016 | 28 January 2019 | 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 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 Less Than 24 Months of Age and Have a CFTR Gating Mutation | Cystic Fibrosis | Drug: ivacaftor | Vertex Pharmaceuticals Incorporated | Recruiting | N/A | 24 Months | All | 35 | Phase 3 | United States;Australia;Canada;Ireland;United Kingdom | |
225 | NCT02848560 | March 2016 | 18 June 2018 | 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 | N/A | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
226 | NCT02649751 | February 22, 2016 | 18 December 2018 | 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. | Not recruiting | 18 Years | N/A | All | 49 | Phase 2 | France |
227 | NCT02679729 | February 11, 2016 | 16 December 2017 | 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 | Not recruiting | 18 Years | 50 Years | All | 63 | Phase 1 | United States | |
228 | NCT03512119 | February 11, 2016 | 11 June 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 | Recruiting | 12 Years | N/A | All | 100 | N/A | France | |
229 | EUCTR2015-002677-38-GB | 04/02/2016 | 28 February 2019 | 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 Level: PT Classification 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: acebilustat CAS Number: 943764-99-6 Current Sponsor code: CTX-4430 Other descriptive name: CRC3357, ZK-355322, Leukoton Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Name: CTX-4430 Product Code: CTX-4430 Pharmaceutical Form: Capsule, hard INN or Proposed INN: acebilustat CAS Number: 943764-99-6 Current Sponsor code: CTX-4430 Other descriptive name: CRC3357, ZK-355322, Leukoton Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Celtaxsys Inc. | Not Recruiting | Female: yes Male: yes | 195 | Phase 2 | France;United States;Canada;Belgium;Germany;Italy;United Kingdom | |||
230 | NCT02625246 | February 4, 2016 | 9 September 2019 | 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 | Not recruiting | 30 Years | 87 Years | All | 6 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
231 | EUCTR2015-003291-77-GB | 02/02/2016 | 2 May 2016 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Not Applicable CAS Number: 1654725-02-6 Current Sponsor code: GLPG1837 Other descriptive name: GLPG1837 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Product Name: GLPG1837 Product Code: GLPG1837 Pharmaceutical Form: Tablet INN or Proposed INN: Not Applicable CAS Number: 1654725-02-6 Current Sponsor code: GLPG1837 Other descriptive name: GLPG1837 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Product Name: GLPG1837 Product Code: GLPG1837 Pharmaceutical Form: Tablet INN or Proposed INN: Not Applicable CAS Number: 1654725-02-6 Current Sponsor code: GLPG1837 Other descriptive name: GLPG1837 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5- | Galapagos NV | Authorised | Female: yes Male: yes | 32 | Phase 2a | Czech Republic;Ireland;Australia;Germany;United Kingdom | |||
232 | NCT02508207 | February 2016 | 16 December 2017 | 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: VX-661/ivacaftor;Drug: ivacaftor;Drug: VX-661/ ivacaftor matching placebo;Drug: ivacaftor matching placebo | Vertex Pharmaceuticals Incorporated | Not recruiting | 18 Years | N/A | All | 34 | Phase 2 | United States | |
233 | NCT02684552 | February 2016 | 12 September 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 | Not recruiting | 18 Years | 90 Years | Both | 8 | N/A | Sweden | |
234 | NCT02694393 | February 2016 | 24 September 2018 | 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 Therapeutics | Recruiting | 18 Years | N/A | All | 35 | Phase 1/Phase 2 | United States |
235 | NCT02709109 | February 2016 | 15 October 2018 | 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 | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 142 | Phase 2 | United States;France;Ireland;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
236 | NCT02840136 | February 2016 | 25 June 2018 | 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 | Not recruiting | 12 Years | N/A | All | 40 | N/A | Belgium |
237 | EUCTR2015-001644-11-GB | 22/01/2016 | 7 January 2019 | 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 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX 809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- INN or Proposed INN: Lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX 809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 256 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | |||
238 | NCT03475381 | January 22, 2016 | 11 June 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;Société Française de la Mucoviscidose | Not recruiting | 12 Years | N/A | All | 685 | N/A | France |
239 | EUCTR2015-003292-30-BE | 18/01/2016 | 8 August 2016 | A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis 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 Pharmaceutical Form: Tablet INN or Proposed INN: Not Applicable CAS Number: 1654725-02-6 Current Sponsor code: GLPG1837 Other descriptive name: GLPG1837 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 62.5- Product Name: GLPG1837 Product Code: GLPG1837 Pharmaceutical Form: Tablet INN or Proposed INN: Not Applicable CAS Number: 1654725-02-6 Current Sponsor code: GLPG1837 Other descriptive name: GLPG1837 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- | Galapagos NV | Not Recruiting | Female: yes Male: yes | 6 | Phase 2 | Belgium;Netherlands | |||
240 | NCT02646995 | January 2016 | 18 June 2018 | 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 | Not recruiting | 5 Years | 18 Years | All | 16 | N/A | Switzerland | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
241 | NCT02661438 | January 2016 | 18 April 2016 | 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 | Not recruiting | 40 Years | N/A | Both | 46 | N/A | United States |
242 | EUCTR2016-001840-20-Outside-EU/EEA | 23 May 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 Pharmaceutical Form: Inhalation powder, hard capsule Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Novartis Pharmaceuticals Corporation | Not Available | Female: yes Male: yes | 45 | Phase 4 | United States | ||||
243 | EUCTR2016-004318-82-Outside-EU/EEA | 22 May 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 Pharmaceutical Form: Capsule INN or Proposed INN: Tobramycin Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 112- | Novartis Pharmaceuticals Corporation | Not Available | Female: yes Male: yes | 200 | Phase 4 | United States | ||||
244 | EUCTR2016-004479-35-IE | 28 February 2019 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: VX-661/ivacaftor 100 mg/ 150 mg Pharmaceutical Form: Film-coated tablet INN or Proposed INN: TEZACAFTOR CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Other descriptive name: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 65 | Phase 3 | France;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland | ||||
245 | EUCTR2016-004786-80-DE | 26 November 2018 | 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 Pharmaceutical Form: Solution for injection in pre-filled syringe INN or Proposed INN: ANAKINRA CAS Number: 143090-92-0 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Solution for injection in pre-filled syringe Route of administration of the placebo: Subcutaneous use | Ruprecht-Karls-University Heidelberg, Medical Faculty | Not Available | Female: yes Male: yes | 52 | Phase 2 | Germany | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
246 | NCT02589444 | December 2015 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 41 | N/A | United States | |
247 | NCT02605590 | December 2015 | 30 May 2016 | 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 | Not recruiting | 18 Years | 55 Years | Male | 18 | Phase 1 | Israel | |
248 | NCT02626182 | December 2015 | 29 July 2019 | 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 | Not recruiting | 18 Years | N/A | All | 14 | Phase 1/Phase 2 | United States | |
249 | NCT02680418 | December 2015 | 11 April 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 | Not recruiting | 18 Years | 55 Years | Female | 8 | Phase 1 | United Kingdom | |
250 | EUCTR2015-003662-87-DK | 13/11/2015 | 2 October 2017 | 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 Level: LLT 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) Pharmaceutical Form: Inhalation vapour, powder INN or Proposed INN: COLISTIMETHATE SODIUM CAS Number: 8068-28-8 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1000000- Trade Name: Piperacillin with Tazobactam (tazocin) Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: PIPERACILLIN Other descriptive name: PIPERACILLIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4000- INN or Proposed INN: TAZOBACTAM Other descriptive name: TAZOBACTAM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | Aarhus University Hospital, Department of Respiratory Medicine | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
251 | NCT02589236 | November 2015 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 138 | Phase 2 | United States |
252 | NCT02598999 | November 2015 | 13 May 2019 | 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 | Recruiting | 18 Years | 50 Years | All | 103 | Phase 1 | France | |
253 | NCT02443688 | October 30, 2015 | 26 August 2019 | 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. | Not recruiting | 18 Years | 30 Years | All | 200 | Phase 2 | United States;Belgium;Canada;France;Germany;Italy;United Kingdom | |
254 | NCT01132482 | October 2015 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 23 | Phase 2 | United States | |
255 | NCT02518672 | October 2015 | 16 December 2017 | 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) | Not recruiting | 18 Years | N/A | All | 11 | Phase 2 | Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
256 | NCT02465450 | September 29, 2015 | 11 June 2018 | 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. | Not recruiting | 18 Years | 65 Years | All | 85 | Phase 2 | United States;Belgium;France;Germany;Italy;Poland;United Kingdom | |
257 | EUCTR2014-004787-37-AT | 21/09/2015 | 5 September 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, 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not yet assigned CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 VRT-0893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 300 | Phase 3 | France;United States;Canada;Spain;Australia;Austria;Israel;Germany | |||
258 | EUCTR2015-002911-13-FR | 15/09/2015 | 7 January 2019 | 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 Pharmaceutical Form: Capsule Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | CHRU de Brest | Not Recruiting | Female: yes Male: yes | 36 | Phase 2 | France | |||
259 | EUCTR2014-004827-29-IT | 01/09/2015 | 21 September 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- INN or Proposed INN: Not yet assigned CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Authorised | 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 | |||
260 | NCT02605538 | September 1, 2015 | 27 August 2018 | 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 | Recruiting | 1 Year | N/A | All | 250 | N/A | Sweden |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
261 | NCT02421120 | September 2015 | 16 December 2017 | 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 Kuti | Cubist Pharmaceuticals LLC;Indiana University Health;University of North Carolina;St. Christopher's Hospital for Children | Not recruiting | 18 Years | N/A | All | 21 | Phase 4 | United States |
262 | NCT02504827 | September 2015 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 12 | Phase 4 | United States | |
263 | NCT02564354 | September 2015 | 21 November 2016 | 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 | Not recruiting | 18 Years | N/A | Both | 18 | Phase 1 | United States;Belgium;France |
264 | NCT03497117 | August 25, 2015 | 22 October 2019 | 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) | Recruiting | 18 Years | 99 Years | All | 16 | Early Phase 1 | United States |
265 | NCT02496780 | August 2015 | 11 November 2019 | 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 | Children's Hospitals and Clinics of Minnesota | Recruiting | 10 Years | 25 Years | All | 80 | Phase 2/Phase 3 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
266 | NCT02531984 | August 2015 | 7 September 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 | Not recruiting | 3 Years | 17 Years | Both | 100 | Phase 3 | ||
267 | NCT02535130 | August 2015 | 29 August 2016 | 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 | Recruiting | 16 Years | 55 Years | Both | 15 | N/A | Belgium | ||
268 | NCT02544451 | August 2015 | 9 October 2018 | 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: Ivacaftor;Drug: Lumacaftor | Vertex Pharmaceuticals Incorporated | Not recruiting | 6 Years | N/A | All | 240 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom | |
269 | NCT02565914 | August 2015 | 22 October 2019 | 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: VX-661/ivacaftor;Drug: ivacaftor | Vertex Pharmaceuticals Incorporated | Recruiting | 12 Years | N/A | All | 1116 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom | |
270 | NCT02740868 | August 2015 | 15 April 2019 | 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 | Recruiting | 8 Years | N/A | All | 30 | Phase 2 | Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
271 | NCT02310789 | July 31, 2015 | 11 June 2018 | (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 | Not recruiting | 18 Years | N/A | All | 8 | N/A | United States | |
272 | NCT02456103 | July 31, 2015 | 4 February 2019 | Extension Study of Ataluren for Nonsense Mutation Cystic Fibrosis | A Phase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Cystic Fibrosis | Cystic Fibrosis | Drug: Ataluren | PTC Therapeutics | Not recruiting | 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 | |
273 | EUCTR2015-001317-28-NL | 30/07/2015 | 22 May 2017 | 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 Pharmaceutical Form: Tablet | UMC Utrecht | Not Recruiting | Female: yes Male: yes | Phase 2 | Netherlands | ||||
274 | NCT02444234 | July 2015 | 11 June 2018 | 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/IV;Drug: Tedizolid IV/PO | University of Southern California | Merck Sharp & Dohme Corp. | Not recruiting | 18 Years | N/A | All | 11 | Phase 4 | United States |
275 | NCT02514473 | July 2015 | 16 December 2017 | 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 | Not recruiting | 6 Years | 11 Years | All | 206 | Phase 3 | United States;Australia;Belgium;Canada;Denmark;France;Germany;Sweden;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
276 | EUCTR2015-000543-16-GB | 19/06/2015 | 13 June 2016 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LUMACAFTOR Other descriptive name: LUMACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | |||
277 | NCT02239458 | June 2015 | 28 April 2015 | DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Saxagliptin | Ram Weiss | Not recruiting | 18 Years | 65 Years | Both | 60 | N/A | Israel | ||
278 | NCT02279498 | June 2015 | 20 August 2018 | 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 | Not recruiting | 7 Years | N/A | All | 128 | Phase 3 | United States;Canada;Czechia;Hungary;Israel;Poland;Spain;Czech Republic | |
279 | NCT02532764 | June 2015 | 16 December 2017 | 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 | Not recruiting | 18 Years | 60 Years | All | 64 | Phase 1/Phase 2 | United States;Belgium;Canada;Czechia;Denmark;France;Germany;Italy;Spain;United Kingdom;Czech Republic;Netherlands |
280 | EUCTR2014-004838-25-IT | 20/05/2015 | 19 February 2018 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Not yet assigned CAS Number: 1152311-62-0 Current Sponsor code: VX-661 Other descriptive name: VRT-893661 VRT-0893661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
281 | NCT02449031 | May 5, 2015 | 14 January 2019 | 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 | Not recruiting | 6 Years | N/A | All | 260 | N/A | United States |
282 | NCT02468908 | May 2015 | 16 December 2017 | 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 | Not recruiting | 18 Years | 55 Years | All | 42 | Phase 1 | United Kingdom |
283 | NCT02343445 | April 2015 | 22 August 2016 | Clearing Lungs With ENAC Inhibition in Cystic Fibrosis | 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 | Vertex Pharmaceuticals Incorporated | Parion Sciences | Not recruiting | 12 Years | 80 Years | Both | 142 | Phase 2 | United States |
284 | NCT02445053 | April 2015 | 26 August 2019 | 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 | Not recruiting | 6 Years | N/A | All | 90 | N/A | Italy;Netherlands;United Kingdom | |
285 | NCT02690064 | April 2015 | 22 October 2019 | 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 | Recruiting | 7 Years | N/A | All | 80 | N/A | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
286 | NCT02325362 | March 17, 2015 | 11 June 2018 | 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) | Not recruiting | 18 Years | N/A | All | 16 | Phase 2/Phase 3 | France |
287 | NCT02378467 | March 1, 2015 | 11 February 2019 | 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 | Not recruiting | 3 Years | 5 Years | All | 150 | N/A | United States;Canada |
288 | NCT02390219 | March 2015 | 16 December 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;Advanced Lung Disease | Drug: Lumacaftor;Drug: Ivacaftor | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 46 | Phase 3 | United States | |
289 | NCT02392234 | March 2015 | 26 February 2018 | 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-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: VX-661/ ivacaftor placebo;Drug: ivacaftor placebo | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 246 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;United Kingdom;Switzerland | |
290 | NCT02275936 | February 2015 | 14 November 2016 | 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. | Not recruiting | 18 Years | 80 Years | Both | 51 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
291 | NCT02453789 | February 2015 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 15 | Phase 2 | Germany | |
292 | NCT02489955 | February 2015 | 3 August 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 | Recruiting | 18 Years | N/A | Both | N/A | United Kingdom | ||
293 | ChiCTR-IPC-15005915 | 2015-01-31 | 18 April 2017 | 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 | Recruiting | 18 | 80 | Both | Experimental group:50; | New Treatment Measure Clinical Study | ||
294 | NCT02248922 | January 27, 2015 | 16 December 2017 | 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 | Not recruiting | 6 Years | N/A | All | 17 | Phase 4 | Germany | |
295 | EUCTR2014-004519-35-HU | 09/01/2015 | 4 August 2015 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: NOT APPLICABLE CAS Number: 8049-47-6 Current Sponsor code: CREON IR Other descriptive name: PANCREATIN (Pancreas Powder) Concentration unit: U unit(s) Concentration type: range Concentration number: 4000-30000 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Kreon 25 000 Product Name: Creon® 25,000 Pharmaceutical Form: Capsule, hard INN or Proposed INN: not assigned CAS Number: 8049-47-6 Other descriptive name: PANCREATIN (Pancreas Powder) Concentration unit: U unit(s) Concentration type: equal Concentration number: 25000- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Abbott Laboratories GmbH | Not Recruiting | Female: yes Male: yes | 78 | Phase 2 | Czech Republic;Hungary;Spain;United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
296 | NCT02347657 | January 2015 | 26 February 2018 | 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/ ivacaftor;Drug: ivacaftor;Drug: VX-661/ ivacaftor placebo;Drug: ivacaftor placebo | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 509 | Phase 3 | United States;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom | |
297 | NCT02359357 | January 2015 | 18 April 2016 | 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 | Not recruiting | 18 Years | 45 Years | Male | 130 | Phase 1 | United Kingdom | |
298 | NCT02507843 | January 2015 | 3 August 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 | Recruiting | 18 Years | N/A | Both | 200 | Phase 4 | China | |
299 | NCT02526004 | January 2015 | 31 August 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 |
300 | NCT04122547 | January 2015 | 22 October 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 | Not recruiting | 18 Years | 80 Years | All | 40 | Phase 3 | Thailand | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
301 | EUCTR2015-000395-97-Outside-EU/EEA | 16 February 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 CAS Number: 78110-38-0 Current Sponsor code: AZLI Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Powder and solvent for nebuliser solution Route of administration of the placebo: Inhalation use | Gilead Sciences, Inc. | Gilead Sciences Pty Ltd;Gilead Sciences Canada, Inc. | Not Available | Female: yes Male: yes | 157 | United States;Australia;Canada | ||||
302 | EUCTR2015-000396-26-Outside-EU/EEA | 16 February 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 CAS Number: 78110-38-0 Current Sponsor code: AZLI Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- | Gilead Sciences, Inc. | Not Available | Female: yes Male: yes | 603 | United States | |||||
303 | EUCTR2015-000397-36-Outside-EU/EEA | 16 February 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 CAS Number: 78110-38-0 Current Sponsor code: AZLI Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- | Gilead Sciences, Inc. | Not Available | Female: yes Male: yes | 45 | Canada | |||||
304 | EUCTR2015-001219-11-Outside-EU/EEA | 7 April 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 Pharmaceutical Form: Capsule INN or Proposed INN: pancrelipase Other descriptive name: PANCRELIPASE AMYLASE Concentration unit: Other Concentration type: up to Concentration number: 10000- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use | Johnson & Johnson Pharmaceutical Research and Development, L.L.C. | Not Available | Female: yes Male: yes | 40 | Phase 3 | United States;Canada | ||||
305 | EUCTR2015-001225-16-Outside-EU/EEA | 10 July 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 Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: DORIPENEM HYDRATE CAS Number: 364622-82-2 Other descriptive name: DORIPENEM HYDRATE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | Johnson & Johnson Pharmaceutical Research & Development L.L.C | Not Available | Female: yes Male: yes | 22 | United States | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
306 | EUCTR2015-001267-39-FR | 2 October 2017 | 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 Pharmaceutical Form: Granules INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Granules Route of administration of the placebo: Oral use Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Trade Name: Kalydeco Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Not Available | Female: yes Male: yes | 50 | Phase 3 | France;Canada;Australia;United Kingdom | ||||
307 | EUCTR2015-001644-11-SE | 18 June 2018 | 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 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX 809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809 / VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- INN or Proposed INN: Lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX 809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- | Vertex Pharmaceuticals Incorporated | Not Available | Female: yes Male: yes | 256 | Phase 3 | France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden | ||||
308 | EUCTR2015-001997-16-GB | 28 February 2019 | 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: 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 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Kalydeco Product Name: Ivacaftor Product Code: VX-770 Pharmaceutical Form: Granules in sachet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- | Vertex Pharmaceuticals Incorporated | Not Available | Female: yes Male: yes | 35 | Phase 3 | United States;Canada;Ireland;Germany;United Kingdom | ||||
309 | EUCTR2015-004841-13-FR | 28 February 2019 | 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 Pharmaceutical Form: Inhalation solution INN or Proposed INN: Not yet assigned Current Sponsor code: VX-371 Other descriptive name: VX-371 Concentration unit: µg/µl microgram(s)/microlitre Concentration type: up to Concentration number: 30- Product Code: VX-371 in saline Pharmaceutical Form: Inhalation solution INN or Proposed INN: Not yet assigned Current Sponsor code: VX-371 Other descriptive name: VX-371 Concentration unit: µg/ml microgram(s)/millilitre Concentration type: up to Concentration number: 30- Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use Trade Name: Orkambi Product Name: lumacaftor/ivacaftor 200mg/125mg tablets Product Code: VX-809/VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Other descriptive name: Ivacaftor Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- INN or Proposed INN: Lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Other descriptive name: LUMACAFTOR Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Product Name: Hypertonic saline Pharmaceutical Form: Inhalation solution INN or Proposed INN: 4.2% NaCl/inhalation solution | Vertex Pharmaceuticals Inc. | Not Recruiting | Female: yes Male: yes | 150 | Phase 2 | United States;France;Czech Republic;Ireland;United Kingdom | ||||
310 | EUCTR2014-002125-35-DE | 18/12/2014 | 20 August 2018 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Oligomer of Sodium Alginate Current Sponsor code: OligoG Other descriptive name: OLIGOG CF-5/20 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 35- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Algipharma AS | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | Germany | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
311 | NCT02262871 | December 2014 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 15 | N/A | Canada | |
312 | NCT02273661 | November 19, 2014 | 6 May 2019 | 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 | Not recruiting | 18 Years | N/A | All | 174 | Phase 2 | France | |
313 | EUCTR2014-001204-21-DE | 17/11/2014 | 2 October 2017 | 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 fibrosis patients 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- Pharmaceutical Form: Nebulisation solution INN or Proposed INN: Tobramycin CAS Number: 3232986-56-4 Current Sponsor code: TBM100 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Novartis Pharma GmbH | Not Recruiting | Female: yes Male: yes | Phase 4 | Germany | ||||
314 | NCT03312140 | November 6, 2014 | 16 December 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 | Not recruiting | 18 Years | N/A | Male | 10 | N/A | ||
315 | EUCTR2013-005357-79-CZ | 15/10/2014 | 8 August 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: 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Mannitol Other descriptive name: MANNITOL Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Pharmaxis Limited | 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 | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
316 | NCT02134353 | October 2014 | 11 June 2018 | 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 | Not recruiting | 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 | |
317 | NCT02157922 | October 2014 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 65 | Phase 2 | Denmark;Germany;Norway;Sweden;United Kingdom |
318 | NCT02194881 | October 2014 | 16 December 2017 | 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 | Not recruiting | 6 Years | N/A | All | 57 | N/A | France |
319 | NCT02227888 | October 2014 | 14 November 2016 | 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. | Not recruiting | 18 Years | N/A | Both | 6 | Phase 1 | United States | |
320 | NCT02372383 | October 2014 | 8 August 2016 | 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 | Not recruiting | 16 Years | 45 Years | Both | 32 | N/A | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
321 | EUCTR2014-000844-13-DK | 25/09/2014 | 8 August 2016 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Oligomer of Sodium Alginate Current Sponsor code: OligoG Other descriptive name: OLIGOG CF-5/20 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 35- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Algipharma AS | Not Recruiting | Female: yes Male: yes | 76 | Phase 2 | Denmark;Germany;Sweden | |||
322 | EUCTR2013-004595-35-GB | 11/09/2014 | 11 June 2018 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Adempas Product Name: Adempas 1.0 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Trade Name: Adempas Product Name: Adempas 2.0 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Riociguat CAS Number: 625115-55-1 Current Sponsor code: BAY63-2521 Other descriptive name: RIOCIGUAT Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- Product Name: Adempas 0.125 mg Product Code: BAY63-2521 Pharmaceutical Form: Film-coated tablet | Bayer AG | Not Recruiting | Female: yes Male: yes | 63 | Phase 2 | France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom | |||
323 | NCT02212587 | September 2014 | 20 June 2016 | 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 | Not recruiting | 6 Years | N/A | Both | 10 | Phase 1 | Canada | |
324 | NCT02803944 | September 2014 | 27 June 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 | Not recruiting | 7 Years | N/A | Both | 2055 | N/A | France | |
325 | EUCTR2013-004987-80-BE | 28/08/2014 | 7 October 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 Pharmaceutical Form: Powder for solution for injection/infusion INN or Proposed INN: Colistineb CAS Number: 8068-28-8 Other descriptive name: COLISTIMETHATE SODIUM (A COMPONENT) Concentration unit: million IU million international units Concentration type: equal Concentration number: 2- | CUB - Hôpital Erasme | Authorised | Female: yes Male: yes | Belgium | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
326 | EUCTR2014-000817-30-NL | 14/08/2014 | 8 August 2016 | 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 Pharmaceutical Form: Film-coated tablet Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg Pharmaceutical Form: Capsule INN or Proposed INN: curcumin CAS Number: 458-37-7 Other descriptive name: CURCUMIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- Product Name: Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg Pharmaceutical Form: Capsule INN or Proposed INN: genistein CAS Number: 446-72-0 Other descriptive name: GENISTEIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 48.5- | University Medical Centre Utrecht | Not Recruiting | Female: yes Male: yes | Phase 2 | Netherlands | ||||
327 | EUCTR2014-002387-32-GB | 05/08/2014 | 20 August 2018 | 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 Level: PT 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Rosuvastatin calcium CAS Number: 287714-41-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- | University of Liverpool | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | United Kingdom | |||
328 | NCT03391414 | August 2014 | 8 January 2018 | 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 | Not recruiting | 12 Years | N/A | All | 12 | Phase 1 | United States |
329 | EUCTR2014-001401-41-NL | 29/07/2014 | 11 August 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 Pharmaceutical Form: Nebulisation solution | Authorised | Female: yes Male: yes | 26 | Netherlands | |||||
330 | EUCTR2014-000284-40-GB | 05/06/2014 | 10 April 2017 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: cysteamine bitartrate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | University of Aberdeen | NHS Grampian | Not Recruiting | Female: yes Male: yes | 12 | Phase 1;Phase 2 | United Kingdom | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
331 | NCT01576315 | June 2014 | 25 April 2016 | 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 | Not recruiting | 12 Years | N/A | Both | 11 | Phase 2 | France;United Kingdom | |
332 | NCT02139306 | June 2014 | 7 December 2015 | 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 Therapeutics;European Cystic Fibrosis Society-Clinical Trial Network (ECFS-CTN) | Not recruiting | 6 Years | N/A | Both | 208 | Phase 3 | United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom |
333 | NCT02141191 | June 2014 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 12 | Phase 1 | United States |
334 | NCT02107859 | May 31, 2014 | 4 February 2019 | 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 (PTC124) | PTC Therapeutics | Not recruiting | 6 Years | N/A | All | 61 | Phase 3 | United States;Belgium;France;Israel;Italy;Spain;Sweden;Germany | |
335 | EUCTR2013-005481-19-DK | 27/05/2014 | 23 May 2016 | 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 Pharmaceutical Form: Effervescent tablet INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200-600 Trade Name: Mucomyst Pharmaceutical Form: Effervescent tablet INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200-600 Trade Name: ACC Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLCYSTEINE Other descriptive name: ACETYLCYSTEINE Concentration unit: mg milligram(s) Concentration type: range Concentration number: 200-600 Trade Name: Tad Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: GLUTATHIONE CAS Number: 8000050-16-0 Other descriptive name: GLUTATHIONE SODIUM Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- | Aarhus University Hospital | Not Recruiting | Female: yes Male: yes | Phase 2 | Denmark | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
336 | NCT02144246 | May 2014 | 18 January 2016 | 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 | Not recruiting | 18 Years | 40 Years | Female | 5 | Phase 1 | United States |
337 | EUCTR2013-004295-35-AT | 30/04/2014 | 27 October 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 Pharmaceutical Form: Powder and solvent for nebuliser solution INN or Proposed INN: aztreonam CAS Number: 827611-49-4 Other descriptive name: AZTREONAM LYSINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75-75 Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel Pharmaceutical Form: Powder and solvent for nebuliser solution INN or Proposed INN: COLISTIMETHATE SODIUM CAS Number: 8068-28-8 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1.000.000-1.000.000 Trade Name: TOBI Pharmaceutical Form: Nebuliser solution INN or Proposed INN: TOBRAMYCIN SULFATE CAS Number: 79645-27-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300-300 | Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III) | Authorised | Female: yes Male: yes | Austria | |||||
338 | EUCTR2014-000057-37-NL | 30/04/2014 | 8 August 2016 | 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 Pharmaceutical Form: Inhalation vapour INN or Proposed INN: SALBUTAMOL CAS Number: 18559-94-9 Concentration unit: µg microgram(s) Concentration type: up to Concentration number: 400- Product Name: Salbutamol Product Code: R03CC02 Pharmaceutical Form: Tablet INN or Proposed INN: SALBUTAMOL CAS Number: 18559-94-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 4- | University Medical Centre Utrecht | Not Recruiting | Female: yes Male: yes | Phase 2 | Netherlands | ||||
339 | EUCTR2013-005366-19-GB | 29/04/2014 | 3 April 2017 | 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 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Ciprofloxacin Hydrochloride CAS Number: 86483-48-9 Current Sponsor code: Ciprofloxacin for Inhalation (CFI) Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- INN or Proposed INN: Ciprofloxacin Hydrochloride CAS Number: 86483-48-9 Current Sponsor code: Free Ciprofloxacin for Inhalation (FCI) Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 20- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Aradigm Corporation | 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 | |||
340 | EUCTR2013-004659-19-DE | 23/04/2014 | 22 May 2017 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Ciprofloxacin Current Sponsor code: BAYq3939 Other descriptive name: CIPROFLOXACIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32.5- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Bayer AG | 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 | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
341 | EUCTR2013-004659-19-NL | 23/04/2014 | 5 December 2016 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Ciprofloxacin Current Sponsor code: BAYq3939 Other descriptive name: CIPROFLOXACIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32.5- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Bayer AG | 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 | |||
342 | NCT01515007 | April 2014 | 29 January 2018 | 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 Inc. | Not recruiting | 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 |
343 | NCT01991028 | April 2014 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 10 | Phase 2 | United Kingdom |
344 | NCT02057458 | April 2014 | 21 January 2019 | Blood Flow and Vascular Function in Cystic Fibrosis | Role of Blood Flow and Vascular Function on Exercise Capacity in Cystic Fibrosis | Cystic Fibrosis | Drug: Acute (1 hour) Sildenafil;Drug: Sub-Chronic (4 weeks) Sildenafil;Drug: Placebo | Augusta University | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Not recruiting | 18 Years | N/A | All | 50 | Phase 2 | United States |
345 | NCT02113397 | April 2014 | 11 June 2018 | 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 | Not recruiting | 12 Years | 75 Years | All | 1 | N/A | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
346 | NCT02141958 | April 2014 | 21 July 2016 | 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 | Not recruiting | 18 Years | N/A | Both | 15 | Phase 1 | Canada | |
347 | NCT03341741 | March 11, 2014 | 16 December 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 | Not recruiting | 12 Years | N/A | All | 26 | Phase 3 | ||
348 | NCT02070744 | March 2014 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 40 | Phase 2 | United States | |
349 | NCT02081963 | March 2014 | 29 April 2019 | 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 | Not recruiting | 18 Years | 80 Years | All | 178 | Phase 4 | China | |
350 | NCT02084043 | March 2014 | 29 June 2015 | 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 | Not recruiting | N/A | N/A | Both | 3 | N/A | Belgium;Switzerland |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
351 | NCT02088216 | March 2014 | 8 August 2016 | Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of Bronchiectaisis | Effect of Long-term, High-dose N-acetylcysteine on Acute Exacerbations of Patients With Non-cystic Fibrosis Bronchiectasis: the BENE Randomized, Controlled Trial | Non-Cystic Fibrosis Bronchiectasis | Drug: N-acetylcysteine;Drug: Placebo | Qilu Hospital | Not recruiting | 18 Years | 80 Years | Both | 150 | Phase 4 | China | |
352 | NCT02148978 | March 2014 | 19 February 2015 | Cystic Fibrosis Related Diabetes | DPP-IV Inhibition in Patients With Cystic Fibrosis | Cystic Fibrosis | Drug: Saxagliptin | Ram Weiss | Recruiting | 18 Years | 65 Years | Both | 30 | N/A | Israel | |
353 | NCT01746784 | February 2014 | 19 October 2017 | 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. | Not recruiting | 18 Years | N/A | All | 66 | Phase 1 | United States | |
354 | NCT01937325 | February 2014 | 8 August 2016 | 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 | Not recruiting | 16 Years | 70 Years | Both | 20 | Phase 4 | Australia | |
355 | EUCTR2013-004488-30-NL | 31/01/2014 | 10 February 2014 | 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 Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: TOBRAMYCIN CAS Number: 32986-56-4 Current Sponsor code: TAPAS-PK-2014 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 600- | Haga Hospital | Authorised | Female: yes Male: yes | Netherlands | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
356 | EUCTR2013-000604-41-IT | 21/01/2014 | 13 June 2016 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: lumacaftor/ivacaftor 200mg/83mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 83- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ivacaftor 125mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | 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 | |||
357 | EUCTR2013-003774-27-GB | 20/01/2014 | 3 April 2017 | 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) Pharmaceutical Form: Inhalation powder INN or Proposed INN: OligoG CAS Number: 9005-38-3 Current Sponsor code: OligoG CF-5/20 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 96- Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation Pharmaceutical Form: Nebuliser solution INN or Proposed INN: OligoG CAS Number: 9005-38-3 Current Sponsor code: OligoG CF-5/20 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 90- | AlgiPharma AS | Not Recruiting | Female: yes Male: yes | 12 | Phase 2 | United Kingdom | |||
358 | NCT02015507 | January 2014 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 34 | Phase 1 | ||
359 | NCT02015663 | January 2014 | 16 December 2017 | 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 | Not recruiting | 6 Years | N/A | All | 32 | Phase 4 | United States | |
360 | NCT02043717 | January 2014 | 16 December 2017 | 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 | Not recruiting | 4 Years | N/A | All | 90 | N/A | Israel | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
361 | EUCTR2014-003023-22-FR | 2 October 2017 | 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 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: AZITHROMYCIN DIHYDRATE Current Sponsor code: azithromycine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 41,92- Trade Name: ZITHROMAX 250 mg Product Name: ZITHROMAX Pharmaceutical Form: Tablet INN or Proposed INN: AZITHROMYCIN DIHYDRATE Current Sponsor code: azithromycine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 262- | ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE | Not Available | Female: yes Male: yes | Phase 3 | France | |||||
362 | EUCTR2014-003882-10-FR | 2 October 2017 | 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 Pharmaceutical Form: Solution for injection CAS Number: 32986-56-4 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: NEBCINE Product Name: NEBCINE Pharmaceutical Form: Solution for injection CAS Number: 32986-56-4 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-0 Trade Name: NEBCINE Product Name: NEBCINE Pharmaceutical Form: Solution for injection CAS Number: 32986-56-4 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: NEBCINE Product Name: NEBCINE Pharmaceutical Form: Solution for injection CAS Number: 32986-56-4 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Trade Name: TOBI Product Name: TOBI Pharmaceutical Form: Nebuliser solution CAS Number: 32986-56-4 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | CHRU de Lille | Not Available | Female: yes Male: yes | Phase 2 | France | |||||
363 | NCT01946412 | December 2013 | 19 October 2017 | 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 | Not recruiting | 2 Years | N/A | All | 33 | Phase 3 | United States;Canada;United Kingdom |
364 | NCT01958944 | December 2013 | 13 June 2016 | 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 | Not recruiting | 10 Years | N/A | Both | 9 | Phase 1/Phase 2 | Israel |
365 | NCT01975259 | December 2013 | 14 September 2015 | 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 | Not recruiting | 17 Years | 50 Years | Both | 50 | N/A | United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
366 | NCT02036879 | December 2013 | 11 February 2019 | 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 | Not recruiting | 18 Years | N/A | All | 55 | N/A | United States | |
367 | NCT02096315 | December 2013 | 16 December 2017 | 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. | Not recruiting | 18 Years | 79 Years | All | 20 | Phase 2 | Spain;United Kingdom | |
368 | EUCTR2013-002819-10-HU | 29/11/2013 | 27 October 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;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Product Name: CREON N 25000 Pharmaceutical Form: Capsule, hard INN or Proposed INN: not applicable CAS Number: 8049-47-6 Current Sponsor code: CREON N Other descriptive name: PANCREATIN Concentration unit: IU/kg international unit(s)/kilogram Concentration type: equal Concentration number: 25000- Trade Name: Creon 25000 Pharmaceutical Form: Capsule, hard INN or Proposed INN: not assigned CAS Number: 8049-47-6 Other descriptive name: PANCREATIN Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 25000- | Abbott Laboratories GmbH | Not Recruiting | Female: yes Male: yes | 40 | Hungary;Spain;Russian Federation | ||||
369 | NCT00924547 | November 2013 | 3 August 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 17 | Phase 2 | United States | |
370 | NCT01702415 | October 2013 | 2 November 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 0 | Phase 4 | United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
371 | NCT01784419 | October 2013 | 19 February 2015 | 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 | University of California, San Francisco | Recruiting | 6 Years | N/A | Both | 30 | N/A | United States | |
372 | NCT01880346 | October 2013 | 7 December 2015 | 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 | Not recruiting | 18 Years | 59 Years | Both | 17 | Phase 4 | United States | |
373 | NCT01931839 | October 2013 | 16 December 2017 | 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 | Not recruiting | 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 | |
374 | NCT02035488 | October 2013 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 8 | Phase 1/Phase 2 | Netherlands | |
375 | EUCTR2013-001258-82-IT | 12/09/2013 | 18 January 2016 | Phase II clinical study for the therapy of cystic fibrosis patients with a specific mutation | A phase II pilot clinical study of experimental research to evaluate the functional 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 Pharmaceutical Form: Capsule | European Institute for Cystic Fibrosis Research (IERFC) | Not Recruiting | Female: yes Male: yes | Phase 2 | Italy | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
376 | EUCTR2013-002202-31-GB | 11/09/2013 | 14 April 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 Pharmaceutical Form: Solution for infusion INN or Proposed INN: POL7080 CAS Number: 944252-63-5 Current Sponsor code: POL7080 Other descriptive name: POL7080 Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 7.5- | Polyphor Ltd. | Authorised | Female: yes Male: yes | 20 | Phase 2 | Spain;United Kingdom | |||
377 | NCT01944735 | September 2013 | 16 March 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 17 | Phase 1 | United Kingdom |
378 | NCT01953367 | September 2013 | 19 February 2015 | 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 | Not recruiting | 18 Years | 50 Years | Both | 72 | Phase 1 | Germany | |
379 | NCT02048592 | September 2013 | 19 February 2015 | 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 | Recruiting | 18 Years | 40 Years | Both | 30 | Phase 4 | Czech Republic | |
380 | NCT02288429 | September 2013 | 15 July 2019 | 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 | Not recruiting | 18 Years | 89 Years | All | 16 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
381 | NCT01885169 | August 2013 | 19 February 2015 | 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 | Not recruiting | 2 Years | 18 Years | Both | 170 | N/A | Canada |
382 | NCT01916577 | August 2013 | 19 February 2018 | 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 | Not recruiting | 18 Years | 70 Years | All | 15 | Phase 1 | United States |
383 | EUCTR2012-000386-20-GB | 31/07/2013 | 28 September 2015 | 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 Pharmaceutical Form: Granules INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Trade Name: Kalydeco Product Name: ivacaftor Product Code: VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 35 | Phase 3 | United States;Canada;United Kingdom | |||
384 | EUCTR2013-000219-25-IT | 18/07/2013 | 30 April 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 Pharmaceutical Form: Tablet INN or Proposed INN: RIFAMPICIN CAS Number: 13292-46-1 Product Name: Trimethoprim-sulfamethoxazole Pharmaceutical Form: Tablet INN or Proposed INN: SULFAMETHOXAZOLE CAS Number: 723-46-6 Other descriptive name: TRIMETHOPRIM Product Name: minocycline Pharmaceutical Form: Tablet CAS Number: 13614-98-7 Other descriptive name: MINOCYCLINE HYDROCHLORIDE | AOU Meyer | Authorised | Female: yes Male: yes | 100 | Phase 3 | Italy | |||
385 | NCT01155752 | July 2013 | 16 December 2017 | 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. | Not recruiting | 12 Years | 65 Years | All | 0 | Phase 3 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
386 | NCT01897233 | July 2013 | 16 December 2017 | 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 | Not recruiting | 6 Years | 11 Years | All | 62 | Phase 3 | United States;Canada | |
387 | NCT01899105 | July 2013 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 28 | Phase 1 | United States | |
388 | EUCTR2012-001565-33-GB | 21/06/2013 | 17 November 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 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- Pharmaceutical Form: Nebulisation solution INN or Proposed INN: Tobramycin CAS Number: 3232986-56-4 Current Sponsor code: TBM100 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical Form: Powder and solvent for nebuliser solution INN or Proposed INN: Colistimethate CAS Number: 30387-39-4 Other descriptive name: COLISTIMETHATE Concentration unit: million IU million international units Concentration type: equal Concentration number: 1- | Novartis Pharma Services AG | Authorised | Female: yes Male: yes | 67 | Phase 4 | Spain;Germany;Switzerland;United Kingdom | |||
389 | EUCTR2012-003990-24-DE | 20/06/2013 | 30 June 2014 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: lumacaftor/ivacaftor 200mg/83mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 83- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ivacaftor 125mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom | |||
390 | EUCTR2012-003990-24-GB | 10/06/2013 | 28 February 2019 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: lumacaftor/ivacaftor 200mg/83mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 83- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ivacaftor 125mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | France;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
391 | NCT01859390 | June 2013 | 16 December 2017 | 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 | Not recruiting | 10 Years | N/A | All | 73 | Phase 2 | United States |
392 | NCT01879228 | June 2013 | 30 September 2019 | 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 | Not recruiting | 18 Years | N/A | All | 26 | N/A | United States |
393 | NCT01887197 | June 2013 | 19 November 2018 | 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 | Not recruiting | 18 Years | N/A | All | 24 | Phase 1 | United States | |
394 | NCT01910415 | June 2013 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 200 | Phase 1 | Netherlands | |
395 | EUCTR2012-004437-16-NL | 15/05/2013 | 3 June 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 | Bronchiectasis Lung infections;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | Product Name: Dry powder tobramycin Product Code: J01GB01 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Tobramycin dry powder CAS Number: 32986-56-4 Other descriptive name: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- | University Medical Center Groningen | Authorised | Female: yes Male: yes | Netherlands | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
396 | EUCTR2012-003989-40-SE | 07/05/2013 | 24 July 2017 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: lumacaftor/ivacaftor 200mg/83mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 83- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: ivacaftor 125mg tablet Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 501 | Phase 3 | United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden | |||
397 | NCT01710644 | May 2013 | 13 June 2016 | 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 | Not recruiting | 12 Years | N/A | Both | 35 | Phase 1/Phase 2 | United States |
398 | NCT01807923 | May 2013 | 19 October 2017 | 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 | Not recruiting | 12 Years | N/A | All | 559 | Phase 3 | United States;Australia;Canada;Czech Republic;France;Germany;Ireland;Italy;Netherlands;Sweden;United Kingdom | |
399 | NCT01840735 | May 2013 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 8 | Phase 1 | United States | |
400 | NCT01851694 | May 2013 | 23 April 2019 | 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 |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
401 | NCT01852448 | May 2013 | 26 August 2019 | 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 | Recruiting | 2 Years | N/A | All | 350 | Phase 1 | United States |
402 | NCT01863238 | May 2013 | 5 September 2016 | 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 | Not recruiting | 6 Years | 11 Years | Both | 95 | N/A | United States |
403 | NCT01807949 | April 2013 | 19 October 2017 | 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 | Not recruiting | 12 Years | 65 Years | All | 563 | Phase 3 | United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Spain;United Kingdom | |
404 | EUCTR2011-003821-93-DE | 13/03/2013 | 6 February 2017 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Not yet assigned Current Sponsor code: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: VX-661 Product Code: VX-661, VRT-893661 Pharmaceutical Form: Tablet INN or Proposed INN: Not yet assigned Current Sponsor code: VX-661 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: Ivacaftor Product Code: VX-770, VRT-813077 Pharmaceutical Form: Tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 220 | Phase 2 | United Kingdom;Germany;Canada;United States | |||
405 | NCT01746095 | March 2013 | 19 February 2015 | 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 inhalation powder;Drug: Placebo inhalation powder | Savara Inc. | Synteract, Inc.;Cystic Fibrosis Foundation Therapeutics | Not recruiting | 12 Years | N/A | Both | 87 | Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
406 | NCT01837355 | March 2013 | 11 June 2018 | 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 | Recruiting | 6 Years | 20 Years | All | 68 | N/A | Switzerland |
407 | NCT01775137 | February 2013 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 45 | Phase 4 | United States;Argentina;Australia;Canada;Germany;Hungary;Italy;Mexico;Spain | |
408 | EUCTR2012-004491-18-GB | 30/01/2013 | 11 March 2013 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: N/A CAS Number: N/A Current Sponsor code: BAY 85-8501 Other descriptive name: BAY 85-8501 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Bayer HealthCare AG | Authorised | Female: yes Male: yes | 90 | Phase 2a | Spain;United Kingdom | |||
409 | EUCTR2012-002699-14-GB | 28/01/2013 | 4 February 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: 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: mannitol CAS Number: 69-95-8 Current Sponsor code: N/A Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Pharmaxis Ltd. | Authorised | Female: yes Male: yes | 160 | Canada;Argentina;United Kingdom | ||||
410 | EUCTR2012-002880-86-GB | 25/01/2013 | 4 February 2013 | 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 Pharmaceutical Form: Solution for injection in pre-filled pen | Liverpool Heart and Chest Hospital NHS Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
411 | NCT00928135 | January 22, 2013 | 11 June 2018 | 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 | Not recruiting | 12 Years | N/A | All | 63 | Phase 1/Phase 2 | United States | |
412 | EUCTR2011-004208-39-DE | 21/01/2013 | 8 August 2016 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Ciprofloxacin Current Sponsor code: BAYq3939 Other descriptive name: CIPROFLOXACIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32.5- Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use | Bayer HealthCare AG | 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 | |||
413 | NCT01705145 | January 2013 | 19 October 2017 | 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 | Not recruiting | 2 Years | 5 Years | All | 35 | Phase 3 | United States;Canada;United Kingdom |
414 | NCT01768663 | January 2013 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 80 | Phase 1 | United States | |
415 | EUCTR2012-002503-17-NL | 21/12/2012 | 7 January 2013 | 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 Pharmaceutical Form: Inhalation solution INN or Proposed INN: TOBRAMYCIN CAS Number: 32986-56-4 Current Sponsor code: TONI-2012 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 600 - | Erasmus University Medical Centre | Authorised | Female: yes Male: yes | Netherlands | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
416 | EUCTR2012-003532-23-HU | 19/12/2012 | 23 February 2015 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 120 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy | |||
417 | NCT01641822 | December 2012 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 107 | Phase 3 | United States | |
418 | NCT01695343 | December 2012 | 19 February 2015 | 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 | Not recruiting | 12 Years | 50 Years | Both | 182 | Phase 2 | United States;Australia;Israel;New Zealand | |
419 | NCT01712334 | December 2012 | 19 October 2017 | 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. | Not recruiting | 6 Years | N/A | All | 99 | Phase 4 | United States | |
420 | NCT01684683 | November 2012 | 23 March 2015 | 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 | Not recruiting | 18 Years | 70 Years | Both | 100 | Phase 4 | China | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
421 | NCT01721382 | November 2012 | 20 June 2016 | 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 | Not recruiting | 13 Years | 20 Years | Both | 6 | Phase 1 | United States | |
422 | EUCTR2012-000389-39-GB | 25/10/2012 | 28 September 2015 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 120 | Phase 3 | France;United States;Belgium;United Kingdom | |||
423 | NCT01316276 | October 5, 2012 | 26 August 2019 | 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 | Not recruiting | 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 | |
424 | NCT01586728 | October 2012 | 29 June 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 8 | N/A | France |
425 | NCT01594827 | October 2012 | 22 January 2018 | 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 Therapeutics | Not recruiting | 12 Years | N/A | All | 29 | Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
426 | NCT01793649 | October 2012 | 19 February 2015 | 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 | Not recruiting | 18 Years | 45 Years | Both | 7 | Phase 1 | United States | |
427 | ChiCTR-TRC-12002470 | 2012-09-15 | 18 April 2017 | 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 | Not Recruiting | 15 | 65 | Both | 1:46;2:46; | Post-market | China | |
428 | NCT01667094 | September 2012 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 50 | Phase 4 | Australia | |
429 | NCT01685801 | September 2012 | 19 October 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 | Drug: Ivacaftor;Drug: Placebo-matched-to-ivacaftor tablet | Vertex Pharmaceuticals Incorporated | Not recruiting | 12 Years | N/A | All | 24 | Phase 2 | United States | |
430 | NCT01694069 | September 2012 | 19 February 2015 | 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 | Not recruiting | 8 Years | N/A | Both | 6 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
431 | NCT02201082 | September 2012 | 7 September 2015 | 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 | Not recruiting | 16 Years | 50 Years | Both | 15 | N/A | Belgium | ||
432 | NCT01194232 | August 2012 | 19 February 2015 | 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 | Not recruiting | 8 Years | 21 Years | Both | 0 | Phase 1/Phase 2 | United States | |
433 | NCT01684410 | August 2012 | 19 October 2017 | 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. | Not recruiting | 18 Years | N/A | All | 30 | Phase 2 | United States | |
434 | NCT01652157 | July 31, 2012 | 24 September 2018 | 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: CREON;Biological: ZENPEP;Biological: ULTRESA;Biological: PANCREAZE;Biological: PERTZYE;Biological: other non-sponsor pancreatic enzyme replacement therapy;Other: No pancreatic enzyme replacement therapy | AbbVie (prior sponsor, Abbott) | Cystic Fibrosis Foundation Therapeutics;Digestive Care, Inc.;Janssen Research & Development, LLC;Forest Research Institute, Inc., an Allergan affiliate;VIVUS, Inc. | Recruiting | N/A | 99 Years | All | 50 | Phase 3 | United States |
435 | NCT02190604 | July 31, 2012 | 15 April 2019 | 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 | Not recruiting | 18 Years | 65 Years | All | 153 | Phase 1/Phase 2 | United States;Belgium;France;Germany;Ireland;Romania;United Kingdom;Netherlands | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
436 | EUCTR2012-000388-26-BE | 23/07/2012 | 21 August 2017 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | France;United States;Belgium | |||
437 | EUCTR2011-005085-37-GB | 20/07/2012 | 7 October 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: 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not assigned CAS Number: Not assigned Current Sponsor code: QBW251 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Product Code: QBW251 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Not assigned CAS Number: Not assigned Current Sponsor code: QBW251 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Novartis Pharma Services AG | Authorised | Female: yes Male: yes | 156 | France;United States;Ireland;Romania;Netherlands;Germany;United Kingdom | ||||
438 | EUCTR2011-005790-23-GB | 17/07/2012 | 28 August 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 Level: LLT Classification code 10000842 Term: Acute lymphatic leukaemia System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA version: 14.1 Level: LLT 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 Pharmaceutical Form: Tablet INN or Proposed INN: Prednisolone CAS Number: 53-03-2 Current Sponsor code: N/A Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 2.5- Product Name: Hydrocortisone Pharmaceutical Form: Tablet INN or Proposed INN: Hydrocortisone CAS Number: 50-23-7 Current Sponsor code: N/A Concentration unit: mg/m2 milligram(s)/square meter Concentration type: equal Concentration number: 5-10 | Birmingham Children's Hospital NHS Foundation Trust | Authorised | Female: yes Male: yes | 60 | United Kingdom | ||||
439 | NCT01614457 | July 2012 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 70 | Phase 3 | United States;United Kingdom;Ireland |
440 | NCT01614470 | July 2012 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 39 | Phase 3 | United States;Belgium;France |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
441 | NCT02014181 | July 2012 | 19 February 2015 | 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 | Not recruiting | 18 Years | 64 Years | Both | 10 | Phase 1 | United States | |
442 | EUCTR2012-000387-19-GB | 11/06/2012 | 17 March 2014 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: IVACAFTOR CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 80 | Phase 3 | United States;United Kingdom | |||
443 | NCT01619657 | June 2012 | 16 December 2017 | 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 | Not recruiting | N/A | 4 Months | All | 42 | Phase 2 | Germany |
444 | NCT01747330 | June 2012 | 19 October 2017 | 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 | Not recruiting | N/A | 4 Years | All | 40 | Phase 3 | Russian Federation | |
445 | EUCTR2011-001916-69-NL | 22/05/2012 | 17 June 2013 | 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 Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use | HagaZiekenhuis, pulmonary department | Not Recruiting | Female: yes Male: yes | 40 | Netherlands | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
446 | NCT01270074 | April 2012 | 9 May 2016 | 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 | Queensland Children's Medical Research Institute | Telethon Kids Institute | Recruiting | 6 Weeks | 6 Months | Both | 130 | Phase 3 | Australia;New Zealand |
447 | NCT01572194 | April 2012 | 11 June 2018 | 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 | Not recruiting | 18 Years | N/A | All | 45 | N/A | France | |
448 | EUCTR2011-004761-33-GB | 08/03/2012 | 28 February 2019 | 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 Pharmaceutical Form: Inhalation solution Other descriptive name: pGM169/GL67A Concentration unit: mg milligram(s) Concentration type: range Concentration number: 2.5-2.8 Pharmaceutical form of the placebo: Inhalation solution Route of administration of the placebo: Inhalation use | Imperial College | Not Recruiting | Female: yes Male: yes | 130 | Phase 2 | United Kingdom | |||
449 | NCT01417481 | March 2012 | 19 October 2017 | 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 | Not recruiting | 5 Years | 15 Years | All | 13 | Phase 2 | Mexico |
450 | NCT03045198 | March 2012 | 20 August 2018 | 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 Hospital, Frankfurt;University of Bonn | Recruiting | 10 Years | 60 Years | All | 20 | Phase 4 | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
451 | NCT01315678 | February 29, 2012 | 15 July 2019 | 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: Tobramycin inhalation solution using a PARI LC® Plus nebulizer.;Drug: Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer. | Insmed Incorporated | Not recruiting | 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 | |
452 | NCT01429259 | February 2012 | 19 October 2017 | 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 | Not recruiting | 6 Years | 17 Years | All | 30 | Phase 4 | United States |
453 | NCT01531673 | February 2012 | 11 June 2018 | 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 | Not recruiting | 12 Years | N/A | All | 194 | Phase 2 | United States;Canada;Germany;United Kingdom | |
454 | NCT01543191 | February 2012 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 10 | Phase 1 | United Kingdom |
455 | NCT01509339 | January 2012 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 10 | Phase 1 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
456 | NCT01731015 | January 2012 | 19 February 2015 | 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 | Not recruiting | 18 Years | 90 Years | Both | 15 | Phase 1 | United States | |
457 | NCT02128984 | January 2012 | 29 July 2019 | 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 | Not recruiting | 1 Year | N/A | All | 109 | N/A | Peru;Spain |
458 | EUCTR2011-002719-27-IT | 30/12/2011 | 27 January 2014 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: MECASERMIN CAS Number: 68562-41-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- | AZIENDA OSPEDALIERA DI PARMA | Not Recruiting | Female: yes Male: yes | 20 | Italy | ||||
459 | NCT01404234 | December 2011 | 19 October 2017 | 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 | Not recruiting | N/A | 12 Years | All | 61 | Phase 3 | United States;France;Germany;Italy;Poland;Spain | |
460 | EUCTR2011-002000-32-HU | 25/11/2011 | 3 February 2014 | 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: 14.0 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tobramycin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 150 | Phase 4 | France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
461 | NCT00889434 | November 1, 2011 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 7 | N/A | Israel | |
462 | NCT01537666 | November 2011 | 19 October 2017 | 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 | Not recruiting | 18 Years | 50 Years | All | 25 | Phase 1 | Australia |
463 | NCT02276898 | November 2011 | 1 June 2015 | 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 | Not recruiting | 6 Years | 18 Years | Both | 24 | Phase 2 | Canada | |
464 | EUCTR2011-006171-19-IT | 27/10/2011 | 3 July 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 Pharmaceutical Form: Tablet INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- Trade Name: BRAMITOB*NEBUL 56F 300MG/4ML Pharmaceutical Form: Nebuliser solution INN or Proposed INN: TOBRAMYCIN CAS Number: 32986-56-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name: CIPROXIN*6CPR RIV 500MG Pharmaceutical Form: Tablet INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE CAS Number: 86483-48-9 Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 750- Trade Name: PROMIXIN*NEBUL 30MONOD 1MUI Pharmaceutical Form: Inhalation powder INN or Proposed INN: COLISTIN MESILATE SODIUM CAS Number: 2680-63-9 Concentration unit: million IU million international units Concentration type: equal Concentration number: 1000000- | AZIENDA OSPEDALIERA MEYER | Authorised | Female: yes Male: yes | Italy | |||||
465 | EUCTR2011-001821-26-IT | 18/10/2011 | 28 August 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 Pharmaceutical Form: Nebuliser liquid INN or Proposed INN: TOBRAMYCIN CAS Number: 32986-56-4 Concentration unit: mg/g milligram(s)/gram Concentration type: equal Concentration number: 300- | FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANO | Not Recruiting | Female: yes Male: yes | Italy | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
466 | NCT01002534 | October 2011 | 4 March 2019 | 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 | Not recruiting | 14 Years | N/A | All | 5 | Phase 2 | Belgium | |
467 | NCT01426256 | October 2011 | 16 December 2017 | 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 | Not recruiting | 16 Years | N/A | All | 91 | Phase 3 | United States |
468 | NCT01537614 | October 2011 | 24 October 2016 | Pharmacokinetic Study of Aerosolized Colimycin in Cystic Fibrosis | Cystic Fibrosis | Drug: COLIMYCINE inhalation;Drug: COLIMYCINE injectable | Poitiers University Hospital | Not recruiting | 18 Years | N/A | Both | 7 | Phase 1 | France | ||
469 | NCT01783613 | October 2011 | 16 December 2017 | 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 | Not recruiting | 2 Months | 100 Years | All | 96 | N/A | Spain | |
470 | EUCTR2011-000801-39-DE | 31/08/2011 | 6 November 2017 | 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 Pharmaceutical Form: Gargle INN or Proposed INN: IgY Current Sponsor code: PsAer IgY Concentration unit: ELISA unit/ml enzyme-linked immunosorbent assay unit/millitre Concentration type: not less then Concentration number: 5- Pharmaceutical form of the placebo: Gargle Route of administration of the placebo: Oromucosal use | Mukoviszidose Institute gGmbH | Not Recruiting | Female: yes Male: yes | 180 | Phase 3 | Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
471 | NCT01375049 | August 2011 | 19 October 2017 | 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 | Not recruiting | 3 Months | 17 Years | All | 105 | Phase 2 | United States;Austria;Belgium;France;Germany;Italy;Netherlands;Poland;Spain;Ireland | |
472 | NCT01772758 | August 2011 | 15 July 2019 | 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 | Not recruiting | 7 Years | N/A | All | 64 | Phase 2 | United States | |
473 | EUCTR2011-000130-11-IT | 25/07/2011 | 27 January 2014 | 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 Level: PT 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone Concentration unit: mg/ml milligram(s)/millilitre Concentration number: 500- | AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA | Authorised | Female: yes Male: yes | Italy | |||||
474 | NCT01381289 | June 2011 | 19 February 2015 | VX-770 Expanded Access Program | VX-770 Expanded Access Program (EAP) | Cystic Fibrosis | Drug: VX-770 | Vertex Pharmaceuticals Incorporated | Not recruiting | 6 Years | N/A | Both | N/A | |||
475 | NCT01755455 | June 2011 | 16 December 2017 | 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 | Not recruiting | 18 Years | 70 Years | All | 22 | N/A | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
476 | NCT02782312 | June 2011 | 13 June 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 | Not recruiting | 18 Years | N/A | Both | 120 | Phase 4 | China | |
477 | NCT01207245 | May 2011 | 3 August 2015 | 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 | Not recruiting | 5 Years | N/A | Both | 18 | Phase 4 | United Kingdom | |
478 | NCT01355796 | May 2011 | 10 September 2018 | 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 | Not recruiting | 16 Years | N/A | All | 30 | Phase 1/Phase 2 | United States |
479 | EUCTR2011-000192-13-GB | 28/04/2011 | 26 June 2012 | 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 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders | Product Name: Colobreathe Product Code: N/A Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Colistimethate sodium CAS Number: 8068288 Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 125- | Forest Laboratories UK Ltd. | Not Recruiting | Female: yes Male: yes | 28 | Germany;United Kingdom;Poland | ||||
480 | NCT01313624 | April 2011 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 266 | Phase 3 | United States;Australia;Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
481 | NCT01314716 | April 2011 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 274 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom | |
482 | NCT01315665 | April 2011 | 16 December 2017 | 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 Therapeutics | Not recruiting | 18 Years | 49 Years | All | 15 | N/A | United States |
483 | NCT01337219 | April 2011 | 19 February 2015 | 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 |
484 | NCT01347190 | April 2011 | 19 February 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 25 | Phase 1 | Bulgaria;Hungary;Poland;United Kingdom | |
485 | NCT01349192 | April 2011 | 16 December 2017 | 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 | Not recruiting | 4 Years | 45 Years | All | 47 | Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
486 | EUCTR2010-023090-19-GB | 29/03/2011 | 19 March 2012 | 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: OligoG CAS Number: 9005-38-3 Current Sponsor code: OligoG Other descriptive name: OligoG-CF5/20, Alginate oligosaccharide (G-block) fragment Concentration unit: % (W/V) percent weight/volume Concentration type: equal Concentration number: 6- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | AlgiPharma AS | Authorised | Female: yes Male: yes | 24 | Phase 2 | United Kingdom;Ireland | |||
487 | NCT01315691 | March 2011 | 20 August 2018 | 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 | Not recruiting | 6 Years | N/A | All | 0 | Phase 3 | ||
488 | NCT02029521 | March 2011 | 19 October 2017 | 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 | Not recruiting | 18 Months | 10 Years | All | 47 | N/A | Italy | |
489 | EUCTR2010-023529-39-GB | 18/02/2011 | 16 October 2012 | 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 Pharmaceutical Form: Inhalation gas | Southampton University Hopsitals NHS Trust | Not Recruiting | Female: yes Male: yes | Phase 2 | United Kingdom | ||||
490 | EUCTR2010-020413-90-BE | 08/02/2011 | 17 August 2015 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Kalydeco Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Kalydeco Product Code: VX-770, VRT-813077 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: Lumacaftor/Ivacaftor Product Code: VX-809/VX-770 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Lumacaftor CAS Number: 936727-05-8 Current Sponsor code: VX-809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- INN or Proposed INN: Ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 293 | Phase 2 | United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
491 | NCT01229553 | January 2011 | 29 June 2015 | 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 | Not recruiting | 2 Months | 23 Months | Both | 0 | N/A | United States | |
492 | NCT01270347 | January 2011 | 29 January 2018 | 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 | Not recruiting | 12 Years | N/A | All | 267 | Phase 3 | United States;France;Germany;Ireland;Israel;United Kingdom |
493 | NCT01280994 | January 2011 | 23 April 2019 | Hyperpolarized 129Xe MRI for Imaging Pulmonary Function | Hyperpolarized 129Xe MR Imaging of the Lung Function in Healthy Volunteers and Subjects With Pulmonary Disease | Interstitial Lung Disease;Cystic Fibrosis;Pulmonary Hypertension;NSIP;Alpha 1-Antitrypsin Deficiency | Drug: Xenon | Bastiaan Driehuys | Recruiting | 18 Years | 80 Years | All | 445 | Phase 1 | United States | |
494 | NCT01494909 | January 2011 | 6 May 2019 | 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 | Not recruiting | 10 Years | N/A | All | 31 | N/A | United States |
495 | NCT02163681 | January 2011 | 16 December 2017 | 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 | Recruiting | 4 Months | 65 Years | All | 77 | N/A | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
496 | NCT00625703 | December 2010 | 30 September 2019 | 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 | Not recruiting | N/A | 18 Years | All | 14 | Phase 2 | United States |
497 | NCT01100892 | December 2010 | 15 April 2019 | 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 | Recruiting | 5 Years | 19 Years | All | 100 | Phase 3 | Australia |
498 | NCT01180634 | November 2010 | 29 January 2018 | 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 | Not recruiting | 12 Years | N/A | All | 330 | Phase 3 | United States;Australia;Canada;Israel;New Zealand |
499 | NCT01299181 | November 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | 75 Years | Both | 60 | Phase 4 | United Kingdom |
500 | NCT01299194 | November 2010 | 16 December 2017 | 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 | Not recruiting | 18 Years | 80 Years | All | 32 | Phase 4 | United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
501 | EUCTR2010-020546-96-GB | 08/10/2010 | 25 September 2012 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Other descriptive name: VRT-813077 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 16 | Phase 2 | United States;Canada;United Kingdom | |||
502 | NCT01161537 | October 2010 | 19 October 2017 | 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 | Not recruiting | 12 Years | N/A | All | 13 | Phase 2 | United States |
503 | NCT01201434 | October 2010 | 19 February 2015 | 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 | Not recruiting | 5 Years | 40 Years | Both | 12 | N/A | ||
504 | NCT01216046 | October 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 48 | Phase 1 | United States | |
505 | NCT01225211 | October 2010 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 312 | Phase 2 | United States;Australia;Belgium;France;Germany;New Zealand;United Kingdom;Ireland | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
506 | EUCTR2009-012842-21-GB | 20/09/2010 | 4 February 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pancreas Powder CAS Number: 8049-47-6 Other descriptive name: PANCREATIN Concentration unit: Other Concentration type: equal Concentration number: 25000- Trade Name: Zenpep Product Name: EUR-1008 Product Code: EUR-1008 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pancreas Powder CAS Number: 53608-75-6 Current Sponsor code: EUR-1008 Other descriptive name: PANCREASLIPASE Concentration unit: Other Concentration type: equal Concentration number: 25000- | Aptalis Pharma US Inc. | Authorised | Female: yes Male: yes | 86 | Bulgaria;Germany;Italy;United Kingdom | ||||
507 | EUCTR2010-020516-11-IT | 16/09/2010 | 19 March 2012 | 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 Level: PT Classification code 10011762 | Trade Name: PREFOLIC*30CPR GASTROR 15MG Pharmaceutical Form: Gastro-resistant tablet INN or Proposed INN: Detoxifying agents for antineoplastic treatment Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 15- Trade Name: INDUSIL*OS GTT FL 30MG+FL 15ML Pharmaceutical Form: Oral drops, solution INN or Proposed INN: Cobamamide Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 2- | AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA | Authorised | Female: yes Male: yes | Italy | |||||
508 | EUCTR2010-019802-17-PT | 13/09/2010 | 9 October 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution CAS Number: 411207313 Current Sponsor code: Ba 679 Br Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 3.124- Pharmaceutical form of the placebo: Inhalation vapour* Route of administration of the placebo: Inhalation use | Boehringer Ingelheim France | Not Recruiting | Female: yes Male: yes | 360 | Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria | |||||
509 | NCT01090908 | September 2010 | 19 February 2015 | 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 | Not recruiting | 6 Years | 18 Years | Both | 0 | N/A | ||
510 | NCT01208285 | September 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 24 | Phase 1 | Czech Republic;Slovakia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
511 | NCT01222273 | September 2010 | 11 June 2018 | 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) | Not recruiting | 12 Years | N/A | All | 7 | N/A | United States |
512 | NCT01223183 | September 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 20 | Phase 1 | United States | |
513 | NCT01257464 | September 2010 | 19 February 2015 | 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 | Not recruiting | 19 Years | N/A | Both | 3 | Phase 2 | Canada | |
514 | EUCTR2010-018454-13-DE | 31/08/2010 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: L-Lysine-N-acetylcysteinate Current Sponsor code: NAL Other descriptive name: Nacystelyn® Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use Product Name: Nacystelyn® Product Code: NAL Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: L-Lysine-N-acetylcysteinate Current Sponsor code: NAL Other descriptive name: Nacystelyn® Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Laboratoires SMB S.A. | Not Recruiting | Female: yes Male: yes | 552 | Phase 3 | Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy | |||
515 | NCT01140451 | August 31, 2010 | 15 April 2019 | 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 (PTC124) | PTC Therapeutics | Cystic Fibrosis Foundation | Not recruiting | 6 Years | N/A | All | 191 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
516 | EUCTR2009-012997-11-FR | 25/08/2010 | 15 May 2012 | 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 Pharmaceutical Form: Tablet CAS Number: 873054-44-5 Current Sponsor code: VX-770 Other descriptive name: VRT-813077 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- | Vertex Pharmaceuticals Incorporated | Authorised | Female: yes Male: yes | 217 | Germany;United Kingdom;Czech Republic;France;Ireland | ||||
517 | NCT00782288 | August 2010 | 25 March 2019 | 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 | Not recruiting | 18 Years | 45 Years | All | 24 | Phase 2 | United States | |
518 | NCT01181622 | August 2010 | 19 February 2015 | 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. | Not recruiting | 2 Years | 4 Years | Both | 25 | Phase 2 | United States | |
519 | NCT01116089 | July 2010 | 19 February 2015 | 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. | Not recruiting | 18 Years | N/A | Both | 25 | Phase 1 | Czech Republic;Moldova, Republic of;Slovakia;Russian Federation | |
520 | NCT01131507 | July 2010 | 16 December 2017 | 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 | Not recruiting | N/A | 12 Months | All | 15 | Phase 4 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
521 | EUCTR2010-018738-27-DE | 02/06/2010 | 1 April 2013 | 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 Pharmaceutical Form: Film-coated tablet Current Sponsor code: SB-656933-AAA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use Product Name: SB-656933 Tablets Product Code: SB-656933-AAA Pharmaceutical Form: Film-coated tablet Current Sponsor code: SB-656933-AAA Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Film-coated tablet Route of administration of the placebo: Oral use | GlaxoSmithKline Research & Development Limited | Not Recruiting | Female: yes Male: yes | 100 | Germany | ||||
522 | NCT01100606 | June 2010 | 19 October 2017 | 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 | Not recruiting | 1 Month | 12 Months | All | 15 | Phase 4 | United States | |
523 | NCT01149005 | June 2010 | 19 February 2015 | 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 | Not recruiting | 10 Years | N/A | Both | 30 | N/A | Israel | |
524 | NCT01153542 | June 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 24 | Phase 1 | United States | |
525 | NCT01450267 | June 2010 | 19 February 2015 | 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 |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
526 | EUCTR2007-001401-15-DK | 21/05/2010 | 5 December 2016 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: ACETYLCYSTEINE CAS Number: 616-91-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- | Rigshospitalet | Not Recruiting | Female: yes Male: yes | Phase 4 | Denmark | ||||
527 | EUCTR2010-019194-15-IT | 12/05/2010 | 19 March 2012 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Amphotericin B Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- | AZIENDA OSPEDALIERA ISTITUTI OSPITALIERI DI VERONA | Authorised | Female: yes Male: yes | Italy | |||||
528 | NCT00967798 | May 2010 | 29 January 2018 | 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 | Not recruiting | 13 Years | N/A | All | 30 | Phase 3 | United States;Canada | |
529 | NCT01092572 | May 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 0 | Phase 1/Phase 2 | Canada | |
530 | NCT01158937 | May 2010 | 1 June 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 2 | N/A | Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
531 | NCT02690857 | May 2010 | 3 June 2019 | 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 | Not recruiting | 6 Years | 30 Years | Male | 10 | Phase 2 | ||
532 | NCT00763477 | April 2010 | 19 February 2015 | Ghrelin in Cystic Fibrosis | The Effect of Ghrelin on Appetite and Immune Function in Patients With Cystic Fibrosis | Cystic Fibrosis | Biological: ghrelin | Papworth Hospital | Recruiting | 18 Years | 80 Years | Both | 20 | N/A | United Kingdom | |
533 | NCT01093521 | April 2010 | 11 February 2019 | 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 | Not recruiting | 18 Years | 55 Years | All | 20 | Phase 1 | United States |
534 | NCT01321905 | April 2010 | 19 February 2015 | 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 |
535 | NCT01460836 | April 2010 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | N/A | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
536 | NCT01086839 | March 2010 | 19 February 2015 | 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 | Not recruiting | 8 Years | N/A | Both | 69 | N/A | Germany | |
537 | NCT01348204 | March 2010 | 19 February 2015 | 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) | Not recruiting | 8 Years | 65 Years | Both | 32 | Phase 2 | United States |
538 | NCT02198079 | March 2010 | 1 June 2015 | 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 | Not recruiting | N/A | 18 Years | Both | 85 | N/A | United States |
539 | EUCTR2009-014412-35-GB | 23/02/2010 | 19 March 2012 | 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE CAS Number: 86483-48-9 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Aradigm Corporation | Authorised | Female: yes Male: yes | 96 | Germany;United Kingdom | ||||
540 | NCT00889967 | February 2010 | 16 December 2017 | 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 | Not recruiting | 18 Years | 80 Years | All | 95 | Phase 2 | United States;Canada;Germany;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
541 | NCT01051999 | February 2010 | 19 February 2015 | 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. | Not recruiting | 18 Years | N/A | Both | 17 | Phase 2 | United States |
542 | NCT01059565 | February 2010 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 102 | Phase 3 | United States;Canada | |
543 | NCT01060566 | February 2010 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 24 | Phase 1 | United States | |
544 | NCT01069705 | February 2010 | 16 December 2017 | 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 | Not recruiting | 6 Years | 21 Years | All | 49 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania;Romania;Russian Federation;South Africa | |
545 | NCT01288170 | February 2010 | 19 February 2015 | 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 |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
546 | EUCTR2009-013340-36-IT | 25/01/2010 | 27 January 2014 | 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 Pharmaceutical Form: Concentrate for solution for infusion INN or Proposed INN: Reparixin CAS Number: 266359-83-5 Current Sponsor code: DF 1681Y Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 33- Pharmaceutical form of the placebo: Concentrate for solution for infusion Route of administration of the placebo: Intravenous use | IST. DI RICERCHE FARMACOLOG. M. NEGRI | Not Recruiting | Female: yes Male: yes | Italy | |||||
547 | EUCTR2009-016734-26-EE | 08/01/2010 | 29 October 2012 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tobramycin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Estonia;Lithuania;Bulgaria;Latvia | |||
548 | NCT00996424 | January 2010 | 19 February 2015 | 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 | Not recruiting | 6 Years | 64 Years | Both | 19 | Phase 4 | Belgium |
549 | NCT01044719 | January 2010 | 19 February 2015 | 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 | Not recruiting | 16 Years | N/A | Both | 240 | Phase 4 | United Kingdom | |
550 | NCT01155115 | January 2010 | 1 June 2015 | 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 | Not recruiting | 6 Years | 18 Years | Both | 46 | N/A | Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
551 | EUCTR2010-019267-11-DE | 29 May 2012 | 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 System Organ Class: 10017947 - Gastrointestinal disorders MedDRA version: 13.1 Level: PT Classification code 10011762 Term: Cystic fibrosis System Organ Class: 10010331 - Congenital, familial and genetic disorders | Trade Name: PANZYTRAT 25000 Product Name: PANZYTRAT 25000 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Pancreas Powder CAS Number: 8049-47-6 Other descriptive name: PANCREATIN Concentration unit: Other Concentration type: equal Concentration number: 25000- Trade Name: KREON 25000 Product Name: KREON 25000 Pharmaceutical Form: Capsule, hard CAS Number: 8049-47-6 Other descriptive name: PANCREATIN Concentration unit: Other Concentration type: equal Concentration number: 25000- | Axcan Pharma Inc. | Not Recruiting | Female: yes Male: yes | 68 | Germany | |||||
552 | EUCTR2010-023235-41-PL | 2 October 2017 | A comparative, randomised, two period, multi-center, cross-over 14 weeks bioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) in cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa infection - T-100 BE | A comparative, randomised, two period, multi-center, cross-over 14 weeks bioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) in cystic fibrosis patients with bronchopulmonary chronic Pseudomonas aeruginosa 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 Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Other descriptive name: Tobramycinum Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 170/1,7- Trade Name: TOBI® Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: TOBRAMYCIN CAS Number: 32986-56-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 300/5,0- | PARI Pharma GmbH | Not Recruiting | Female: yes Male: yes | 60 | Phase 1 | Poland | ||||
553 | EUCTR2010-023533-34-FR | 2 October 2017 | 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 Pharmaceutical Form: Inhalation vapour, solution Trade Name: Tobi Product Name: Tobi Pharmaceutical Form: Inhalation vapour, solution | EREMPHARMA SAS | Not Available | Female: yes Male: yes | Phase 1 | France | |||||
554 | EUCTR2009-016590-15-HU | 29/12/2009 | 4 August 2015 | 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 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 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 Level: LLT 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 50 | France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland | ||||
555 | NCT00812045 | December 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 44 | Phase 2 | Canada;Netherlands;Poland;Spain | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
556 | NCT01025713 | December 2009 | 3 August 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 0 | Phase 1 | Australia | |
557 | NCT01035853 | December 2009 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 10 | Phase 2 | Germany | |
558 | NCT01658449 | December 2009 | 19 February 2015 | 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 | Not recruiting | 8 Years | N/A | Both | 40 | N/A | Italy | ||
559 | EUCTR2008-008317-20-BE | 13/11/2009 | 7 October 2014 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Acetylcysteine CAS Number: 616-91-1 Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 3- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Inhalation use | University Hospital Ghent | Not Recruiting | Female: yes Male: yes | Belgium | |||||
560 | EUCTR2009-016662-90-FR | 03/11/2009 | 19 March 2012 | 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 Pharmaceutical Form: Capsule* Product Name: Vaccin grippal pandémique H1N1 Pharmaceutical Form: Solution for injection INN or Proposed INN: Vaccin grippal pandémique H1N1 | Inserm | Authorised | Female: yes Male: yes | France | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
561 | NCT01018368 | November 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Male | 24 | Phase 1 | United States | |
562 | NCT01094704 | November 2009 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 16 | Phase 1 | United States |
563 | EUCTR2009-014042-28-GB | 16/10/2009 | 19 March 2012 | 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 Pharmaceutical Form: Powder for infusion* INN or Proposed INN: Meropenem CAS Number: 119478-56-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 50- Trade Name: Ceftazidime Product Name: Ceftazidime Pharmaceutical Form: Powder for injection* INN or Proposed INN: Ceftazidime CAS Number: 72558-82-8 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 200- Trade Name: Tobramycin Product Name: Tobramycin Pharmaceutical Form: Solution for injection INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: up to Concentration number: 40- | Imperial College, London | Authorised | Female: yes Male: yes | 240 | United Kingdom | ||||
564 | EUCTR2009-015875-28-IT | 07/10/2009 | 3 April 2012 | 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 Level: SOC Classification code 10038738 | Pharmaceutical Form: Capsule, hard INN or Proposed INN: Lactic acid producing organisms Concentration unit: CFU/g colony forming unit(s)/gram Concentration type: equal Concentration number: 20000000000- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II | Authorised | Female: yes Male: yes | Italy | |||||
565 | NCT00999531 | October 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 24 | Phase 1 | Australia | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
566 | NCT00903201 | September 28, 2009 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 146 | Phase 2 | United States;Canada;France;Germany;Israel | |
567 | EUCTR2009-014050-15-BE | 18/09/2009 | 14 October 2013 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- INN or Proposed INN: TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- INN or Proposed INN: TACROLIMUS CAS Number: 104987113 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5- Trade Name: Advagraf prolonged-release hard capsules Product Name: Tacrolimus prolonged-release hard capsules Pharmaceutical Form: Capsule, hard | Hopital Erasme - Chest service | Authorised | Female: yes Male: yes | Belgium | |||||
568 | EUCTR2009-013660-39-FR | 10/09/2009 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: tobramycine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Trade Name: Tobi Product Name: Tobi Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: tobramycine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Erempharma SAS | Authorised | Female: yes Male: yes | France | |||||
569 | EUCTR2008-002318-22-LT | 07/09/2009 | 29 May 2012 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: tobramycin Other descriptive name: TBM100C Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | |||
570 | EUCTR2008-004764-39-LT | 07/09/2009 | 15 May 2012 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: tobramycin Current Sponsor code: TBM100C Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | Bulgaria;Estonia;Latvia;Lithuania | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
571 | NCT00951522 | September 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | 45 Years | Male | 15 | Phase 1 | Australia | |
572 | NCT00953706 | September 2009 | 19 October 2017 | 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 | Not recruiting | 12 Years | N/A | All | 140 | Phase 2 | United States |
573 | NCT00966602 | September 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | 55 Years | Both | 24 | Phase 1 | Netherlands | |
574 | NCT00970346 | September 2009 | 11 April 2016 | 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 | Not recruiting | 18 Years | 65 Years | Male | 26 | Phase 1 | United Kingdom |
575 | NCT00975663 | September 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 180 | Phase 4 | Belgium;France | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
576 | NCT00989807 | September 2009 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | N/A | Canada | ||
577 | NCT01031706 | September 2009 | 16 December 2017 | 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) | Not recruiting | 5 Years | 12 Years | All | 23 | N/A | United States |
578 | NCT01111383 | September 2009 | 11 June 2018 | 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. | Not recruiting | 6 Years | N/A | All | 209 | Phase 3 | France;Poland;Ukraine | |
579 | NCT01710449 | September 2009 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 44 | Phase 1 | United States | |
580 | NCT01961661 | September 2009 | 19 February 2015 | 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 | Not recruiting | 2 Years | 18 Years | Both | 22 | Phase 3 | Italy | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
581 | EUCTR2008-006446-25-NL | 26/08/2009 | 19 March 2012 | 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 Level: LLT Classification code 10011764 Term: Cystic fibrosis NOS | Product Name: VX-809 Product Code: VX-809 Pharmaceutical Form: Capsule, hard CAS Number: 936727-05-8 Current Sponsor code: VX-809 Other descriptive name: VRT-826809 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25-50 Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 90 | Germany;Netherlands;Belgium | ||||
582 | EUCTR2008-007416-15-IE | 11/08/2009 | 10 July 2015 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Other descriptive name: VRT-813077 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 100 | Phase 3 | France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom | |||
583 | EUCTR2008-007479-26-IE | 11/08/2009 | 29 May 2012 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: ivacaftor CAS Number: 873054-44-5 Current Sponsor code: VX-770 Other descriptive name: VRT-813077 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | Germany;United Kingdom;Canada;France;Ireland;United States;Australia | |||
584 | NCT00803205 | July 2009 | 16 December 2017 | 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 (PTC124);Drug: Placebo | PTC Therapeutics | Cystic Fibrosis Foundation Therapeutics | Not recruiting | 6 Years | N/A | All | 238 | Phase 3 | United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom |
585 | NCT00910351 | July 2009 | 19 February 2015 | 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 | Not recruiting | 6 Years | 12 Years | Both | 19 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
586 | NCT00945347 | July 2009 | 19 February 2015 | 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 | Not recruiting | 14 Years | N/A | Both | 10 | Phase 2 | Belgium | |
587 | EUCTR2008-007877-19-DE | 15/06/2009 | 29 April 2013 | 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Colistimethat-Natrium Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 1 million- | University of Jena | Not Recruiting | Female: yes Male: yes | 14 | Germany | ||||
588 | EUCTR2009-009869-34-DE | 08/06/2009 | 11 March 2013 | 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 Classification code 10006445 Term: Bronchiectasis | Product Name: Cipro Inhale Product Code: BAYq3939 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Ciprofloxacin CAS Number: 85721-33-1 Current Sponsor code: BAYQ3939 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32,5- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 122 | Spain;Germany;United Kingdom;Sweden | ||||
589 | ChiCTR-TRC-13003979 | 2009-05-07 | 18 April 2017 | 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 | Not Recruiting | 18 | 70 | Both | Roxithromycin group:26;Control group:26; | Post-market | China | |
590 | NCT01737983 | May 2009 | 19 February 2015 | 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 | Not recruiting | 6 Years | 42 Years | Both | 61 | Phase 4 | Italy | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
591 | NCT01880723 | May 2009 | 19 October 2017 | 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) | Not recruiting | 15 Years | 55 Years | All | 32 | N/A | United States |
592 | EUCTR2009-011289-27-IT | 22/04/2009 | 3 April 2012 | Probiotics in Cystic Fibrosis - ND | Probiotics in Cystic Fibrosis - ND | Cystic Fibrosis Patients MedDRA version: 9.1 Level: SOC Classification code 10017947 | Pharmaceutical Form: Modified-release capsule, soft INN or Proposed INN: Lactic acid producing organisms Concentration unit: CFU/g colony forming unit(s)/gram Concentration type: equal Concentration number: 20000000000- Pharmaceutical form of the placebo: Modified-release capsule, soft Route of administration of the placebo: Oral use | UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II | Authorised | Female: yes Male: yes | Italy | |||||
593 | EUCTR2008-003924-52-SE | 08/04/2009 | 19 November 2012 | 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 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: ataluren CAS Number: 775304-57-9 Current Sponsor code: PTC124 Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Pharmaceutical form of the placebo: Powder for oral suspension Route of administration of the placebo: Oral use Product Name: PTC124 Product Code: PTC124 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: ataluren CAS Number: 775304-57-9 Current Sponsor code: PTC124 Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Powder for oral suspension Route of administration of the placebo: Oral use Product Name: PTC124 Product Code: PTC124 Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: ataluren CAS Number: 775304-57-9 Current Sponsor code: PTC124 Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1000- Pharmaceutical form of the placebo: Powder for oral suspension Route of administration of the placebo: Oral use | PTC Therapeutics, Inc | Not Recruiting | Female: yes Male: yes | 208 | Phase 3 | France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden | |||
594 | NCT00709280 | April 2009 | 19 February 2015 | 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) | Not recruiting | 4 Months | 59 Months | Both | 321 | N/A | United States;Canada |
595 | NCT00775528 | April 2009 | 19 October 2017 | 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 | Not recruiting | 1 Month | 6 Years | All | 19 | Phase 3 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
596 | NCT00840333 | April 2009 | 29 January 2018 | 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. | Not recruiting | 6 Years | 16 Years | All | 27 | Phase 1 | United States | |
597 | NCT00843817 | April 2009 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 15 | Phase 4 | France | |
598 | NCT00880100 | April 2009 | 16 December 2017 | 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 | Not recruiting | 2 Years | 6 Years | All | 49 | Phase 3 | United States | |
599 | NCT00885365 | April 2009 | 19 October 2017 | 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. | Not recruiting | 6 Years | N/A | All | 324 | Phase 3 | Czech Republic;France;Germany;Hungary;Poland;Russian Federation;Spain;Ukraine | |
600 | EUCTR2008-001530-27-GB | 11/03/2009 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: none CAS Number: none Current Sponsor code: AZD9668 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 30- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 70 | Phase 2 | Germany;United Kingdom;Denmark;Sweden | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
601 | EUCTR2009-009875-37-NL | 11/03/2009 | 10 June 2013 | 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 Pharmaceutical Form: Tablet Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Staf Longziekten | Not Recruiting | Female: yes Male: yes | 25 | Netherlands | ||||
602 | NCT00865904 | March 2009 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 93 | Phase 2 | United States;Belgium;Canada;Germany;Netherlands | |
603 | NCT01377792 | March 2009 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 71 | Phase 4 | Spain | |
604 | EUCTR2008-005080-33-IT | 05/02/2009 | 3 April 2012 | 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: Glutathione Concentration unit: mg/kg milligram(s)/kilogram Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Powder for nebuliser solution Route of administration of the placebo: Inhalation use | AZIENDA OSPEDALIERA VINCENZO MONALDI DI NAPOLI | Authorised | Female: yes Male: yes | Italy | |||||
605 | NCT00663975 | February 2009 | 19 February 2015 | 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. | Not recruiting | N/A | 2 Years | Both | 24 | N/A | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
606 | NCT00846781 | February 2009 | 19 February 2015 | 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. | Not recruiting | 5 Years | N/A | Both | 308 | Phase 3 | United States;Australia;Canada;New Zealand | ||
607 | EUCTR2008-008228-34-GB | 28/01/2009 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: MANNITOL CAS Number: 69658 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 400- | Pharmaxis Ltd | Not Recruiting | Female: yes Male: yes | 18 | United Kingdom | ||||
608 | EUCTR2008-001284-11-ES | 19/01/2009 | 19 March 2012 | 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% Pharmaceutical Form: Nebuliser solution INN or Proposed INN: CLORURO SODICO 7% Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 10-12H Trade Name: CLORURO SODICO 7% Product Name: CLORURO SODICO 7% Pharmaceutical Form: INN or Proposed INN: CLORURO SODICO 7% Concentration unit: ml millilitre(s) Concentration type: equal Concentration number: 5-12H | ADELAIDA LAMAS FERREIRO | Authorised | Female: yes Male: yes | Spain | |||||
609 | NCT03905642 | January 8, 2009 | 15 April 2019 | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE™) - Extension Phase | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKACE TM) in Cystic Fibrosis Patients With Chronic Infections Due to Pseudomonas Aeruginosa | Cystic Fibrosis | Drug: Arikace | Insmed Incorporated | Not recruiting | 6 Years | N/A | All | 49 | Phase 2 | Belgium;Hungary;Macedonia, The Former Yugoslav Republic of;Poland;Serbia;Slovakia;Ukraine | |
610 | EUCTR2009-011740-19-Outside-EU/EEA | 16 February 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 CAS Number: 78110-38-0 Current Sponsor code: AZLI Other descriptive name: N/A Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Powder and solvent for nebuliser solution Route of administration of the placebo: Inhalation use | Gilead Sciences, Inc. | Not Available | Female: yes Male: yes | 100 | Phase 3b | United States;Canada | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
611 | EUCTR2008-005045-34-GB | 15/12/2008 | 9 May 2016 | 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 Pharmaceutical Form: Powder for nebuliser solution Other descriptive name: colistimethate sodium Concentration unit: Munit million units Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Profile Pharma Ltd | Not Recruiting | Female: yes Male: yes | 144 | Phase 3 | Ukraine;Ireland;Russian Federation;United Kingdom | |||
612 | NCT00685971 | December 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 200 | N/A | Canada | |
613 | NCT00792714 | December 2008 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 18 | Phase 1 | Australia;United Kingdom | |
614 | EUCTR2008-002740-42-DE | 13/11/2008 | 3 September 2012 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Mannitol CAS Number: 69658 Concentration unit: mg milligram(s) Concentration number: 40- Product Name: Inhaled dry powder mannitol Product Code: IDPM Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Mannitol CAS Number: 69658 Concentration unit: mg milligram(s) Concentration number: 5- Product Name: Inhaled dry powder mannitol Product Code: MTT Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Mannitol CAS Number: 69658 Concentration unit: mg milligram(s) Concentration number: 40- | Pharmaxis Pharmaceuticals Limited | Not Recruiting | Female: yes Male: yes | 300 | Germany;Netherlands;Belgium;France | ||||
615 | EUCTR2007-006648-23-DE | 12/11/2008 | 19 March 2012 | 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 Level: LLT Classification code 10000244 Term: ABPA | Trade Name: Xolair 150 mg Pulver und Injektionslösung zur Herstellung einer Injektionslösung Product Name: Xolair Product Code: IGE025 Pharmaceutical Form: Powder and solvent for solution for injection INN or Proposed INN: Omalizumab CAS Number: 242138-07-4 Current Sponsor code: IGE025 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150- Pharmaceutical form of the placebo: Powder for solution for injection Route of administration of the placebo: Subcutaneous use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 60 | United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
616 | NCT00787917 | November 2008 | 19 October 2017 | 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 | Not recruiting | 12 Years | N/A | All | 14 | Phase 4 | Belgium;Germany;Italy;Netherlands;United Kingdom | |
617 | NCT00789867 | November 2008 | 29 June 2015 | 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 | Not recruiting | 16 Years | 70 Years | Both | 27 | Phase 1/Phase 2 | United Kingdom |
618 | NCT00794586 | November 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 120 | Phase 2 | United States | |
619 | NCT00800579 | November 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | 45 Years | Male | 12 | Phase 1 | Australia | |
620 | NCT00803179 | November 2008 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 5 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
621 | NCT00809094 | November 2008 | 19 October 2017 | 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 | Not recruiting | 7 Years | N/A | All | 70 | Phase 2 | United States |
622 | NCT00846573 | November 2008 | 19 October 2017 | 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 | Not recruiting | 5 Years | N/A | All | 14 | N/A | United States | |
623 | NCT01112059 | November 2008 | 16 December 2017 | 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 | Not recruiting | 19 Years | N/A | All | 40 | N/A | United States |
624 | EUCTR2008-004699-34-NL | 28/10/2008 | 26 June 2012 | 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 Pharmaceutical Form: Tablet Current Sponsor code: AZD1236 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | AstraZeneca AB | Not Recruiting | Female: yes Male: yes | 50 | Phase 2 | Netherlands;Spain | |||
625 | EUCTR2006-004155-38-BE | 21/10/2008 | 7 October 2014 | 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 Pharmaceutical Form: Capsule, soft Other descriptive name: OMEGA-3-ACID TRIGLYCERIDES Concentration unit: mg milligram(s) Concentration type: up to Concentration number: 300- Pharmaceutical form of the placebo: Capsule, soft Route of administration of the placebo: Oral use | Hôpital Universitaire Des Enfants Reine Fabiola (H.U.D.E.R.F.) | Authorised | Female: yes Male: yes | 80 | Belgium | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
626 | NCT00757848 | October 2008 | 19 October 2017 | 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 | Not recruiting | 16 Years | N/A | All | 56 | Phase 2 | Denmark;Germany;Poland;Russian Federation;Sweden;United Kingdom | |
627 | NCT00774072 | October 2008 | 19 February 2015 | 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 | Not recruiting | 8 Years | N/A | Both | 9 | Phase 2 | Germany | |
628 | NCT00788138 | October 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | 70 Years | Both | 30 | N/A | United States | ||
629 | NCT00934362 | October 2008 | 16 December 2017 | 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 | Not recruiting | 14 Years | N/A | All | 16 | Phase 2 | United States |
630 | EUCTR2008-001769-27-GB | 29/09/2008 | 19 March 2012 | 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 Fibrosis Specifically 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 Pharmaceutical Form: Oral suspension Pharmaceutical form of the placebo: Oral solution Route of administration of the placebo: Oral use | Southampton University Hospital Trust | Authorised | Female: yes Male: yes | 45 | United Kingdom | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
631 | EUCTR2008-001156-43-FR | 19/09/2008 | 10 July 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution Other descriptive name: TIOTROPIUM Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 2.5- Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation Pharmaceutical Form: Inhalation vapour, solution Other descriptive name: TIOTROPIUM Concentration unit: µg microgram(s) Concentration type: equal Concentration number: 1.25- Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use | Boehringer Ingelheim France | Authorised | Female: yes Male: yes | 596 | Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy | ||||
632 | EUCTR2007-004050-85-GB | 15/09/2008 | 26 June 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution | Imperial College | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
633 | EUCTR2007-006276-11-GB | 01/09/2008 | 11 February 2013 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: HEPARIN SODIUM CAS Number: 9041081 Concentration unit: IU/mg international unit(s)/milligram Concentration type: not less then Concentration number: 150- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Vectura Limited | Not Recruiting | Female: yes Male: yes | 64 | Phase 1/2 | Ireland;Italy;United Kingdom | |||
634 | NCT00630812 | September 2008 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 318 | Phase 3 | United States;Argentina;Belgium;Canada;France;Germany;Netherlands |
635 | EUCTR2007-004956-35-GB | 27/08/2008 | 19 March 2012 | 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 Level: LLT Classification code 10060439 Term: Stress induced hyperglycaemia MedDRA version: 9.1 Level: LLT Classification code 10022484 Term: Insulin hypoglycaemia MedDRA version: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis | Trade Name: Actrapid 100 IU/ml, Solution for injection in a vial Pharmaceutical Form: Solution for injection Trade Name: Levemir 100 U/ml solution for injection in a cartridge, Levemir 100 U/ml solution for injection in a pre-filled pen Pharmaceutical Form: Solution for injection 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. Pharmaceutical Form: Solution for injection 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 Pharmaceutical Form: Solution for injection | St George's, University of London | Not Recruiting | Female: yes Male: yes | United Kingdom | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
636 | EUCTR2008-001728-30-DE | 26/08/2008 | 11 March 2013 | A Phase 2, 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 Cystic Fibrosis Patients | A Phase 2, 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 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 Level: LLT Classification code 10021860 Term: Infection pseudomonas aeruginosa | Product Name: MP-376 Product Code: MP-376 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: levofloxacin CAS Number: 100986-85-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Mpex Pharmaceuticals, Inc. | Not Recruiting | Female: yes Male: yes | 190 | Phase 2 | Netherlands;Germany | |||
637 | EUCTR2007-004507-36-DE | 19/08/2008 | 19 November 2012 | 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name: Tobi Product Name: Tobi Product Code: TBM100 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name: Tobi Product Name: Tobi Product Code: TBM100 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Trade Name: Tobi Product Name: Tobi Product Code: TBM100 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Current Sponsor code: TBM100 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Novartis Pharma GmbH | Not Recruiting | Female: yes Male: yes | Germany | |||||
638 | EUCTR2008-000164-17-DE | 13/08/2008 | 15 April 2013 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: tobramycin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Inhalation use | University of Jena | Not Recruiting | Female: yes Male: yes | 14 | Germany | ||||
639 | EUCTR2008-002352-20-BE | 11/08/2008 | 7 October 2014 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: miglustat CAS Number: 72599-27-0 Current Sponsor code: OGT918 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Not Recruiting | Female: yes Male: yes | Belgium | |||||
640 | NCT00639626 | August 2008 | 11 June 2018 | 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 | Not recruiting | 16 Years | 45 Years | All | 6 | Phase 2/Phase 3 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
641 | NCT00659529 | August 2008 | 16 December 2017 | 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 Therapeutics | Not recruiting | 14 Years | N/A | All | 36 | Phase 1/Phase 2 | United States |
642 | NCT00662675 | August 2008 | 19 October 2017 | 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. | Not recruiting | 7 Years | 60 Years | All | 40 | Phase 3 | United States;Canada | |
643 | NCT00742092 | August 2008 | 19 February 2015 | 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 | Not recruiting | 12 Years | N/A | Both | 11 | Phase 2 | Belgium | |
644 | NCT00744250 | August 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 3 | Phase 4 | United States |
645 | NCT00757237 | August 2008 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 274 | Phase 3 | United States;Austria;Belgium;Denmark;France;Germany;Ireland;Italy;Netherlands;Portugal;Spain;Switzerland;United Kingdom;Poland |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
646 | EUCTR2006-006215-68-CZ | 29/07/2008 | 19 March 2012 | 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 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung | Trade Name: Bramitob Product Name: Tobrineb/Bramitob Pharmaceutical Form: Nebuliser solution INN or Proposed INN: tobramycin CAS Number: as32986-56-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300mg-4ml Trade Name: Tobi 300mg/5ml Nebuliser solution. Product Name: Tobi Pharmaceutical Form: Nebuliser solution INN or Proposed INN: tobramycin CAS Number: 49842-07-1 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300mg-5ml | Chiesi Farmaceutici S.p.A | Authorised | Female: yes Male: yes | 320 | Hungary;Germany;Czech Republic;France;Spain | ||||
647 | EUCTR2007-004063-21-NL | 24/07/2008 | 19 March 2012 | 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 Pharmaceutical Form: Powder for oral solution INN or Proposed INN: Bucelipase alfa CAS Number: 9026-00-0 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 170- Trade Name: Nexium 20 Product Name: Nexium Pharmaceutical Form: Film-coated tablet INN or Proposed INN: Esomeprazole CAS Number: 161796-78-7 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- | Biovitrum AB | Not Recruiting | Female: yes Male: yes | 18 | Netherlands | ||||
648 | NCT00706004 | July 2008 | 19 October 2017 | 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. | Not recruiting | 18 Years | N/A | All | 9 | N/A | United States |
649 | NCT01172301 | July 2008 | 17 August 2015 | 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 | Not recruiting | 10 Years | 21 Years | Both | 14 | N/A | United States |
650 | NCT00566241 | June 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 15 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
651 | NCT00677365 | June 2008 | 29 January 2018 | 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. | Not recruiting | 16 Years | N/A | All | 151 | Phase 2 | United States;Germany;Netherlands | |
652 | NCT00680316 | June 2008 | 19 October 2017 | 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. | Not recruiting | 3 Years | 5 Years | All | 3 | Phase 4 | United States | |
653 | NCT00690820 | June 2008 | 19 October 2017 | 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 | Not recruiting | 7 Years | 11 Years | All | 17 | Phase 3 | United States | |
654 | NCT00411736 | May 2008 | 19 February 2015 | 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 | Not recruiting | 1 Year | N/A | Both | 45 | Phase 4 | Denmark;Norway;Sweden |
655 | NCT00645788 | May 2008 | 19 October 2017 | 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 | Not recruiting | 12 Years | N/A | All | 288 | Phase 2 | United States;Australia;Canada;Denmark;Germany;Israel;Norway;Sweden;United Kingdom |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
656 | NCT00712166 | May 2008 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 160 | Phase 3 | United States;Australia;Canada | |
657 | EUCTR2007-004277-26-BE | 29/04/2008 | 10 July 2012 | 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: aztreonam lysine Current Sponsor code: AZLI Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 75- Trade Name: TOBI Pharmaceutical Form: Nebuliser solution INN or Proposed INN: tobramycin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- | Gilead Sciences Inc | Authorised | Female: yes Male: yes | 273 | Phase 3 | Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria | |||
658 | EUCTR2008-006502-42-IT | 22/04/2008 | 26 June 2012 | 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- Pharmaceutical Form: Powder and solvent for solution for infusion INN or Proposed INN: Colistin Concentration unit: million IU million international units Concentration type: equal Concentration number: 1- Pharmaceutical Form: Tablet INN or Proposed INN: Ciprofloxacin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 500- | AZIENDA OSPEDALIERA MEYER | Authorised | Female: yes Male: yes | Italy | |||||
659 | EUCTR2007-001782-15-IT | 09/04/2008 | 19 March 2012 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Dexamethasone Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- | ISTITUTO GIANNINA GASLINI | Authorised | Female: yes Male: yes | Italy | |||||
660 | NCT00700050 | April 2008 | 19 February 2015 | 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 | Recruiting | N/A | 22 Years | Both | 32 | Phase 3 | Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
661 | NCT01323101 | April 2008 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 21 | Phase 4 | United States | |
662 | NCT01759342 | April 2008 | 3 August 2015 | 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 | Not recruiting | 6 Years | 21 Years | Both | 23 | N/A | United States | |
663 | EUCTR2007-003868-22-FR | 19/03/2008 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution Pharmaceutical form of the placebo: Inhalation vapour, liquid | Laboratoire Erempharma | Authorised | Female: yes Male: yes | France | |||||
664 | NCT00628134 | March 2008 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 8 | N/A | United States |
665 | NCT00635141 | March 2008 | 19 February 2015 | 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 | Not recruiting | 6 Years | 18 Years | Both | 20 | Phase 3 | Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
666 | NCT00638365 | March 2008 | 19 October 2017 | 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 | Not recruiting | 12 Years | N/A | All | 27 | Phase 1/Phase 2 | United States | |
667 | NCT00762918 | March 2008 | 19 February 2015 | 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 | Not recruiting | 10 Years | 25 Years | Both | 0 | Phase 3 | United States | |
668 | EUCTR2007-004004-12-BG | 28/02/2008 | 19 March 2012 | 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 Level: LLT Classification code 10033596 Term: Pancreatectomy | Trade Name: Creon 10000 Product Name: Pancrelipase Delayed Release Capsule Pharmaceutical Form: Capsule, hard Other descriptive name: Pancrelipase/Pancreas Powder Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 12000- Pharmaceutical form of the placebo: Capsule, hard Route of administration of the placebo: Oral use Trade Name: Creon 25000 Product Name: Pancrelipase Delayed Release Capsule Pharmaceutical Form: Capsule, hard Other descriptive name: Pancrelipase/Pancreas Powder Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 24000- | Solvay Pharmaceuticals GmbH | Not Recruiting | Female: yes Male: yes | 52 | Bulgaria | ||||
669 | NCT00605761 | February 2008 | 19 February 2015 | 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 | Not recruiting | 16 Years | N/A | Both | 9 | Phase 1 | United States | |
670 | NCT00625612 | February 2008 | 19 February 2015 | 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. | Not recruiting | 5 Years | N/A | Both | 466 | Phase 3 | United States;Australia;Canada;New Zealand | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
671 | NCT00634192 | February 2008 | 16 December 2017 | 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 | Not recruiting | 6 Years | N/A | All | 50 | Phase 3 | Germany | |
672 | NCT01983774 | February 2008 | 28 April 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 13 | Phase 2 | United States | |
673 | NCT00557089 | January 2008 | 19 February 2015 | 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 | Not recruiting | 6 Years | 18 Years | Both | 17 | Phase 4 | Canada | |
674 | NCT00558844 | January 2008 | 17 October 2016 | Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikace™) In Cystic Fibrosis Patients | Phase 1b/2a Multidose Safety and Tolerability Study of Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patient With Chronic Infections Due to Pseudomonas Aeruginosa. | Cystic Fibrosis | Drug: Placebo;Drug: Arikace™ | Insmed Incorporated | Not recruiting | 6 Years | N/A | Both | 46 | Phase 1/Phase 2 | United States | |
675 | NCT00719381 | January 2008 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 24 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
676 | EUCTR2008-002673-13-DE | 18 April 2012 | 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 Pharmaceutical Form: Capsule* INN or Proposed INN: Amitriptyline CAS Number: 50486 Current Sponsor code: Amitriptyline Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 12.5- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | PSKS | Authorised | Female: yes Male: yes | Germany | ||||||
677 | EUCTR2007-005346-20-GB | 04/12/2007 | 19 March 2012 | 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: tobramycin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Leeds Teaching Hospitals NHS Trust | Not Recruiting | Female: yes Male: yes | 30 | United Kingdom | ||||
678 | NCT00484263 | December 2007 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 40 | Phase 3 | Australia | |
679 | EUCTR2007-003628-39-IT | 22/11/2007 | 19 March 2012 | 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 Pharmaceutical Form: Nasal spray, solution INN or Proposed INN: TOBRAMYCIN Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 6- Pharmaceutical form of the placebo: Nasal spray, solution Route of administration of the placebo: Nasal use | ECUPHARMA S.R.L. | Not Recruiting | Female: yes Male: yes | Italy | |||||
680 | NCT00510484 | November 2007 | 19 October 2017 | 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 | Not recruiting | 12 Years | N/A | All | 35 | Phase 3 | United States;Hungary;Israel;South Africa;Spain | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
681 | NCT00537602 | November 2007 | 19 February 2015 | 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 | Not recruiting | 12 Years | N/A | Both | 6 | Phase 2 | Spain | |
682 | EUCTR2007-002912-24-DE | 30/10/2007 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: CIPROFLOXACIN CAS Number: 85721331 Current Sponsor code: BAY q 3939 Other descriptive name: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[1-piperazinyl]-3-quinoline carboxylic acid Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 32,5- | Bayer HealthCare AG | Not Recruiting | Female: yes Male: yes | 16 | Germany | ||||
683 | EUCTR2007-002657-23-DE | 01/10/2007 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: NA Current Sponsor code: VX-770 Other descriptive name: VRT-813077 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use Product Name: VX-770 Product Code: VX-770, VRT-813077 Pharmaceutical Form: Tablet INN or Proposed INN: NA Current Sponsor code: VX-770 Other descriptive name: VRT-813077 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- | Vertex Pharmaceuticals Incorporated | Not Recruiting | Female: yes Male: yes | 36 | Phase 2a | Germany | |||
684 | NCT00528190 | October 2007 | 16 December 2017 | 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 | Not recruiting | 6 Years | N/A | All | 35 | Phase 4 | Canada |
685 | NCT00541190 | October 2007 | 16 December 2017 | 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 | Not recruiting | 18 Years | N/A | All | 21 | N/A | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
686 | NCT00686361 | October 2007 | 19 February 2015 | 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 | Not recruiting | 5 Years | 17 Years | Both | 34 | N/A | Canada |
687 | NCT01070446 | October 2007 | 19 February 2015 | 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) | Not recruiting | 5 Years | 17 Years | Both | 34 | N/A | Canada |
688 | EUCTR2007-000724-40-BE | 27/09/2007 | 19 March 2012 | 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 Pharmaceutical Form: Oral powder Current Sponsor code: PTC124 Concentration unit: % (W/W) percent weight/weight Concentration type: equal Concentration number: 25- | PTC Therapeutics, Inc. | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | Belgium | |||
689 | EUCTR2007-001412-23-IE | 27/09/2007 | 19 March 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: 9.1 Level: LLT Classification code 10011762 Term: Cystic fibrosis | Product Name: Inhaled dry powder mannitol Product Code: IDPM Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Mannitol CAS Number: 69658 Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Pharmaxis Pharmaceuticals Limited | Not Recruiting | Female: yes Male: yes | 250 | United Kingdom;Ireland | ||||
690 | NCT00221546 | September 2007 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 17 | Phase 2 | Belgium |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
691 | NCT00499837 | September 2007 | 20 June 2016 | 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. | Not recruiting | 5 Years | N/A | Both | 21 | Phase 2 | Israel | |
692 | NCT00531882 | September 2007 | 16 December 2017 | 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 | Not recruiting | 18 Years | 50 Years | All | 25 | N/A | United States | |
693 | NCT00534079 | September 2007 | 19 February 2015 | 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 | Not recruiting | 5 Years | N/A | Both | 23 | Phase 3 | Germany | |
694 | NCT00546663 | September 2007 | 19 February 2015 | 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 | Not recruiting | 12 Months | 30 Months | Both | 19 | N/A | United States;Canada |
695 | NCT01851642 | September 2007 | 26 August 2019 | 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 | Recruiting | 18 Years | N/A | All | 220 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
696 | EUCTR2007-000959-33-DE | 16/08/2007 | 19 March 2012 | 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 Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin Current Sponsor code: T100 PARI Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 100- Trade Name: TOBI® Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin Current Sponsor code: TOBI® Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- | PARI GmbH | Not Recruiting | Female: yes Male: yes | 25 | Germany | ||||
697 | NCT01018303 | August 2007 | 19 February 2015 | 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) | Not recruiting | 10 Years | 40 Years | Both | 17 | Phase 1/Phase 2 | United States |
698 | EUCTR2006-002049-35-ES | 22/07/2007 | 19 March 2012 | 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 Pharmaceutical Form: Capsule, hard INN or Proposed INN: Miglustat CAS Number: 72599-27-0 Current Sponsor code: OGT 918 Other descriptive name: 1,5 (Butylimino)-1,5-dideoxy-D-glucitol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Actelion Pharmaceuticals Ltd | Authorised | Female: yes Male: yes | 25 | Spain | ||||
699 | NCT00425165 | July 2007 | 19 February 2015 | 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. | Not recruiting | 10 Years | N/A | Both | 6 | Phase 2 | United States | |
700 | NCT00506792 | July 2007 | 19 February 2015 | 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 | Not recruiting | 18 Years | 50 Years | Both | 9 | Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
701 | NCT00513682 | July 2007 | 16 December 2017 | 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 | Not recruiting | 7 Years | 11 Years | All | 9 | Phase 3 | United States | |
702 | NCT01293084 | July 2007 | 19 October 2017 | 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 | Not recruiting | 7 Years | 12 Years | All | 17 | Phase 2 | |
703 | EUCTR2007-002707-40-BE | 28/06/2007 | 7 October 2014 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Sodium Chloride CAS Number: 7647-14-5 Concentration unit: % percent Concentration type: equal Concentration number: 7- Product Name: Normal saline solution Pharmaceutical Form: Solution for injection INN or Proposed INN: Sodium Chloride CAS Number: 7647-14-5 Concentration unit: % percent Concentration type: equal Concentration number: 0,9- | University Hospital Ghent | Not Recruiting | Female: yes Male: yes | 60 | Belgium | ||||
704 | EUCTR2006-006980-22-HU | 14/06/2007 | 19 March 2012 | 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™) Pharmaceutical Form: Nebuliser suspension | Transave, Inc. | Not Recruiting | Female: yes Male: yes | 60 | Hungary;Belgium | ||||
705 | NCT00449904 | June 2007 | 19 February 2015 | 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 | Not recruiting | 7 Years | N/A | Both | 214 | Phase 3 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
706 | NCT00503490 | June 2007 | 29 January 2018 | 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. | Not recruiting | 16 Years | N/A | All | 40 | Phase 1 | United States | |
707 | EUCTR2006-003275-12-DK | 23/05/2007 | 16 August 2016 | 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. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study | 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. 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: AZITHROMYCIN CAS Number: 83905015 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 250- Pharmaceutical form of the placebo: Coated tablet Route of administration of the placebo: Oral use Trade Name: Zitromax Product Name: zitromax Product Code: zitromax Pharmaceutical Form: Powder for oral suspension INN or Proposed INN: AZITHROMYCIN CAS Number: 83905015 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Granules for oral solution Route of administration of the placebo: Oral use | Copenhagen CF-centre | Not Recruiting | Female: yes Male: yes | 250 | Phase 4 | Denmark | |||
708 | EUCTR2006-006693-24-AT | 09/05/2007 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use | AOP Orphan Pharmaceuticals AG | Not Recruiting | Female: yes Male: yes | 160 | Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden | ||||
709 | NCT00449878 | May 2007 | 19 February 2015 | 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 | Not recruiting | 7 Years | N/A | Both | 163 | Phase 3 | United States | |
710 | NCT00457821 | May 2007 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 39 | Phase 2 | United States;Canada;Germany |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
711 | EUCTR2007-001007-38-FR | 25/04/2007 | 19 March 2012 | 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 Pharmaceutical Form: Oral solution INN or Proposed INN: d-a-tocopheryl PEG 1000 succinate Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 50- | ORPHAN | Authorised | Female: yes Male: yes | France | |||||
712 | EUCTR2006-006362-41-GB | 05/04/2007 | 19 March 2012 | 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 Pharmaceutical Form: Film-coated tablet INN or Proposed INN: VORICONAZOLE CAS Number: 137234629 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200- | Leeds Teaching Hospital NHS Trust | Authorised | Female: yes Male: yes | United Kingdom | |||||
713 | EUCTR2006-004078-28-GB | 14/03/2007 | 21 August 2017 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: MANNITOL CAS Number: 69658 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Pharmaceutical form of the placebo: Inhalation powder, hard capsule Route of administration of the placebo: Inhalation use | Pharmaxis UK Limited | Not Recruiting | Female: yes Male: yes | 250 | Phase 3 | United Kingdom | |||
714 | NCT00434278 | March 2007 | 16 December 2017 | 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. | Not recruiting | 14 Years | N/A | All | 27 | Phase 4 | United States | |
715 | NCT00446680 | March 2007 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 340 | Phase 3 | Australia;Ireland;United Kingdom | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
716 | NCT00458341 | March 2007 | 19 February 2015 | PTC124 for Pediatric Patients With Cystic Fibrosis | A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis | Cystic Fibrosis | Drug: PTC124 | PTC Therapeutics | Not recruiting | 6 Years | 18 Years | Both | 30 | Phase 2 | Belgium;France;Israel | |
717 | NCT00431964 | February 2007 | 19 October 2017 | 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 | Not recruiting | 6 Years | 18 Years | All | 263 | Phase 4 | United States;Canada |
718 | NCT00777296 | February 2007 | 28 November 2016 | Multidose Safety and Tolerability Study of Dose Escalation of Liposomal Amikacin for Inhalation (ARIKAYCE™) | Phase 1b/2a 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™;Drug: Placebo | Insmed Incorporated | Not recruiting | 6 Years | N/A | Both | Phase 1/Phase 2 | Belgium;Hungary;Macedonia, The Former Yugoslav Republic of;Poland;Serbia;Slovakia;Ukraine;Bulgaria | ||
719 | NCT00406536 | January 2007 | 19 February 2015 | 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) | Not recruiting | 6 Years | 17 Years | Both | 110 | Phase 2 | United States |
720 | NCT00432861 | January 2007 | 19 February 2015 | 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. | Not recruiting | 7 Years | N/A | Both | 29 | Phase 3 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
721 | EUCTR2007-000171-41-PL | 2 October 2017 | 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 Pharmaceutical Form: Capsule* INN or Proposed INN: NA CAS Number: 9001-62-1 Other descriptive name: Lipase CLEC Concentration unit: U unit(s) Concentration type: equal Concentration number: 32,500 U- INN or Proposed INN: NA CAS Number: 9000-90-2 Other descriptive name: Amylase Concentration unit: U unit(s) Concentration type: equal Concentration number: 3,750 U- INN or Proposed INN: NA CAS Number: 9074-07-1 Other descriptive name: Protease Concentration unit: U unit(s) Concentration type: equal Concentration number: 25,000 U- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Altus Pharmaceuticals Inc | Not Available | Female: yes Male: yes | 176 | Phase 3 | Slovakia;Poland;Italy | ||||
722 | EUCTR2007-000178-21-PL | 2 October 2017 | 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 Pharmaceutical Form: Capsule* INN or Proposed INN: NA CAS Number: 9001-62-1 Other descriptive name: Lipase CLEC Concentration unit: U unit(s) Concentration type: equal Concentration number: 32,500 USP Units- INN or Proposed INN: NA CAS Number: 9000-90-2 Other descriptive name: Amylase Concentration unit: U unit(s) Concentration type: equal Concentration number: 3,750 USP Units- INN or Proposed INN: NA CAS Number: 9074-07-1 Other descriptive name: Protease Concentration unit: U unit(s) Concentration type: equal Concentration number: 25,000 USP Units- | Altus Pharmaceuticals Inc. | Not Recruiting | Female: yes Male: yes | 200 | Phase 3 | Slovakia;Poland;Italy | ||||
723 | EUCTR2007-000935-25-NL | 19 March 2012 | ‘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 Level: LLT Classification code 10011763 Term: Cystic fibrosis lung | Trade Name: Pulmozyme (Dornase alpha) Product Name: Pulmozyme Pharmaceutical Form: Nebuliser solution | ErasmusMC - Sophia Children's Hospital | Authorised | Female: yes Male: yes | 50 | Netherlands | |||||
724 | EUCTR2007-001548-36-DE | 2 October 2017 | 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 Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: Dornase alfa Other descriptive name: recombiant human Desoxyribonuclease ( rhDNase) Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1- Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Inhalation use | University of Jena | Not Recruiting | Female: yes Male: yes | 16 | Phase 3 | Germany | ||||
725 | EUCTR2006-005180-25-DE | 15/12/2006 | 19 March 2012 | A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiency Randomized, 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 insufficiency Randomized, 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 Pharmaceutical Form: Capsule* Current Sponsor code: LU 70274 Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 90000- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Nordmark Arzneimittel GmbH | Not Recruiting | Female: no Male: yes | 20 | Germany | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
726 | NCT00351078 | December 2006 | 8 January 2018 | 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 | Not recruiting | 18 Years | N/A | All | 19 | Phase 2 | Israel | |
727 | NCT00416182 | December 2006 | 19 October 2017 | 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. | Not recruiting | 5 Years | N/A | All | 16 | Phase 2 | United States |
728 | NCT00547053 | December 2006 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 25 | Phase 1 | United States |
729 | NCT00721071 | December 2006 | 19 February 2015 | 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 | Not recruiting | 6 Years | 18 Years | Both | 95 | Phase 2 | Canada | |
730 | EUCTR2006-001254-27-FR | 30/11/2006 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Répaglinide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 0.5- Trade Name: Actrapid Penfill 100UI/ml Product Name: Actrapid Penfill 100UI/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Insuline humaine recombinante Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 300- Trade Name: NovoNorm 1 mg Product Name: NovoNorm 1 mg Pharmaceutical Form: Tablet INN or Proposed INN: Répaglinide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 1- Trade Name: NovoNorm 2 mg Product Name: NovoNorm 2 mg Pharmaceutical Form: Tablet INN or Proposed INN: Répaglinide Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 2- | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | Authorised | Female: yes Male: yes | France | |||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
731 | NCT00405665 | November 2006 | 19 February 2015 | 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 | Not recruiting | 14 Years | N/A | Both | 20 | Phase 2 | Canada | |
732 | NCT00408317 | November 2006 | 16 December 2017 | 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 | Not recruiting | 7 Years | N/A | All | 36 | Phase 3 | United States | |
733 | NCT00450073 | November 2006 | 19 October 2017 | 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 | Not recruiting | 18 Years | 60 Years | All | 30 | N/A | United States |
734 | NCT00763412 | November 2006 | 16 December 2017 | 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) | Not recruiting | 12 Years | 24 Years | All | 31 | N/A | United States |
735 | EUCTR2005-005594-29-HU | 31/10/2006 | 19 March 2012 | 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 Pharmaceutical Form: Nebuliser solution CAS Number: 1391-36-2 Current Sponsor code: Moli1901 Other descriptive name: Duramycin, 2622U90 Concentration unit: g/l gram(s)/litre Concentration type: equal Concentration number: 0,5- Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | AOP Orphan Pharmaceuticals AG | Authorised | Female: yes Male: yes | 360 | Hungary;Czech Republic | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
736 | EUCTR2005-003870-88-DE | 20/10/2006 | 27 January 2014 | 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 Pharmaceutical Form: Inhalation vapour, liquid INN or Proposed INN: Glutathione Current Sponsor code: GSH Other descriptive name: reduced glutathione Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 600- Pharmaceutical form of the placebo: Inhalation vapour, liquid Route of administration of the placebo: Inhalation use | Mukoviszidose Institut gGmbH i. G. | Not Recruiting | Female: yes Male: yes | 160 | Germany | ||||
737 | EUCTR2006-002259-33-DE | 10/10/2006 | 24 April 2012 | Protocol for a Phase II-study Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study - | Protocol for a Phase II-study Anti-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 Pharmaceutical Form: Capsule* INN or Proposed INN: AMITRIPTYLINE CAS Number: 50486 Current Sponsor code: Amitriptyline Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 75- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use Trade Name: Amitriptylin-ct Tabletten Pharmaceutical Form: Capsule* INN or Proposed INN: AMITRIPTYLINE CAS Number: 50486 Current Sponsor code: Amitriptyline Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50- Trade Name: Amitriptylin-ct Tabletten Pharmaceutical Form: Capsule* INN or Proposed INN: AMITRIPTYLINE CAS Number: 50486 Current Sponsor code: Amitriptyline Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25- | Paediatrisches Sekretariat fuer Klinische Studien | Authorised | Female: yes Male: yes | Phase 2 | Germany | ||||
738 | NCT00515229 | October 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | 50 Years | Both | 18 | Phase 2 | Germany | |
739 | NCT00671723 | October 2006 | 16 December 2017 | 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 | Not recruiting | 18 Years | 90 Years | All | 33 | N/A | United States | |
740 | NCT01463371 | October 2006 | 19 February 2015 | 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 | Not recruiting | 16 Years | 80 Years | Both | 30 | N/A | Spain |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
741 | NCT02172534 | September 2006 | 19 February 2015 | 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 | Not recruiting | N/A | N/A | Both | 113 | Phase 1 | ||
742 | EUCTR2006-000945-20-GB | 22/08/2006 | 19 March 2012 | 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 Pharmaceutical Form: Capsule* INN or Proposed INN: Menadiol sodium diphosphate Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 10- Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | Barts and the London NHS Trust | Authorised | Female: yes Male: yes | 40 | United Kingdom | ||||
743 | EUCTR2005-002997-31-GB | 10/08/2006 | 18 April 2012 | 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 Pharmaceutical Form: Solution for injection | Sheffield Children's NHS Trust | Authorised | Female: yes Male: yes | 40 | United Kingdom | ||||
744 | NCT00357279 | July 2006 | 19 February 2015 | 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. | Not recruiting | 5 Years | N/A | Both | 352 | Phase 3 | United States;Canada | |
745 | NCT00458614 | June 2006 | 19 February 2015 | 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 | Not recruiting | 2 Years | 10 Years | Both | 18 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
746 | EUCTR2005-004344-30-HU | 10/05/2006 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution CAS Number: 1391-36-2 Current Sponsor code: Moli1901 Other descriptive name: Duramycin, 2622U90 Concentration unit: g/l gram(s)/litre Concentration type: equal Concentration number: 0,5- Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use | AOP Orphan Pharmaceuticals AG | Not Recruiting | Female: yes Male: yes | 18 | Hungary | ||||
747 | EUCTR2005-004103-10-DE | 03/05/2006 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: Tobramycin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 150-1,5 Trade Name: Tobi Product Name: TOBI® Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: Tobramycin Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 300 -5 | PARI Pharma GmbH | Not Recruiting | Female: yes Male: yes | 60 | Germany | ||||
748 | NCT00297167 | May 2006 | 16 December 2017 | 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 | Not recruiting | 7 Years | N/A | All | 34 | Phase 3 | United States | |
749 | NCT00399945 | May 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | 65 Years | Both | 12 | Phase 1 | United Kingdom | |
750 | NCT00981214 | May 2006 | 16 December 2017 | 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 | Not recruiting | N/A | 7 Years | All | 19 | Phase 3 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
751 | NCT00322868 | April 2006 | 5 March 2018 | 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 Therapeutics | Not recruiting | 18 Years | N/A | All | 21 | N/A | United States |
752 | NCT00420836 | April 2006 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 20 | Phase 1 | ||
753 | NCT00308243 | March 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 15 | Phase 1 | United States |
754 | NCT00311883 | March 2006 | 19 February 2015 | Hydroxychloroquine in Cystic Fibrosis | Phase 1 Study of Hydroxychloroquine in Cystic Fibrosis | Cystic Fibrosis | Drug: hydroxychloroquine | Vanderbilt University | Not recruiting | 16 Years | N/A | Both | 20 | Phase 1 | United States | |
755 | NCT00753987 | March 2006 | 19 February 2015 | 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 | Not recruiting | 2 Months | 2 Years | Both | 13 | Phase 1 | Canada | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
756 | NCT00287456 | February 2, 2006 | 21 January 2019 | 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 | Not recruiting | 12 Years | 32 Years | All | 0 | N/A | United States | ||
757 | NCT00298922 | February 2006 | 19 February 2015 | 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 | Not recruiting | 19 Years | N/A | Both | 45 | Phase 2 | Canada |
758 | NCT00332215 | February 2006 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 70 | Phase 1 | United States |
759 | NCT00388505 | February 2006 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 517 | Phase 3 | United States;Australia;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom | |
760 | NCT00483769 | February 2006 | 19 February 2015 | 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 | Not recruiting | 3 Years | 20 Years | Both | 20 | Phase 4 | Italy | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
761 | EUCTR2005-003772-37-GB | 06/01/2006 | 10 July 2015 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 28- Trade Name: TOBI Product Name: TOBI Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin CAS Number: 32986-56-4 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 60- | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 500 | Phase 3 | Hungary;Greece;Spain;Germany;Italy;United Kingdom | |||
762 | NCT00274313 | January 2006 | 19 February 2015 | 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 | Not recruiting | 14 Years | N/A | Both | 40 | Phase 1/Phase 2 | United States | |
763 | NCT00287430 | January 2006 | 25 March 2019 | 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 | Not recruiting | 6 Years | 40 Years | All | 0 | N/A | ||
764 | EUCTR2005-004389-17-HU | 28/12/2005 | 19 March 2012 | 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 Pharmaceutical Form: Nebuliser suspension INN or Proposed INN: amikacin Other descriptive name: amikin, amiklin, amicacin, BB-K8, Biklin, Fabianol, Kaminax, Mikavir, Novamin, Pierami Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 40-55 | Transave, Inc | Authorised | Female: yes Male: yes | 15 | Hungary | ||||
765 | EUCTR2005-004899-21-BE | 22/12/2005 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation vapour, solution INN or Proposed INN: Amikacin CAS Number: 37517-28-5 6 Current Sponsor code: NA Other descriptive name: amikin®, amiklin, amicacin, BB-K8, Biklin®, Fabianol®, Kaminax, Mikavir, Novamin®, Pierami Concentration unit: mg/ml milligram(s)/millilitre Concentration type: range Concentration number: 40-55 | Transave, Inc. | Not Recruiting | Female: yes Male: yes | 15 | Belgium | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
766 | NCT00265434 | December 2005 | 19 February 2015 | 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 | Not recruiting | 5 Years | N/A | Both | 5 | Phase 3 | Germany |
767 | EUCTR2005-000311-98-GB | 09/11/2005 | 28 February 2019 | 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 Pharmaceutical Form: Capsule* Pharmaceutical form of the placebo: Capsule* Route of administration of the placebo: Oral use | University of Nottingham | Not Recruiting | Female: yes Male: yes | 30 | Phase 2 | United Kingdom | |||
768 | NCT00117208 | November 2005 | 19 February 2015 | 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 | Not recruiting | 8 Years | 18 Years | Both | 20 | Phase 2 | United Kingdom | |
769 | NCT00237380 | November 2005 | 19 February 2015 | Safety and Efficacy of 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 | Not recruiting | 18 Years | N/A | Both | 24 | Phase 2 | Israel | |
770 | EUCTR2005-004344-30-AT | 31/10/2005 | 10 June 2013 | 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 Pharmaceutical Form: Inhalation vapour, solution CAS Number: 1391-36-2 Current Sponsor code: Moli1901 Other descriptive name: Duramycin, 2622U90 Concentration unit: g/l gram(s)/litre Concentration type: equal Concentration number: 0,5- Pharmaceutical form of the placebo: Inhalation vapour, solution Route of administration of the placebo: Inhalation use | AOP Orphan Pharmaceuticals AG | Not Recruiting | Female: yes Male: yes | 18 | Hungary;Austria | ||||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
771 | NCT00231192 | October 2005 | 23 March 2015 | 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 | Not recruiting | 12 Years | 20 Years | Both | 0 | N/A | United States | |
772 | NCT00251056 | October 2005 | 19 February 2015 | 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 | Not recruiting | 7 Years | N/A | Both | 48 | Phase 2 | Argentina;Canada | |
773 | EUCTR2005-003837-42-GB | 26/09/2005 | 18 April 2012 | 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 Pharmaceutical Form: Coated tablet | Belfast City Hospital Trust | Authorised | Female: yes Male: yes | 60 | United Kingdom | ||||
774 | EUCTR2005-002035-28-LT | 19/09/2005 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Tobramycine Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 112- Pharmaceutical form of the placebo: Inhalation powder Route of administration of the placebo: Inhalation use | Novartis Pharma Services AG | Not Recruiting | Female: yes Male: yes | 220 | Phase 3 | Lithuania | |||
775 | NCT00125346 | September 2005 | 19 February 2015 | 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 | Not recruiting | 6 Years | 21 Years | Both | 98 | Phase 3 | United States;Argentina;Brazil;Bulgaria;Canada;Chile;Lithuania;Mexico;Former Serbia and Montenegro | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
776 | NCT00234663 | September 2005 | 19 February 2015 | 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 | Not recruiting | 18 Years | N/A | Both | 24 | Phase 2 | United States |
777 | NCT00128492 | August 2005 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 274 | Phase 3 | United States;Australia;Canada;New Zealand | |
778 | NCT00130182 | August 2005 | 19 February 2015 | 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. | Not recruiting | 5 Years | 7 Years | Both | 13 | Phase 2 | United States | |
779 | EUCTR2005-002135-27-IT | 06/07/2005 | 19 March 2012 | 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 Pharmaceutical Form: Solution for injection INN or Proposed INN: Insulin glargine Concentration unit: IU international unit(s) Concentration type: equal Concentration number: 300- | ISTITUTO GIANNINA GASLINI | Not Recruiting | Female: yes Male: yes | Italy | |||||
780 | NCT00217204 | July 2005 | 19 February 2015 | 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. | Not recruiting | 6 Months | 30 Months | Both | 18 | Phase 2 | Belgium;Netherlands | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
781 | EUCTR2004-005019-28-GB | 09/05/2005 | 19 March 2012 | 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 Pharmaceutical Form: Injection* INN or Proposed INN: Novo Rapid CAS Number: 133107-64-9 Current Sponsor code: P00966 Concentration unit: IU/ml international unit(s)/millilitre Concentration type: range Trade Name: Rapeglinide Pharmaceutical Form: INN or Proposed INN: Rapeglinide CAS Number: 135062-02-1 Current Sponsor code: P00996 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 0.25-1.0 Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Papworth Hospital NHS Foundation Trust | Authorised | Female: yes Male: yes | 150 | United Kingdom | ||||
782 | NCT00112359 | May 2005 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 166 | Phase 3 | United States;Australia;Canada;New Zealand | |
783 | EUCTR2004-003675-36-DK | 28/04/2005 | 19 March 2012 | 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 Pharmaceutical Form: Inhalation powder, hard capsule INN or Proposed INN: Colistimethate sodium CAS Number: 8068-28-8 Other descriptive name: Colomycin Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 125- Product Name: TOBI® Pharmaceutical Form: Nebuliser solution INN or Proposed INN: Tobramycin Other descriptive name: TOBI® Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 300- | Forest Laboratories UK Ltd | Not Recruiting | Female: yes Male: yes | 360 | Belgium;Denmark | ||||
784 | EUCTR2005-000313-35-GB | 13/04/2005 | 3 April 2012 | 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 Pharmaceutical Form: Nebuliser solution Pharmaceutical form of the placebo: Nebuliser solution Route of administration of the placebo: Inhalation use | Aerovance Inc | Not Recruiting | Female: yes Male: yes | 106 | Phase 1/2 | United Kingdom | |||
785 | EUCTR2004-004334-13-IE | 08/04/2005 | 19 March 2012 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Talniflumate CAS Number: 66898-62-2 Current Sponsor code: MSI-1995 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 370- Pharmaceutical form of the placebo: Tablet Route of administration of the placebo: Oral use | Genaera Corporation | Authorised | Female: yes Male: yes | 220 | Phase 2 | Ireland | |||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
786 | NCT00198289 | April 2005 | 19 February 2015 | 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 | Not recruiting | 7 Years | N/A | Both | 30 | Phase 2 | United States | |
787 | NCT00219882 | April 2005 | 19 February 2015 | 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 | Not recruiting | 18 Years | 40 Years | Both | 11 | Phase 1 | United States |
788 | EUCTR2004-002341-12-DE | 14/02/2005 | 19 March 2012 | 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 Pharmaceutical Form: Powder for nebuliser solution INN or Proposed INN: Depelestat Current Sponsor code: EPIhNE4 DX-890 Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 5.65- INN or Proposed INN: Depelestat Current Sponsor code: EPI-hNE4 DX-890 Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 11.3- Pharmaceutical form of the placebo: Powder for nebuliser solution Route of administration of the placebo: Inhalation use | Debiopharm SA | Not Recruiting | Female: yes Male: yes | 90 | United Kingdom;Germany;Belgium;Italy | ||||
789 | NCT00104520 | February 2005 | 19 October 2017 | 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 | Not recruiting | 6 Years | N/A | All | 211 | Phase 3 | United States | |
790 | NCT00103714 | January 2005 | 2 November 2015 | 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. | Not recruiting | 8 Years | 50 Years | Both | 72 | Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
791 | NCT00105183 | January 2005 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 223 | Phase 3 | United States;Australia;Austria;Canada | |
792 | NCT00179998 | January 2005 | 19 February 2015 | 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) | Nationwide Children's Hospital | Genentech, Inc. | Not recruiting | 1 Month | 30 Months | Both | 24 | Phase 2 | United States |
793 | EUCTR2005-001438-34-BE | 2 October 2017 | 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 Pharmaceutical Form: Tablet INN or Proposed INN: Pancreatin CAS Number: 8049-47-6 Concentration unit: IU international unit(s) Concentration type: not less then Concentration number: 450- | McNeil Consumer and Specialty Pharmaceuticals | Not Available | Female: yes Male: yes | 20 | Phase 2 | Belgium | ||||
794 | EUCTR2004-001888-21-GB | 03/12/2004 | 21 August 2012 | 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 Pharmaceutical Form: Inhalation powder INN or Proposed INN: Mannitol Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 40- Trade Name: Pulmozyme (dornase alfa) Product Name: Pulmozyme (dornase alfa) Pharmaceutical Form: Nebuliser liquid* INN or Proposed INN: Dornase alfa Other descriptive name: rhDNAse Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 1.0- | Pharmaxis Ltd | Authorised | Female: yes Male: yes | 42 | United Kingdom | ||||
795 | NCT00377741 | December 2004 | 19 October 2017 | 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 | Not recruiting | 14 Years | N/A | All | 31 | Phase 1 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
796 | NCT00097773 | September 2004 | 19 October 2017 | 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 | Not recruiting | 1 Year | 12 Years | All | 304 | Phase 2 | United States |
797 | NCT00219895 | August 2004 | 19 February 2015 | 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 | Not recruiting | 10 Years | N/A | Both | 120 | N/A | United States |
798 | NCT00255242 | July 2004 | 19 February 2015 | 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 | Not recruiting | 10 Years | N/A | Both | 40 | Phase 1 | United States |
799 | NCT00570349 | July 2004 | 19 October 2017 | 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 | Not recruiting | 12 Years | N/A | All | 18 | Phase 1/Phase 2 | United States | |
800 | NCT00823238 | July 2004 | 19 February 2015 | 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 | Not recruiting | 3 Months | 16 Years | Both | 21 | Phase 1 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
801 | NCT00095732 | June 2004 | 19 February 2015 | 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 | Not recruiting | 7 Years | N/A | Both | 129 | Phase 2 | United States |
802 | NCT02010411 | June 2004 | 19 February 2015 | 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 | Not recruiting | 14 Years | N/A | Both | 17 | Phase 2 | Canada | |
803 | NCT00104494 | May 2004 | 10 August 2015 | 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 | Not recruiting | 8 Years | 14 Years | Both | 30 | N/A | United States | |
804 | NCT00730509 | April 2004 | 19 February 2015 | 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 | Not recruiting | 3 Years | 8 Years | Both | 31 | N/A | Italy | |
805 | NCT00153634 | March 2004 | 19 February 2015 | 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 | Not recruiting | 14 Years | N/A | Both | 75 | N/A | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
806 | NCT00455130 | March 2004 | 19 February 2015 | A Phase 2 Study to Determine the Safety and Efficacy of Inhaled Dry Powder Mannitol in Cystic Fibrosis | Cystic Fibrosis | Drug: Inhaled mannitol | Pharmaxis | Not recruiting | 8 Years | N/A | Both | Phase 2 | Australia;New Zealand | |||
807 | NCT00163852 | February 2004 | 19 February 2015 | 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 |
808 | NCT00728715 | January 2004 | 19 February 2015 | 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) | Not recruiting | 18 Years | 80 Years | Both | 40 | N/A | Spain |
809 | NCT00157690 | December 2003 | 19 February 2015 | 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. | Not recruiting | 18 Years | N/A | Both | 56 | Phase 4 | Canada |
810 | NCT00486837 | December 2003 | 19 October 2017 | 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. | Not recruiting | 8 Years | N/A | All | 72 | Phase 2 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
811 | NCT00391976 | November 2003 | 19 October 2017 | 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 | Not recruiting | 6 Months | N/A | All | 123 | Phase 3 | ||
812 | NCT00633191 | November 2003 | 12 September 2016 | 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 | Not recruiting | N/A | N/A | Both | 14 | Phase 1/Phase 2 | Sweden | |
813 | NCT00499720 | October 2003 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | N/A | United States;Puerto Rico | ||
814 | NCT00079742 | September 2003 | 19 February 2015 | 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. | Not recruiting | 5 Years | 13 Years | Both | 68 | Phase 2 | United States | |
815 | NCT00287443 | July 2003 | 19 February 2015 | 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. | Not recruiting | 7 Years | 17 Years | Both | 48 | N/A | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
816 | NCT01055847 | June 2003 | 19 February 2015 | 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. | Not recruiting | 13 Years | N/A | Both | 105 | Phase 2 | United States |
817 | NCT00060801 | May 2003 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 420 | Phase 2 | United States | |
818 | NCT00056147 | April 2003 | 19 February 2015 | 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 | Not recruiting | 8 Years | 50 Years | Both | 90 | Phase 2 | United States |
819 | NCT00222521 | April 2003 | 19 February 2015 | 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. | Not recruiting | 12 Years | N/A | Both | 20 | Phase 3 | United States |
820 | NCT00157183 | March 2003 | 19 February 2015 | 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 | Not recruiting | 18 Years | 75 Years | Both | 59 | Phase 1/Phase 2 | Australia |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
821 | NCT00530244 | March 2003 | 11 June 2018 | 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 Therapeutics | Not recruiting | N/A | 56 Days | All | 76 | N/A | United States |
822 | NCT00590538 | February 2003 | 19 October 2017 | 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 | Not recruiting | 18 Years | N/A | All | 9 | Phase 1/Phase 2 | United States |
823 | NCT00376428 | January 2003 | 9 March 2015 | 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 | Not recruiting | N/A | N/A | Both | 20 | Phase 2 | France | |
824 | NCT01812551 | October 2002 | 19 February 2015 | 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 | Not recruiting | 5 Years | 30 Years | Both | 171 | Phase 3 | Holy See (Vatican City State);Italy |
825 | NCT00043342 | April 2002 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 51 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
826 | NCT02269189 | April 2002 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 36 | Phase 1 | ||
827 | NCT00177645 | March 2002 | 23 February 2016 | 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 | Not recruiting | 12 Years | N/A | Both | 16 | Phase 1 | United States |
828 | NCT00333385 | October 2001 | 19 February 2015 | 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 | Not recruiting | 8 Years | N/A | Both | 120 | Phase 4 | France | |
829 | NCT02265679 | October 2001 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 45 | Phase 1 | ||
830 | NCT00016744 | September 2001 | 19 February 2015 | 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) | Not recruiting | 18 Years | N/A | Both | 12 | Phase 1/Phase 2 | United States |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
831 | NCT00662714 | September 2001 | 19 February 2015 | 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 | Not recruiting | 10 Years | N/A | Both | 73 | Phase 3 | Austria;France;Germany;Italy |
832 | NCT01400750 | August 2001 | 19 February 2015 | 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 | Not recruiting | N/A | 18 Years | Both | 61 | Phase 4 | Belgium | |
833 | NCT00274391 | July 2001 | 19 February 2015 | 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 | Not recruiting | 14 Years | N/A | Both | 24 | Phase 2 | United States |
834 | NCT00034515 | June 2001 | 2 March 2015 | 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. | Not recruiting | 5 Years | N/A | Both | 63 | Phase 1/Phase 2 | United States | |
835 | NCT00072904 | June 2001 | 19 February 2015 | 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 | Not recruiting | 16 Years | N/A | Both | 108 | Phase 3 | United States;Canada |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
836 | NCT00220259 | May 2001 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 240 | N/A | United Kingdom |
837 | NCT01882400 | May 2001 | 18 January 2018 | 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 | Not recruiting | 5 Years | 18 Years | All | 11 | Phase 4 | Canada |
838 | NCT00014768 | February 2001 | 19 February 2015 | 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 | Not recruiting | N/A | N/A | Female | 36 | N/A | United States | |
839 | NCT00016445 | February 2001 | 19 February 2015 | Phase II Study of Growth Hormone in Children With Cystic Fibrosis | Cystic Fibrosis | Drug: growth hormone | University of Utah | Not recruiting | 5 Years | 12 Years | Both | 40 | Phase 2 | United States | ||
840 | NCT00043316 | February 2001 | 19 February 2015 | 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 | Not recruiting | 12 Years | N/A | Both | 66 | Phase 1/Phase 2 | United States | |
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
841 | NCT00164021 | February 2001 | 25 January 2016 | 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 |
842 | NCT00205634 | December 2000 | 20 August 2018 | 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 | Not recruiting | 6 Years | 50 Years | All | 50 | Phase 2 | United States |
843 | NCT00271310 | September 2000 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 164 | Phase 3 | |
844 | NCT00005110 | April 2000 | 19 February 2015 | 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) | Not recruiting | 5 Years | 45 Years | Both | N/A | United States | |||
845 | NCT00005112 | April 2000 | 19 February 2015 | Growth Hormone Use in Cystic Fibrosis - a Multicenter Study | Cystic Fibrosis | Drug: Human recombinant growth hormone | National Center for Research Resources (NCRR) | Genentech, Inc. | Not recruiting | 5 Years | 12 Years | Both | Phase 3 | United States | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
846 | NCT00006280 | February 2000 | 19 February 2015 | 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) | Not recruiting | 6 Months | 5 Years | Both | 98 | Phase 2 | United States |
847 | NCT00256555 | February 2000 | 21 January 2019 | 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. | Not recruiting | 5 Years | 12 Years | All | 0 | Phase 2/Phase 3 | |
848 | NCT00004533 | August 1999 | 16 December 2017 | 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 | Not recruiting | 15 Years | N/A | All | 19 | Phase 1 | |
849 | NCT00006063 | July 1999 | 19 February 2015 | 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 | Not recruiting | N/A | N/A | Both | 24 | N/A | ||
850 | NCT00004489 | October 1998 | 7 April 2015 | 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 | Not recruiting | 18 Years | 45 Years | Both | 60 | N/A | United States | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
851 | NCT00004441 | September 1997 | 7 April 2015 | Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis | Cystic Fibrosis | Drug: tauroursodeoxycholic acid;Drug: ursodiol | Children's Hospital Medical Center, Cincinnati | Not recruiting | N/A | N/A | Both | 39 | N/A | United States;Italy | ||
852 | NCT00004705 | September 1996 | 7 April 2015 | 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 | Not recruiting | 4 Years | N/A | Both | N/A | |||
853 | NCT00004440 | August 1996 | 7 April 2015 | 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 | Not recruiting | 5 Years | N/A | Both | 75 | N/A | ||
854 | NCT00004315 | November 1995 | 19 February 2015 | 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 | Not recruiting | 4 Months | N/A | Both | 20 | Phase 2 | United States | |
855 | NCT00004747 | July 1995 | 19 February 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 170 | Phase 2 | ||
No. | TrialID | Date_ enrollement | Last_Refreshed_ on | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
856 | NCT00004829 | June 1995 | 7 April 2015 | 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 | Not recruiting | 6 Years | N/A | Both | 200 | Phase 3 |