299. 嚢胞性線維症 Cystic fibrosis Clinical trials / Disease details


臨床試験数 : 1,696 薬物数 : 1,644 - (DrugBank : 272) / 標的遺伝子数 : 96 - 標的パスウェイ数 : 170

  
1044 trials found
No.TrialIDDate_
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PhaseCountries
1NCT04580368
(ClinicalTrials.gov)
March 30, 20222/10/2020Testing Drug Efficacy in Cystic Fibrosis Through N-of-1 TrialsTesting Drug Efficacy in Cystic Fibrosis Through N-of-1 TrialsCystic FibrosisDrug: CFTR ModulatorsChildren's Hospital Medical Center, CincinnatiNULLNot yet recruiting6 YearsN/AAll50N/ANULL
2EUCTR2021-000694-85-DK
(EUCTR)
17/03/202227/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Denmark;Australia;Germany;Netherlands;Norway;Sweden
3NCT05274269
(ClinicalTrials.gov)
March 20221/3/2022Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR MutationCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVA;Other: Placebo (matched to ELX/TEZ/IVA);Other: Placebo (matched to IVA)Vertex Pharmaceuticals IncorporatedNULLNot yet recruiting6 YearsN/AAll270Phase 3NULL
4NCT05225805
(ClinicalTrials.gov)
February 15, 20227/1/2022Study to Assess the Safety and PK of Oral and IV Xenleta in Adults With Cystic FibrosisA Phase 1, Open-Label, Randomized, Crossover Study to Assess the Safety and Pharmacokinetics Following Single Doses of Oral and Intravenous Xenleta (Lefamulin) in Adult Patients With Cystic FibrosisCystic FibrosisDrug: LefamulinNabriva Therapeutics AGNULLNot yet recruiting18 Years80 YearsAll12Phase 1NULL
5NCT05239611
(ClinicalTrials.gov)
February 14, 202210/1/2022Feasibility of Home-based Exercise Program for Adults With Cystic FibrosisFeasibility of Home-based Exercise Program for Adults With Cystic Fibrosis to Improve Patient-centered Outcomes, Including a Novel Measure of VentilationCystic FibrosisDrug: ExerciseUniversity of Kansas Medical CenterNULLRecruiting18 YearsN/AAll30Phase 2United States
6NCT05223881
(ClinicalTrials.gov)
February 14, 202224/1/2022Gastroparesis in Cystic Fibrosis13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic FibrosisGastroparesisDevice: 13^C Spirulina Platensis Gastric Emptying Breath Test (GEBT)University of MiamiNULLNot yet recruiting4 YearsN/AAll100N/AUnited States
7EUCTR2019-004511-31-ES
(EUCTR)
31/01/202230/08/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children´s HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
8EUCTR2021-005320-38-ES
(EUCTR)
21/01/202201/12/2021Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
270Phase 3France;Portugal;Belgium;Spain;Austria;Netherlands;Germany;Switzerland;Italy
9EUCTR2021-000712-31-SE
(EUCTR)
18/01/202222/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden
10EUCTR2021-000712-31-PT
(EUCTR)
14/01/202216/11/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
11EUCTR2021-000712-31-DE
(EUCTR)
12/01/202223/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
400Phase 3Portugal;United States;Czechia;Spain;Ireland;Israel;United Kingdom;Hungary;Czech Republic;Australia;Germany;New Zealand;Sweden
12EUCTR2019-004511-31-DE
(EUCTR)
10/01/202230/07/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
INN or Proposed INN: Posaconazole
Other descriptive name: Posaconazole
Trade Name: Noxafil 100 mg
Product Name: Noxafil
INN or Proposed INN: Posaconazole
Other descriptive name: Posaconazole
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
13EUCTR2019-004511-31-NL
(EUCTR)
03/01/202229/04/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Germany;Netherlands;United Kingdom;Switzerland;Italy;Sweden
14EUCTR2021-000694-85-IT
(EUCTR)
21/12/202115/10/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation - A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous fo Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: [VX-770]
INN or Proposed INN: ivacaftor
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: [VX-121/TEZ/D-IVA]
INN or Proposed INN: tezacaftor
INN or Proposed INN: deutivacaftor
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: [ELX/TEZ/IVA]
INN or Proposed INN: elexacaftor
INN or Proposed INN: tezacaftor
INN or Proposed INN: ivacaftor
VERTEX PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
15EUCTR2021-000694-85-DE
(EUCTR)
20/12/202127/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
16EUCTR2021-000694-85-NL
(EUCTR)
09/12/202127/10/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Germany;Norway;Sweden
17EUCTR2021-000694-85-GR
(EUCTR)
07/12/202119/10/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Netherlands;Norway;Sweden
18EUCTR2021-000694-85-NO
(EUCTR)
03/12/202120/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Netherlands;Norway;Germany;New Zealand;Sweden
19NCT05090904
(ClinicalTrials.gov)
November 30, 202114/10/2021A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic FibrosisA Phase 2a, Single-Blind, Placebo-Controlled, Parallel-Group Study to Assess Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic FibrosisCystic FibrosisDrug: Brensocatib;Drug: PlaceboInsmed IncorporatedNULLRecruiting18 YearsN/AAll48Phase 2United States
20EUCTR2021-000694-85-SE
(EUCTR)
10/11/202122/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Norway;Netherlands;Germany;New Zealand;Sweden
21NCT04938726
(ClinicalTrials.gov)
November 1, 20219/6/2021Ketone Supplementation in Cystic FibrosisKetone Monoester Supplementation in Cystic Fibrosis: A Pilot and Feasibility StudyCystic FibrosisDietary Supplement: Ketone MonoesterUniversity of Alabama at BirminghamNULLNot yet recruiting18 Years89 YearsAll25N/ANULL
22NCT05076149
(ClinicalTrials.gov)
October 27, 202129/9/2021A Study of VX-121 Combination Therapy in Participants With Cystic Fibrosis (CF) Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive (TCR) CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationCystic FibrosisDrug: VX-121/TEZ/D-IVA;Drug: ELX/TEZ/IVA;Drug: IVA;Drug: Placebo (matched to VX-121/TEZ/D-IVA);Drug: Placebo (matched to ELX/TEZ/IVA);Drug: Placebo (matched to IVA)Vertex Pharmaceuticals IncorporatedNULLRecruiting12 YearsN/AAll550Phase 3United States;Australia;Canada;France;Germany;Italy;Netherlands;United Kingdom
23NCT03925194
(ClinicalTrials.gov)
October 1, 202119/4/2019A Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With CFA Phase IIa, Randomized, Placebo-controlled, Double-blind, Cross-over Study to Evaluate Safety and Efficacy of Subcutaneous Administration of Anakinra in Patients With Cystic FibrosisCystic Fibrosis, 10011762Drug: AnakinraHeidelberg UniversityNULLNot yet recruiting12 YearsN/AAll52Phase 2Germany
24NCT05010577
(ClinicalTrials.gov)
October 202111/8/2021Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary InfectionA Phase 1b/2a, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate Nebulized Bacteriophage Treatment in Outpatient Adult Cystic Fibrosis (CF) Subjects With Chronic Pseudomonas Aeruginosa (PsA) Pulmonary InfectionChronic Pseudomonas Aeruginosa Infection;Cystic FibrosisDrug: BX004-A;Drug: PlaceboBiomX, Inc.NULLNot yet recruiting18 YearsN/AAll32Phase 1/Phase 2NULL
25EUCTR2019-004511-31-GR
(EUCTR)
16/09/202104/03/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
26NCT05006573
(ClinicalTrials.gov)
July 21, 202123/6/2021Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis BronchiectasisA Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52 Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE)Non-cystic Fibrosis BronchiectasisBiological: Benralizumab;Biological: Placebo to BenralizumabAstraZenecaNULLRecruiting18 Years130 YearsAll420Phase 3United States;Argentina;Australia;Canada;China;Denmark;Germany;India;Italy;Korea, Republic of;Philippines;Poland;Russian Federation;Spain;United Kingdom;Vietnam
27EUCTR2019-004511-31-PT
(EUCTR)
18/06/202118/01/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children's HospitalNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
135Phase 2;Phase 3France;Portugal;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
28NCT04294043
(ClinicalTrials.gov)
June 17, 20211/3/2020IV Gallium Study for Patients With Cystic Fibrosis Who Have NTM (ABATE Study)A Phase 1b, Multi-center Study of Intravenous (IV) Gallium Nitrate in Patients With Cystic Fibrosis (CF) Who Are Colonized With Nontuberculous Mycobacteria (NTM) (The ABATE Study)Nontuberculous Mycobacterium InfectionDrug: Gallium nitrateChris GossCystic Fibrosis FoundationRecruiting18 YearsN/AAll40Phase 1United States
29NCT04926701
(ClinicalTrials.gov)
June 11, 202110/6/2021A First in Human Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Inhaled ETD001 in Healthy SubjectsA First in Human Randomised, Double Blind, Placebo-controlled, Two-part Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses (SAD and MAD) of Inhaled ETD001 in Healthy Male and Female SubjectsCystic FibrosisDrug: ETD001 single dose;Drug: Placebo single dose;Drug: ETD001 multiple twice daily doses;Drug: Placebo multiple twice daily doses;Drug: ETD001 multiple once daily doses;Drug: Placebo multiple once daily dosesEnterprise Therapeutics LtdNULLActive, not recruiting18 Years50 YearsAll98Phase 1United Kingdom
30EUCTR2020-003688-25-SK
(EUCTR)
01/06/202110/12/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1660Phase 3Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Bulgaria;Germany;New Zealand;Japan
31EUCTR2020-004068-24-IT
(EUCTR)
21/05/202102/08/2021Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis BronchiectasisA Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE Non-cystic fibrosis bronchiectasis (NCFB)
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: NA
Product Name: benralizumab
Product Code: [MEDI-563]
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
Product Name: Atropina
Product Code: [NA]
Product Name: Antistaminici H1 - H2
Product Code: [na]
Product Name: C01CA04 - Dopamina
Product Code: [na]
Product Name: Adrenalina
Product Code: [NA]
Product Name: Salbutamolo
Product Code: [NA]
Product Name: H02 - Corticosteroidi Sistemici
Product Code: [NA]
ASTRAZENECA ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Vietnam;Canada;Argentina;Poland;Australia;Denmark;Germany;China;Korea, Republic of
32JPRN-jRCT2031210048
30/04/202122/04/2021A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis BronchiectasisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - ASPEN Non-Cystic Fibrosis Bronchiectasis- Experimental: Brensocatib 10 mg
Participants will receive brensocatib 10 mg once daily, for 52 weeks.

- Experimental: Brensocatib 25 mg
Participants will receive brensocatib 25 mg once daily, for 52 weeks.

- Placebo Comparator: Placebo
Participants will receive a brensocatib-matching placebo once daily.
Fernandez CNULLRecruiting>= 18age old<= 85age oldBoth1620Phase 3United States;Canada;Germany;Australia;New Zealand;Taiwan;Japan
33NCT04884308
(ClinicalTrials.gov)
April 28, 20217/5/2021Bacille Calmette-Guerin (BCG) Vaccine for Immune Protection Against InfectionsEffects of BCG Vaccine on the Immune System of Individuals With Cystic Fibrosis, Non-Cystic Fibrosis Bronchiectasis, and Healthy VolunteersCystic Fibrosis;Bronchiectasis Adult;Non-Tuberculous MycobacteriaBiological: BCG TICE VaccineJohns Hopkins UniversityCystic Fibrosis FoundationRecruiting18 Years65 YearsAll180Phase 2United States
34EUCTR2020-003688-25-DE
(EUCTR)
08/04/202112/10/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
35EUCTR2020-004068-24-DE
(EUCTR)
06/04/202121/01/2021Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis BronchiectasisA Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE Non-cystic fibrosis bronchiectasis (NCFB)
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fasenra
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Canada;Argentina;Poland;Viet Nam;Australia;Denmark;Germany;China;Japan;Korea, Republic of
36EUCTR2019-003501-10-NO
(EUCTR)
08/03/202129/05/2020Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a phase 4 multicenter randomized controlled study.Use of repeated Multiple Breath Washout to detect and treat pulmonary exacerbation in children with Cystic Fibrosis, a phase 4 multicenter randomized controlled study. - MBWtodetectPEXinCF Cystic fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: Amoxicillin
Product Name: Amoxicillin
INN or Proposed INN: AMOXICILLIN
Trade Name: Amoxicillin and Clavulanic acid
Product Name: Augmentin
INN or Proposed INN: AMOXICILLIN
INN or Proposed INN: CLAVULANIC ACID
Trade Name: Heracillin
Product Name: Heracillin
INN or Proposed INN: FLUCLOXACILLIN
Trade Name: Dicloxacillin
Product Name: Dicloxacillin
INN or Proposed INN: DICLOXACILLIN
Trade Name: Trimethoprim and Sulfamethoxazole
Product Name: Bactrim
INN or Proposed INN: Trimetoprim
Other descriptive name: TRIMETHOPRIM
INN or Proposed INN: SULFAMETHOXAZOLE
Trade Name: Clarithromycin
Product Name: Klacid
INN or Proposed INN: Klacid
Other descriptive name: CLARITHROMYCIN
Trade Name: Rifampicin
Product Name: Rimactan
INN or Proposed INN: RIFAMPICIN
Trade Name: Doxycycline
Product Name: Doxycyclin
INN or Proposed INN: DOXYCYCLINE
Product Name: Fucidin Tablets
INN or Proposed INN: Fusidin
Other descriptive name: FUSIDIC ACID
Trade Name: Ciprofloxacin
Product Name: Ciprofloxacin
INN or Proposed INN: Ciproxin
Other descriptive name: CIPROFLOXACIN
Trade Name: Linez
Vãstre Gõtalandsregionen, SwedenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
100Phase 4Denmark;Norway;Sweden
37EUCTR2020-003688-25-LT
(EUCTR)
05/03/202107/12/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
38NCT04656275
(ClinicalTrials.gov)
March 4, 20211/12/2020A Study in Patients With Non-cystic Fibrosis Bronchiectasis to Test How Well Different Doses of BI 1323495 Are Tolerated and How BI 1323495 Affects Biomarkers of InflammationSafety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Different Oral Doses of BI 1323495 Bid Versus Placebo in Patients With Non-cystic Fibrosis Bronchiectasis (Randomised, Double-blind, Placebo-controlled, Parallel Group Trial)Non-cystic Fibrosis BronchiectasisDrug: BI 1323495;Drug: PlaceboBoehringer IngelheimNULLSuspended18 Years80 YearsAll36Phase 1Germany;United Kingdom
39EUCTR2020-003688-25-EE
(EUCTR)
01/03/202106/01/2021A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Estonia;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Israel;Chile;Russian Federation;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
40EUCTR2020-004068-24-DK
(EUCTR)
15/02/202122/12/2020Efficacy and Safety of Benralizumab in Patients With Non-cystic Fibrosis BronchiectasisA Multicentre, Randomised, Double-blind, Parallel-group, Placebo-controlled, 52-Week, Phase III Study With an Open-label Extension to Evaluate the Efficacy and Safety of Benralizumab in Patients With Non-Cystic Fibrosis Bronchiectasis (MAHALE) - MAHALE Non-cystic fibrosis bronchiectasis (NCFB)
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Fasenra
Product Name: benralizumab
Product Code: MEDI-563
INN or Proposed INN: benralizumab
Other descriptive name: benralizumab
AstraZeneca ABNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Philippines;Spain;Russian Federation;United Kingdom;Italy;India;Vietnam;Canada;Argentina;Poland;Denmark;Australia;Germany;China;Japan;Korea, Republic of
41EUCTR2020-003688-25-AT
(EUCTR)
11/02/202110/12/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
42NCT04793867
(ClinicalTrials.gov)
February 8, 202123/2/2021Regional Phenotyping of CF and Non-CF BronchiectasisRegional Phenotyping of Cystic Fibrosis Lung Disease and Non-CF BronchiectasisCystic Fibrosis;Non-CF BronchiectasisDiagnostic Test: XenonChildren's Hospital Medical Center, CincinnatiNULLRecruiting5 Years100 YearsAll100United States
43EUCTR2020-003688-25-BG
(EUCTR)
27/01/202104/12/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1660Phase 3United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Brazil;Bulgaria;Germany;New Zealand;Japan
44NCT04599465
(ClinicalTrials.gov)
January 18, 202121/10/2020A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)A Phase 3b Open-label Study to Assess the Effect of Elexacaftor/Tezacaftor/Ivacaftor on Glucose Tolerance in Cystic Fibrosis Subjects With Abnormal Glucose MetabolismCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll69Phase 3Spain;Netherlands;Italy;France;Czechia;Belgium;Australia
45EUCTR2020-003688-25-IE
(EUCTR)
18/01/202130/10/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
46EUCTR2020-003688-25-PT
(EUCTR)
15/01/202116/10/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Lithuania;Latvia;Netherlands;Denmark;Australia;Peru;Malaysia;France;Italy;Colombia;Chile;Israel;Russian Federation;Ireland;Ukraine;Thailand;Spain;Greece;Slovakia;Estonia;Taiwan;United States;Serbia;Portugal;Germany;New Zealand;Japan
47EUCTR2020-003688-25-IT
(EUCTR)
15/01/202115/06/2021A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis –The ASPEN Study - ASPEN Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: [INS1007]
INN or Proposed INN: Brensocatib
Product Name: Brensocatib
Product Code: [INS1007]
INN or Proposed INN: Brensocatib
INSMED INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Malaysia;Denmark;Netherlands;Korea, Republic of;Turkey;Lithuania;Austria;United Kingdom;Hungary;Canada;Argentina;Poland;Brazil;Belgium;Romania;Bulgaria;Germany;New Zealand;Japan
48EUCTR2019-002840-26-DE
(EUCTR)
15/01/202101/10/2020Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasisA randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QBW251
INN or Proposed INN: Icenticaftor
Other descriptive name: CFTR potentiator
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2Spain;Germany;United Kingdom;China
49EUCTR2020-003688-25-BE
(EUCTR)
15/01/202115/01/2021A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3United States;Serbia;Portugal;Taiwan;Estonia;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
50NCT04545515
(ClinicalTrials.gov)
January 11, 20213/9/2020A Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis (CF) Subjects 6 Years and Older and F/MF GenotypesA Phase 3b Open-label Study Evaluating the Long-term Safety and Efficacy of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Ages 6 Years and Older Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)Cystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll120Phase 3Australia;Canada;Denmark;France;Germany;Israel;Netherlands;Spain;Switzerland;United Kingdom
51EUCTR2020-003688-25-HU
(EUCTR)
06/01/202116/11/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3United States;Serbia;Portugal;Estonia;Taiwan;Slovakia;Greece;Thailand;Spain;Ukraine;Ireland;Russian Federation;Chile;Israel;Colombia;Italy;France;Malaysia;Peru;Denmark;Australia;Latvia;Netherlands;Turkey;Lithuania;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;Japan;New Zealand
52NCT04687319
(ClinicalTrials.gov)
January 20217/12/2020RHEology of the Pulmonary MUcusProtocol for the Collection of Lung Mucus Samples From Care for a Rheology Research ProgrammeBronchial Mucus in COPD and Cystic FibrosisBiological: bronchial mucus collectionUniversity Hospital, GrenobleUniversity Grenoble AlpsNot yet recruiting18 YearsN/AAll100NULL
53EUCTR2019-002840-26-GB
(EUCTR)
22/12/202003/09/2020Study of safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in subjects with bronchiectasisA randomized, subject- and investigator-blinded, placebo-controlled, parallel group study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of QBW251 in patients with bronchiectasis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QBW251
INN or Proposed INN: Icenticaftor
Other descriptive name: CFTR potentiator
Novartis Pharma AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
72Phase 2Spain;Germany;China;United Kingdom
54EUCTR2020-003688-25-GR
(EUCTR)
18/12/202023/11/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
55EUCTR2020-003688-25-DK
(EUCTR)
09/12/202022/10/2020A study to evaluate the effects of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN StudyA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis – The ASPEN Study Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 23.0;Level: LLT;Classification code 10083611;Term: Non-cystic fibrosis bronchiectasis;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Product Name: Brensocatib
Product Code: INS1007
INN or Proposed INN: Brensocatib
Other descriptive name: AZD7986
Insmed IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1620Phase 3Portugal;Serbia;United States;Taiwan;Estonia;Slovakia;Greece;Spain;Thailand;Ukraine;Ireland;Russian Federation;Israel;Chile;Colombia;Italy;France;Malaysia;Peru;Australia;Denmark;Netherlands;Latvia;Lithuania;Turkey;Austria;United Kingdom;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Belgium;Croatia;Bulgaria;Germany;New Zealand;Japan
56NCT04643587
(ClinicalTrials.gov)
December 7, 202019/11/2020Study to Assess CSL787 in Non-cystic Fibrosis Bronchiectasis (NCFB)A Phase 1, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Exploratory Efficacy of Nebulized CSL787 in Healthy Subjects and Subjects With Non-Cystic Fibrosis Bronchiectasis (NCFB)Noncystic Fibrosis Bronchiectasis (NCFB)Biological: CSL787;Drug: PlaceboCSL BehringNULLRecruiting18 YearsN/AAll64Phase 1United Kingdom
57NCT03698448
(ClinicalTrials.gov)
December 1, 20203/10/2018A Dose-finding Study of Inhaled OligoG vs Placebo in Patients With Cystic FibrosisA Randomized, Double Blind, Dose-finding Study of Inhaled Oligosaccharide (OligoG) vs Placebo in Patients With Cystic FibrosisCystic FibrosisDrug: OligoG Dry powder for inhalationAlgiPharma ASImperial College London;Cystic Fibrosis Foundation;European Cystic Fibrosis Society;University Hospital of Cologne;Cystic Fibrosis EuropeNot yet recruiting12 YearsN/AAll120Phase 2/Phase 3Germany
58EUCTR2016-004558-13-DE
(EUCTR)
01/12/202009/04/2020A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;France;United States;Greece;Canada;Argentina;Poland;Germany;Italy
59NCT04594369
(ClinicalTrials.gov)
December 1, 202014/10/2020A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis BronchiectasisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects With Non-Cystic Fibrosis Bronchiectasis - The ASPEN StudyNon-Cystic Fibrosis BronchiectasisDrug: Brensocatib 10 mg;Drug: Brensocatib 25 mg;Drug: PlaceboInsmed IncorporatedNULLRecruiting18 Years85 YearsAll1620Phase 3United States;Argentina;Australia;Austria;Belgium;Brazil;Bulgaria;Canada;Chile;Colombia;Denmark;France;Germany;Greece;Hungary;Ireland;Israel;Italy;Japan;Korea, Republic of;Latvia;Malaysia;Mexico;Netherlands;New Zealand;Peru;Poland;Portugal;Serbia;Slovakia;Spain;Taiwan;Thailand;Turkey;Ukraine;United Kingdom;Estonia;Lithuania
60NCT04537793
(ClinicalTrials.gov)
November 19, 202028/8/2020Evaluation of ELX/TEZ/IVA in Cystic Fibrosis (CF) Subjects 2 Through 5 YearsA Phase 3 Study Evaluating the Safety, Tolerability, and Pharmacokinetics of Elexacaftor/Tezacaftor/Ivacaftor Triple Combination Therapy in Cystic Fibrosis Subjects 2 Through 5 Years of AgeCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting2 Years5 YearsAll93Phase 3United States;Australia;Canada;Germany;United Kingdom
61NCT04509050
(ClinicalTrials.gov)
November 18, 20206/8/2020Study to Evaluate Biological & Clinical Effects of Significantly Corrected CFTR Function in Infants & Young ChildrenA Prospective Study to Evaluate Biological and Clinical Effects of Significantly Corrected CFTR Function in Infants and Young Children (BEGIN Study)Cystic FibrosisDrug: Ivacaftor or elexacaftor/tezacaftor/ivacaftorSonya HeltsheCystic Fibrosis Foundation;University of Washington;University of Alabama at BirminghamActive, not recruitingN/A5 YearsAll210United States
62NCT04322929
(ClinicalTrials.gov)
November 12, 202024/3/2020Roflumilast in Non-CF Bronchiectasis Study (2019)Anti-inflammatory Effects of Roflumilast Treatment for 12 Weeks in Stable-state Non-cystic Fibrosis BronchiectasisNon-cystic Fibrosis BronchiectasisDrug: Roflumilast Oral TabletThe University of Hong KongNULLRecruiting18 YearsN/AAll27Phase 2Hong Kong
63NCT04624490
(ClinicalTrials.gov)
November 2, 202031/10/2020Hyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary DiseaseHyperpolarized 129Xe MR Imaging of Lung Function in Healthy Volunteers and Subjects With Pulmonary DiseaseAsthma;COPD;Interstitial Lung Disease;Cystic Fibrosis;Pulmonary Hypertension;Pulmonary Infection;Other Lung DiseaseDrug: Hyperpolarized Xe129Mario Castro, MD, MPHNULLRecruiting3 YearsN/AAll260Phase 1United States
64EUCTR2019-003554-86-FR
(EUCTR)
29/10/202002/04/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypesA Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Product Name: 150-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland
65EUCTR2019-004511-31-IT
(EUCTR)
21/10/202007/10/2020Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE
Product Name: Noxafil
Product Code: [NA]
INN or Proposed INN: Posaconazolo
Trade Name: Noxafil
Product Name: Noxafil
Product Code: [NA]
INN or Proposed INN: POSACONAZOLO
Trade Name: Noxafil
Product Name: Noxafil
Product Code: [NA]
INN or Proposed INN: POSACONAZOLO
Product Name: Noxafil
Product Code: [na]
INN or Proposed INN: POSACONAZOLO
Trade Name: NOXAFIL - 40 MG/ML SOSPENSIONE ORALE USO ORALE FLACONE (VETRO) 105 ML 1 FLACONE
Product Name: Noxafil
Product Code: [na]
INN or Proposed INN: POSACONAZOLO
Trade Name: Noxafil
Product Name: Noxafil
Product Code: [na]
INN or Proposed INN: Posaconazolo
IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMANULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
66EUCTR2016-004558-13-IT
(EUCTR)
19/10/202021/10/2020A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasischronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin
Product Name: Colistimethate sodium
Product Code: [NA]
Other descriptive name: Colistimethate Sodium
Trade Name: Salbutamol-ratiopharm® N metered-dose aerosol inhaler
Product Name: Salbutamol-ratiopharm® N metereddose aerosol inhaler
Product Code: [Salbutamol]
INN or Proposed INN: SALBUTAMOL
Other descriptive name: Salbutamol
ZAMBON SPANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;United States;France;Greece;Canada;Argentina;Poland;Germany;Italy
67NCT04467957
(ClinicalTrials.gov)
October 1, 202019/6/2020Non-contrast Lung Perfusion Mapping Applied for New Insights in Cystic FibrosisNon-contrast Lung Perfusion Mapping Applied for New Insights in Cystic FibrosisCystic FibrosisDrug: Initiation of CFTR Modulator;Drug: Hyperpolarized Xenon 129Children's Hospital Medical Center, CincinnatiNULLNot yet recruiting6 Years21 YearsAll26Phase 4NULL
68NCT04658277
(ClinicalTrials.gov)
October 1, 202031/8/2020Effect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian PopulationsEffect of Long Term Clarithromycin for Prevention of Exacerbations in Non-cystic Fibrosis Bronchiectasis in Asian PopulationsBronchiectasis AdultDrug: Clarithromycin;Other: Usual careChinese University of Hong KongNULLRecruiting50 YearsN/AAll40N/AHong Kong
69EUCTR2020-001762-11-GB
(EUCTR)
17/09/202023/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
70NCT04602468
(ClinicalTrials.gov)
September 3, 202020/10/2020Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)Real World Clinical Outcomes With Novel Modulator Therapy Combinations in People With CF (RECOVER)Cystic Fibrosis;Cystic Fibrosis Liver Disease;Cystic Fibrosis in Children;Adherence, Medication;Cystic Fibrosis Gastrointestinal DiseaseDrug: KaftrioRoyal College of Surgeons, IrelandImperial College London;University College Dublin;University of Limerick;Cystic Fibrosis Registry of Ireland;Erasmus Medical Center;Medizinische Hochschule Brandenburg Theodor Fontane;Queen's University, Belfast;Teagasc;The Hospital for Sick ChildrenRecruiting6 YearsN/AAll237Phase 4Ireland;United Kingdom
71NCT04509661
(ClinicalTrials.gov)
September 1, 202022/4/2020Efficacy and Safety of Inhaled Bronchodilator in Non-CF Bronchiectasis With Airflow LimitationEfficacy and Safety of Inhaled Bronchodilator in Non-cystic Fibrosis Bronchiectasis Patients With Airflow Limitation: a Multicenter, Open-label Randomized Controlled TrialBronchiectasis AdultDrug: LABA/LAMA or Placebo inhalationShanghai Pulmonary Hospital, Shanghai, ChinaNULLNot yet recruiting18 YearsN/AAll200Phase 4NULL
72EUCTR2020-001762-11-HU
(EUCTR)
26/08/202002/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
73EUCTR2019-003554-86-DK
(EUCTR)
19/08/202027/03/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypesA Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Product Name: 150-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 3Germany;United Kingdom;Switzerland;France;Canada;Spain;Australia;Denmark;Israel;Netherlands
74NCT04381429
(ClinicalTrials.gov)
August 17, 202030/4/2020Effect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related DiabetesEffect of Postprandial Insulin Administration of Faster-acting Insulin Analogue Versus Pre-prandial Administration of Acting-insulin Analogue in Cystic Fibrosis Related Diabetes : MIRE TrialCystic Fibrosis-related DiabetesDrug: A-F-A-F (NovoRapid-FIASP-NovoRapid-FIASP);Drug: F-A-F-A (FIASP-NovoRapid-FIASP-NovoRapid)University Hospital, Strasbourg, FranceNULLRecruiting18 YearsN/AAll40Phase 4France
75EUCTR2019-003554-86-DE
(EUCTR)
14/08/202012/03/2020A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 through 11 Years Old With Cystic Fibrosis and F/MF genotypesA Phase 3b, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects 6 Through 11 Years of Age Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
Product Name: 150-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100 mg ELX/50 mg TEZ/75 mg IVA fixed dose combination
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 3France;Canada;Spain;Denmark;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland
76NCT04375514
(ClinicalTrials.gov)
August 10, 202030/4/2020Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic FibrosisA Phase 1/2a Dose-Escalating Study to Evaluate the Safety, Tolerability and Pharmacokinetic Effects of ARO-ENaC in Normal Healthy Volunteers and Safety, Tolerability and Efficacy in Patients With Cystic FibrosisCystic Fibrosis, PulmonaryDrug: ARO-ENaC;Drug: PlaceboArrowhead PharmaceuticalsNULLRecruiting18 Years55 YearsAll92Phase 1/Phase 2Australia;New Zealand
77EUCTR2016-004558-13-PT
(EUCTR)
27/07/202020/04/2020A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3France;United States;Portugal;Greece;Canada;Argentina;Poland;Germany;Italy
78NCT04458129
(ClinicalTrials.gov)
July 8, 202030/6/2020Polyethylene Glycol and Intestinal Inflammation in Cystic FibrosisEFFECT OF POLYETHYLENE GLYCOL TREATMENT ON INTESTINAL INFLAMMATION ASSOCIATED WITH CYSTIC FIBROSIS IN CHILDRENCystic FibrosisDrug: Treatment with polyethylene glycol (Macrogol 4000)University Hospital, BordeauxNULLNot yet recruiting4 Years17 YearsAll23Phase 2NULL
79EUCTR2016-004558-13-GR
(EUCTR)
07/07/202014/05/2020A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;France;United States;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;Italy;New Zealand
80NCT04315311
(ClinicalTrials.gov)
May 6, 202018/3/2020Study Of Effects Of Oral CREON Capsules In Adult Participants With Exocrine Pancreatic Insufficiency Not Due To Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic CancerA Phase 4 Open-Label Single-Arm Study To Evaluate The Use Of CREON In Subjects With EPI Due To Etiologies Other Than Cystic Fibrosis, Chronic Pancreatitis, Pancreatectomy, Or Pancreatic CancerExocrine Pancreatic Insufficiency (EPI)Drug: CREONAbbVieNULLWithdrawn18 YearsN/AAll0Phase 4United States
81NCT04362761
(ClinicalTrials.gov)
May 4, 202022/4/2020A Study Evaluating the Long-Term Safety of Elexacaftor Combination TherapyA Phase 3b Open-label Extension Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis SubjectsCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll172Phase 3Australia;Belgium;Germany;United Kingdom
82ChiCTR2000031817
2020-04-302020-04-11Evaluation and comparison of quality of life between acetylcysteine tablets and placebo in patients with non cystic fibrosis bronchiectasisA Randomized, Double-Blinded, Placebo-Controlled, Multiple-Center Clinical Trial to Compare the Quality of Life of Acetylcysteine Tablets 600 Mg BID Treatment With Placebo in Patients With Non-Cystic Fibrosis Bronchiectasis bronchiectasiaexperimental group:Acetylcysteine;control group:placebo;West China Hospital, Sichuan UniversityNULLPending18Bothexperimental group:79;control group:40;Phase 4China
83EUCTR2019-003455-11-DE
(EUCTR)
08/04/202009/12/2019Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis SubjectsA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Trikafta
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: Ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
158Phase 3Belgium;Australia;Germany;United Kingdom
84EUCTR2019-004940-31-DK
(EUCTR)
24/03/202024/03/2020Effect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trialEffect of timing of enzyme replacement therapy (Creon®) at meals on fat malabsorption in adult patients with cystic fibrosis - a cross-over trial GI pains and fat malabsorption in cysticfibrosis patients with pancreas insufficiency
MedDRA version: 20.1;Level: LLT;Classification code 10025479;Term: Malabsorption syndrome;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Creon 10.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Trade Name: Creon 25.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Trade Name: Creon 40.000, hårde enterokapsler
INN or Proposed INN: Pankreatin
Other descriptive name: PANCREATIN
Terese KatzensteinNULLNot RecruitingFemale: yes
Male: yes
30Phase 4Denmark
85EUCTR2018-000378-30-DE
(EUCTR)
04/03/202006/06/2019A dose finding study of OligoG in patients with CF.A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20, 17,5 mg, Hartkapsel mit Pulver zur Inhalation
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20, 27,5 mg, Hartkapsel mit Pulver zur Inhalation
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20, 37,5 mg, Hartkapsel mit Pulver zur Inhalation
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
168Phase 2Poland;Ireland;Austria;Germany;United Kingdom
86NCT04235140
(ClinicalTrials.gov)
February 24, 202015/1/2020Long-term Safety of Lumacaftor/Ivacaftor in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationA Phase 3, Open-label, and Rollover Study to Evaluate the Long-term Safety and Tolerability of Lumacaftor/Ivacaftor Treatment in Subjects With Cystic Fibrosis Who Are Homozygous for F508del and 12 to <24 Months of Age at Treatment InitiationCystic FibrosisDrug: LUM/IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 MonthsN/AAll52Phase 3United States;Canada
87NCT04183790
(ClinicalTrials.gov)
February 17, 202028/11/2019Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll64Phase 3United States;Australia;Canada;Ireland;United Kingdom
88NCT04166396
(ClinicalTrials.gov)
February 17, 202014/11/2019Non-pulmonary Contributors of Exercise Intolerance in Patients With Cystic FibrosisNon-pulmonary Contributors of Exercise Intolerance in Patients With Cystic FibrosisCystic FibrosisDietary Supplement: Resveratrol;Dietary Supplement: NR;Dietary Supplement: PlaceboVirginia Commonwealth UniversityNULLRecruiting18 YearsN/AAll36N/AUnited States
89EUCTR2018-003831-31-ES
(EUCTR)
24/01/202002/12/2019MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis.A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs Exocrine Pancreatic Insufficiency
MedDRA version: 20.0;Level: LLT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MS1819-SD
INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica
Other descriptive name: LIPASE LIP2
AzurRxNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Hungary;Poland;Spain
90EUCTR2018-002835-76-NL
(EUCTR)
22/01/202017/09/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Germany;Netherlands;United Kingdom;Italy
91EUCTR2019-003455-11-GB
(EUCTR)
17/01/202009/12/2019Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor in Cystic Fibrosis SubjectsA Phase 3b Open-label Study Evaluating the Safety of Elexacaftor/Tezacaftor/Ivacaftor Combination Therapy in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg ELX / 50-mg TEZ / 75 -mg IVA FDC
Product Code: ELX/TEZ/IVA
INN or Proposed INN: SUB185183
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
158 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noBelgium;Australia;Germany;United Kingdom
92NCT03988816
(ClinicalTrials.gov)
December 6, 201914/6/2019Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With BronchiectasisEffect 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 StudyBronchiectasis AdultDrug: Roflumilast;Drug: Placebo oral tabletUniversity of Sao Paulo General HospitalFAPESP - Fundação de Apoio à Pesquisa do Estado de São PauloRecruiting18 YearsN/AAll30Phase 2Brazil
93NCT04058366
(ClinicalTrials.gov)
December 5, 201914/8/2019Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA 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 FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll251Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Italy;Netherlands;Spain;United Kingdom
94NCT04135495
(ClinicalTrials.gov)
November 25, 201916/8/2019A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD of ELX-02 in Cystic Fibrosis Patients With G542X AlleleA 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 AlleleCystic FibrosisDrug: ELX-02;Drug: IvacaftorEloxx Pharmaceuticals, Inc.NULLRecruiting18 YearsN/AAll16Phase 2United States;Canada
95EUCTR2019-000833-37-ES
(EUCTR)
19/11/201909/08/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
250 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
96EUCTR2019-003178-25-HU
(EUCTR)
19/11/201920/11/2019A study of safety, tolerability and effect of SNSP113 in Cystic FibrosisA Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Effect of Inhaled SNSP113 in Adult Subjects with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SNSP113
Product Code: SNSP113
INN or Proposed INN: not assigned
Other descriptive name: PAAG15
Synspira Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
56Phase 2Hungary
97EUCTR2018-000966-12-DE
(EUCTR)
18/11/201925/06/2019A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic FibrosisA Phase 2 Open Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dose Levels of Subcutaneously Administered ELX-02 in Patients with Cystic Fibrosis with at Least One G542X Allele Cystic fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Code: ELX-02
INN or Proposed INN: Not Assigned
Trade Name: Kalydeco
Product Name: Kalydeco
INN or Proposed INN: Ivacaftor
Eloxx Pharmaceuticals IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
16Phase 2Australia;Israel;Germany
98EUCTR2019-000750-63-FR
(EUCTR)
15/11/201922/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;France;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Belgium;Spain;Netherlands;United Kingdom
99EUCTR2019-000261-21-GB
(EUCTR)
05/11/201905/06/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM) 1A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM) 1 Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
98Phase 2Sweden;United Kingdom;Germany;Ireland;Belgium;Spain;Canada;France;United States
100NCT04126473
(ClinicalTrials.gov)
November 5, 201916/8/2019A Phase 2 Study to Evaluate the Safety, Tolerability, PK and PD in Cystic Fibrosis Patients With at Least 1 G542X AlleleA 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 AlleleCystic FibrosisDrug: ELX-02Eloxx Pharmaceuticals, Inc.NULLRecruiting16 YearsN/AAll16Phase 2Australia;Germany;Israel
101EUCTR2018-000378-30-AT
(EUCTR)
04/11/201905/07/2019A dose finding study of OligoG in patients with CF.A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF-5/20
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF-5/20
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
168Phase 2Poland;Ireland;Austria;Germany;United Kingdom
102EUCTR2019-000750-63-NL
(EUCTR)
31/10/201905/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
INN or Proposed INN: TBD
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLNot RecruitingFemale: yes
Male: yes
189Phase 2Serbia;United States;Slovakia;Spain;United Kingdom;France;Czech Republic;Hungary;Canada;Puerto Rico;Belgium;Poland;Netherlands
103EUCTR2018-002835-76-GB
(EUCTR)
29/10/201927/06/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;Italy;United Kingdom
104EUCTR2018-002835-76-IE
(EUCTR)
21/10/201928/06/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
105EUCTR2018-002835-76-DE
(EUCTR)
21/10/201903/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
106EUCTR2018-002835-76-DK
(EUCTR)
16/10/201909/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United Kingdom;Italy;Germany;Netherlands;Denmark;Australia;Ireland;Spain;Belgium;Canada;United States;France
107EUCTR2019-000261-21-ES
(EUCTR)
10/10/201905/07/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhalerA randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim, S.A.NULLNot RecruitingFemale: yes
Male: yes
98Phase 2Spain;United States;France;Canada;Belgium;Ireland;Germany;United Kingdom;Sweden
108EUCTR2018-001695-38-GB
(EUCTR)
09/10/201919/08/2019Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 YearsA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Product Name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom
109EUCTR2019-000261-21-SE
(EUCTR)
08/10/201929/04/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhalerA randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
110EUCTR2019-000261-21-BE
(EUCTR)
07/10/201929/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler – BALANCE – CF(TM)1A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis – BALANCE – CF(TM)1 Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
111EUCTR2018-002835-76-IT
(EUCTR)
04/10/201912/02/2021A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF)Subjects Heterozygous for F508del and a Gating or Residual FunctionMutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating theEfficacy and Safety of VX-445 Combination Therapy in Subjects With CysticFibrosis Who Are Heterozygous for the F508del Mutation and a Gating orResidual Function Mutation (F/G and F/RF Genotypes) - NA Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75- mg IVA FDC
Product Code: [VX-445/TEZ/IVA]
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: VX-661 / VX-770
Product Code: [VX-661 / VX-770]
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: [VX-770]
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
VERTEX PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
250Phase 3France;United States;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
112NCT04090294
(ClinicalTrials.gov)
October 1, 201921/8/2019Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis BronchiectasisAssessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis BronchiectasisBronchiectasisDrug: RoflumilastAssiut UniversityNULLNot yet recruiting18 Years75 YearsAll35Early Phase 1NULL
113EUCTR2019-000750-63-BE
(EUCTR)
27/09/201907/08/2019Cystic Fibrosis: A Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in subjects who have two copies of the F508del mutationA Phase 2 Study of ABBV-3067 Alone and in Combination with ABBV-2222 in Cystic Fibrosis Subjects Who Are Homozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: ABBV-2222
Product Code: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
INN or Proposed INN: Galicaftor
Other descriptive name: ABBV-2222
Product Name: ABBV-3067
Product Code: ABBV-3067
Other descriptive name: ABBV-3067
AbbVie DeutschlandNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
189 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;United States;Hungary;Czech Republic;Slovakia;Puerto Rico;Canada;Spain;Belgium;Netherlands;United Kingdom
114EUCTR2019-001735-31-GB
(EUCTR)
13/09/201924/06/2019A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic FibrosisA Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: ELEXACAFTOR
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
158Phase 3Belgium;Australia;Germany;United Kingdom
115EUCTR2018-003970-28-NL
(EUCTR)
12/09/201909/05/2019A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
INN or Proposed INN: DEUTIVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Belgium;Ireland;Australia;Germany;Netherlands;United Kingdom
116NCT04006873
(ClinicalTrials.gov)
September 3, 20192/7/2019Gut Imaging for Function & Transit in Cystic Fibrosis Study 2A Randomised Crossover Pilot Study of the Effects of Tezacaftor/Ivacaftor and Ivacaftor on Gastrointestinal Function Using Magnetic Resonance Imaging Parameters in People With Cystic FibrosisCystic FibrosisDrug: Tezacaftor/Ivacaftor + Ivacaftor;Drug: Placebo oral tabletNottingham University Hospitals NHS TrustVertex Pharmaceuticals Incorporated;Cystic Fibrosis Foundation;Cystic Fibrosis Trust;University of Nottingham;Nottingham University Hospitals CharityCompleted12 Years40 YearsAll12Phase 2United Kingdom
117NCT04302428
(ClinicalTrials.gov)
August 29, 20196/3/2020Zinc Status and Growth in Cystic FibrosisZinc Status and Growth in Cystic FibrosisCystic;FibrosisBiological: Serum Zn;Biological: Red Blood Cell ZnIndiana UniversityNULLActive, not recruiting3 Months3 YearsAll35United States
118EUCTR2019-000261-21-DE
(EUCTR)
12/08/201916/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhalerA randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
119EUCTR2018-003970-28-DE
(EUCTR)
12/08/201921/05/2019A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
120NCT04043806
(ClinicalTrials.gov)
August 9, 201931/7/2019A Study Evaluating the Long-term Safety of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety of VX-445 Combination Therapy in Subjects With Cystic FibrosisCystic FibrosisDrug: ELX/TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll458Phase 3United States;Australia;Canada;Denmark;Germany;Ireland;Israel;Poland;Spain;Switzerland;United Kingdom
121NCT03903913
(ClinicalTrials.gov)
August 8, 201915/2/2019Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF BronchiectasisA Phase IIa Open Label Study to Evaluate the Safety, Tolerability and Efficacy of S-1226 Administered by Nebulization in Subjects With Mild to Moderate Cystic Fibrosis and Non CF BronchiectasisCystic Fibrosis;BronchiectasisDrug: S-1226SolAeroMed Inc.NULLRecruiting14 Years50 YearsAll12Phase 2Canada
122EUCTR2019-000261-21-IE
(EUCTR)
26/07/201930/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat® inhaler - BALANCE - CF(TM)1A randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis - BALANCE - CF(TM)1 Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim LimitedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
98 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Ireland;Germany;United Kingdom;Sweden
123EUCTR2019-000261-21-FR
(EUCTR)
19/07/201921/05/2019A 4-week study to test different doses of BI 1265162 in adolescents and adults with cystic fibrosis using the Respimat®inhalerA randomised, double-blind, placebo-controlled and parallel group trial to evaluate efficacy and safety of twice daily inhaled doses of BI 1265162 delivered by Respimat® inhaler as add-on therapy to standard of care over 4 weeks in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BI 1265162 10 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 25 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 50 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Product Name: BI 1265162 100 µg
INN or Proposed INN: not yet available
Other descriptive name: BI 1265162
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
98Phase 2United States;France;Canada;Spain;Belgium;Ireland;Germany;United Kingdom;Sweden
124EUCTR2017-004134-29-DE
(EUCTR)
12/07/201905/03/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
125EUCTR2018-002496-18-NL
(EUCTR)
08/07/201913/02/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: N/A
Other descriptive name: VX-121
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: VX-561
INN or Proposed INN: N/A
Other descriptive name: VX-561
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Portugal;Germany;Netherlands;United Kingdom
126EUCTR2018-003970-28-BE
(EUCTR)
04/07/201923/04/2019A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
127NCT03650712
(ClinicalTrials.gov)
July 1, 201918/7/2018EnVision CF Multicenter Study of Glucose Tolerance in Cystic FibrosisEnVision CF Multicenter Study of Glucose Tolerance in Cystic FibrosisCystic Fibrosis-related DiabetesDiagnostic Test: Oral glucose tolerance test;Diagnostic Test: Continuous glucose monitoring;Diagnostic Test: Dexa scanKatie Larson OdeNULLActive, not recruiting6 YearsN/AAll404N/AUnited States
128NCT04302662
(ClinicalTrials.gov)
June 27, 20194/3/2020Phase 2 Combination Study With Escalating Doses of MS1819-SD on Top of a Stable Dose of PPEsA 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 PPEsCystic Fibrosis;Cystic Fibrosis Gastrointestinal Disease;Cystic Fibrosis of PancreasDrug: MS1819-SDAzurRx SASNULLCompleted12 YearsN/AAll20Phase 2Hungary;Turkey
129NCT03597347
(ClinicalTrials.gov)
June 20, 201912/7/2018Trial of Inhaled Molgramostim in CF Subjects With NTM InfectionAn Open-label, Non-controlled, Multicenter, Pilot Trial, Using Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial (NTM) InfectionMycobacterium Infections, Nontuberculous;Cystic Fibrosis (CF)Drug: Molgramostim nebulizer solution;Device: PARI eFlow nebulizer systemSavara Inc.NULLTerminated18 YearsN/AAll14Phase 2United States
130EUCTR2018-003970-28-GB
(EUCTR)
18/06/201917/04/2019A Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind Study to Evaluate the Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Deutivacaftor
Product Code: VX-561
INN or Proposed INN: DEUTIVACAFTOR
INN or Proposed INN: DEUTIVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
88Phase 2United States;Belgium;Ireland;Australia;Netherlands;Germany;United Kingdom
131NCT04010799
(ClinicalTrials.gov)
May 27, 201910/6/2019A 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) BronchiectasisA 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 BronchiectasisCystic Fibrosis;Non-Cystic Fibrosis BronchiectasisDrug: CHF 6333;Drug: PlaceboChiesi Farmaceutici S.p.A.NULLCompleted18 YearsN/AAll68Phase 1Germany
132EUCTR2018-002496-18-PT
(EUCTR)
20/05/201905/02/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: N/A
Other descriptive name: VX-121
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: VX-561
INN or Proposed INN: N/A
Other descriptive name: VX-561
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 2United States;Portugal;Netherlands;Germany;United Kingdom
133NCT03822455
(ClinicalTrials.gov)
May 16, 201929/1/2019A Phase 2b Randomised, Placebo Controlled Study of OligoG in Patients With Cystic FibrosisA 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 FibrosisDrug: OligoG DPIAlgiPharma ASAlgiPharma Australia Pty. Ltd.Active, not recruiting18 YearsN/AAll20Phase 2Australia
134EUCTR2017-003723-29-PL
(EUCTR)
09/05/201907/11/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
135EUCTR2019-001314-41-NL
(EUCTR)
06/05/201906/05/2019This study investigates the effect of switching from Orkambi treatment to Symkevi. In particuar we want to investigate the effect of the switch on the uptake, concentration in the blood an degradation of ivacaftor.Kinetics of ivacaftor at Switch Orkambi Symkevi study - SOS Cystic fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Orkambi: contains lumacaftor and ivacaftor
Product Name: Orkambi
Trade Name: Symkevi
Product Name: Symkevi
Trade Name: Kalydeco
Product Name: Kalydeco
NULLNot RecruitingFemale: yes
Male: yes
100Phase 4Netherlands
136EUCTR2018-002496-18-DE
(EUCTR)
02/05/201928/01/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: N/A
Other descriptive name: VX-121
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: VX-561
INN or Proposed INN: N/A
Other descriptive name: VX-561
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
108 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noPortugal;United States;Netherlands;Germany;United Kingdom
137NCT03961516
(ClinicalTrials.gov)
May 1, 201916/5/2019Glycemic Characterization and Pancreatic Imaging Correlates in Cystic FibrosisGlycemic Characterization and Pancreatic Imaging Correlates in Cystic FibrosisCystic Fibrosis;Cystic Fibrosis-related Diabetes;Cystic Fibrosis Liver Disease;Pancreatic Steatosis;Hepatic SteatosisDevice: Frequently Sampled Oral Glucose Tolerance Test and CGM;Radiation: MRI Pancreas and LiverUniversity Hospitals Cleveland Medical CenterNULLActive, not recruiting6 Years40 YearsAll40United States
138NCT02748798
(ClinicalTrials.gov)
May 201919/4/2016Developing Optimal Parameters for Hyperpolarized Noble Gas and Inert Fluorinated Gas MRI of Lung DisordersDeveloping Optimal Parameters for Hyperpolarized Noble Gas (3He and 129Xe) and Inert Fluorinated Gas Magnetic Resonance Imaging of Lung DisordersLung 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 ApneaDrug: 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 CoilThunder Bay Regional Research InstituteThunder Bay Regional Health Sciences Centre;St. Joseph's Care Group;Lakehead UniversityUnknown status18 YearsN/AAll160Early Phase 1Canada
139EUCTR2018-003831-31-HU
(EUCTR)
28/03/201909/10/2018MS1819-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-SDAzurRxNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Hungary;Poland;Spain
140EUCTR2017-001259-29-GB
(EUCTR)
12/03/201921/12/2018A study to establish the tolerabilty and adverse effects in people with a severe form of Cystic Fibrosi (delta F 508 homozygous) when using a combination of two products - cyteamine (a licensed medicine being used in a new disease) and EGCG (a food supplement).A PHASE 1B/2A STUDY TO ASSESS THE TOLERABILITY AND ADVERSE EFFECT PROFILE OF CYSTEAMINE (CYSTAGON) IN ADULTS AND CHILDREN WITH HOMOZYGOUS ?F508 CYSTIC FIBROSIS, IN PATIENTS TAKING EPIGALLOCATECHIN-3-GALLATE (EGCG, EPINERVE) FOOD SUPPLEMENTATION - Delta Dose Study DeltaF508 Homozygous Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cystagon
Product Name: Cystagon
INN or Proposed INN: cysteamine bitartrate
Other descriptive name: 2-aminoethanethiol;2,3-dihydroxybutanedioic acid
University of LIverpoolNULLNot RecruitingFemale: yes
Male: yes
44Phase 1;Phase 2United Kingdom
141EUCTR2018-002496-18-GB
(EUCTR)
08/03/201930/01/2019A Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-121 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: N/A
Other descriptive name: VX-121
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: VX-561
INN or Proposed INN: N/A
Other descriptive name: VX-561
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
108Phase 2Portugal;United States;Netherlands;Germany;United Kingdom
142EUCTR2017-003723-29-NL
(EUCTR)
25/02/201920/06/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
143EUCTR2017-002533-32-BE
(EUCTR)
17/01/201928/09/2018A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
144EUCTR2015-004143-39-IT
(EUCTR)
19/12/201820/09/2018Saline hypertonic in preschoolers and lung structure as measured by computed tomography.A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: SODIUM CHLORIDE 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy
145EUCTR2015-002743-33-NL
(EUCTR)
14/12/201818/07/2018A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Netherlands;Germany;New Zealand
146NCT03624101
(ClinicalTrials.gov)
December 1, 20187/8/2018Novel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsNovel Therapeutic Approaches for Treatment of CF Patients With W1282X Premature Termination Codon MutationsCystic FibrosisDrug: Trikafta;Drug: symdeko/Trikafta;Drug: Ivacaftor/TrikaftaUniversity of Alabama at BirminghamNULLCompleted18 YearsN/AAll1Phase 4United States
147EUCTR2017-003723-29-CZ
(EUCTR)
27/11/201809/07/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
148NCT03756922
(ClinicalTrials.gov)
November 27, 201827/11/2018A DDI Study of FDL169 and FDL176 in Healthy SubjectsA Phase 1/2, Drug-Drug Interaction Study of FDL169 and FDL176 in Healthy Subjects and in Cystic Fibrosis Subjects Homozygous for the F508del-CFTR MutationCystic FibrosisDrug: FDL169;Drug: FDL176Flatley Discovery Lab LLCNULLSuspended18 Years55 YearsAll78Phase 1/Phase 2United Kingdom
149EUCTR2015-002743-33-GR
(EUCTR)
27/11/201814/11/2018A clinical trial to investigate the efficacy and safety of inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3New Zealand;Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands
150EUCTR2018-000243-87-GB
(EUCTR)
19/11/201821/08/2018A study in people with cystic fibrosis who have a fungal lung infection, looking at the safety of inhaled PC945, it's effect on the body and how the body affects the drug.An open-label study to assess the safety, pharmacokinetics and pharmacodynamics of inhaled PC945 in adult Cystic Fibrosis (CF) patients with persistent pulmonary Aspergillus fumigatus infection. Pulmonary aspergillosis
MedDRA version: 20.0;Level: LLT;Classification code 10059259;Term: Pulmonary aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: PC945Pulmocide LtdNULLNot RecruitingFemale: yes
Male: yes
18Phase 2United Kingdom
151EUCTR2017-003723-29-PT
(EUCTR)
19/11/201821/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;Poland;Belgium;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden;Canada;Hungary;Czech Republic;France
152EUCTR2017-003723-29-DE
(EUCTR)
19/11/201814/02/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
153EUCTR2017-003319-21-BE
(EUCTR)
08/11/201821/08/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2United States;France;Canada;Belgium;Denmark;Germany;United Kingdom
154NCT03748199
(ClinicalTrials.gov)
November 8, 20185/11/2018Clinical Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of POL6014 in Patients With CFPhase-Ib/IIa Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Orally Inhaled Multiple Doses of POL6014 in Patients With Cystic FibrosisCystic FibrosisDrug: POL6014;Drug: PlaceboSanthera PharmaceuticalsNULLCompleted18 Years55 YearsAll32Phase 1/Phase 2Germany
155NCT03617718
(ClinicalTrials.gov)
November 1, 201819/7/2018Project 2 Airway Potential Hydrogen (pH) in AsthmaMethods to Identify and Treat Severe Asthma Patients Project 2: Airway pH PhenotypingCystic Fibrosis;Asthma;Severe Persistent Asthma;HealthyDrug: Glycine BufferUniversity Hospitals Cleveland Medical CenterNational Institutes of Health (NIH)Recruiting18 Years50 YearsAll75Phase 1/Phase 2United States
156EUCTR2017-003723-29-GR
(EUCTR)
15/10/201808/08/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
157NCT03525574
(ClinicalTrials.gov)
October 9, 20182/5/2018A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA 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 MutationCystic FibrosisDrug: VX-445;Drug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll507Phase 3United States;Australia;Austria;Belgium;Canada;Czechia;France;Germany;Greece;Italy;Netherlands;Sweden;United Kingdom
158EUCTR2018-000183-28-CZ
(EUCTR)
01/10/201809/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
159EUCTR2018-000183-28-GR
(EUCTR)
01/10/201825/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
160EUCTR2018-000184-89-GB
(EUCTR)
27/09/201804/07/2018A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Product Name: 100 mg TEZ/150 mg IVA FDC
Product Code: TEZ/IVA
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Belgium;Netherlands;United Kingdom
161EUCTR2018-000183-28-GB
(EUCTR)
27/09/201804/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
162EUCTR2016-004479-35-PL
(EUCTR)
26/09/201817/05/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation - A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic F Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Poland;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
163EUCTR2017-004134-29-PL
(EUCTR)
24/09/201813/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
164EUCTR2017-003723-29-BG
(EUCTR)
21/09/201808/05/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
165EUCTR2018-000183-28-DE
(EUCTR)
20/09/201803/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
166EUCTR2018-000183-28-IT
(EUCTR)
17/09/201809/02/2021A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) - NA Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: [VX-445/TEZ/IVA]
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: [VX-770]
INN or Proposed INN: Ivacaftor
VERTEX PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Czechia;Greece;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
167EUCTR2018-000184-89-NL
(EUCTR)
12/09/201816/08/2018A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Product Name: 100 mg TEZ/150 mg IVA FDC
Product Code: TEZ/IVA
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belgium;Netherlands;United Kingdom
168EUCTR2018-002550-71-DE
(EUCTR)
12/09/201818/07/2018A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic FibrosisPhase-Ib/IIa study to investigate safety, tolerability, pharmacokinetics and pharmacodynamics of orally inhaled multiple doses of POL6014 in patients with Cystic Fibrosis Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: POL6014
INN or Proposed INN: lonodelestat
Other descriptive name: CYCLO[L-ALANYL-L-SERYL-L-ISOLEUCYL-L-PROLYL-L-PROLYL-L-GLUTAMINYL-L-LYSYL-L-TYROSYL-D-PROLYL-L-PROLYL-(2S)-2-AMINODECANOYL-L-ALPHA-GLUTAMYL-L-THREONYL]
Santhera Pharmaceuticals (Switzerland) LtdNULLNot RecruitingFemale: yes
Male: yes
32Phase 1;Phase 2Germany
169EUCTR2017-003723-29-IT
(EUCTR)
11/09/201812/02/2021A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: [JBT-101]
Other descriptive name: Lenabasum
Product Name: Lenabasum
Product Code: [JBT-101]
Other descriptive name: Lenabasum
CORBUS PHARMACEUTICALS, INCNULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Czechia;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
170EUCTR2018-000184-89-BE
(EUCTR)
07/09/201809/07/2018A Phase 3 Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F).A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg VX-445/50mg TEZ /75mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Product Name: 100 mg TEZ/150 mg IVA FDC
Product Code: TEZ/IVA
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Belgium;Netherlands;United Kingdom
171EUCTR2018-000183-28-BE
(EUCTR)
07/09/201809/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
172EUCTR2018-000183-28-NL
(EUCTR)
03/09/201818/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Netherlands;Germany;Sweden
173EUCTR2017-004134-29-DK
(EUCTR)
29/08/201803/07/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland
174EUCTR2017-002533-32-DK
(EUCTR)
28/08/201809/11/2017A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
175EUCTR2018-000183-28-SE
(EUCTR)
27/08/201829/06/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
176EUCTR2018-002579-16-SE
(EUCTR)
26/08/201816/07/2018Measurement of the posaconazole concentration in exhaled breath in CF patients after a single dose posaconazole to correlate to the concentration in blood and saliva.Evaluation of the possible use of analysis of posaconazole in exhaled breath as a surrogate marker for the lung to monitor adequate dosages of posaconazole in CF patients treated for Aspergillus spp. related lung-disease. Part 1. Pharmacokinetic single center study. Cystic Fibrosis (CF) is the most common life–limiting autosomal recessive disease among people of European heritage. The condition is a result of a mutation in the cystic fibrosis transmembrane conductance regulator (cftr) gene on chromosome seven, which encodes a chloride channel. In the lung defective channel activity leads to thick, viscous secretion and impaired mucociliary clearance. This causes trapping of mucus, colonization with bacteria and fungi, and a persistent inflammatory response.
MedDRA version: 20.0;Level: PT;Classification code 10074549;Term: Cystic fibrosis respiratory infection suppression;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Noxafil®Karolinska University Hospital, Stockholm CF centerNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 2Sweden
177EUCTR2018-000183-28-AT
(EUCTR)
24/08/201820/07/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
178EUCTR2018-002366-39-GB
(EUCTR)
23/08/201820/06/2019A pilot trial of intravenous iron for the treatment of low iron levels in adult patients with cystic fibrosis.A pilot trial of intravenous iron for the treatment of iron deficiency in adult patients with cystic fibrosis - Intravenous iron in adults with cystic fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Ferinject
Product Name: Ferinject
INN or Proposed INN: Ferric carboxymaltose
University of Oxford / Clinical Trials and Research GovernanceNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
179EUCTR2017-004134-29-GB
(EUCTR)
22/08/201823/02/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom
180NCT03625466
(ClinicalTrials.gov)
August 10, 20187/8/2018A Study to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delAn 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 F508delCystic FibrosisDrug: LUM;Drug: IVA;Drug: Matched PlacebosVertex Pharmaceuticals IncorporatedNULLActive, not recruiting2 Years5 YearsAll51Phase 2Germany
181EUCTR2016-004479-35-FR
(EUCTR)
08/08/201804/06/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
182NCT03551691
(ClinicalTrials.gov)
August 7, 201829/5/2018PPIs and Fat Absorption in CF and EPIProton Pump Inhibitors and Fat Absorption in Subjects With Cystic Fibrosis and Pancreatic InsufficiencyPancreatic Insufficiency;Cystic FibrosisDrug: Omeprazole 40mg Capsule;Drug: Placebo oral capsuleChildren's Hospital of PhiladelphiaChiesi USA, Inc.Active, not recruiting12 YearsN/AAll16Phase 2United States
183EUCTR2017-003319-21-DE
(EUCTR)
20/07/201809/04/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: N-(5-hydroxy-2,4- bis(trimethylsilyl)phenyl)-4-oxo- 1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2United States;France;Canada;Belgium;Denmark;Germany;United Kingdom
184EUCTR2017-002968-40-DK
(EUCTR)
28/06/201824/06/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland
185EUCTR2017-003723-29-BE
(EUCTR)
27/06/201829/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Romania;Bulgaria;Germany;Netherlands;Sweden
186EUCTR2017-003761-99-DE
(EUCTR)
27/06/201819/02/2018A Study of the Effects of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508delAn Exploratory Phase 2, 2-part, Randomized, Double blind, Placebo controlled Study With a Long term, Open label Period to Explore the Impact of Lumacaftor/Ivacaftor on Disease Progression in Subjects Aged 2 Through 5 Years With Cystic Fibrosis, Homozygous for F508del Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor / ivacaftor
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Orkambi 100 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Germany
187EUCTR2016-004479-35-BE
(EUCTR)
26/06/201830/03/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
188EUCTR2016-004479-35-DE
(EUCTR)
26/06/201806/04/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
189EUCTR2018-000098-61-GB
(EUCTR)
22/06/201801/06/2018A study to evaluate the efficacy, safety, tolerability and pharmacokinetics of the combination of GLPG3067, GLPG2222 and GLPG2737 in adult patients with cystic fibrosisA Phase II, randomized, double-blind, placebo-controlled, multi-center study to evaluate the efficacy, safety, tolerability and pharmacokinetics of orally administered combination of GLPG3067, GLPG2222 and GLPG2737, in adult subjects with cystic fibrosis homozygous or heterozygous for F508del CFTR Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG3067
Product Code: G914167
INN or Proposed INN: Not applicable
Other descriptive name: GLPG3067
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
144 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;France;United States;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;New Zealand;United Kingdom
190NCT04278040
(ClinicalTrials.gov)
June 20, 20187/2/2020Inhalations of Ultra-low Doses of Melphalan for the Treatment of Non-cystic Fibrosis BronchiectasisSafety, Tolerability and Efficacy of Ultra-low Doses of Alkylating Drug Melphalan Inhalations for the Treatment of Non-cystic Fibrosis BronchiectasisNon-cystic Fibrosis BronchiectasisDrug: MelphalanFederal State Budgetary Institution, Pulmonology Scientific Research InstituteMoscow State University of Medicine and DentistryRecruiting18 Years70 YearsAll7Phase 2Russian Federation
191EUCTR2018-001573-24-BE
(EUCTR)
11/06/201808/05/2018Evaluation 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 imagingFunctional Respiratory Imaging (FRI) to assess the short-term effect of the product ORKAMBI (lumacaftor/ ivacaftor) on lung function in ORKAMBI-naive patients with Cystic Fibrosis Homozygous for Phe508del. Cystic Fibrosis Homozygous (homozygous for the F508del mutation)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Orkambi
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Antwerp University HospitalNULLNot RecruitingFemale: yes
Male: yes
20Phase 4Belgium
192EUCTR2017-003723-29-SE
(EUCTR)
07/06/201801/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
193EUCTR2017-003319-21-GB
(EUCTR)
04/06/201803/07/2018Study Assessing the Safety, Tolerability and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic FibrosisA Phase 1 / 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PTI-808 in Healthy Adult Subjects and in Adults with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: N-(5-hydroxy-2,4-bis(trimethylsilyl)phenyl)-4-oxo-1,4-dihydroquinoline-3-carboxamide
Product Code: PTI-808
INN or Proposed INN: None
Other descriptive name: PTI-808
Product Name: Sodium (R)-8-methyl-2-(3-methylbenzofuran-2-yl)-5-(1-(tetrahydro-2H-pyran-4-yl)ethoxy)quinoline-4-ca
Product Code: PTI-801
INN or Proposed INN: None
Other descriptive name: PTI-801
Product Name: N-(trans-3-(5-((R)-1-hydroxyethyl)-1,3,4-oxadiazol-2-yl)cyclobutyl)-3-phenylisoxazole-5-carboxamide
Product Code: PTI-428
INN or Proposed INN: None
Other descriptive name: PTI-428
Proteostasis Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
240Phase 1;Phase 2France;United States;Canada;Belgium;Denmark;Germany;United Kingdom
194EUCTR2016-001440-18-NL
(EUCTR)
30/05/201816/01/2018The influence of cytochrome P450 3A4 inhibitors on serum levels of Ivacaftor in cystic fibrosis patients and healthy subjects.Pharmacokinetic interactions between ivacaftor and cytochrome P450 3A4 inhibitors in cystic fibrosis patients and healthy controls - IACI cystic fibrosis and healthy subjects;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Ivacaftor
Trade Name: claritromycin 500mg film coated tablets
Product Name: Claritromycin
Trade Name: Azithromycin 500 mg film-coated tablet
Product Name: azithromycin
Trade Name: Norvir 100 mg film-coated tablets
Product Name: Norvir
university medical center utrechtNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
12Phase 4Netherlands
195NCT03482960
(ClinicalTrials.gov)
May 29, 201823/3/2018Comparison of 129Xe MRI With 19F MRI in CF Lung DiseaseComparison of 129Xe MRI With 19F MRI in CF Lung DiseaseCystic FibrosisDrug: Hyperpolarized Xenon gas;Drug: PFPUniversity of North Carolina, Chapel HillCystic Fibrosis FoundationCompleted18 YearsN/AAll11Early Phase 1United States
196EUCTR2017-003723-29-ES
(EUCTR)
21/05/201809/04/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Australia;Bulgaria;Netherlands;Germany;Sweden
197EUCTR2017-004133-82-ES
(EUCTR)
18/05/201815/03/2018A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor/100mg/150mg
Product Code: VX-661/VX-770 (TEZ/IVA)
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United Kingdom;Germany;Australia;Ireland;Spain;United States
198EUCTR2017-004132-11-ES
(EUCTR)
18/05/201805/03/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
199EUCTR2017-003723-29-AT
(EUCTR)
17/05/201828/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;United States;Serbia;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
200EUCTR2017-004134-29-IE
(EUCTR)
15/05/201805/03/2018A Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/ TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
460Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
201EUCTR2017-003723-29-GB
(EUCTR)
11/05/201805/02/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: LENABASUM
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
202NCT03375047
(ClinicalTrials.gov)
May 10, 20187/9/2017Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic FibrosisA 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 FibrosisCystic FibrosisDrug: MRT5005;Drug: Normal salineTranslate Bio, Inc.NULLRecruiting18 YearsN/AAll40Phase 1/Phase 2United States
203NCT03428334
(ClinicalTrials.gov)
May 10, 201826/1/2018Roflumilast in Non-CF Bronchiectasis StudyA 4-week Single-arm Study of Roflumilast in Stable-state Non-cystic Fibrosis BronchiectasisNon-cystic Fibrosis BronchiectasisDrug: Oral roflumilastThe University of Hong KongNULLCompleted18 YearsN/AAll20Phase 2Hong Kong
204EUCTR2016-002749-42-NL
(EUCTR)
09/05/201829/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Netherlands;Germany
205NCT03579173
(ClinicalTrials.gov)
May 8, 201825/6/2018Determinants of Early Cystic Fibrosis Lung DiseaseDeterminants of Early Cystic Fibrosis Lung DiseaseCystic Fibrosis in ChildrenDiagnostic Test: Infant PFT;Diagnostic Test: Lung Clearance Index;Diagnostic Test: Passive tidal breathingIndiana UniversityNULLActive, not recruiting1 Month5 YearsAll55United States
206EUCTR2017-004132-11-DK
(EUCTR)
08/05/201802/03/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Ireland;Australia;Denmark;Israel;Norway;Germany;United Kingdom;Switzerland
207EUCTR2017-004133-82-GB
(EUCTR)
02/05/201814/06/2018A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor/100mg/150mg
Product Code: VX-661/VX-770 (TEZ/IVA)
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Australia;Germany;United Kingdom
208EUCTR2017-004132-11-GB
(EUCTR)
02/05/201823/02/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3United States;Canada;Spain;Poland;Ireland;Denmark;Australia;Israel;Norway;Germany;Switzerland;United Kingdom
209EUCTR2017-004132-11-IE
(EUCTR)
01/05/201805/03/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;Germany;United Kingdom;Switzerland
210EUCTR2017-004133-82-IE
(EUCTR)
01/05/201805/03/2018A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor/100mg/150mg
Product Code: VX-661/VX-770 (TEZ/IVA)
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Spain;Ireland;Australia;Germany;United Kingdom
211EUCTR2017-003723-29-SK
(EUCTR)
26/04/201823/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Netherlands;Sweden
212EUCTR2017-002533-32-NL
(EUCTR)
26/04/201829/11/2017A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden;Korea, Republic of
213NCT03537651
(ClinicalTrials.gov)
April 25, 201815/5/2018A Study to Evaluate the Safety and Efficacy of Long-term Treatment With TEZ/IVA in CF Subjects With an F508del CFTR MutationA 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 MutationCystic FibrosisDrug: TEZ;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting6 YearsN/AAll130Phase 3United States;Australia;Belgium;Canada;Denmark;France;Germany;Ireland;Poland;Switzerland;United Kingdom
214EUCTR2017-004132-11-DE
(EUCTR)
25/04/201827/02/2018A Study to Evaluate the Efficacy and Safety of VX-659 Drug in Combination With Other Drugs in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Germany;United States;Canada;Poland;Spain;Ireland;Denmark;Australia;Israel;Norway;United Kingdom;Switzerland
215EUCTR2016-004479-35-GB
(EUCTR)
24/04/201826/04/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150mg
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
65Phase 3France;Poland;Belgium;Ireland;Denmark;Australia;Germany;Switzerland;United Kingdom
216EUCTR2016-004479-35-DK
(EUCTR)
18/04/201822/02/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Australia;Denmark;Germany;United Kingdom;Switzerland
217EUCTR2017-003723-29-HU
(EUCTR)
16/04/201827/02/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2Portugal;Serbia;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
218NCT03489629
(ClinicalTrials.gov)
April 3, 201829/3/2018STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)Cystic FibrosisDrug: Trimethoprim Sulfamethoxazole (TMP/SMX);Drug: Minocycline;Drug: Mupirocin;Drug: Chlorhexidine Gluconate;Behavioral: Environmental DecontaminationUniversity of North Carolina, Chapel HillUniversity of Washington;Cook Children's Medical Center;Indiana University;University of Michigan;University of Texas Southwestern Medical Center;St. Louis Children's HospitalRecruiting2 Years45 YearsAll42Phase 2United States
219EUCTR2017-002533-32-ES
(EUCTR)
29/03/201822/11/2017A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Canada;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
220EUCTR2017-002533-32-PL
(EUCTR)
28/03/201818/01/2018A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Spain;Italy;United Kingdom;Poland;Belgium;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
221EUCTR2017-002533-32-BG
(EUCTR)
23/03/201801/12/2017A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
222EUCTR2017-002533-32-GB
(EUCTR)
22/03/201823/10/2017A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United Kingdom;United States;Spain;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
223EUCTR2017-002533-32-DE
(EUCTR)
15/03/201803/11/2017A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Spain;United Kingdom;Italy;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Korea, Republic of;Sweden
224EUCTR2018-000126-55-NL
(EUCTR)
15/03/201815/05/2018A study to investigate the safety and the movement of the study drug VX-121 around the body in healthy people and patients with cystic fibrosisA Phase 1/2 Study of VX-121 in Healthy Subjects and in Subjects With Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121
INN or Proposed INN: Not yet assigned
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 1;Phase 2Netherlands
225NCT04411901
(ClinicalTrials.gov)
March 1, 201822/5/2020The Role of Vitamin D3 in Pediatric Bronchiectasis SeverityThe Role of Vitamin D3 in Pediatric Bronchiectasis Severity( CF Versus Non CF Bronchioectasis)Cystic Fibrosis and Non CF BronchiectasisDrug: Cholecalciferol (vitaminD3)Heba OmaraNULLCompleted1 Year17 YearsAll40Phase 2/Phase 3Egypt
226EUCTR2017-002533-32-SE
(EUCTR)
30/01/201814/11/2017A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic Fibrosis Bronchiectasis.A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study. Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Product Name: INS1007
INN or Proposed INN: not available
Other descriptive name: AZD7986
Insmed IncorporatedNULLNot Recruiting Female: yes
Male: yes
240 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;United Kingdom;Italy;France;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
227NCT03460704
(ClinicalTrials.gov)
January 29, 201814/2/2018Trial in Non-cystic Fibrosis Bronchiectasis Patients With Chronic Lung Infections Treated With Colistimethate Sodium (PROMIS II)A Double-blind, Placebo-controlled, Multi-centre, Clinical Trial to Investigate the Efficacy and Safety of 12 Months of Therapy With Inhaled Colistimethate Sodium in the Treatment of Subjects With Non-cystic Fibrosis Bronchiectasis Chronically Infected With Pseudomonas Aeruginosa (P. Aeruginosa)Non Cystic Fibrosis BronchiectasisDrug: Colistimethate sodium;Drug: Saline SolutionZambon SpANULLActive, not recruiting18 Years90 YearsAll287Phase 3United States;Argentina;Australia;Canada;France;Germany;Greece;Israel;Italy;New Zealand;Poland;Portugal
228EUCTR2017-002533-32-IT
(EUCTR)
23/01/201805/11/2020A Study to Assess the Efficacy and Safety of Study Drug INS1007 Administered Once Daily in Patients with Non-Cystic FibrosisA Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center Study to Assess the Efficacy, Safety and Tolerability, and Pharmacokinetics of INS1007 Administered Once Daily for 24 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The Willow Study - N/A Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 20.0;Level: SOC;Classification code 10038738;Term: Respiratory, thoracic and mediastinal disorders;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: INS1007
Product Code: [N/A]
Product Name: INS1007
Product Code: [N/A]
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
240Phase 2United States;Spain;Italy;United Kingdom;Belgium;Poland;Singapore;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden;Korea, Republic of
229EUCTR2016-002749-42-GR
(EUCTR)
12/01/201803/10/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
230EUCTR2016-002749-42-DK
(EUCTR)
15/12/201711/10/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
231EUCTR2016-002749-42-FR
(EUCTR)
12/12/201701/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000113915;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
232NCT03218917
(ClinicalTrials.gov)
December 1, 201711/7/2017Assessment of INS1007 in Subjects With Non-Cystic Fibrosis BronchiectasisRandomized, 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 StudyNon-Cystic Fibrosis BronchiectasisDrug: INS1007 10 mg oral tablet;Drug: INS1007 25 mg oral tablet;Drug: Placebo Oral TabletInsmed IncorporatedNULLCompleted18 Years85 YearsAll256Phase 2United States;Australia;Belgium;Bulgaria;Denmark;Germany;Italy;Korea, Republic of;Netherlands;New Zealand;Poland;Singapore;Spain;United Kingdom;Sweden
233NCT03474042
(ClinicalTrials.gov)
November 29, 201715/3/2018GLPG2737 on Top of Orkambi in Subjects With Cystic FibrosisA Phase IIa, Randomized, Double-blind, Placebo-controlled Study to Evaluate GLPG2737 in Orkambi-treated Subjects With Cystic Fibrosis Homozygous for the F508del MutationCystic FibrosisDrug: GLPG2737;Drug: PlaceboGalapagos NVNULLCompleted18 YearsN/AAll22Phase 2Germany
234NCT03219164
(ClinicalTrials.gov)
November 28, 201713/7/2017Safety and Efficacy of 2 Treatment Regimens of Aztreonam for Inhalation Solution in Children With Cystic Fibrosis and New Onset Pseudomonas Aeruginosa InfectionRandomized, 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/ColonizationPseudomonas Aeruginosa Respiratory Tract Infection;Cystic FibrosisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted3 Months18 YearsAll149Phase 3United Kingdom;Austria;Belgium;Denmark;France;Germany;Greece;Israel;Italy;Netherlands;Spain;United States
235EUCTR2016-005110-22-DE
(EUCTR)
20/11/201723/06/2017A clinical study to investigate safety, tolerability and dose of orally inhaled multiple doses of POL6014 in patients with Cystic FibrosisPhase-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: POL6014Santhera Pharmaceuticals (Switzerland) LtdNULLNot RecruitingFemale: yes
Male: yes
40Phase 1;Phase 2Germany
236EUCTR2016-005230-30-IT
(EUCTR)
15/11/201705/11/2020A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SPX-101
Product Code: [SPX-101]
INN or Proposed INN: SPX-101
SPYRYX BIOSCIENCES, INC.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Portugal;France;Canada;Australia;United Kingdom;Italy
237EUCTR2015-004263-36-DE
(EUCTR)
13/11/201706/09/2017Study to assess the effects of inhaled RPL554 in adults with cystic fibrosis.A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis. - Study to assess the effects of inhaled RPL554 in patients with cystic fibrosis. Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: RPL554
Product Code: RPL554
INN or Proposed INN: RPL554
Other descriptive name: RPL554
Verona Pharma plcNULLNot RecruitingFemale: yes
Male: yes
10Phase 2Germany;United Kingdom
238NCT03206788
(ClinicalTrials.gov)
November 11, 201729/6/2017Losartan and Inflammation in Cystic FibrosisLosartan as Anti-inflammatory Therapy to Augment F508del Cystic Fibrosis Transmembrane (CFTR) RecoveryCystic FibrosisDrug: Losartan;Drug: placeboUniversity of MiamiUniversity of Alabama at Birmingham;Children's Hospital Medical Center, Cincinnati;University of Kansas Medical Center;Cystic Fibrosis FoundationTerminated12 YearsN/AAll7Phase 2United States
239EUCTR2017-000540-18-DE
(EUCTR)
08/11/201713/09/2017Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Germany
240EUCTR2017-002181-42-DE
(EUCTR)
27/10/201728/07/2017GLPG2737 on top of Orkambi in subjects with cystic fibrosisA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2737 in Orkambi-treated subjects with cystic fibrosis homozygous for the F508del mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2737
Product Code: G1117337
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2737
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
241EUCTR2017-000797-11-NL
(EUCTR)
06/10/201730/05/2017A Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Belgium;Australia;Netherlands
242NCT02566044
(ClinicalTrials.gov)
September 27, 201718/9/2015Safety, Pharmacokinetics and Pharmacodynamics Study of Inhaled QBW276 in Patients With Cystic FibrosisA Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Doses of Inhaled QBW276 in Patients With Cystic FibrosisPulmonary Cystic FibrosisOther: Placebo;Drug: QBW276Novartis PharmaceuticalsNULLCompleted18 YearsN/AAll16Phase 1/Phase 2United States;Germany;United Kingdom
243EUCTR2016-002749-42-DE
(EUCTR)
22/09/201702/08/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 22.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
244EUCTR2017-000571-85-GB
(EUCTR)
19/09/201711/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel;United Kingdom
245EUCTR2016-002749-42-BE
(EUCTR)
18/09/201724/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
246EUCTR2017-000571-85-LT
(EUCTR)
15/09/201720/07/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000173123
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
247NCT03771313
(ClinicalTrials.gov)
September 1, 201711/7/2018Pharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic FibrosisPharmacokinetic and Pharmacodynamic Analysis of Ceftaroline in Children and Adolescents With Cystic FibrosisCystic FibrosisDrug: CeftarolineChildren's Hospital Medical Center, CincinnatiNULLActive, not recruiting2 Years21 YearsAll24Phase 4United States
248EUCTR2017-000797-11-BE
(EUCTR)
28/08/201715/06/2017A Study of VX-445 in Healthy Subjects and Subjects with Cystic FibrosisA Phase 1/2 Study of VX-445 in Healthy Subjects and Subjects with Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Product Name: Deuterated Ivacaftor
Product Code: VX-561 (CTP-656)
INN or Proposed INN: VX-561
Other descriptive name: VX-561
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
104Phase 2United States;Belgium;Australia;Netherlands
249EUCTR2015-003040-39-NL
(EUCTR)
28/08/201723/01/2017Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Spain;Ireland;Germany;Netherlands;Italy;United Kingdom;Switzerland
250EUCTR2016-005230-30-PT
(EUCTR)
28/08/201731/05/2017A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SPX-101
INN or Proposed INN: SPX-101
Product Name: SPX-101
INN or Proposed INN: SPX-101
Spyryx Biosciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2France;Portugal;Canada;Australia;Italy;United Kingdom
251EUCTR2016-004558-13-PL
(EUCTR)
14/08/201730/06/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3United States;Portugal;France;Canada;Greece;Argentina;Poland;Australia;Israel;Germany;New Zealand;Italy
252EUCTR2016-003585-11-GB
(EUCTR)
10/08/201710/07/2017Study to Evaluate the Safety and Efficacy of VX-659 drug in combination with other drugs in Subjects Aged 18 Years and Older With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-659 Combination Therapy in Subjects Aged 18 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659
Product Code: VX-659
INN or Proposed INN: VX-659
Other descriptive name: VX-659
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: TEZACAFTOR
Product Name: Deuterated Ivacaftor
Product Code: VX-561 (CTP-656)
INN or Proposed INN: Deuterated Ivacaftor
Other descriptive name: VX-561 (CTP-656)
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;Ireland;Israel;United Kingdom
253EUCTR2016-002749-42-AT
(EUCTR)
07/08/201727/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 21.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
140Phase 3United States;Greece;Spain;Ireland;Austria;Israel;Italy;United Kingdom;France;Belgium;Denmark;Germany;Netherlands
254EUCTR2016-001214-24-DE
(EUCTR)
27/07/201710/04/2017A 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 FibrosisA Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428 Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: PTI-428
Product Code: PTI-428
Proteostasis TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
132Phase 1;Phase 2France;United States;Czech Republic;Canada;Denmark;Germany;Italy;United Kingdom
255EUCTR2014-004915-35-DE
(EUCTR)
26/07/201714/10/2015Safety and effect of QBW276 in patients with cystic fibrosis A randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: QBW276 300mcg
Product Code: QBW276
INN or Proposed INN: Not established
Other descriptive name: QBW276 Succinate
Product Name: QBW276 1500mcg
Product Code: QBW276
INN or Proposed INN: Not established
Other descriptive name: QBW276 Succinate
Novartis Pharma AGNULLNot Recruiting Female: yes
Male: yes
56 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Germany;United Kingdom
256EUCTR2016-005230-30-GB
(EUCTR)
14/07/201703/05/2017A research study to find out if SPX-101 helps people with Cystic Fibrosis and to find out if it is safe.A Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of SPX-101 Inhalation Solution in Subjects with Cystic Fibrosis (HOPE-1 STUDY: HYDRATION FOR OPTIMAL PULMONARY EFFECTIVENESS) - HOPE-1 Study: Hydration for Optimal Pulmonary Effectiveness Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SPX-101
INN or Proposed INN: SPX-101
Product Name: SPX-101
INN or Proposed INN: SPX-101
Spyryx Biosciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
90Phase 2Portugal;France;Canada;Australia;Italy;United Kingdom
257EUCTR2015-002743-33-PT
(EUCTR)
13/07/201710/07/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
258EUCTR2016-001214-24-DK
(EUCTR)
10/07/201728/04/2017A 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 FibrosisA Phase I/II Multi-center, Randomized, Placebo-Controlled, Study Designed to Assess the Safety, Tolerability, and Pharmacokinetics of PTI-428 in Subjects with Cystic Fibrosis - Proteostasis PTI428 Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: PTI-428
Product Code: PTI-428
Product Code: PTI-428
Product Code: PTI-428
Proteostasis TherapeuticsNULLNot RecruitingFemale: yes
Male: yes
144Phase 1;Phase 2United States;France;Czech Republic;Canada;Denmark;Germany;United Kingdom;Italy
259EUCTR2016-004033-25-ES
(EUCTR)
19/06/201731/03/2017Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosisEfect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10074550;Term: Preventive antimicrobial therapy in cystic fibrosis;System Organ Class: 100000004865
MedDRA version: 20.0;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Sodium bicarbonate
INN or Proposed INN: Sodium Bicarbonate
Other descriptive name: SODIUM BICARBONATE BP
Product Name: sodium chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE
Product Name: sodium chloride
INN or Proposed INN: Sodium chloride
Other descriptive name: SODIUM CHLORIDE
Product Name: Water for injections
INN or Proposed INN: water for injections
Other descriptive name: WATER FOR INJECTIONS, EP
Fundació Parc TaulíNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Spain
260EUCTR2017-000571-85-HU
(EUCTR)
15/06/201713/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
261NCT03093974
(ClinicalTrials.gov)
June 6, 20179/3/2017Long 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 BronchiectasisDrug: Colistimethate Sodium;Drug: Saline SolutionZambon SpANULLCompleted18 YearsN/AAll377Phase 3Australia;Belgium;Germany;Greece;Israel;Italy;Netherlands;New Zealand;Portugal;Spain;Switzerland;United Kingdom
262EUCTR2017-000571-85-ES
(EUCTR)
01/06/201721/04/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Hungary;Poland;Spain;Lithuania;Israel
263EUCTR2016-004477-40-ES
(EUCTR)
31/05/201710/03/2017A 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 allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
264EUCTR2016-004558-13-FR
(EUCTR)
30/05/201720/03/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS II Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin, 1 million International Units (IU) Powder for Nebuliser Solution
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
264Phase 3United States;France;Canada;Poland
265EUCTR2015-002743-33-DE
(EUCTR)
29/05/201701/03/2017A clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLNot RecruitingFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
266EUCTR2016-004477-40-GB
(EUCTR)
26/05/201706/02/2017A 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 allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSerbia;United States;Belgium;Spain;Netherlands;United Kingdom
267EUCTR2016-004477-40-BE
(EUCTR)
08/05/201721/02/2017A 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 allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
50Phase 2United States;Serbia;Spain;Belgium;Netherlands;United Kingdom
268EUCTR2016-000454-36-NL
(EUCTR)
05/05/201702/11/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;Netherlands;Italy;United Kingdom;Sweden
269EUCTR2016-004996-33-ES
(EUCTR)
03/05/201710/03/2017A Pilot Study to Evaluate the Use of Smart Adherence Technology to Measure Lumacaftor/Ivacaftor Adherence in CF Subjects Homozygous for the F508del-CFTR MutationA Phase 4, Open-label Treatment, Randomized, Multicenter, 2-arm, Parallelgroup, Pilot Study of Adherence to Lumacaftor/Ivacaftor in CF Subjects Homozygous for the F508del-CFTR Mutation Cystic fibrosis subjects Homozygous for the F508del-CFTR Mutation
MedDRA version: 19.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi
Product Name: Orkambi
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Vertex Pharmaceuticals IncoporatedNULLNot RecruitingFemale: yes
Male: yes
75Phase 4United States;Canada;Spain;Australia;United Kingdom
270NCT03051490
(ClinicalTrials.gov)
April 28, 20179/2/2017RESULT: Reliable, Emergent Solution Using Liprotamase TreatmentA 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 InsufficiencyExocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Liprotamase;Drug: porcine PERTAnthera PharmaceuticalsNULLUnknown status7 YearsN/AAll140Phase 3United States;Hungary;Israel;Lithuania;Poland;Spain;United Kingdom
271EUCTR2015-004143-39-ES
(EUCTR)
19/04/201731/03/2017Saline hypertonic in preschoolers and lung structure as measured by computed tomography.A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: HYPERTONIC SALINE
Other descriptive name: SALINE
Product Name: Isotonic saline
INN or Proposed INN: ISOTONIC SALINE
Other descriptive name: STERILE PYROGEN-FREE ISOTONIC NACL SOLUTE (0.9% W / V)
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Denmark;Australia;Netherlands
272EUCTR2016-004477-40-NL
(EUCTR)
10/04/201714/02/2017A 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 allelesA Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Serbia;United States;Belgium;Spain;Netherlands;United Kingdom
273NCT03104855
(ClinicalTrials.gov)
April 3, 201717/2/2017Clearance of 25-hydroxyvitamin D in Cystic FibrosisClearance of 25-hydroxyvitamin D in Cystic FibrosisCystic FibrosisDrug: d6-25-hydroxyvitamin D3University of WashingtonNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Active, not recruiting18 YearsN/AAll10Phase 1United States
274NCT03584841
(ClinicalTrials.gov)
March 31, 201727/5/2018Implementation of a Non-invasive Version of the Imaging ß-adrenergic-dependent Sweat Secretion TestImplementation of a Non-invasive Version of the Imaging ß-adrenergic-dependent Sweat Secretion Test: Value for Diagnosis and Efficacy of Target Therapies for Cystic FibrosisMucoviscidosis Involving the LungDiagnostic Test: Iontophoresis sessions in forearm of subjects with pilocarpineCliniques universitaires Saint-Luc- Université Catholique de LouvainNULLRecruiting18 Years100 YearsAll120N/ABelgium
275NCT03256799
(ClinicalTrials.gov)
March 17, 201718/8/2017Evaluation of Ivacaftor in Patients Using Ataluren for Nonsense MutationsAn 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 MutationsCystic FibrosisDrug: Ivacaftor/AtalurenUniversity of Alabama at BirminghamNULLCompleted19 YearsN/AAll1Phase 4United States
276EUCTR2015-002743-33-ES
(EUCTR)
13/03/201710/02/2017A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled Promixin® (colistimethate sodium) in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
264Phase 3Portugal;Belgium;Spain;Germany;Italy;United Kingdom
277EUCTR2015-002743-33-IT
(EUCTR)
02/03/201725/01/2021A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo-controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - Promis 1 Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
Product Code: [-]
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: -
Trade Name: Ventolin¿ Evohaler¿
Product Name: Ventolin
Product Code: [Ventolin]
INN or Proposed INN: SALBUTAMOL
Other descriptive name: Ventolin® Evohaler
ZAMBON SPANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3Portugal;Greece;Spain;Israel;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;New Zealand
278NCT02498535
(ClinicalTrials.gov)
February 22, 201712/7/2015Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) PatientsProspective, Randomized, Placebo Controlled Trial of the Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) PatientsCystic FibrosisDrug: Nitric Oxide 160 ppmNovoteris, LLCCystic Fibrosis Foundation;MallinckrodtTerminated18 YearsN/AAll49Phase 2United States;Canada
279EUCTR2015-002743-33-GB
(EUCTR)
21/02/201713/12/2016A double-blind, placebo controlled, multicentre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa)A double-blind, placebo controlled, multi-centre, clinical trial to investigate the efficacy and safety of 12 months of therapy with inhaled colistimethate sodium in the treatment of subjects with non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa (P. aeruginosa) - PROMIS I Non-cystic fibrosis bronchiectasis chronically infected with Pseudomonas aeruginosa
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin/Tadim
Product Name: Colistimethate sodium
INN or Proposed INN: COLISTIMETHATE SODIUM
Other descriptive name: Colistimethate Sodium
Zambon S.p.A.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
420Phase 3New Zealand;Netherlands;Germany;Australia;Belgium;France;Switzerland;Italy;United Kingdom;Israel;Spain;Greece;Portugal
280EUCTR2015-004143-39-DK
(EUCTR)
14/02/201725/10/2016Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study.A Phase 3 randomised, double-blind, controlled trial of inhaled 7%hypertonic saline versus0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6years of age inparallel with the North American SHIP clinical trial - Ship-CT study Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: sodium chloride 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline 0.9%
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Australia;Denmark;Netherlands;Italy
281NCT02712983
(ClinicalTrials.gov)
February 8, 20175/2/2016Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA 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 InfectionNon-cystic Fibrosis BronchiectasisDrug: TIP;Drug: TIP and placebo;Drug: PlaceboNovartis PharmaceuticalsQueen's University Belfast, UK;University Hospital Antwerp, BE;University of Milan, IT;Fundacion Clinic per a la Recerca Biomedica;Erasmus Medical Center;Papworth Hospital Cambridge, UK;Royal Brompton Hospital Trust, UK;University of Dundee;University of Edinburgh, UKCompleted18 YearsN/AAll107Phase 2Belgium;France;Germany;Italy;Spain;United Kingdom;Netherlands
282NCT03256968
(ClinicalTrials.gov)
January 27, 201718/8/2017PTC Study to Evaluate Ataluren in Combination With IvacaftorAn 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 FibrosisCystic FibrosisDrug: AtalurenUniversity of Alabama at BirminghamNULLCompleted6 YearsN/AAll1Phase 4United States
283EUCTR2016-000454-36-BE
(EUCTR)
24/01/201725/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Spain;Belgium;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
284EUCTR2016-000454-36-ES
(EUCTR)
18/01/201726/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
285EUCTR2016-000454-36-IT
(EUCTR)
16/01/201727/02/2018A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVACAFTOR
VERTEX PHARMACEUTICALS INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
286EUCTR2015-003399-58-DK
(EUCTR)
14/01/201707/01/2016Can antibiotic treatment improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma?Target-ABC (Targeted AntiBiotics for Chronic pulmonary disease):Can targeted antibiotic therapy improve the prognosis of Pseudomonas aeruginosa infected patients with chronic pulmonary obstructive disease, non-cystic fibrosis bronchiectasis and asthma? - Target-ABC (Targetted AntiBiotics for Chronic pulmonary disease) Respiratory tract infection Bacterial infection with Pseudomonas aeruginosaChronic obstructive pulmonary disease (COPD)Non-cystic fibrosis bronchiectasisAsthma
MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin
INN or Proposed INN: ciprofloxacin hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE MONOHYDRATE
Product Name: Piperacillin/Tazobactam
INN or Proposed INN: piperacillin sodium , tazobactam sodium
Other descriptive name: PIPERACILLIN SODIUM
COP:TRIN Region Hovedstaden (Gentofte hospital)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 4Denmark
287EUCTR2015-004986-99-IT
(EUCTR)
11/01/201706/09/2016A 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 bitartrateNovaBiotics, LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 2United States;Netherlands;United Kingdom;Italy
288EUCTR2016-000454-36-GB
(EUCTR)
10/01/201707/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
198 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
289EUCTR2016-000454-36-DE
(EUCTR)
04/01/201712/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
290EUCTR2016-002837-31-CZ
(EUCTR)
04/01/201724/10/2016A 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) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
291EUCTR2015-004841-13-CZ
(EUCTR)
04/01/201710/08/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Ivacaftor
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
292EUCTR2016-000454-36-AT
(EUCTR)
03/01/201707/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Denmark;Australia;Austria;Netherlands;Germany;Italy;United Kingdom;Sweden
293NCT02947126
(ClinicalTrials.gov)
January 201725/10/2016Multilevel Models of Therapeutic Response in the LungsMultilevel Models of Therapeutic Response in the LungsCystic FibrosisDrug: Hypertonic Saline;Drug: Isotonic Saline;Drug: Indium-DTPA;Drug: Technetium Sulfur ColloidTim CorcoranNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting12 YearsN/AAll62Phase 1United States
294EUCTR2016-002837-31-DE
(EUCTR)
29/12/201624/10/2016A 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) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation - Albatross Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
295EUCTR2015-003040-39-BE
(EUCTR)
27/12/201601/09/2016Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Spain;Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
296EUCTR2015-003040-39-DE
(EUCTR)
23/12/201611/10/2016Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
297EUCTR2016-001585-29-NL
(EUCTR)
21/12/201618/07/2016Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR MutationA Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of Lumacaftor/Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis Who Have an A455E-CFTR Mutation Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi 200 mg/125 mg film-coated tablets
Product Name: LUM/IVA fixed-dose combination
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
20Phase 2Netherlands
298EUCTR2015-003040-39-FR
(EUCTR)
16/12/201621/09/2018Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
299EUCTR2016-002837-31-BE
(EUCTR)
16/12/201624/10/2016A 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) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
300EUCTR2015-003040-39-IE
(EUCTR)
16/12/201616/12/2016Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
301EUCTR2009-012575-10-SE
(EUCTR)
08/12/201604/10/2016Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CFTrial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF Product Name: Ceftazidime
INN or Proposed INN: Ceftazidime
Other descriptive name: N/A
Product Name: Tobramycin
INN or Proposed INN: Tobramycin
Other descriptive name: N/A
Product Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: N/A
Product Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: N/A
University Hospitals Bristol NHS Foundation TrustUniversity of LiverpoolNot RecruitingFemale: yes
Male: yes
260Phase 4United Kingdom;Sweden
302EUCTR2015-004263-36-GB
(EUCTR)
07/12/201630/08/2016Study to assess the effects of inhaled RPL554 in adults with cystic fibrosis.A Phase IIa, randomised, double blind, placebo controlled, three way crossover study to assess the pharmacokinetics of RPL554 administered to adult patients with Cystic Fibrosis. - To assess the effects of inhaled RPL554 in adults with cystic fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: RPL554
Product Code: RPL554
INN or Proposed INN: RPL554
Other descriptive name: RPL554
Verona Pharma plcNULLNot Recruiting Female: yes
Male: yes
10 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany;United Kingdom
303EUCTR2016-002837-31-GB
(EUCTR)
05/12/201617/10/2016A 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) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
304EUCTR2016-002837-31-IE
(EUCTR)
02/12/201604/10/2016A 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) mutationA phase IIa, randomized, double-blind, placebo-controlled study to evaluate GLPG2222 in ivacaftor-treated subjects with Cystic Fibrosis harbouring one F508del CFTR mutation and a second gating (class III) mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Product Name: GLPG2222
Product Code: G957389
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG2222
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
35Phase 2Czech Republic;Belgium;Ireland;Australia;Germany;United Kingdom
305NCT03000348
(ClinicalTrials.gov)
December 201611/12/2016A Study of the Dosing, Efficacy, and Safety of Oral Cysteamine in Adult Patients With Cystic Fibrosis ExacerbationsA 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 DiseaseCystic FibrosisDrug: Cysteamine;Drug: Placebo Oral CapsuleNovaBiotics Ltd.Agility Clinical, Inc.;PSR Group B.V.Completed18 YearsN/AAll91Phase 2United States;Italy;United Kingdom
306EUCTR2015-004143-39-BE
(EUCTR)
30/11/201613/10/2016Saline hypertonic in preschoolers and lung structure as measured by computed tomography.A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 19.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: SODIUM CHLORIDE 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
120Phase 3United States;Spain;Belgium;Denmark;Australia;Netherlands
307EUCTR2016-000454-36-DK
(EUCTR)
18/11/201610/10/2016A Study Evaluating the Safety and Efficacy of VX-440 Combination Therapy in Subjects With Cystic FibrosisA Phase 2, Randomized, Double-blind, Controlled Study to Evaluate the Safety and Efficacy of VX-440 Combination Therapy in Subjects Aged 12 Years and Older With Cystic Fibrosis Cystic fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-440
INN or Proposed INN: VX-440
Other descriptive name: VX-440
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor
Product Code: VX-661
INN or Proposed INN: Tezacaftor (TEZ)
Other descriptive name: VX-661
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
198Phase 2United States;Canada;Belgium;Spain;Austria;Australia;Denmark;Netherlands;Germany;Italy;United Kingdom;Sweden
308NCT02759562
(ClinicalTrials.gov)
November 4, 201629/4/2016Effect of Andecaliximab on FEV1 in Adults With Cystic FibrosisA Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects With Cystic FibrosisCystic FibrosisDrug: Andecaliximab;Drug: PlaceboGilead SciencesNULLTerminated18 YearsN/AAll6Phase 2Australia;France;Germany;Spain;United Kingdom;Belgium;Canada;Ireland;United States
309NCT02934698
(ClinicalTrials.gov)
November 1, 201613/10/2016An Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing MutationsAn Efficacy and Safety Study of Ivacaftor in Patients With Cystic Fibrosis and Two Splicing MutationsCystic FibrosisDrug: IvacaftorMedical University of South CarolinaVertex Pharmaceuticals IncorporatedCompleted18 YearsN/AFemale2Phase 3NULL
310NCT02613884
(ClinicalTrials.gov)
November 201620/11/2015Safety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic FibrosisSafety, Efficacy, and Feasibility of High-dose Cholecalciferol in Pediatric Patients With Cystic FibrosisVitamin D DeficiencyDrug: TreatmentJohns Hopkins All Children's HospitalNULLCompleted36 Months18 YearsAll30Phase 2United States
311NCT02953314
(ClinicalTrials.gov)
November 201618/10/2016A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)A Phase 3, Open Label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661 in Combination With Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR MutationCystic FibrosisDrug: TEZ;Drug: TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLCompleted6 Years11 YearsAll83Phase 3United States;Canada
312NCT02951195
(ClinicalTrials.gov)
November 201626/10/2016A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisA Phase 2, Randomized, Double Blind, Controlled Study to Evaluate the Safety of VX-152 Combination Therapy in Adults With Cystic FibrosisCystic FibrosisDrug: VX-152;Drug: Tezacaftor;Drug: Ivacaftor;Drug: Triple Placebo;Drug: Placebo for VX-152Vertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll80Phase 2United States
313NCT03056326
(ClinicalTrials.gov)
November 20163/2/2017A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy SubjectsA 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 SubjectsNon-Cystic Fibrosis Bronchiectasis;Cystic FibrosisDrug: CHF6333 (Part 1 - SAD);Drug: Placebo (Part 1 - SAD);Drug: CHF6333 (Part 2 - MAD);Drug: Placebo (Part 2 - MAD)Chiesi Farmaceutici S.p.A.NULLCompleted18 Years55 YearsMale72Phase 1Belgium
314NCT03029455
(ClinicalTrials.gov)
November 201611/1/2017A Study to Evaluate Safety and Pharmacokinetics of VX-659 in Healthy Subjects and in Adults With Cystic FibrosisA 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 FibrosisCystic FibrosisDrug: VX-659;Drug: Tezacaftor;Drug: Ivacaftor;Drug: VX-659 Matching Placebo;Drug: Triple Combination (TC) Matching PlacebosVertex Pharmaceuticals IncorporatedNULLCompleted18 YearsN/AAll163Phase 1United Kingdom
315EUCTR2015-004986-99-GB
(EUCTR)
31/10/201606/09/2016A 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 bitartrateNovaBiotics, LtdNULLNot RecruitingFemale: yes
Male: yes
120Phase 2United States;Netherlands;Italy;United Kingdom
316EUCTR2015-003040-39-GB
(EUCTR)
18/10/201630/01/2017Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.1;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
180 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Belgium;Spain;Ireland;Netherlands;Germany;Italy;Switzerland;United Kingdom
317EUCTR2016-002851-92-CZ
(EUCTR)
05/10/201602/08/2016NAAn Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Liprotamase
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: LIPASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: PROTEASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: AMYLASE
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 4United States;Hungary;Czech Republic;Canada;Spain;Poland;Israel
318NCT02912637
(ClinicalTrials.gov)
October 201613/9/2016Hyperpolarized Xenon Imaging in Patients With Cystic FibrosisHyperpolarised 129Xe MRI for Non-invasive Assessment of Ventilation, Perfusion and the Alveolar Membrane - a Physiological Study in Healthy Volunteers & Cystic Fibrosis PatientsCystic FibrosisOther: Hyperpolarized Xenon MRIPapworth Hospital NHS Foundation TrustUniversity of SheffieldSuspended18 Years70 YearsAll30United Kingdom
319EUCTR2015-003040-39-ES
(EUCTR)
29/09/201630/08/2016Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 19.0;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: Tobramycin inhalation powder
Product Code: TBM100
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Belgium;Spain;Ireland;Netherlands;Germany;Italy;United Kingdom;Switzerland
320EUCTR2016-002851-92-ES
(EUCTR)
19/09/201608/08/2016NAAn Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Liprotamasa
INN or Proposed INN: SIN ASIGNAR
Other descriptive name: LIPASA
INN or Proposed INN: SIN ASIGNAR
Other descriptive name: PROTEASA
INN or Proposed INN: SIN ASIGNAR
Other descriptive name: AMILASA
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;Hungary;Canada;Poland;Spain;Israel
321EUCTR2015-003040-39-IT
(EUCTR)
14/09/201628/09/2018Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa InfectionA randomized, blinded, parallel group, multi-center dose-finding study, to assess the efficacy, safety and tolerability of different doses of tobramycin inhalation powder in patients with Non-Cystic Fibrosis Bronchiectasis and pulmonary P. aeruginosa infection - Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder i Pseudomonas aeruginosa infection in patients with non-cystic fibrosis bronchiectasis
MedDRA version: 20.1;Level: PT;Classification code 10070295;Term: Infective exacerbation of bronchiectasis;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 20.1;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE
Product Name: Tobramicina polvere inalatoria
Product Code: TBM100
INN or Proposed INN: TOBRAMICINA
Other descriptive name: TOBRAMICINA
Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE
Product Name: Tobramicina polvere inalatoria
Product Code: TBM100
INN or Proposed INN: TOBRAMICINA
Other descriptive name: TOBRAMICINA
Trade Name: TOBI PODHALER - 28 MG POLVERE PER INALAZIONE CAPSULA RIGIDA USO INALATORIO BLISTER(ALU/ALU) 56 CAPSULE + 1 INALATORE
Product Name: Tobramicina polvere inalatoria
Product Code: TBM100
INN or Proposed INN: TOBRAMICINA
Other descriptive name: TOBRAMICINA
NOVARTIS PHARMA SERVICES AGNULLNot RecruitingFemale: yes
Male: yes
180Phase 2France;Spain;Belgium;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy
322EUCTR2016-002851-92-HU
(EUCTR)
08/09/201625/07/2016NAAn Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Liprotamase
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: LIPASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: PROTEASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: AMYLASE
ANTHERA Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 3United States;Hungary;Canada;Spain;Israel
323EUCTR2015-002192-23-ES
(EUCTR)
16/08/201609/06/2016An investigational study to assess the effect of GS-5745 on adult patients with Cystic Fibrosis.A Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis. Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Belgium;Spain;Ireland;Australia;Germany;United Kingdom
324EUCTR2014-004838-25-DE
(EUCTR)
16/08/201617/05/2016A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3United States;France;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
325NCT02657473
(ClinicalTrials.gov)
August 13, 201613/1/2016Inhaled Nebulized Tobramycin in Non-cystic Fibrosis BronchiectasisLong-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 BronchiectasisDrug: tobramycin inhalation solution;Drug: Saline 0.9% inhalation solutionMedical Center AlkmaarNULLCompleted18 YearsN/AAll58Phase 2/Phase 3Netherlands
326EUCTR2015-004143-39-NL
(EUCTR)
09/08/201621/12/2015Saline hypertonic in preschoolers and lung structure as measured by computed tomography.A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline
INN or Proposed INN: SODIUM CHLORIDE 7%
Other descriptive name: SODIUM CHLORIDE 7%
Product Name: Isotonic saline
INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%
Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Spain;Belgium;Denmark;Australia;Netherlands;Italy
327EUCTR2016-000166-35-NL
(EUCTR)
08/08/201617/05/2016Inhaled nebulized tobramycin in non-CF bronchiectasisEffects 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 solutionNoordwest ZiekenhuisgroepNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2;Phase 3Netherlands
328EUCTR2015-004841-13-IE
(EUCTR)
08/08/201607/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic Saline
INN or Proposed INN: 4.2% NaCl/Inhalation solution
Vertex Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Czech Republic;Ireland;United Kingdom
329NCT02866721
(ClinicalTrials.gov)
August 20167/8/2016Safety and Tolerability Study of Allogeneic Mesenchymal Stem Cell Infusion in Adults With Cystic FibrosisA 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 CFCystic FibrosisBiological: Mesenchymal Stem CellsErica RoeschCase Western Reserve University;Cystic Fibrosis FoundationActive, not recruiting18 YearsN/AAll14Phase 1United States
330NCT02918409
(ClinicalTrials.gov)
August 201612/4/2016IV Colistin for Pulmonary Exacerbations: Improving Safety and EfficacyIV Colistin for Pulmonary Exacerbations: Improving Safety and EfficacyCystic FibrosisDrug: Colistin;Drug: TobramycinNational Jewish HealthNULLActive, not recruiting18 YearsN/AAll51Phase 4United States
331EUCTR2015-004841-13-GB
(EUCTR)
20/07/201609/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/Inhalation solution
Vertex Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Ireland;United Kingdom
332EUCTR2015-002192-23-BE
(EUCTR)
18/07/201618/05/2016An investigational study to assess the effect of GS-5745 on adult patients with Cystic FibrosisA Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Spain;Belgium;Ireland;Australia;Germany;United Kingdom
333EUCTR2016-000066-34-GB
(EUCTR)
24/06/201625/07/2017A Study of the Effects of Lumacaftor/Ivacaftor on Exercise Tolerance in Subjects With Cystic Fibrosis, Homozygous for the F508del-CFTR MutationA Phase 4, Randomized, Double-Blind, Placebo-Controlled, Parallel-Design Study of the Effect of Lumacaftor/Ivacaftor Combination Therapy on Exercise Tolerance in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation. Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: lumacaftor
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
66 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesAustralia;United Kingdom
334EUCTR2015-001267-39-GB
(EUCTR)
20/06/201624/08/2015A study to assess the efficacy and safety of ivacaftor in children aged 3 to 5 with Cystic Fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3b, 2-part, Randomized, Double-blind, Placebo-controlled Crossover Study With a Long term Open-label Period to Investigate Ivacaftor in Subjects With Cystic Fibrosis Aged 3 Through 5 Years Who Have a Specified CFTR Gating Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
50 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Canada;Australia;United Kingdom
335EUCTR2015-002192-23-DE
(EUCTR)
03/06/201611/05/2016An investigational study to assess the effect of GS-5745 on adult patients with Cystic FibrosisA Phase 2b, Dose-Ranging Study of the Effect of GS-5745 on FEV1 in Adult Subjects with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: GS-5745
INN or Proposed INN: GS-5745
Other descriptive name: GS-5745
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Belgium;Spain;Ireland;Australia;Germany;United Kingdom
336EUCTR2014-004788-18-BE
(EUCTR)
03/06/201603/03/2016A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
337EUCTR2014-004838-25-AT
(EUCTR)
02/06/201620/04/2016A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
338EUCTR2013-005357-79-SE
(EUCTR)
01/06/201602/04/2016Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Israel;Russian Federation;Italy;Macedonia, the former Yugoslav Republic of;Australia;South Africa;Turkey;Czech Republic;Hungary;European Union;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;New Zealand;Sweden
339EUCTR2015-003291-77-DE
(EUCTR)
25/05/201611/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
340EUCTR2015-001644-11-DE
(EUCTR)
25/05/201631/03/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
341EUCTR2015-003881-96-IT
(EUCTR)
17/05/201605/11/2020Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic ¿brosisPseudomonas aeruginosa eradication in patients with cystic fibrosis: a randomised multicentre study comparing classic treatment protocols with classic treatment together with antibiotic treatment of upper airways. - Clinical study to assess two different Pseudomonas aeruginosa eradication protocols in patients with cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: COLIMICINA - 1000000 U/4 ML POLVERE E SOLVENTE PER SOLUZIONE INIETTABILE PER USO INTRAMUSCOLARE1 FLACONCINO POLVERE + 1 FIALA SOLVENTE 4 ML
Product Name: NA
Product Code: [NA]
INN or Proposed INN: COLISTIMETATO SODICO
Other descriptive name: COLISTIN
AZIENDA OSPEDALIERO-UNIVERSITARIA MEYERNULLNot RecruitingFemale: yes
Male: yes
112Phase 3Italy
342EUCTR2016-000354-35-DK
(EUCTR)
12/05/201610/02/2016High dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urineHigh dose antioxidant treatment of patients with cystic fibrosis evaluated by measuring desmosine/isodesmosine in urine cystic fibrosis
MedDRA version: 19.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Mucolysin
INN or Proposed INN: ACETYLCYSTEINE SODIUM
Trade Name: AAC Hexal
INN or Proposed INN: ACETYLCYSTEINE SODIUM
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
343EUCTR2015-002677-38-BE
(EUCTR)
11/05/201603/03/2016An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Celtaxsys Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2France;United States;Canada;Belgium;Germany;Italy;United Kingdom
344EUCTR2015-002677-38-DE
(EUCTR)
09/05/201603/11/2015An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Celtaxsys Inc.NULLNot RecruitingFemale: yes
Male: yes
195Phase 2France;United States;Canada;Belgium;Germany;Italy;United Kingdom
345EUCTR2013-004302-26-SK
(EUCTR)
22/04/201626/01/2016Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients. Glaucoma or Ocular Hypertension
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Tafluprost
INN or Proposed INN: tafluprost
Other descriptive name: TAFLUPROST
Santen OyNULLNot RecruitingFemale: yes
Male: yes
18Phase 1United States;Hungary;Slovakia;Poland;United Kingdom
346EUCTR2015-002581-23-DE
(EUCTR)
20/04/201626/10/2015A study of safety and efficacy of JBT-101 in cystic fibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function.
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2United States;France;Poland;Belgium;Israel;Germany;United Kingdom;Italy
347EUCTR2015-001644-11-BE
(EUCTR)
06/04/201608/01/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
348EUCTR2014-005355-83-GR
(EUCTR)
05/04/201608/02/2016Confirmatory extension study of ataluren in patients with Cystic FibrosisA Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
349NCT02724527
(ClinicalTrials.gov)
April 201611/3/2016Study of Cavosonstat (N91115) in CF Patients Who Are Heterozygous for F508del-CFTR and a Gating Mutation and Being Treated With IvacaftorA 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 IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.NULLActive, not recruiting18 YearsN/ABoth19Phase 2United States
350EUCTR2014-005355-83-GB
(EUCTR)
22/03/201615/02/2016Confirmatory extension study of ataluren in patients with Cystic Fibrosis A Phase 3 extension Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
351EUCTR2015-001644-11-FR
(EUCTR)
16/03/201620/04/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
352EUCTR2015-001644-11-DK
(EUCTR)
15/03/201608/02/2016Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
353EUCTR2015-002739-17-CZ
(EUCTR)
09/03/201613/10/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
150Phase 3United States;Hungary;Czech Republic;Canada;Spain;Israel
354EUCTR2016-000398-19-BE
(EUCTR)
08/03/201609/02/2016Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients.Pilot study: pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem in blood and sputum of cystic fibrosis patients. - pharmacokinetics of beta-lactam antibiotics, piperacillin-tazobactam, ceftazidim and meropenem Cystic fibrosis;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Trade Name: Meropenem Fresenius Kabi 1 g poeder voor oplossing voor injectie of infusie
INN or Proposed INN: Meropenem Fresenius Kabi
Other descriptive name: MEROPENEM TRIHYDRATE
Trade Name: Ceftazidim Fresenius Kabi 2000 mg poeder voor oplossing voor injectie of infusie
INN or Proposed INN: Ceftazidim Fresenius Kabi
Other descriptive name: CEFTAZIDIME PENTAHYDRATE
Trade Name: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Other descriptive name: PIPERACILLIN SODIUM
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 2 g/0,25 g poeder voor oplossing voor infusie
Other descriptive name: TAZOBACTAM SODIUM
Trade Name: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Other descriptive name: PIPERACILLIN SODIUM
INN or Proposed INN: Piperacilline/Tazobactam Fresenius Kabi 4 g/0,5 g poeder voor oplossing voor infusie
Other descriptive name: TAZOBACTAM SODIUM
Ghent UniversityNULLNot RecruitingFemale: yes
Male: yes
45Phase 4Belgium
355NCT02354859
(ClinicalTrials.gov)
March 201630/7/2014A 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 FibrosisDrug: Gallium nitrate;Drug: Normal SalineUniversity of WashingtonCystic Fibrosis FoundationCompleted18 YearsN/AAll119Phase 2United States
356NCT02725567
(ClinicalTrials.gov)
March 201614/3/2016A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR MutationA Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age and Have an Ivacaftor-Responsive CFTR MutationCystic FibrosisDrug: ivacaftorVertex Pharmaceuticals IncorporatedNULLActive, not recruitingN/A24 MonthsAll56Phase 3United States;Australia;Canada;Ireland;United Kingdom
357EUCTR2013-004302-26-HU
(EUCTR)
29/02/201621/12/2015Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients. Glaucoma or Ocular Hypertension
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Tafluprost
INN or Proposed INN: tafluprost
Other descriptive name: TAFLUPROST
Santen OyNULLNot RecruitingFemale: yes
Male: yes
18Phase 1United States;Hungary;Slovakia;Poland;United Kingdom
358EUCTR2015-003292-30-NL
(EUCTR)
26/02/201602/12/2015A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Belgium;Netherlands
359EUCTR2014-004827-29-DE
(EUCTR)
24/02/201621/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
360EUCTR2014-005355-83-BG
(EUCTR)
19/02/201616/12/2015Confirmatory extension study of ataluren in patients with Cystic FibrosisA Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
361EUCTR2013-005357-79-BG
(EUCTR)
12/02/201611/01/2016Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United 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
362NCT02625246
(ClinicalTrials.gov)
February 4, 20164/12/2015Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non-Cystic Fibrosis BronchiectasisA 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 BronchiectasisBronchiectasisBiological: hMSCsMarilyn GlassbergNULLCompleted30 Years87 YearsAll6Phase 1United States
363EUCTR2015-002677-38-GB
(EUCTR)
04/02/201627/10/2015An investigation of the effect of CTX-4430 on lung inflammation in patients with cystic fibrosisA Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability of CTX-4430 Administered Orally Once-Daily for 48 Weeks in Adult Patients with Cystic Fibrosis - EMPIRE CF Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Product Name: CTX-4430
Product Code: CTX-4430
INN or Proposed INN: acebilustat
Other descriptive name: CRC3357, ZK-355322, Leukoton
Celtaxsys Inc.NULLNot Recruiting Female: yes
Male: yes
195 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Germany;Italy;United Kingdom
364EUCTR2015-003291-77-IE
(EUCTR)
03/02/201603/12/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
365EUCTR2015-003291-77-GB
(EUCTR)
02/02/201603/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot Recruiting Female: yes
Male: yes
32 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noCzech Republic;Ireland;Australia;Germany;United Kingdom
366EUCTR2013-005357-79-GR
(EUCTR)
02/02/201617/12/2015Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United 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
367NCT02684552
(ClinicalTrials.gov)
February 201612/2/2016Non Invasive Ventilation During Physical Training in Cystic FibrosisPhysiotherapist in Charge of the StudyCystic FibrosisDevice: Non invasive ventilation;Device: OxygenKarolinska University HospitalNULLCompleted18 Years90 YearsBoth8N/ASweden
368NCT02840136
(ClinicalTrials.gov)
February 201618/7/2016LC-MS/MS Based Method Development for the Monitoring of Antibiotic Concentrations in Sputum of Cystic Fibrosis PatientsOptimisation, 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 ValidationCystic FibrosisDrug: Piperacillin-tazobactam combination product;Drug: Meropenem;Drug: CeftazidimeUniversity GhentKing Baudouin Foundation;Belgische Vereniging voor Strijd tegen MucoviscidoseSuspended12 YearsN/AAll40N/ABelgium
369NCT02694393
(ClinicalTrials.gov)
February 201611/1/2016Inhaled Sodium Nitrite as an Antimicrobial for Cystic FibrosisPhase I/II Study of Inhaled Sodium Nitrite as an Antimicrobial for Pseudomonas Infection in Cystic FibrosisCystic FibrosisDrug: sodium nitriteSchmidhofer, Mark, MDMast Therapeutics, Inc.;Cystic Fibrosis FoundationActive, not recruiting18 YearsN/AAll35Phase 1/Phase 2United States
370EUCTR2015-003291-77-CZ
(EUCTR)
26/01/201616/11/2015A study looking at the safety of the drug GLPG1837 in patients with cystic fibrosis and the G551D mutationA phase IIa, open label study of multiple doses of GLPG1837 in subjects with cystic fibrosis and the G551D mutation Cystic fibrosis with the G551D mutation
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
32Phase 2Czech Republic;Ireland;Australia;Germany;United Kingdom
371EUCTR2014-005355-83-NL
(EUCTR)
22/01/201625/11/2015Confirmatory extension study of ataluren in patients with Cystic FibrosisA Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
372EUCTR2015-001644-11-GB
(EUCTR)
22/01/201610/11/2015Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment with Lumacaftor in Combination with Ivacaftor.A Phase 3, Rollover Study to Evaluate the Safety andEfficacy of Long-term Treatment With Lumacaftor inCombination With Ivacaftor in Subjects Aged 6 Yearsand Older With Cystic Fibrosis, Homozygous for theF508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: lumacaftor
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: Ivacaftor
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
256Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
373EUCTR2015-003292-30-BE
(EUCTR)
18/01/201626/11/2015A study looking at the safety of the drug GLPG1837 in patients with cysticfibrosis and the S1251N mutationA phase IIa, open-label study of two doses of GLPG1837 in subjects with cystic fibrosis and the S1251N mutation. Cystic fibrosis with the S1251N mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Product Name: GLPG1837
Product Code: GLPG1837
INN or Proposed INN: Not Applicable
Other descriptive name: GLPG1837
Galapagos NVNULLNot RecruitingFemale: yes
Male: yes
6Phase 2Belgium;Netherlands
374NCT02661438
(ClinicalTrials.gov)
January 12, 201630/12/2015Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using PlaceboMulticenter 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 PlaceboBronchiectasis;Pulmonary Disease, Chronic ObstructiveDrug: Placebo to Ciprofloxacin DPI (BAYQ3939)BayerNovartisCompleted40 YearsN/AAll46N/AUnited States
375EUCTR2014-004827-29-ES
(EUCTR)
12/01/201618/11/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
376EUCTR2015-002739-17-HU
(EUCTR)
30/12/201513/10/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czech Republic;Hungary;Canada;Spain;Israel
377EUCTR2015-002581-23-FR
(EUCTR)
23/12/201518/01/2016A study of safety and efficacy of JBT-101 in cystic fibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis Cystic Fibrosis Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function.
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Corbus Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Poland;Belgium;Israel;Germany;Italy;United Kingdom
378EUCTR2015-002581-23-GB
(EUCTR)
22/12/201521/03/2016A study of safety and efficacy of JBT-101 in cystic fibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis Cystic Fibrosis Cystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function.
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Corbus Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
70 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom
379EUCTR2015-002739-17-ES
(EUCTR)
16/12/201503/11/2015Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - SOLUTION Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: Not assigned
Other descriptive name: LIPASE
INN or Proposed INN: PROTEASE
INN or Proposed INN: Amylase
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: Not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Czech Republic;Hungary;Canada;Spain;Israel
380EUCTR2014-004837-13-DE
(EUCTR)
15/12/201521/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
381EUCTR2014-004827-29-SE
(EUCTR)
09/12/201527/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
382EUCTR2014-005355-83-FR
(EUCTR)
08/12/201504/12/2015Confirmatory extension study of ataluren in patients with Cystic FibrosisA Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
383EUCTR2015-002581-23-BE
(EUCTR)
03/12/201512/10/2015A study of safety and efficacy of JBT-101 in cystic fibrosisA Phase 2, Double-blind, Randomized, Placebo-controlled Multicenter Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of JBT-101 in Cystic Fibrosis Cystic FibrosisCystic Fibrosis is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections, fibrosis of the lungs and digestive tract and abnormal immune function.
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: JBT-101
Product Code: JBT-101
INN or Proposed INN: JBT-101
Other descriptive name: JBT-101
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 2France;United States;Poland;Belgium;Israel;Germany;Italy;United Kingdom
384EUCTR2014-004915-35-GB
(EUCTR)
02/12/201516/10/2015Safety and effect of QBW276 in patients with cystic fibrosisA randomized, double blind, placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of multiple doses of inhaled QBW276 in patients with cystic fibrosis - Safety,pharmacokinetics and pharmacodynamics study of inhaledQBW276 in patients with cystic fibrosis Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: QBW276 300mcg
Product Code: QBW276
INN or Proposed INN: Not established
Other descriptive name: QBW276 Succinate
Product Name: QBW276 1500mcg
Product Code: QBW276
INN or Proposed INN: Not established
Other descriptive name: QBW276 Succinate
Novartis Pharma AGNULLNot RecruitingFemale: yes
Male: yes
56Phase 1;Phase 2United States;Germany;United Kingdom
385EUCTR2014-004827-29-DK
(EUCTR)
30/11/201511/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
386EUCTR2014-004827-29-AT
(EUCTR)
27/11/201527/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
387EUCTR2015-003662-87-DK
(EUCTR)
13/11/201522/09/2015Pseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of lifePseudomonas Aeruginosa - Inhalation treatment, biomarkers and quality of life - Pseudomonas, Tazocin or Colistin Chronic pulmonary disease patients, except cystic fibrosis patients, with confirmed pulmonary infection by sputum sample positive for Pseudomonas Aeruginosa.
MedDRA version: 18.1;Level: LLT;Classification code 10051190;Term: Pneumonia Pseudomonas aeruginosa;System Organ Class: 100000004862
MedDRA version: 18.1;Classification code 10050700;Term: Chronic respiratory disease NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: colistimethate sodium (promixin)
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: Piperacillin with Tazobactam (tazocin)
INN or Proposed INN: PIPERACILLIN
Other descriptive name: PIPERACILLIN
INN or Proposed INN: TAZOBACTAM
Other descriptive name: TAZOBACTAM
Aarhus University Hospital, Department of Respiratory MedicineNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
388EUCTR2014-004827-29-GB
(EUCTR)
03/11/201505/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Symkevi
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;United Kingdom;Switzerland;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
389EUCTR2014-004827-29-NL
(EUCTR)
03/11/201521/09/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
390NCT02598999
(ClinicalTrials.gov)
November 20154/11/2015Dose Escalation Study of ALX-009 in Healthy Men and Cystic Fibrosis (CF) and Non-CF Bronchiectasis PatientsRandomized, 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 PatientsCystic Fibrosis;BronchiectasisDrug: ALX-009;Drug: OSCN-;Drug: bLF;Drug: PlaceboAlaxia SASNULLRecruiting18 Years50 YearsAll103Phase 1France
391NCT02589236
(ClinicalTrials.gov)
November 201526/10/2015Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR MutationA 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/IvacaftorCystic FibrosisDrug: Cavosonstat;Drug: PlaceboNivalis Therapeutics, Inc.Medidata SolutionsCompleted18 YearsN/AAll138Phase 2United States
392EUCTR2014-004787-37-ES
(EUCTR)
26/10/201525/08/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Austria;Australia;Israel;Germany
393EUCTR2014-004827-29-BE
(EUCTR)
21/10/201506/08/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
394EUCTR2014-004827-29-IE
(EUCTR)
19/10/201509/07/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
1375 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
395EUCTR2014-005355-83-IT
(EUCTR)
16/10/201526/08/2015Confirmatory extension study of ataluren (PTC124) in patients with Cystic FibrosisA Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis - NA Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
396EUCTR2013-004595-35-NL
(EUCTR)
15/10/201509/07/2015Safety and tolerability of BAY63-2521 in Cystic Fibrosis patientsMulti-center, randomized, double-blind, placebo-controlled phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;United States;Canada;Belgium;Germany;Netherlands;United Kingdom
397EUCTR2015-000543-16-DE
(EUCTR)
14/10/201518/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
398EUCTR2014-005355-83-ES
(EUCTR)
08/10/201502/09/2015Confirmatory extension study of ataluren in patients with Cystic FibrosisA Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
399EUCTR2014-005355-83-BE
(EUCTR)
01/10/201524/08/2015Confirmatory extension study of ataluren in patients with Cystic FibrosisA Phase 3 extension Study of Ataluren (PTC124®) in Patients withNonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Bulgaria;Netherlands;Germany
400EUCTR2013-004581-34-BE
(EUCTR)
01/10/201531/07/2014Confirmatory study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
401EUCTR2014-004787-37-DE
(EUCTR)
24/09/201519/06/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Austria;Australia;Israel;Germany
402EUCTR2015-000543-16-BE
(EUCTR)
24/09/201508/06/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
403EUCTR2015-000543-16-DK
(EUCTR)
23/09/201522/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Australia;Denmark;Germany;United Kingdom;Sweden
404EUCTR2014-004787-37-AT
(EUCTR)
21/09/201518/06/2015A study in people with Cystic Fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugs.A Phase 3, Randomized, Double-blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and With a Second CFTR Mutation That Is Not Likely to Respond to VX-661 and/or Ivacaftor Therapy (F508del/NR) Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Spain;Australia;Austria;Israel;Germany
405EUCTR2015-002911-13-FR
(EUCTR)
15/09/201505/08/2015A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis.A Phase II, dose ranging, multicenter, double-blind, placebo controlled study to evaluate safety and efficacy of (R)-roscovitine in subjects with Cystic Fibrosis, homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa, a study involving 36 CF patients (24 treated, 12 controls). - ROSCO-CF Cystic Fibrosis treated by 'roscovitine' in subjects homozygous for the F508del-CFTR mutation and chronically infected with Pseudomonas aeruginosa.
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: SELICICLIB
Product Code: CYC202
CHRU de BrestNULLNot RecruitingFemale: yes
Male: yes
36Phase 2France
406EUCTR2013-004595-35-BE
(EUCTR)
03/09/201523/07/2015Safety and tolerability of BAY63-2521 in Cystic Fibrosis patientsMulti-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Adempas 0.125 mg
Product Code: BAY63-2521
INN or Proposed INN: RIOCIGUAT
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
63Phase 2France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom
407EUCTR2014-004827-29-IT
(EUCTR)
01/09/201508/07/2015A study to assess the efficacy and safety of a combination of two experimental drugs in people with cystic fibrosis (a rare hereditary lung disease)A Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long term Treatment With VX 661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor (VX-770) 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
1375Phase 3United States;Spain;Ireland;Austria;Israel;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
408NCT02421120
(ClinicalTrials.gov)
September 201513/4/2015Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis PatientsA Prospective, Multicenter, Open-Label Study to Assess Population Pharmacokinetics and Safety of Intravenous Ceftolozane/Tazobactam in Adult Cystic Fibrosis Patients Admitted With Acute Pulmonary ExacerbationCystic Fibrosis;Cystic Fibrosis Pulmonary Exacerbation;Pseudomonas Aeruginosa InfectionDrug: Ceftolozane/TazobactamJoseph L. Kuti, PharmDCubist Pharmaceuticals LLC;Indiana University Health;University of North Carolina;St. Christopher's Hospital for ChildrenCompleted18 YearsN/AAll21Phase 4United States
409NCT02456103
(ClinicalTrials.gov)
August 31, 201526/5/2015Extension Study of Ataluren in Participants With Nonsense Mutation Cystic FibrosisPhase 3 Extension Study of Ataluren (PTC124) in Patients With Nonsense Mutation Cystic FibrosisCystic FibrosisDrug: AtalurenPTC TherapeuticsNULLTerminated6 YearsN/AAll246Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
410NCT03497117
(ClinicalTrials.gov)
August 25, 201529/3/201819F MRI of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary Exacerbation19F Magnetic Resonance Imaging of Ventilation in Subjects With Cystic Fibrosis Undergoing Treatment for Pulmonary ExacerbationCystic FibrosisDevice: Lung Clearance Index;Drug: MRI with PFPUniversity of North Carolina, Chapel HillNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Terminated18 Years99 YearsAll5Early Phase 1United States
411EUCTR2013-005449-35-FR
(EUCTR)
25/08/201518/06/2015Extension study of ataluren in patients with Cystic FibrosisAn Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
76Phase 3United States;France;Spain;Belgium;Israel;Germany;Italy;Sweden
412EUCTR2015-000543-16-SE
(EUCTR)
19/08/201520/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
413NCT02496780
(ClinicalTrials.gov)
August 201518/6/2015The Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis PatientsThe Impact of Insulin Therapy on Protein Turnover in Pre-Diabetic Cystic Fibrosis PatientsCystic FibrosisDrug: novolog insulin;Drug: levemir insulin;Drug: placeboUniversity of MinnesotaNULLActive, not recruiting10 Years25 YearsAll66Phase 2/Phase 3United States
414NCT02531984
(ClinicalTrials.gov)
August 201521/8/2015The Efficacy of Azithromycin in Treating Children With Non Cystic Fibrosis BronchiectasisOpen 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 ChildrenDrug: AzithromycinAssistance Publique Hopitaux De MarseilleNULLActive, not recruiting3 Years17 YearsBoth100Phase 3NULL
415NCT02516410
(ClinicalTrials.gov)
August 201528/7/2015A 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 MutationA 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 FibrosisDrug: VX-661 plus ivacaftor combination;Drug: Ivacaftor;Drug: Placebo (matched to VX-661 plus ivacaftor combination);Drug: Placebo (matched to ivacaftor)Vertex Pharmaceuticals IncorporatedNULLCompleted12 YearsN/AAll168Phase 3United States;Australia;Austria;Canada;France;Israel;Spain
416NCT02565914
(ClinicalTrials.gov)
August 201518/9/2015A 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 MutationA 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 MutationCystic FibrosisDrug: TEZ/IVA;Drug: IVAVertex Pharmaceuticals IncorporatedNULLActive, not recruiting12 YearsN/AAll1044Phase 3United States;Australia;Austria;Belgium;Canada;Denmark;France;Germany;Ireland;Israel;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom
417EUCTR2014-004838-25-BE
(EUCTR)
31/07/201526/05/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
418EUCTR2015-001317-28-NL
(EUCTR)
30/07/201519/05/2015A B2-agonist as a CFTR activator in CF - Part 2A 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: SalbutamolUMC UtrechtNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
419EUCTR2013-004581-34-GR
(EUCTR)
29/07/201523/07/2015Confirmatory study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
420EUCTR2014-004788-18-DE
(EUCTR)
24/07/201531/03/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;United Kingdom;Switzerland
421EUCTR2014-004837-13-IT
(EUCTR)
22/07/201527/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
422EUCTR2014-004788-18-IT
(EUCTR)
15/07/201519/03/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;United Kingdom;Switzerland;Italy
423EUCTR2014-004788-18-NL
(EUCTR)
10/07/201508/04/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
204Phase 3France;United States;Canada;Belgium;Australia;Israel;Germany;Netherlands;Italy;United Kingdom
424EUCTR2014-004837-13-NL
(EUCTR)
10/07/201508/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Germany;Netherlands;Italy;United Kingdom;Switzerland;Sweden
425EUCTR2014-004837-13-ES
(EUCTR)
02/07/201515/06/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
426NCT03489590
(ClinicalTrials.gov)
July 1, 201529/3/201819F MRI to Evaluate Regional Ventilation in Healthy Subjects and Subjects With Cystic Fibrosis19F Magnetic Resonance Imaging to Evaluate Regional Ventilation in Healthy Subjects and Subjects With Cystic FibrosisCystic FibrosisDrug: PFPUniversity of North Carolina, Chapel HillNULLCompleted18 Years99 YearsAll42Early Phase 1United States
427EUCTR2014-004837-13-DK
(EUCTR)
24/06/201526/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
428EUCTR2014-004838-25-IE
(EUCTR)
22/06/201510/04/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
155Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
429EUCTR2015-000543-16-GB
(EUCTR)
19/06/201515/05/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
430EUCTR2014-004837-13-IE
(EUCTR)
11/06/201505/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3France;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;United Kingdom;Switzerland;Sweden
431EUCTR2014-004788-18-GB
(EUCTR)
08/06/201508/04/2015A study in people with cystic fibrosis (a rare hereditary lung disease) to assess the efficacy and safety of two experimental drugs: ivacaftor and VX-661 in combination with ivacaftorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of Ivacaftor and VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation, and a Second Allele With a CFTR Mutation Predicted to Have Residual Function Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150 mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
204 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Australia;Israel;Netherlands;Germany;Italy;Switzerland;United Kingdom
432NCT02569229
(ClinicalTrials.gov)
June 201512/8/2015Glucose Tolerance in Children With Cystic FibrosisGlucose Tolerance and Its Clinical Impact in Children and Adolescents With Cystic FibrosisGlucose Intolerance;Cystic FibrosisOther: Diagnostics for glucose tolerance with 3 different methods.Christoph SanerUniversity Hospital Inselspital, BerneActive, not recruiting10 Years20 YearsAll14Switzerland
433NCT02279498
(ClinicalTrials.gov)
June 201528/10/2014SOLUTION: Study of Oral Liprotamase Unit-Matched Therapy Of Non-Porcine Origin in Patients With Cystic FibrosisA 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 InsufficiencyExocrine Pancreatic Insufficiency;Cystic FibrosisDrug: Liprotamase;Drug: porcine (pig) PERTAnthera PharmaceuticalsNULLCompleted7 YearsN/AAll128Phase 3United States;Canada;Czechia;Hungary;Israel;Poland;Spain;Czech Republic
434NCT02239458
(ClinicalTrials.gov)
June 20158/9/2014DPP-IV Inhibition Prior to Development of Diabetes in Patients With Cystic FibrosisCystic FibrosisDrug: SaxagliptinRam WeissNULLNot yet recruiting18 Years65 YearsBoth60N/AIsrael
435EUCTR2011-005085-37-FR
(EUCTR)
21/05/201517/06/2015Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QBW251
INN or Proposed INN: Not assigned
Product Code: QBW251
INN or Proposed INN: Not assigned
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
140United States;France;Belgium;Ireland;Germany;United Kingdom
436EUCTR2014-004838-25-IT
(EUCTR)
20/05/201530/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double-Blind, Ivacaftor-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Heterozygous for the F508del-CFTR Mutation and a Second CFTR Allele With a Gating Defect That Is Clinically Demonstrated to be Ivacaftor Responsive Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Ireland;Austria;Germany;United Kingdom;Italy
437EUCTR2013-005366-19-FR
(EUCTR)
19/05/201522/06/2015A 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 bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Germany;Netherlands;New Zealand
438EUCTR2014-004837-13-GB
(EUCTR)
12/05/201520/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
490 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Ireland;Denmark;Netherlands;Germany;Italy;Switzerland;United Kingdom;Sweden
439EUCTR2011-005085-37-BE
(EUCTR)
06/05/201526/03/2015Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QBW251
INN or Proposed INN: Not assigned
Product Code: QBW251
INN or Proposed INN: Not assigned
Product Code: QBW251
INN or Proposed INN: Not assigned
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156France;United States;Belgium;Ireland;United Kingdom
440NCT02449031
(ClinicalTrials.gov)
May 5, 20154/5/2015Observational Study in Cystic Fibrosis Patients Using TOBI® Podhaler™ or Other FDA Approved Inhaled Antipseudomonal Antibacterial DrugsA 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 DrugsPseudomonas Aeruginosa in Cystic FibrosisDrug: TOBI Podhaler;Drug: TOBI;Drug: Bethkis;Drug: CaystonMylan Inc.Cystic Fibrosis FoundationActive, not recruiting6 YearsN/AAll260United States
441EUCTR2014-004837-13-SE
(EUCTR)
24/04/201506/03/2015A study in people with Cystic Fibrosis ( a rare hereditary lung disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX-661 in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: Not yet assigned
Other descriptive name: VRT-893661 VRT-0893661
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
490Phase 3United States;France;Canada;Spain;Ireland;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
442EUCTR2013-004581-34-NL
(EUCTR)
26/02/201506/08/2014Confirmatory study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
208Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
443EUCTR2014-004519-35-GB
(EUCTR)
23/02/201508/12/2014A 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 FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (PAncreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
444EUCTR2014-004519-35-CZ
(EUCTR)
18/02/201519/11/2014A 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 FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (PAncreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Hungary;Czech Republic;Spain;United Kingdom
445EUCTR2013-005348-28-PL
(EUCTR)
11/02/201526/11/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany
446EUCTR2013-005366-19-PL
(EUCTR)
11/02/201526/11/2014A Multi-centre, Randomised, Double-Blind, Placebo-Controlled Study to evaulate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Coprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to the non-cystic fibrosis bronchiectasis. The study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3Serbia;United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand
447EUCTR2013-004581-34-BG
(EUCTR)
05/02/201506/01/2015Confirmatory study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
448ChiCTR-IPC-15005915
2015-01-312014-07-06A Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of BronchiectasisA Randomized, Controlled Study of Combined the therapy of bronchoalveolar lavage and Amikacin injection in Patients with Acute Exacerbation of Bronchiectasis non-cystic fibrosis bronchiectasisExperimental 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 MedicineNULLRecruiting1880BothExperimental group:50;NULL
449EUCTR2014-004519-35-ES
(EUCTR)
30/01/201504/12/2014A 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 FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: KREON de Liberación Inmediata
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATINA (Páncreas Polvo
Trade Name: Kreon 25 000
Product Name: Kreon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATINA (Páncreas Polvo)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
450NCT02248922
(ClinicalTrials.gov)
January 27, 201522/9/2014Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.AeruginosaAn 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 AeruginosaChronic Lung Infection With Pseudomonas Aeruginosa in Cystic FibrosisDrug: TIS or TIPNovartis PharmaceuticalsNULLTerminated6 YearsN/AAll17Phase 4Germany
451EUCTR2014-004519-35-HU
(EUCTR)
09/01/201512/11/2014A 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 FibrosisA Phase II, Multicenter, Parallel-Group, Active-Controlled, Randomized, Double-blind, Dose-Ranging Study to Evaluate the Efficacy and Safety of Different Doses of Creon IR in Subjects with Pancreatic Exocrine Insufficiency due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON IR
INN or Proposed INN: NOT APPLICABLE
Other descriptive name: PANCREATIN (Pancreas Powder)
Trade Name: Kreon 25 000
Product Name: Creon® 25,000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN (Pancreas Powder)
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
78Phase 2Czech Republic;Hungary;Spain;United Kingdom
452EUCTR2012-001565-33-IE
(EUCTR)
08/01/201511/09/2014An 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 colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
67Phase 4Switzerland;United Kingdom;Germany;Ireland;Spain
453NCT02507843
(ClinicalTrials.gov)
January 201522/7/2015Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis BronchiectasisVitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis: a Double-blind Randomised Controlled TrialBronchiectasisDrug: Cholecalciferol;Drug: PlaceboShanghai Pulmonary Hospital, Shanghai, ChinaNULLRecruiting18 YearsN/ABoth200Phase 4China
454NCT04122547
(ClinicalTrials.gov)
January 20158/10/2019Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis BronchiectasisEfficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis: a Randomized Double-blind Placebo-controlled TrialExacerbation Copd;Bronchiectasis;Lung Function DecreasedDrug: Roflumilast;Drug: PlaceboPrince of Songkla UniversityNULLCompleted18 Years80 YearsAll40Phase 3Thailand
455EUCTR2014-002125-35-DE
(EUCTR)
18/12/201421/07/2014A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp.A randomized double-blind, placebo-controlled cross-over study of inhaled alginate oligosaccharide (OligoG) for 28 days in subjects with Cystic Fibrosis using aztreonam due to chronic colonization with Burkholderia spp. - A phase IIb study of OligoG in subjects with cystic fibrosis colonized with Burkholderia spp. Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: OligoG CF-5/20
INN or Proposed INN: Oligomer of Sodium Alginate
Other descriptive name: OLIGOG CF-5/20
Algipharma ASNULLNot RecruitingFemale: yes
Male: yes
12Phase 2Germany
456EUCTR2013-004659-19-SK
(EUCTR)
15/12/201406/10/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer Healthcare AG, D-51368 Leverkusen, GermanyNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
492Phase 3United States;Portugal;Serbia;Philippines;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Latvia;Netherlands;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
457EUCTR2013-002202-31-DE
(EUCTR)
03/12/201408/10/2014Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: POL7080
Product Code: POL7080
INN or Proposed INN: POL7080
Polyphor Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain;Germany;United Kingdom
458NCT02262871
(ClinicalTrials.gov)
December 20147/10/2014HFN Versus NIV in Cystic Fibrosis. The HIFEN StudyRandomized Cross-over Physiologic Study of High Flow Nasal Oxygen Cannula Versus Non-invasive Ventilation in Cystic Fibrosis. The HIFEN StudyCystic FibrosisDevice: High flow nasal oxygen cannula;Device: Noninvasive ventilationSt. Michael's Hospital, TorontoNULLCompleted18 YearsN/AAll15N/ACanada
459EUCTR2013-004581-34-DE
(EUCTR)
25/11/201405/08/2014Confirmatory study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
460NCT02273661
(ClinicalTrials.gov)
November 19, 201422/10/2014Evaluation 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 AspergillosisDrug: Liposomal amphotericin B (Ambisome®);Drug: placeboPoitiers University HospitalNULLCompleted18 YearsN/AAll174Phase 2France
461EUCTR2013-005357-79-IT
(EUCTR)
18/11/201406/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 17.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Chile;Israel;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Belgium;Poland;Romania;Bulgaria;Sweden
462EUCTR2011-004208-39-SK
(EUCTR)
18/11/201421/10/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Germany;Latvia;New Zealand;Japan
463EUCTR2014-001204-21-DE
(EUCTR)
17/11/201422/08/2014An open-label clinical trial that evaluates the lung clearance index in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosaAn 8 week open-label interventional multicenter study to evaluate the lung clearance index as endpoint for clinical trials in cystic fibrosis patients = 6 years of age, chronically infected with Pseudomonas aeruginosa Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Phase 4Germany
464EUCTR2013-005357-79-HU
(EUCTR)
13/11/201406/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Israel;Italy;United Kingdom;France;Hungary;Czech Republic;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;South Africa;Sweden
465EUCTR2011-004208-39-LV
(EUCTR)
11/11/201426/09/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
400Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Australia;Denmark;Latvia;Germany;New Zealand;Japan
466EUCTR2013-004659-19-LV
(EUCTR)
11/11/201430/09/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 17.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer Healthcare AG, D-51368 Leverkusen, GermanyNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
467EUCTR2013-005348-28-IE
(EUCTR)
07/11/201411/09/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
MedDRA version: 19.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 19.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
468NCT03312140
(ClinicalTrials.gov)
November 6, 20144/10/2017Examination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic FibrosisExamination of the Lipid Metabolism of the Liver After Choline Substitution in Cystic FibrosisCystic Fibrosis Liver DiseaseDrug: Choline ChlorideUniversity Hospital TuebingenNULLCompleted18 YearsN/AMale10N/ANULL
469NCT02202876
(ClinicalTrials.gov)
November 201425/7/2014Redox Imbalance and the Development of Cystic Fibrosis DiabetesRedox Imbalance and the Development of Cystic Fibrosis DiabetesDiabetes Mellitus, Type 2;Cystic FibrosisOther: Oral Glucose Tolerance Test;Other: High Glycemic Index Meal;Other: Low Glycemic Index Meal;Other: Test Soda;Other: Fruit juiceEmory UniversityCystic Fibrosis FoundationCompleted1 YearN/AAll34N/AUnited States
470EUCTR2014-000844-13-SE
(EUCTR)
21/10/201421/07/2014A phase IIb study of OligoG in subjects with cystic fibrosisA double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: OligoG CF-5/20
INN or Proposed INN: Oligomer of Sodium Alginate
Other descriptive name: OLIGOG CF-5/20
Algipharma ASNULLNot RecruitingFemale: yes
Male: yes
76Phase 2Denmark;Germany;Sweden
471EUCTR2013-005357-79-CZ
(EUCTR)
15/10/201404/06/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 19.0;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United 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
472EUCTR2013-005449-35-DE
(EUCTR)
01/10/201404/08/2014Extension study of ataluren in patients with Cystic FibrosisAn Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) Nonsense Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
76Phase 3France;United States;Belgium;Spain;Israel;Germany;Italy;Sweden
473NCT02372383
(ClinicalTrials.gov)
October 201420/6/2014Improving Treatment of Nontuberculous Mycobacterial Infection in Cystic FibrosisPharmacokinetic Evaluation of Nontuberculous Mycobacterial Antibiotics in Cystic Fibrosis Versus ControlsCystic FibrosisDrug: Ethambutol;Drug: Rifampin;Drug: Azithromycin;Drug: PancrelipaseUniversity of Colorado, DenverCystic Fibrosis Foundation Therapeutics;Colorado Clinical & Translational Sciences InstituteCompleted16 Years45 YearsBoth32N/AUnited States
474EUCTR2013-004659-19-BG
(EUCTR)
26/09/201405/08/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
475EUCTR2014-000844-13-DK
(EUCTR)
25/09/201408/07/2014A phase IIb study of OligoG in subjects with cystic fibrosisA double-blind, randomized, placebo-controlled cross over study of inhaled alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis. - A phase IIb study of OligoG in subjects with cystic fibrosis Cystic Fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20
INN or Proposed INN: Oligomer of Sodium Alginate
Other descriptive name: OLIGOG CF-5/20
Algipharma ASNULLNot RecruitingFemale: yes
Male: yes
76Phase 2Denmark;Germany;Sweden
476EUCTR2013-005449-35-IT
(EUCTR)
16/09/201425/06/2014An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) An Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) Nonsense Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
76Phase 3United States;France;Spain;Belgium;Israel;Germany;Italy;Sweden
477EUCTR2013-004581-34-IT
(EUCTR)
15/09/201410/06/2014Confirmatory study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands
478EUCTR2013-004581-34-GB
(EUCTR)
12/09/201425/09/2014Confirmatory study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3United States;Greece;Spain;Israel;Italy;United Kingdom;France;Canada;Argentina;Poland;Belgium;Brazil;Australia;Denmark;Bulgaria;Netherlands;Germany
479EUCTR2013-005357-79-SK
(EUCTR)
11/09/201426/08/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 18.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
PHARMAXIS LTDNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United States;Slovakia;Greece;Spain;Ukraine;Russian Federation;Chile;Israel;Italy;United Kingdom;France;Czech Republic;Hungary;Mexico;Canada;Argentina;Poland;Belgium;Romania;Bulgaria;Sweden
480EUCTR2013-004595-35-GB
(EUCTR)
11/09/201416/05/2014Safety and tolerability of BAY63-2521 in Cystic Fibrosis patientsMulti-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Adempas 0.125 mg
Product Code: BAY63-2521
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
63Phase 2France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom
481EUCTR2013-004302-26-GB
(EUCTR)
05/09/201401/05/2014Study of how tafluprost is distributed in blood circulation after ocular administration in children who have glaucoma or elevated intraocular pressure. Tolerance to the drug and safety in general will also be assessed.A phase I study to evaluate the pharmacokinetics, safety and tolerability of preservative free tafluprost ophthalmic solution (0.0015%) in pediatric patients diagnosed with glaucoma or ocular hypertension. - Phase I Study to Evaluate Tafluprost Eye Drops in Paediatric Patients. Glaucoma or Ocular Hypertension
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Eye Diseases [C11]
Trade Name: Tafluprost
INN or Proposed INN: tafluprost
Other descriptive name: TAFLUPROST
Santen OyNULLNot Recruiting Female: yes
Male: yes
18 Human pharmacology (Phase 1): yes Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Hungary;Slovakia;Poland;United Kingdom
482EUCTR2013-004659-19-PT
(EUCTR)
02/09/201403/07/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer Healthcare AG, D-51368 Leverkusen, GermanyNULLNot RecruitingFemale: yes
Male: yes
492Phase 3United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand
483EUCTR2013-004581-34-ES
(EUCTR)
01/09/201414/08/2014Confirmatory study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of Ataluren (PTC124®) in Patients with Nonsense Mutation Cystic Fibrosis Nonsense Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
210Phase 3United States;Greece;Spain;Turkey;Israel;Russian Federation;United Kingdom;Italy;Canada;Argentina;Brazil;Belgium;Australia;Bulgaria;Germany;Netherlands
484EUCTR2013-005449-35-ES
(EUCTR)
01/09/201411/08/2014Extension study of ataluren in patients with Cystic FibrosisAn Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) Nonsense Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
76Phase 3France;United States;Belgium;Spain;Israel;Germany;Italy;Sweden
485EUCTR2013-004595-35-DE
(EUCTR)
29/08/201429/08/2014Safety and tolerability of BAY63-2521 in Cystic Fibrosis patientsMulti-center phase 2 study to assess the safety, tolerability and early signs of efficacy of tid orally administered BAY63-2521 in adult deltaF508 homozygous Cystic Fibrosis patients - Early signs of efficacy study with BAY63-2521 in adult homozygous deltaF508 Cystic Fibrosis patients Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Adempas
Product Name: Adempas 0.5 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 1.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Trade Name: Adempas
Product Name: Adempas 2.0 mg
Product Code: BAY63-2521
INN or Proposed INN: Riociguat
Other descriptive name: RIOCIGUAT
Product Name: Adempas 0.125 mg
Product Code: BAY63-2521
INN or Proposed INN: RIOCIGUAT
Other descriptive name: RIOCIGUAT
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
63Phase 2France;United States;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom
486EUCTR2013-004659-19-CZ
(EUCTR)
27/08/201420/05/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 20.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3United States;Portugal;Taiwan;Hong Kong;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Turkey;Lithuania;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Poland;Bulgaria;Germany;New Zealand
487EUCTR2013-005449-35-BE
(EUCTR)
26/08/201404/06/2014Extension study of ataluren in patients with Cystic FibrosisAn Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) Nonsense Mutation Cystic Fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3France;United States;Spain;Belgium;Israel;Germany;Italy;Sweden
488EUCTR2013-005357-79-BE
(EUCTR)
20/08/201401/07/2014Long Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis SubjectsLong Term Administration of Inhaled Mannitol in Cystic Fibrosis – A Safety and Efficacy Trial in Adult Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Bronchitol
Product Name: Bronchitol
INN or Proposed INN: Mannitol
Other descriptive name: MANNITOL
Pharmaxis LimitedNULLNot RecruitingFemale: yes
Male: yes
440Phase 3United 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
489EUCTR2014-000817-30-NL
(EUCTR)
14/08/201422/05/2014Comparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutationComparing the effect of curcumin and genistein to treatment with Ivacaftor in CF patients with a class III mutation - TICTAC-study Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Trade Name: Ivacaftor/Kalydeco
Product Name: Curcuma Longa Extract cpl formaat 00 23,2 x 8,5 mm 723 mg
INN or Proposed INN: curcumin
Other descriptive name: CURCUMIN
Product Name: Genisteine Plus 150 mg cpl formaat 1 18,7 x 6,4 mm 438 mg
INN or Proposed INN: genistein
Other descriptive name: GENISTEIN
University Medical Centre UtrechtNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
490EUCTR2013-005449-35-SE
(EUCTR)
06/08/201405/06/2014Extension study of ataluren in patients with Cystic FibrosisAn Open-Label Safety and Efficacy Study for Patients with Nonsense Mutation Cystic Fibrosis Previously Treated with Ataluren (PTC124®) Nonsense Mutation Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3France;United States;Spain;Belgium;Israel;Germany;Italy;Sweden
491EUCTR2014-002387-32-GB
(EUCTR)
05/08/201427/06/2014Trial of Rosuvastatin for the Prevention of Kidney Toxicity caused by Tobramycin in Children with Cystic FibrosisPhase IIa, Randomised, Controlled, Open-Label Trial of Rosuvastatin for the Prevention of Aminoglycoside-Induced Kidney Toxicity in Children with Cystic Fibrosis - PROteKT Aminoglycoside-induced nephrotoxicity
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Classification code 10069022;Term: Kidney injury molecule-1;System Organ Class: 10022891 - Investigations
MedDRA version: 18.0;Level: LLT;Classification code 10067571;Term: Nephrotoxicity;System Organ Class: 100000004857;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]
Trade Name: Crestor
Product Name: Crestor
INN or Proposed INN: Rosuvastatin calcium
University of LiverpoolNULLNot RecruitingFemale: yes
Male: yes
50Phase 2United Kingdom
492NCT02139306
(ClinicalTrials.gov)
August 201413/5/2014Study 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 FibrosisCystic FibrosisDrug: Ataluren (PTC124®);Drug: PlaceboPTC TherapeuticsCystic Fibrosis Foundation;ECFS-Clinical Trial Network (ECFS-CTN)Completed6 YearsN/AAll279Phase 3United States;Argentina;Australia;Belgium;Brazil;Bulgaria;Canada;France;Germany;Greece;Israel;Italy;Netherlands;Poland;Spain;United Kingdom
493NCT02178540
(ClinicalTrials.gov)
August 201424/6/2014Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis PatientsA 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 CapsulesCystic FibrosisDrug: Placebo;Device: Tobi PodhalerNovartis PharmaceuticalsNULLCompleted6 YearsN/AAll45Phase 4United States
494EUCTR2013-005366-19-RO
(EUCTR)
30/07/201430/05/2014A 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 bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand
495EUCTR2013-005348-28-RO
(EUCTR)
30/07/201430/05/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Georgia;South Africa;Germany;Latvia;Netherlands;New Zealand
496EUCTR2013-005348-28-LV
(EUCTR)
28/07/201408/05/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Latvia;Germany;New Zealand
497EUCTR2011-000801-39-ES
(EUCTR)
25/07/201425/04/2014Placebo 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 fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Belgium;Spain;Ireland;Austria;Germany;Italy;Sweden
498EUCTR2013-004659-19-AT
(EUCTR)
17/06/201413/05/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;Serbia;United States;Philippines;Hong Kong;Taiwan;Slovakia;Thailand;Russian Federation;Australia;South Africa;Netherlands;Latvia;China;Korea, Republic of;Lithuania;Turkey;Austria;Czech Republic;Argentina;Brazil;Poland;Romania;Bulgaria;Germany
499EUCTR2013-005366-19-ES
(EUCTR)
17/06/201411/04/2014A multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of Pulmaquin®(ARD-3150, dual reléase ciprofloxacin for inhalation)in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with non-cystic fibrosis bronchiectasis (ORBIT 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862
MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: ciprofloxacin hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
500EUCTR2013-005348-28-ES
(EUCTR)
16/06/201411/04/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 17.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 17.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;Latvia;Germany;Netherlands;New Zealand
501EUCTR2011-000801-39-AT
(EUCTR)
11/06/201424/04/2014Placebo 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 fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
502EUCTR2011-005085-37-IE
(EUCTR)
05/06/201410/04/2014Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients cystic fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QBW251
INN or Proposed INN: Not assigned
Product Code: QBW251
INN or Proposed INN: Not assigned
Product Code: QBW251
INN or Proposed INN: Not assigned
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156France;United States;Belgium;Ireland;United Kingdom
503EUCTR2014-000284-40-GB
(EUCTR)
05/06/201429/04/2014Cysteamine in Cystic FibrosisAn open label investigation of the tolerability and pharmacokinetics of oral cysteamine in adults with Cystic Fibrosis. - Cysteamine in Cystic Fibrosis (2) Cystic Fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cystagon (cysteamine bitartrate) immediate-release capsules
Product Name: Cystagon (cysteamine bitartrate) immediate-release capsules
INN or Proposed INN: cysteamine bitartrate
University of AberdeenNHS GrampianNot RecruitingFemale: yes
Male: yes
12Phase 1;Phase 2United Kingdom
504NCT02104245
(ClinicalTrials.gov)
May 28, 201428/3/2014Phase 3 Study With Ciprofloxacin Dispersion for Inhalation in Non-CF Bronchiectasis (ORBIT-4)A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections With Pseudomonas Aeruginosa in Patients With Non-Cystic Fibrosis Bronchiectasis, Including 28 Day Open-Label ExtensionNon Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin dispersion for inhalation;Drug: PlaceboAradigm CorporationGrifols Therapeutics LLCCompleted18 YearsN/AAll304Phase 3United States;Australia;Canada;Former Serbia and Montenegro;France;Georgia;Hungary;Israel;Italy;Korea, Republic of;New Zealand;Peru;Poland;Romania;Spain;United Kingdom;Germany
505EUCTR2012-002699-14-IT
(EUCTR)
28/05/201420/02/2014Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Argentina;Belgium;Netherlands;United Kingdom;Italy;Canada
506EUCTR2013-005481-19-DK
(EUCTR)
27/05/201427/05/2014High Dose Antioxidant Treatment for Patients with Cystic FibrosisHigh Dose Antioxidant Treatment for Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 17.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Mucolysin
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: Mucomyst
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: ACC
INN or Proposed INN: ACETYLCYSTEINE
Other descriptive name: ACETYLCYSTEINE
Trade Name: Tad
INN or Proposed INN: GLUTATHIONE
Other descriptive name: GLUTATHIONE SODIUM
Aarhus University HospitalNULLNot RecruitingFemale: yes
Male: yes
Phase 2Denmark
507NCT02107859
(ClinicalTrials.gov)
May 23, 20144/4/2014Study of Ataluren (PTC124) in Cystic FibrosisAn Open-Label Safety and Efficacy Study for Patients With Nonsense Mutation Cystic Fibrosis Previously Treated With Ataluren (PTC124)Cystic FibrosisDrug: AtalurenPTC TherapeuticsNULLTerminated6 YearsN/AAll61Phase 3United States;Belgium;France;Israel;Italy;Spain;Sweden;Germany
508EUCTR2011-000801-39-HU
(EUCTR)
22/05/201403/04/2014Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
509EUCTR2013-005348-28-IT
(EUCTR)
22/05/201424/03/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862
MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;Italy;United Kingdom;Hungary;Canada;Poland;Romania;Australia;Latvia;Netherlands;Germany;New Zealand
510EUCTR2013-005366-19-IT
(EUCTR)
22/05/201427/03/2014A 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 bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862
MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Israel;Italy;United Kingdom;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
511EUCTR2013-004659-19-LT
(EUCTR)
12/05/201420/03/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;Portugal;United States;Hong Kong;Taiwan;Slovakia;Thailand;Lithuania;Turkey;Austria;Russian Federation;Czech Republic;Argentina;Poland;Brazil;Romania;Australia;South Africa;Bulgaria;Netherlands;Latvia;Germany;China;Korea, Republic of
512EUCTR2011-005085-37-DE
(EUCTR)
09/05/201431/03/2014Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.A randomized, double blind placebo-controlled study to assess the safety,tolerability, pharmacokinetics, and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients cystic fibrosis
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QBW251
INN or Proposed INN: Not assigned
Product Code: QBW251
INN or Proposed INN: Not assigned
Product Code: QBW251
INN or Proposed INN: Not assigned
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 1;Phase 2France;United States;Belgium;Ireland;Germany;United Kingdom
513EUCTR2013-005366-19-HU
(EUCTR)
08/05/201421/03/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Serbia;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Georgia;Germany;New Zealand
514EUCTR2013-005348-28-HU
(EUCTR)
06/05/201421/03/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis.
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
515EUCTR2013-005348-28-GB
(EUCTR)
06/05/201412/03/2014A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® (ARD-3150, Dual Release Ciprofloxacin for Inhalation) in subjects who have a lung infection that includes the bacteria Pseudomonas aeruginosa due to non-cystic fibrosis bronchiectasis. This study includes a 28-day open-label extension (all patients will receive study drug for the last 28 days of the study).A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections with Pseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension and Pharmacokinetic Substudy (ORBIT-3) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (ORBIT 3) Chronic lung infections with Pseudomonas aeruginosa in subjects withnon-cystic fibrosis bronchiectasis.
MedDRA version: 18.0;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 18.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Ireland;Israel;United Kingdom;Italy;Hungary;Canada;Poland;Romania;Australia;South Africa;Germany;Latvia
516NCT02144246
(ClinicalTrials.gov)
May 201419/5/2014Contraceptive Hormones and Women With Cystic FibrosisContraceptive Hormones and Women With Cystic Fibrosis: Satisfaction and Effects on DiseaseCystic Fibrosis Exacerbations While on and Off Hormonal ContraceptionOther: Non-hormonal period;Drug: Ortho-cyclen, Ethinyl estradiol/norgestimate, 0.035 mg/0.250 mgUniversity of PennsylvaniaSociety of Family PlanningTerminated18 Years40 YearsFemale5Phase 1United States
517NCT02106832
(ClinicalTrials.gov)
April 30, 20144/4/2014Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.BronchiectasisDrug: Ciprofloxacin (BAYQ3939) dry powder for inhalation;Drug: PlaceboBayerNovartisCompleted18 YearsN/AAll521Phase 3United States;Argentina;Australia;Austria;Brazil;Bulgaria;China;Czechia;Germany;Hong Kong;Korea, Republic of;Latvia;Lithuania;Netherlands;Philippines;Poland;Portugal;Romania;Russian Federation;Serbia;Slovakia;South Africa;Taiwan;Thailand;Turkey;Czech Republic
518EUCTR2014-000057-37-NL
(EUCTR)
30/04/201412/02/2014Bronchodilcation as a CFTR activator in CFA B2-agonist as a CFTR activator in CF - ABBA study Cystic Fibrosis;Therapeutic area: Body processes [G] - Metabolic Phenomena [G03]Product Name: Salbutamol
Product Code: R03AC02
INN or Proposed INN: SALBUTAMOL
Product Name: Salbutamol
Product Code: R03CC02
INN or Proposed INN: SALBUTAMOL
University Medical Centre UtrechtNULLNot RecruitingFemale: yes
Male: yes
Phase 2Netherlands
519EUCTR2013-004295-35-AT
(EUCTR)
30/04/201402/04/2014Lung 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 studyLung Clearance Index as an OUTcome parameter to detect the efficacy f Aztreonam Lysine Inhalation in cystic fibrosis patients with near normal spirometry - an observational proof-of concept study - LCI-OUT Chronic lung P. Aeruginosa Infection
MedDRA version: 16.1;Level: PT;Classification code 10061229;Term: Lung infection;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
Product Name: Cayston 75 mg Pulver und Lösungsmittel zur Herstellung einer Lösung für einen Vernebler
INN or Proposed INN: aztreonam
Other descriptive name: AZTREONAM LYSINE
Trade Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
Product Name: Colistin Forest - Trockenstechampullen mit Lösungsmittel
INN or Proposed INN: COLISTIMETHATE SODIUM
Trade Name: TOBI
Product Name: Tobi
INN or Proposed INN: TOBRAMYCIN SULFATE
Medical University Innsbruck - Department für Kinder- und Jugendheilkunde (Pädiatrie III)NULLNot RecruitingFemale: yes
Male: yes
15Phase 4Austria
520EUCTR2013-005366-19-GB
(EUCTR)
29/04/201417/03/2014A 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 bronchiectasisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Pulmaquin® in the Management of Chronic Lung Infections withPseudomonas aeruginosa in Subjects with Non-Cystic Fibrosis Bronchiectasis, including 28 Day Open-Label Extension (ORBIT-4) - Pulmaquin® with Non-Cystic Fibrosis Bronchiectasis (Orbit 4) Chronic lung infections with Pseudomonas aeruginosa in subjects with non-cystic fibrosis bronchiectasis
MedDRA version: 16.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 100000004862
MedDRA version: 16.1;Classification code 10006446;Term: Bronchiectasis NOS;System Organ Class: 100000004855;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Pulmaquin®
Product Code: ARD-3150
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
INN or Proposed INN: Ciprofloxacin Hydrochloride
Other descriptive name: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
255Phase 3United States;Spain;Israel;United Kingdom;Italy;France;Hungary;Canada;Poland;Romania;Australia;Netherlands;Germany;New Zealand
521EUCTR2013-004659-19-DE
(EUCTR)
23/04/201403/02/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Serbia;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
522EUCTR2013-004659-19-NL
(EUCTR)
23/04/201427/02/2014Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - Respire 2 non-CF bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Ciprofloxacin DPI
Product Code: BAYQ3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer AGNULLNot RecruitingFemale: yes
Male: yes
492Phase 3Portugal;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
523NCT02088216
(ClinicalTrials.gov)
April 1, 20145/3/2014Effect of Long-term, High-dose N-acetylcysteine on Exacerbations of BronchiectaisisEffect of N-acetylcysteine on Exacerbations of Bronchiectasis (BENE): a Randomized Controlled TrialNon-Cystic Fibrosis BronchiectasisDrug: N-acetylcysteine;Other: On-demand treatmentQilu Hospital of Shandong UniversityNULLCompleted18 Years80 YearsAll161N/AChina
524NCT02113397
(ClinicalTrials.gov)
April 20149/4/2014Evaluation of Inhaled Antibiotics on Bacterial Diversity and Richness in the Cystic Fibrosis LungComparative 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 ColistimethateCystic FibrosisDrug: TOBI™ Podhaler™ 112 mg inhaled twice daily;Drug: Colistimethate 75 mg inhaled two times dailyDartmouth-Hitchcock Medical CenterNovartis PharmaceuticalsTerminated12 Years75 YearsAll1United States
525NCT01515007
(ClinicalTrials.gov)
March 31, 201410/1/2012Phase 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 BronchiectasisDrug: Ciprofloxacin dispersion for inhalation;Drug: PlaceboAradigm CorporationGrifols Therapeutics LLCCompleted18 YearsN/AAll278Phase 3United States;Australia;Canada;Germany;Hungary;Ireland;Israel;Italy;Korea, Republic of;Latvia;Poland;Romania;South Africa;Spain;Taiwan;United Kingdom;New Zealand
526EUCTR2012-002699-14-NL
(EUCTR)
10/03/201402/10/2013Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160Argentina;France;Canada;Belgium;Austria;Germany;Netherlands;Italy;United Kingdom
527EUCTR2013-000604-41-DE
(EUCTR)
10/03/201420/09/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
528NCT02084043
(ClinicalTrials.gov)
March 20148/3/2014In Vitro Assessment of a Breath-synchronized Vibrating Mesh Nebulizer During Non Invasive VentilationIn 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;AsthmaDrug: Nebulization of Amikacin during NIV (RR: 15 cycles/minute);Drug: Nebulization of Amikacin during NIV (RR: 25 cycles/minute)University Hospital St Luc, BrusselsUniversité Catholique de Louvain;University of Applied Sciences of Western Switzerland;School of Gestion and Engineering Vaud, SwitzerlandCompletedN/AN/ABoth3N/ABelgium;Switzerland
529NCT02081963
(ClinicalTrials.gov)
March 20146/3/2014Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis BronchiectasisA Randomized, Controlled Study of Combined Administration of Nebulized Amikacin in Patients With Acute Exacerbation of Non-Cystic Fibrosis BronchiectasisNon-Cystic Fibrosis BronchiectasisDrug: Amikacin;Drug: Normal salineQilu Hospital of Shandong UniversityNULLCompleted18 Years80 YearsAll178Phase 4China
530EUCTR2013-000604-41-NL
(EUCTR)
14/02/201426/09/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
531NCT02036879
(ClinicalTrials.gov)
February 201426/12/2013Gender Disparity and Hormones in Cystic FibrosisGender Disparity and Hormones in Cystic FibrosisCystic Fibrosis (CF)Drug: Loestrin (norethindrone acetate and ethinyl estradiol)University of Texas Southwestern Medical CenterNULLCompleted18 YearsN/AAll55Early Phase 1United States
532NCT01746784
(ClinicalTrials.gov)
February 20146/12/2012Safety and Pharmacokinetic Study of N6022 in Subjects With Cystic Fibrosis Homozygous for the F508del-CFTR MutationA 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 FibrosisDrug: N6022;Drug: Normal salineNivalis Therapeutics, Inc.NULLCompleted18 YearsN/AAll66Phase 1United States
533NCT01937325
(ClinicalTrials.gov)
February 20144/9/2013CPET in CF Patients With One G551D Mutation Taking VX770Airway Infection, Inflammatory Markers and Exercise Capacity in Patients With Cystic Fibrosis and at Least One G551D Mutation Taking VX770 (Ivacaftor)Cystic FibrosisDrug: ivacaftor;Drug: placeboThe AlfredNULLActive, not recruiting16 Years70 YearsBoth20Phase 4Australia
534EUCTR2013-000604-41-IT
(EUCTR)
21/01/201414/08/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
535EUCTR2013-003774-27-GB
(EUCTR)
20/01/201427/11/2013A study to investigate lung deposition of radiolabelled OligoG(v1.0)An open label, randomised, two-way crossover scintigraphic study to investigate lung deposition of radiolabelled OligoG delivered as a dry powder and as a nebulised solution in cystic fibrosis patients - A study to investigate lung deposition of radiolabelled OligoG (v1.0) Cystic fibrosis (CF) is an autosomal, recessive inheritable disease caused by a homozygote defect at the long arm of Chromosome 7. This mutation causes absence or defect of the cystic fibrosis transmembrane conductance regulator, an ion channel transporting chloride and bicarbonate ions across the cell membrane in exocrine glands. Decreased chloride transport leads to dehydration of the mucus layer, and decreased bicarbonate to increased mucus adhesion. Mucus stagnation results.;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Radiolabelled OligoG CF-5/20 Dry Powder for Inhalation (DPI)
INN or Proposed INN: OligoG
Product Name: Radiolabelled OligoG CF-5/20 6% Solution for Nebulisation
INN or Proposed INN: OligoG
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
12Phase 2United Kingdom
536EUCTR2010-020413-90-IE
(EUCTR)
08/01/201413/12/2013Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 2France;United States;Belgium;Ireland;Australia;Germany;United Kingdom
537EUCTR2010-020413-90-GB
(EUCTR)
06/01/201410/12/2013Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Belgium;Ireland;Australia;Germany;United Kingdom
538NCT02015663
(ClinicalTrials.gov)
January 201413/12/2013Tobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off CyclesA 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 FibrosisCystic FibrosisDrug: Tobramycin Inhalation PowderNovartis PharmaceuticalsNULLTerminated6 YearsN/AAll32Phase 4United States
539EUCTR2013-002819-10-ES
(EUCTR)
26/12/201312/11/2013A 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 FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects ? 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: KREON N 25000
INN or Proposed INN: Not applicable
Other descriptive name: PANCREATIN
Trade Name: Kreon 25000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATINA
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Russian Federation
540EUCTR2013-000604-41-CZ
(EUCTR)
18/12/201313/09/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
541EUCTR2013-000604-41-SE
(EUCTR)
10/12/201313/09/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
542EUCTR2013-000604-41-IE
(EUCTR)
09/12/201310/10/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
543EUCTR2013-000604-41-BE
(EUCTR)
04/12/201317/09/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
544EUCTR2009-016590-15-PL
(EUCTR)
03/12/201311/10/2013A 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 includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862
MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg / 5 mL nebuliser solution
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
50United States;Greece;Russian Federation;Switzerland;Italy;France;Egypt;Hungary;Canada;Argentina;Poland;Romania;Germany
545EUCTR2013-000604-41-ES
(EUCTR)
03/12/201308/10/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
546NCT02096315
(ClinicalTrials.gov)
December 201318/3/2014Safety, 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 TreatmentBronchiectasis;Lower Respiratory InfectionDrug: POL7080Polyphor Ltd.NULLTerminated18 Years79 YearsAll20Phase 2Spain;United Kingdom
547EUCTR2013-002819-10-HU
(EUCTR)
29/11/201314/10/2013A 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 FibrosisA Double-blind, Randomized, Multicenter, Cross-over Study to Compare the Effect of Creon N and Creon® on Fat Digestion in Subjects = 12 years of Age with Pancreatic Exocrine Insufficiency Due to Cystic Fibrosis Pancreatic exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: CREON N 25000
INN or Proposed INN: not applicable
Other descriptive name: PANCREATIN
Trade Name: Creon 25000
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
Abbott Laboratories GmbHNULLNot RecruitingFemale: yes
Male: yes
40Hungary;Spain;Russian Federation
548EUCTR2013-000604-41-DK
(EUCTR)
19/11/201319/11/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Australia;Netherlands;Germany;Sweden
549NCT00924547
(ClinicalTrials.gov)
November 201317/6/2009Oral Docosahexanoic Acid Supplementation in Cystic FibrosisOral Docosahexanoic Acid Supplementation in Cystic Fibrosis: Effects on Exhaled Pro-inflammatory Isoprostanes and Analysis of Its Esterification Sites in PlasmaCystic FibrosisDietary Supplement: Docosahexanoic Acid Supplement;Dietary Supplement: PlaceboVanderbilt UniversityNULLCompleted6 YearsN/ABoth17Phase 2United States
550EUCTR2013-000604-41-AT
(EUCTR)
23/10/201316/09/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
551EUCTR2013-000604-41-GB
(EUCTR)
10/10/201317/09/2013A 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 drugsA Phase 3, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic fibrosis in patients homozygous or heterozygous for the F508del-CFTR Mutation
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
1000Phase 3United States;Spain;Ireland;Austria;Italy;United Kingdom;France;Czech Republic;Canada;Belgium;Australia;Denmark;Netherlands;Germany;Sweden
552NCT01784419
(ClinicalTrials.gov)
October 20133/2/2013Short Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis PatientsShort Term Effects of Ivacaftor in Non-G551D Cystic Fibrosis PatientsCystic FibrosisDrug: ivacaftor;Drug: PlaceboUniversity of California, San FranciscoNULLCompleted6 YearsN/AAll10N/AUnited States
553NCT01702415
(ClinicalTrials.gov)
October 20134/10/2012Zoledronic Acid in Cystic FibrosisRandomised, Double Blind, Placebo Controlled Trial to Ascertain the Efficacy and Safety of Intravenous Zoledronic Acid in Adult Patients With Cystic Fibrosis.Cystic FibrosisDrug: Zoledronic acid;Drug: PlaceboPapworth Hospital NHS Foundation TrustNovartis PharmaceuticalsWithdrawn18 YearsN/ABoth0Phase 4United Kingdom
554NCT02035488
(ClinicalTrials.gov)
October 201327/12/2013Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis BronchiectasisPharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis BronchiectasisBronchiectasisDrug: TobramycinUniversity Medical Centre GroningenNULLCompleted18 YearsN/ABoth8Phase 1/Phase 2Netherlands
555EUCTR2013-002202-31-ES
(EUCTR)
24/09/201301/08/2013Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: POL7080
Product Code: POL7080
INN or Proposed INN: POL7080
Other descriptive name: POL7080
Polyphor Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2Spain;Germany;United Kingdom
556EUCTR2013-001258-82-IT
(EUCTR)
12/09/201329/07/2013Phase II clinical study for the therapy of cystic fibrosis patients with aspecific mutationA phase II pilot clinical study of experimental research to evaluate thefunctional rescue of CFTR protein through proteostasis regulators - Proteostasis regulators effect in cystic fibrosis therapy Cystic fibrosis patients with F508del-CFTR in homozygous or compound heterozygous with Class I or II mutations;Therapeutic area: Body processes [G] - Genetic Phenomena [G05]Trade Name: Cystagon
Product Name: Cysteamine bitartrate (Cystagon)
Product Code: EMEA/H/C/000125
European Institute for Cystic Fibrosis Research (IERFC)NULLNot RecruitingFemale: yes
Male: yes
Phase 2Italy
557EUCTR2013-002202-31-GB
(EUCTR)
11/09/201319/06/2013Study conducted in several hospitals to verify the tolerance, safety and efficacy to cure of the study medication (POL7080) and its distribution in the body when given to patients with bronchiectasis caused by bacterium Pseudomonas aeruginosa,requiring intravenous treatment.A phase II, open-label, multi-center study to assess the tolerance, safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of POL7080 in the treatment of patients with acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection requiring intravenous treatment. - POL7080-002 Acute exacerbation of non-cystic fibrosis bronchiectasis due to Pseudomonas aeruginosa infection.;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]Product Name: POL7080
Product Code: POL7080
INN or Proposed INN: POL7080
Other descriptive name: POL7080
Polyphor Ltd.NULLNot RecruitingFemale: yes
Male: yes
20Phase 2United Kingdom;Germany;Spain
558EUCTR2012-003990-24-AT
(EUCTR)
26/08/201303/04/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Australia;Austria;Germany;United Kingdom
559NCT01844778
(ClinicalTrials.gov)
August 201329/4/2013Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)An Open-label, Crossover, Interventional Phase IV Study to Compare the Ease of Use of TIP With Nebulized TIS and Nebulized COLI for the Treatment of Pulmonary Pseudomonas Aeruginosa (P.a) in Patients With Cystic FibrosisCystic FibrosisDrug: Tobramycin Inhalation Powder;Drug: Tobramycin inhalation solution;Drug: ColistimethateNovartis PharmaceuticalsNULLCompleted6 YearsN/AAll60Phase 4Germany;Ireland;Spain;Switzerland;United Kingdom
560NCT01885169
(ClinicalTrials.gov)
August 201320/6/2013LAIV (Flumist®) Administration in CF PatientsSafety of Live-attenuated Influenza Vaccine (LAIV, Flumist®) in Patients With Cystic Fibrosis (CF)Cystic FibrosisBiological: Flumist®McGill University Health CenterMinistere de la Sante et des Services Sociaux;Canadian Cystic Fibrosis Foundation;PHAC/CIHR Influenza Research NetworkActive, not recruiting2 Years18 YearsBoth170N/ACanada
561EUCTR2012-000386-20-GB
(EUCTR)
31/07/201326/04/2013A Roll-over study in children with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the long-term safety and pharmacodynamics of ivacaftorA Phase 3, 2-Arm, Roll-Over Study to Evaluate the Long-term Safety and Pharmacodynamics of Ivacaftor Treatment in Pediatric Subjects With Cystic Fibrosis and a CFTR Gating Mutation cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;United Kingdom
562EUCTR2012-001565-33-ES
(EUCTR)
04/07/201316/05/2013An 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 colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosispatients
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 16.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Trade Name: TOBI 300 mg/5 ml solución para inhalación por nebulizador
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Trade Name: Promixin,1 millón de Unidades Internacionales,polvo para solución para inhalación por nebulizador
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
563EUCTR2012-000204-15-GB
(EUCTR)
28/06/201326/04/2013A study in children aged 2 to 5 with Cystic Fibrosis (a rare hereditary pulmonary disease) to assess the safety, pharmacokinetics and pharmacodynamics of ivacaftorA Phase 3, 2 Part, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who are 2 Through 5 Years of Age and Have a CFTR Gating Mutation cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;United Kingdom
564EUCTR2012-003990-24-DK
(EUCTR)
27/06/201317/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Austria;Australia;Denmark;Germany;United Kingdom
565EUCTR2009-012842-21-HU
(EUCTR)
27/06/201310/05/2013Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
566EUCTR2012-003989-40-CZ
(EUCTR)
26/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
567EUCTR2012-003990-24-BE
(EUCTR)
25/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
568EUCTR2012-001565-33-GB
(EUCTR)
21/06/201316/04/2013An 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 colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
67 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesSpain;Ireland;Germany;Switzerland;United Kingdom
569EUCTR2012-003990-24-DE
(EUCTR)
20/06/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Canada;Spain;Belgium;Denmark;Austria;Australia;Germany;United Kingdom
570EUCTR2012-003532-23-DE
(EUCTR)
20/06/201305/02/2013An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 15.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 15.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
571EUCTR2012-002699-14-BE
(EUCTR)
18/06/201315/02/2013Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 17.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot RecruitingFemale: yes
Male: yes
160France;Canada;Belgium;Netherlands;Germany;Italy;United Kingdom;Switzerland
572EUCTR2012-003990-24-GB
(EUCTR)
10/06/201313/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Belgium;Spain;Denmark;Austria;Australia;Germany;United Kingdom
573EUCTR2012-003989-40-GB
(EUCTR)
10/06/201313/05/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
501 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
574EUCTR2012-003989-40-IE
(EUCTR)
07/06/201311/04/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;Italy;United Kingdom;Sweden
575EUCTR2012-001565-33-DE
(EUCTR)
05/06/201318/04/2013An 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 colistinAn open-label, crossover, interventional Phase IV study to compare the ease of use of tobramycin inhalation powder with tobramycin inhalation solution and nebulized colistimethate for the treatment of pulmonary Pseudomonas aeruginosa in patients with cystic fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 18.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.1;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
INN or Proposed INN: Colistimethate
Other descriptive name: COLISTIMETHATE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
67Phase 4Spain;Ireland;Germany;United Kingdom;Switzerland
576EUCTR2011-004208-39-GB
(EUCTR)
30/05/201311/12/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
400 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noSerbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
577EUCTR2012-003989-40-IT
(EUCTR)
22/05/201321/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
578EUCTR2012-003989-40-DE
(EUCTR)
17/05/201326/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Netherlands;Germany;United Kingdom;Italy;Sweden
579EUCTR2012-004437-16-NL
(EUCTR)
15/05/201319/03/2013Pharmacokinetic evaluation and local tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasisPharmacokinetic evaluation and tolerability of dry powder tobramycin by a novel device in patients with non cystic fibrosis bronchiectasis - Tobra-02 BronchiectasisLung infections;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: Dry powder tobramycin
Product Code: J01GB01
INN or Proposed INN: Tobramycin dry powder
Other descriptive name: TOBRAMYCIN
University Medical Center GroningenNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Netherlands
580EUCTR2011-000801-39-IE
(EUCTR)
07/05/201312/02/2013Placebo 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 fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
581EUCTR2012-003989-40-SE
(EUCTR)
07/05/201318/03/2013A study in people with Cystic Fibrosis ( a rare hereditary pulmonary disease) to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Randomized, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 12 Years and Older With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic fibrosis in patients homozygous for the F508del-CFTR Mutation
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: lumacaftor/ivacaftor 200mg/83mg tablet
INN or Proposed INN: lumacaftor
INN or Proposed INN: IVACAFTOR
Product Name: ivacaftor 125mg tablet
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
501Phase 3United States;France;Czech Republic;Canada;Ireland;Australia;Germany;Netherlands;United Kingdom;Italy;Sweden
582EUCTR2012-004491-18-IT
(EUCTR)
07/05/201321/07/2016Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs.A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 19.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BAY 85-8501
Product Code: BAY 85-8501
Other descriptive name: BAY 85-8501
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom;Italy
583NCT01764841
(ClinicalTrials.gov)
May 2, 20138/1/2013Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)Randomized, Double-blind, Placebo-controlled, Multicenter Study Comparing Ciprofloxacin DPI 32.5 mg BID (Twice a Day) Intermittently Administered for 28 Days on / 28 Days Off or 14 Days on / 14 Days Off Versus Placebo to Evaluate the Time to First Pulmonary Exacerbation and Frequency of Exacerbations in Subjects With Non-Cystic Fibrosis Bronchiectasis.BronchiectasisDrug: Ciprofloxacin DPI (BAYQ3939);Drug: PlaceboBayerNovartisCompleted18 YearsN/AAll416Phase 3United States;Argentina;Australia;Denmark;France;Germany;Israel;Italy;Japan;Latvia;New Zealand;Slovakia;Spain;United Kingdom
584NCT01710644
(ClinicalTrials.gov)
May 201317/10/2012Efficacy and Tolerability of NM-BL in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisA 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 FibrosisPancreatic Insufficiency;Cystic Fibrosis;Digestive System Diseases;Lung Diseases;Respiratory Tract DiseasesDrug: Burlulipase;Drug: Placebo (Caramel in sterile water)Nordmark Arzneimittel GmbH & Co. KGParexelCompleted12 YearsN/ABoth35Phase 1/Phase 2United States
585NCT01852448
(ClinicalTrials.gov)
May 20139/5/2013Genetics of Insulin and Incretins in Cystic FibrosisEvaluation of the Enteroinsular Axis in Cystic FibrosisCystic FibrosisGenetic: Blood or Saliva Sample Collection;Other: Glucose -potentiated arginine (GPA) stimulation testsChildren's Hospital of PhiladelphiaUniversity of PennsylvaniaActive, not recruiting2 YearsN/AAll550United States
586NCT01818544
(ClinicalTrials.gov)
April 20138/3/2013Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) BronchiectasisA Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY85-8501 in Patients With Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: BAY85-8501;Drug: PlaceboBayerNULLCompleted18 YearsN/ABoth94Phase 2France;Germany;Italy;Spain;United Kingdom
587EUCTR2011-004208-39-FR
(EUCTR)
22/03/201327/06/2013Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 16.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Spain;Israel;United Kingdom;Italy;France;United States;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
588EUCTR2011-003821-93-DE
(EUCTR)
13/03/201323/12/2011A 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 MutationA Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-661
Product Code: VX-661, VRT-893661
INN or Proposed INN: Not yet assigned
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Product Name: VX-661
Product Code: VX-661, VRT-893661
INN or Proposed INN: Not yet assigned
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
220Phase 2United States;Canada;Germany;United Kingdom
589EUCTR2011-004208-39-DK
(EUCTR)
12/03/201317/12/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 17.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
400Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Denmark;Australia;Latvia;Germany;New Zealand;Japan
590EUCTR2012-004491-18-ES
(EUCTR)
19/02/201321/12/2012Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs.A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BAY 85-8501
Product Code: BAY 85-8501
INN or Proposed INN: -
Other descriptive name: BAY 85-8501
Bayer HealthCare AGNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
90Phase 2Spain;United Kingdom
591NCT01775137
(ClinicalTrials.gov)
February 201322/1/2013Ext. Long-term Safety Study in CF Patients: Single Arm TIPA 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 TIPDrug: TBM100Novartis PharmaceuticalsNULLCompleted6 YearsN/AAll45Phase 4United States;Argentina;Australia;Canada;Germany;Hungary;Italy;Mexico;Spain
592NCT01707290
(ClinicalTrials.gov)
February 20139/10/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR MutationA 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 MutationCystic FibrosisDrug: IvacaftorVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 YearsN/AAll125Phase 3United States;Belgium;France;United Kingdom;Ireland
593EUCTR2012-004491-18-GB
(EUCTR)
30/01/201318/12/2012Safety and Efficacy of Oral BAY 85-8501 in Patients with inflammation of the tubes in the lungs.A Phase IIa, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety and Efficacy of 28 Day Oral Administration of BAY 85-8501 in Patients with non-Cystic Fibrosis Bronchiectasis Non-Cystic Fibrosis Bronchiectasis
MedDRA version: 15.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: BAY 85-8501
Product Code: BAY 85-8501
INN or Proposed INN: N/A
Other descriptive name: BAY 85-8501
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Italy;United Kingdom
594EUCTR2011-004208-39-ES
(EUCTR)
29/01/201326/11/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non-CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
595EUCTR2012-003532-23-ES
(EUCTR)
29/01/201329/11/2012An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Farmaceutica, S.A.NULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
596EUCTR2012-002699-14-GB
(EUCTR)
28/01/201303/07/2012Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Canada;Argentina;Belgium;Netherlands;Italy;United Kingdom
597EUCTR2011-004208-39-DE
(EUCTR)
21/01/201323/10/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 18.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Other descriptive name: CIPROFLOXACIN
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
400Phase 3Serbia;United States;Slovakia;Spain;Israel;United Kingdom;Italy;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
598EUCTR2012-003532-23-IT
(EUCTR)
18/01/201321/12/2012An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10057582;Term: Lung infection pseudomonal;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;Level: HLT;Classification code 10037132;Term: Pseudomonal infections;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI PODHALER*448CPS 28MG+10IN
INN or Proposed INN: Tobramycin
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
120Phase 4United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
599EUCTR2011-004208-39-IT
(EUCTR)
11/01/201311/12/2012Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis (non–CF BE)Randomized, double-blind, placebo-controlled, multicEnter Study comParing CIprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to fiRst pulmonary exacErbation and frequency of exacerbations in subjects with non–cystic fibrosis bronchiectasis. - RESPIRE 1 bronchiectasis
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]
Product Name: Ciprofloxacin DPI
Product Code: BAYq3939
INN or Proposed INN: CIPROFLOXACIN
BAYER HEALTHCARE AGNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Spain;Israel;Italy;United Kingdom;France;Argentina;Brazil;Australia;Denmark;Latvia;Germany;New Zealand;Japan
600EUCTR2012-003532-23-HU
(EUCTR)
19/12/201231/10/2012An extension of a clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA 48 week extension to CTBM100C2401, a single arm open-label, multicenter, phase IV trial, to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Chronic lung infection with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TOBI Podhaler
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
120Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Spain;Australia;Germany;Italy
601EUCTR2011-000443-24-DK
(EUCTR)
14/12/201222/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
602EUCTR2009-012842-21-BE
(EUCTR)
19/11/201214/05/2012Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREASLIPASE
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Phase 3Hungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
603NCT01684683
(ClinicalTrials.gov)
November 201211/9/2012The Effect of Theophylline in the Treatment of BronchiectasisClinical Efficacy and Safety of Theophylline in the Treatment of Non-Cystic Fibrosis(NCF) BronchiectasisBronchiectasisDrug: Theophylline;Drug: Placebo(for Theophylline)The First Affiliated Hospital of Guangzhou Medical UniversityNULLCompleted18 Years70 YearsBoth100Phase 4China
604NCT01721382
(ClinicalTrials.gov)
November 201226/10/2012Treatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic FibrosisTreatment of Dysglycemia Using Sitagliptin in Adolescents With Cystic Fibrosis.Cystic FibrosisDrug: SitagliptinNemours Children's ClinicNULLCompleted13 Years20 YearsBoth6Phase 1United States
605EUCTR2012-003140-68-GB
(EUCTR)
29/10/201228/09/2012A Study to Look at the Way the Body Absorbs and Distributes Posaconazole in the Blood and Lungs of Lung Transplant Recipients (PAPAL Study)A Pharmacokinetic Analysis of Posaconazole in the Plasma and Alveolar Compartment of Lung Transplant Recipients - Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients Invasive fungal infection (IFI) in lung transplant patients with and without cystic fibrosis.
MedDRA version: 15.0;Level: PT;Classification code 10049085;Term: Antifungal prophylaxis;System Organ Class: 10042613 - Surgical and medical procedures;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Noxafil
Product Name: Noxafil
INN or Proposed INN: Posaconazole
MSDNULLNot RecruitingFemale: yes
Male: yes
40United Kingdom
606EUCTR2012-000389-39-GB
(EUCTR)
25/10/201220/04/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-Term Ivacaftor Treatment in Subjects 6 Years of Age and Older with Cystic Fibrosis and a Non-G551D CFTR Mutation cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Belgium;United Kingdom
607NCT01586728
(ClinicalTrials.gov)
October 201218/1/2012Oxygen Therapy in Cystic FibrosisIndication and Benefits of Nocturnal Oxygen Therapy in Cystic FibrosisCystic FibrosisOther: Air - oxygen;Other: Oxygen - AirAssistance Publique - Hôpitaux de ParisVaincre la MucoviscidoseTerminated6 YearsN/ABoth8N/AFrance
608ChiCTR-TRC-12002470
2012-09-152012-08-02The effect of theophylline in the treatment of bronchiectasis, a random, double blind studyThe effect of theophylline in the treatment of bronchiectasis, a random, double blind study. bronchiectasis not due to cystic fibrosis1:theophylline;2:theophylline;The first affiliated hospital of Guangzhou Medical UniversityNULLCompleted1565Both1:46;2:46;China
609EUCTR2011-000441-20-NL
(EUCTR)
11/09/201206/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany;United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom
610EUCTR2012-000389-39-BE
(EUCTR)
03/09/201226/04/2012Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non-G551D CFTR MutationA Phase 3, Two-Arm, Rollover Study to Evaluate the Safety of Long-TermIvacaftor Treatment in Subjects 6 Years of Age and Older with CysticFibrosis and a Non-G551D CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
120Phase 3France;United States;Belgium;United Kingdom
611NCT01667094
(ClinicalTrials.gov)
September 201213/8/2012A Study Comparing Continuous Infusion Antibiotics to Standard Treatment for Lung Infections in Cystic FibrosisContinuous-infusion Anti-pseudomonal ß-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic FibrosisCystic FibrosisDrug: 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 tazobactamThe AlfredNULLActive, not recruiting18 YearsN/AAll50Phase 4Australia
612NCT02190604
(ClinicalTrials.gov)
July 31, 201211/7/2014Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis PatientsA 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 PatientsCystic FibrosisDrug: Placebo;Drug: QBW251Novartis PharmaceuticalsNULLTerminated18 Years65 YearsAll153Phase 1/Phase 2United States;Belgium;France;Germany;Ireland;Romania;United Kingdom;Netherlands
613NCT01652157
(ClinicalTrials.gov)
July 31, 201225/7/2012Long-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 ColonopathyBiological: ULTRESA;Biological: PANCREAZE;Biological: CREON;Biological: ZENPEP;Biological: other non-sponsor pancreatic enzyme replacement therapy;Biological: PERTZYE;Other: No pancreatic enzyme replacement therapyAbbVieCystic Fibrosis Foundation;Digestive Care, Inc.;Nestle Health Science;VIVUS, Inc.TerminatedN/A99 YearsAll17United States
614EUCTR2012-000388-26-BE
(EUCTR)
23/07/201220/04/2012Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating MutationA Phase 3, Two-Part, Randomized, Double-Blind, Placebo-Controlled, Crossover Study With an Open-Label Period to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis Who Have a Non-G551D CFTR Gating Mutation Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 3France;United States;Belgium
615EUCTR2011-005085-37-GB
(EUCTR)
20/07/201224/05/2012Safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of QBW251 in healthy subjects and cystic fibrosis patients.A randomized, double blind placebo-controlled study to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics of single and multiple ascending doses of QBW251 in healthy subjects and multiple doses in cystic fibrosis patients. cystic fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: QBW251
INN or Proposed INN: Not assigned
Product Code: QBW251
INN or Proposed INN: Not assigned
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
156Phase 1;Phase 2United States;France;Belgium;Ireland;Romania;Netherlands;Germany;United Kingdom
616NCT01614470
(ClinicalTrials.gov)
July 20125/6/2012Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating MutationA 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 MutationCystic FibrosisDrug: Ivacaftor;Drug: PlaceboVertex Pharmaceuticals IncorporatedCystic Fibrosis Foundation TherapeuticsCompleted6 YearsN/AAll39Phase 3United States;Belgium;France
617EUCTR2011-001255-36-AT
(EUCTR)
25/06/201218/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
618EUCTR2011-000801-39-IT
(EUCTR)
20/06/201221/06/2012Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY Prospective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT -PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially effects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbility and mortality. PA infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
MUKOVISZIDOSE E.V.NULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
619EUCTR2011-000441-20-BG
(EUCTR)
13/06/201203/05/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
620EUCTR2012-000387-19-GB
(EUCTR)
11/06/201220/04/2012Study of Ivacaftor in Subjects With Cystic Fibrosis Who Have the R117H-CFTR MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ivacaftor in Subjects With Cystic Fibrosis who Have the R117H-CFTR Mutation cystic fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
80Phase 3United States;United Kingdom
621EUCTR2011-000443-24-SE
(EUCTR)
24/05/201207/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
622EUCTR2011-001916-69-NL
(EUCTR)
22/05/201207/02/2012treatment with insulin in patients with cystic fibrosis without diabetesinsulin 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 cartridgeHagaZiekenhuis, pulmonary departmentNULLNot RecruitingFemale: yes
Male: yes
40Netherlands
623EUCTR2011-000441-20-IE
(EUCTR)
02/05/201226/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Code: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
624EUCTR2011-003821-93-GB
(EUCTR)
01/05/201219/04/2012A 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 MutationA Phase 2, Multicenter, Double Blinded, Placebo Controlled Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-661 Monotherapy and VX-661/Ivacaftor Cotherapy in Subjects with Cystic Fibrosis, Homozygous or Heterozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]Product Name: VX-661
Product Code: VX-661, VRT-893661
INN or Proposed INN: Not yet assigned
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Product Name: VX-661
Product Code: VX-661, VRT-893661
INN or Proposed INN: Not yet assigned
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
220 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Germany;United Kingdom
625EUCTR2011-000801-39-BE
(EUCTR)
26/04/201209/01/2012Placebo 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 fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 16.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
626EUCTR2011-000443-24-IT
(EUCTR)
10/04/201219/03/2012Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
250Greece;Spain;Ireland;Austria;Italy;United Kingdom;Hungary;Canada;Belgium;Denmark;Australia;Bulgaria;Germany;Netherlands;New Zealand;Sweden
627EUCTR2011-000441-20-DK
(EUCTR)
29/03/201222/07/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
628EUCTR2011-001362-18-DE
(EUCTR)
19/03/201220/12/2011Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa
MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Spain;Poland;Germany;Italy
629EUCTR2011-001255-36-NL
(EUCTR)
13/03/201219/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;France;Spain;Poland;Belgium;Ireland;Austria;Germany;Netherlands;Italy
630EUCTR2011-004761-33-GB
(EUCTR)
08/03/201214/12/2011Repeated application of gene therapy in patients with cystic fibrosisA randomised double-blind placebo-controlled Phase 2B clinical trial of repeated application of gene therapy in patients with cystic fibrosis - Repeated application of gene therapy in patients with CF v01-010204 Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: pGM169/GL67A
Other descriptive name: pGM169/GL67A
Imperial CollegeNULLNot Recruiting Female: yes
Male: yes
130 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
631EUCTR2011-002000-32-IT
(EUCTR)
09/02/201206/03/2012A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial to assess long term safety of tobramycin inhalation powder (TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Tobramycin inhalation powder
Product Code: TBM100C
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;Hungary;Mexico;Canada;Argentina;Spain;Brazil;Australia;Germany;Italy
632EUCTR2011-000801-39-SE
(EUCTR)
08/02/201213/12/2011Placebo 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 fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 14.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
633EUCTR2011-001362-18-IT
(EUCTR)
08/02/201222/02/2012Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) Open-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways. - PALS (Pediatric Aztreonam Lysine Safety) Cystic fibrosis and chronic infection of lower respiratory tract with Pseudomonas aeruginosa.
MedDRA version: 14.1;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: CAYSTON aztreonam 75 mg powder and solvent for nebuliser solution
INN or Proposed INN: AZTREONAM
Other descriptive name: NA
GILEAD SCIENCES INC.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3France;United States;Spain;Germany;Italy
634EUCTR2011-001255-36-BE
(EUCTR)
07/02/201213/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2France;United States;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy
635EUCTR2011-001255-36-IE
(EUCTR)
06/02/201224/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2France;United States;Belgium;Spain;Poland;Ireland;Austria;Netherlands;Germany;Italy
636EUCTR2011-000443-24-BE
(EUCTR)
30/01/201225/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
637EUCTR2011-000441-20-BE
(EUCTR)
30/01/201225/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: N/A
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
Product Code: N/A
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Netherlands;Germany
638EUCTR2011-001255-36-IT
(EUCTR)
27/01/201228/09/2012Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy of Aztreonam 75 mg Powder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Pediatric Patients with Cystic Fibrosis (CF) and New Onset Lower Respiratory Tract Culture Positive for Pseudomonas aeruginosa (PA) Aztreonam Lysine for Pseudomonas Infection Eradication (ALPINE)study - ALPINE Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 15.0;Level: PT;Classification code 10056971;Term: Infective exacerbation of chronic obstructive airways disease;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 15.0;Level: SOC;Classification code 10021881;Term: Infections and infestations;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston Aztreonam 75 mg powder and solvent for nebuliser solution
INN or Proposed INN: AZTREONAM
GILEAD SCIENCES INC.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;Spain;Ireland;Austria;Netherlands;Germany;Italy
639EUCTR2011-001362-18-ES
(EUCTR)
25/01/201221/12/2011Study of the Safety of Aztreonam for Inhalation in Children with Cystic Fibrosis and Chronic Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 3 Trial to Evaluate the Safety of Aztreonam 75 mgPowder and Solvent for Nebuliser Solution/Aztreonam for Inhalation Solution (AZLI) in Children with Cystic Fibrosis (CF) and Chronic Pseudomonas aeruginosa (PA) in the Lower Airways - PALS (Pediatric Aztreonam Lysine Safety) Cystic fibrosis and chronic infection of lower respiratory tract withPseudomonas aeruginosa
MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam solución para inhalación
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 3United States;France;Poland;Spain;Germany;Italy
640EUCTR2011-000443-24-PL
(EUCTR)
20/01/201206/10/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
641EUCTR2011-001255-36-DE
(EUCTR)
16/01/201211/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 14.1;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
105Phase 2United States;France;Spain;Poland;Belgium;Ireland;Austria;Netherlands;Germany;Italy
642NCT01731015
(ClinicalTrials.gov)
January 201216/11/2012Imaging Lung Function Using Oxygen Enhanced MRIA 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 AgentCOPD;Asthma;Cystic Fibrosis;Emphysema;Small Airways DiseaseDrug: Medical Grade OxygenHal C CharlesNULLCompleted18 Years90 YearsBoth15Phase 1United States
643NCT01519661
(ClinicalTrials.gov)
January 201224/1/2012Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic FibrosisA Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic FibrosisPulmonary Infections;Pseudomonas Aeruginosa in Cystic FibrosisDrug: TBM100Novartis PharmaceuticalsNULLCompleted6 YearsN/AAll157Phase 4United States;Argentina;Australia;Canada;France;Germany;Hungary;Italy;Mexico;Spain;Brazil
644NCT01509339
(ClinicalTrials.gov)
January 20129/1/2012Pharmacokinetics of Vancomycin for Inhalation in Cystic FibrosisPharmacokinetics of Vancomycin for Inhalation in Cystic FibrosisCystic Fibrosis;Methicillin-resistant Staphylococcus AureusDrug: VancomycinCase Western Reserve UniversityCystic Fibrosis Foundation TherapeuticsActive, not recruiting18 YearsN/ABoth10Phase 1United States
645EUCTR2011-002719-27-IT
(EUCTR)
30/12/201113/03/2012EFFECT OF RECOMBINANT HUMAN INSULIN-LIKE GROWTH FACTOR-I ON GLUCOSE TOLERANCE AND AS PREVENTION TOWARDS THE DEVELOPMENT OF CYSTIC FIBROSIS RELATED DIABETES MELLITUSGLUCOSE METABOLISM AND INFLAMMATORY PARAMETERS UNDER IGF-I TREATMENT IN CYSTIC FIBROSIS - RH-IGF-I IN CYSTIC FIBROSIS PATIENTS WITH CYSTIC FIBROSIS
MedDRA version: 14.1;Level: PT;Classification code 10011766;Term: Cystic fibrosis pancreatic;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Hormonal diseases [C19]
Trade Name: INCRELEX*SC 1FL 4ML 10MG/ML
INN or Proposed INN: MECASERMIN
AZIENDA OSPEDALIERA DI PARMANULLNot RecruitingFemale: yes
Male: yes
20Italy
646EUCTR2011-002000-32-DE
(EUCTR)
13/12/201131/10/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation
Product Name: TOBI Podhaler 28 mg Hartkapseln mit Pulver zur Inhalation
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
647EUCTR2011-002000-32-HU
(EUCTR)
25/11/201105/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler 28 mg inhalációs por, kemény kapszula
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
150Phase 4France;United States;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
648EUCTR2011-001255-36-ES
(EUCTR)
23/11/201118/10/2011Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaOpen-Label Phase 2 Trial to Evaluate the Safety and Efficacy ofAztreonam 75 mg Powder and Solvent for NebuliserSolution/Aztreonam for Inhalation Solution (AZLI) in PediatricPatients with Cystic Fibrosis (CF) and New Onset Lower RespiratoryTract Culture Positive for Pseudomonas aeruginosa (PA) - ALPINE (Aztreonam Lysine for Pseudomonas Infection Eradication) Cystic fibrosis and new onset lower respiratory tract culture positive for P.aeruginosa.
MedDRA version: 14.0;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 10021881 - Infections and infestations
MedDRA version: 14.0;Level: PT;Classification code 10070608;Term: Infective pulmonary exacerbation of cystic fibrosis;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Name: Aztreonam for Inhalation Solution
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Other descriptive name: N/A
Gilead Sciences, Inc.NULLNot RecruitingFemale: yes
Male: yes
80Phase 2United States;France;Poland;Belgium;Spain;Ireland;Austria;Netherlands;Germany;Italy
649EUCTR2011-002000-32-ES
(EUCTR)
17/11/201128/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis - not available Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI PODHALER
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Farmaceutica S. ANULLNot RecruitingFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
650NCT00889434
(ClinicalTrials.gov)
November 1, 201120/4/2009Efficacy 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 CFCystic FibrosisDietary Supplement: ECGC;Dietary Supplement: Tocotrienol;Dietary Supplement: EGCG + TocotrienolHadassah Medical OrganizationNULLCompleted18 YearsN/AAll7N/AIsrael
651NCT01537666
(ClinicalTrials.gov)
November 201117/2/2012Inhaled Vancomycin Tolerability, Safety and PharmacokineticsPhase I, Reference-controlled, Dose Escalating Study to Examine the Pharmacokinetics and Safety of AeroVanc Inhalation Powder.Healthy;Cystic FibrosisDrug: AeroVanc;Drug: IV vancomycin hydrochlorideSavara Inc.INC Research LimitedCompleted18 Years50 YearsAll25Phase 1Australia
652NCT02276898
(ClinicalTrials.gov)
November 201122/10/2014A Randomized-Controlled Trial of Inhaled Hypertonic Saline (7%) to Evaluate the Lung Clearance IndexA 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 FibrosisDrug: Hypertonic Saline 7%;Drug: Isotonic Saline 0.9% (Placebo)The Hospital for Sick ChildrenNULLCompleted6 Years18 YearsBoth24Phase 2Canada
653EUCTR2011-001821-26-IT
(EUCTR)
18/10/201120/03/2012Aerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosisAerosol Tobramycin 300 mg single dose in adult patient with cystic fibrosis: pilot study of antimicrobial activity Adult patient with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: BRAMITOB*NEBUL 28F 300MG/4ML
INN or Proposed INN: TOBRAMYCIN
FONDAZIONE IRCCS CA' GRANDA OSPEDALE MAGGIORE POLICLINICO DI MILANONULLNot RecruitingFemale: yes
Male: yes
Italy
654EUCTR2011-000443-24-DE
(EUCTR)
11/10/201130/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
655EUCTR2011-000442-38-BG
(EUCTR)
03/10/201105/07/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
656EUCTR2011-000443-24-BG
(EUCTR)
03/10/201128/07/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
657EUCTR2011-000441-20-IT
(EUCTR)
01/10/201108/03/2012Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection/colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: Tobi
INN or Proposed INN: TOBRAMYCIN
INSMED INCORPORATEDNULLNot RecruitingFemale: yes
Male: yes
300Hungary;Greece;Canada;Spain;Ireland;Denmark;Austria;Bulgaria;Netherlands;United Kingdom;Italy
658NCT01002534
(ClinicalTrials.gov)
October 201126/10/2009Does 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 FibrosisDrug: Vardenafil;Drug: PlaceboCliniques universitaires Saint-Luc- Université Catholique de LouvainNULLTerminated14 YearsN/AAll5Phase 2Belgium
659EUCTR2011-000443-24-ES
(EUCTR)
22/09/201103/11/2011Estudio de seguridad y tolerabilidad a largo plazo de la administración abierta Arikace en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosaEstudio de seguridad y tolerabilidad a largo plazo de la administración abierta de amicacina liposomal para inhalación (Arikace) en pacientes con fibrosis quística con infección crónica por Pseudomonas aeruginosa - NCT0131627 Infeccion pulmonar por Pseudomonas Aeruginosa/ colonizacion en pacientes con fibrosis quistica
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace TM)
INN or Proposed INN: Sulfato de amikacina
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Serbia;United States;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
660EUCTR2011-000442-38-ES
(EUCTR)
21/09/201111/11/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaESTUDIO ALEATORIZADO, CONTROLADO CON PLACEBO, DOBLE CIEGO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE™ EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Poland;Spain;Ukraine;Australia;Bulgaria;Sweden;New Zealand
661EUCTR2011-000441-20-ES
(EUCTR)
21/09/201111/11/2011ESTUDIO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSAESTUDIO ALEATORIZADO, ABIERTO, CONTROLADO CON MEDICAMENTO ACTIVO Y MULTICÉNTRICO PARA EVALUAR LA EFICACIA, SEGURIDAD Y TOLERABILIDAD DE ARIKACE EN PACIENTES CON FIBROSIS QUÍSTICA CON INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA - TR02-108 Infección pulmonar con Pseudomonas aeruginosa/ colonización en pacientes con fibrosis quística
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Amikacina liposomal (Arikace?)
INN or Proposed INN: Sulfato de amikacina
Trade Name: TOBI 300mg/ 5ml solución para inhalación con nebulizador
INN or Proposed INN: tobramicina
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Australia;Denmark;Bulgaria;Germany;Netherlands
662EUCTR2011-000441-20-DE
(EUCTR)
19/09/201130/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
Product Name: TOBI
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
663EUCTR2010-019692-30-ES
(EUCTR)
07/09/201129/07/2011Extension study of ataluren in patients with Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Belgium;Spain;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden
664EUCTR2011-000801-39-DE
(EUCTR)
31/08/201104/04/2011Placebo 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 fibrosisProspective randomized, placebo-controlled, double blind, multicenter study (phase III) to evaluate clinical efficacy and safety of avian polyclonal anti-Pseudomonas antibodies (IgY) in prevention of recurrence of Pseudomonas aeruginosa infection in cystic fibrosis patients - IMPACTT-PsAer-IgY Cystic fibrosis (CF) is a chronic and progressive genetic disease of the body's exocrine glands. CF especially affects the respiratory system. A common effect leads to massive production of abnormal mucus of high viscosity, which clogs the airways and leads to infections. Pulmonary infections are major causes of morbidity and mortality. Pseudomonas aeruginosa (PA) infections are most common in CF patients and chronic infection with PA ultimately occurs in virtually all patients.
MedDRA version: 17.1;Level: LLT;Classification code 10011764;Term: Cystic fibrosis NOS;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: avian polyclonal IgY antibody against PA
Product Code: PsAer IgY
INN or Proposed INN: IgY
Mukoviszidose Institute gGmbHNULLNot RecruitingFemale: yes
Male: yes
180Phase 3Hungary;Spain;Belgium;Ireland;Austria;Germany;Italy;Sweden
665EUCTR2010-019692-30-GB
(EUCTR)
22/08/201123/08/2011Extension study of ataluren in patients with Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, IncNULLNot Recruiting Female: yes
Male: yes
200 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom;Sweden
666EUCTR2010-019634-26-GB
(EUCTR)
18/08/201107/02/2011Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) PatientsA Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: Aeroquin
Product Code: MP-376
INN or Proposed INN: levofloxacin
Other descriptive name: levofloxacin hemihydrate
Trade Name: Tobi 300 mg/5 ml Nebuliser Solution
INN or Proposed INN: TOBRAMYCIN
Mpex Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
330 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Ireland;Israel;Germany;United Kingdom
667EUCTR2011-000443-24-GR
(EUCTR)
09/08/201123/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
668EUCTR2011-000443-24-IE
(EUCTR)
05/08/201126/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
669EUCTR2011-000443-24-GB
(EUCTR)
03/08/201124/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
670EUCTR2011-000441-20-GB
(EUCTR)
03/08/201124/05/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
671EUCTR2011-000443-24-FR
(EUCTR)
28/07/201131/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
Product Code: NA
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;Serbia;Slovakia;Greece;Spain;Ukraine;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Macedonia, the former Yugoslav Republic of;Belgium;Poland;Denmark;Australia;Bulgaria;Netherlands;Germany;New Zealand;Sweden
672EUCTR2005-003772-37-IE
(EUCTR)
26/07/201108/07/2008A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder (TIP)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Trade Name: TOBI
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom
673EUCTR2011-000443-24-AT
(EUCTR)
22/07/201127/06/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 18.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Germany;Netherlands;New Zealand;Sweden
674EUCTR2011-000441-20-AT
(EUCTR)
19/07/201121/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
675EUCTR2011-000441-20-GR
(EUCTR)
15/07/201122/06/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300United States;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
676EUCTR2011-000192-13-PL
(EUCTR)
08/07/201131/05/2011A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosisA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
28Poland;Ukraine;Germany;United Kingdom
677EUCTR2011-000441-20-SK
(EUCTR)
04/07/201125/11/2014Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 17.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Denmark;Bulgaria;Netherlands;Germany
678EUCTR2011-000443-24-SK
(EUCTR)
04/07/201120/02/2014Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3Germany;New Zealand;Sweden;United States;Serbia;Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Macedonia, the former Yugoslav Republic of;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands
679EUCTR2009-016590-15-IT
(EUCTR)
01/07/201114/03/2012Evaluation of the efficacy and safety of tobramycin for the treatment of early infections of P. aeruginosa in cystic fibrosis subjects aged from 3 months to less than 7 years.A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients.
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML
INN or Proposed INN: TOBRAMYCIN
Other descriptive name: NA
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
72France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Switzerland;Italy
680EUCTR2011-000441-20-HU
(EUCTR)
29/06/201120/04/2011Efficacy, safety and tolerability of Arikace™ compared to TOBI in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosaRandomized, open-label, active-controlled, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patients with cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Trade Name: TOBI 300mg/5ml Nebuliser solution
INN or Proposed INN: TOBRAMYCIN
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Slovakia;Greece;Spain;Ireland;Austria;United Kingdom;Italy;France;Hungary;Canada;Belgium;Poland;Denmark;Bulgaria;Germany;Netherlands
681EUCTR2011-000443-24-HU
(EUCTR)
29/06/201111/05/2011Long Term Safety and Tolerability Study of Arikace™ in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosaLong Term Safety and Tolerability Study of Open-Label Liposomal Amikacin for Inhalation (Arikace™) in Cystic Fibrosis Patients with Chronic Infection due to Pseudomonas aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250United States;Slovakia;Greece;Spain;Ireland;Austria;Italy;United Kingdom;France;Hungary;Canada;Poland;Belgium;Australia;Denmark;Bulgaria;Netherlands;Germany;New Zealand;Sweden
682NCT02782312
(ClinicalTrials.gov)
June 201117/5/2016Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis BronchiectasisSalmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis With Airway Limitation: a Prospective StudyBronchiectasisDrug: ICS+LABA;Other: routine therapyShanghai Pulmonary Hospital, Shanghai, ChinaNULLCompleted18 YearsN/ABoth120Phase 4China
683EUCTR2010-019634-26-DE
(EUCTR)
24/05/201125/01/2011Trial of Aeroquin Versus Tobramycin Inhalation Solution (TIS) in Cystic Fibrosis (CF) PatientsA Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy of MP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution (TIS) in Stable Cystic Fibrosis Patients Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: Aeroquin
Product Code: MP-376
INN or Proposed INN: levofloxacin
Other descriptive name: levofloxacin hemihydrate
Trade Name: TOBI 300 mg/5 ml Lösung für einen
INN or Proposed INN: TOBRAMYCIN
Mpex Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3France;United States;Canada;Ireland;Israel;Germany;United Kingdom
684EUCTR2010-019692-30-DE
(EUCTR)
11/05/201113/04/2011Extension study of ataluren in patients with Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Spain;Belgium;Israel;Netherlands;Germany;United Kingdom;Italy;Sweden
685EUCTR2011-000192-13-DE
(EUCTR)
05/05/201105/04/2011A study to investigate the drug levels of colistimethate sodium after inhalation of Colobreathe® in subjects with cystic fibrosisA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study systemic exposure of colobreathe in cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
40Poland;Ukraine;Germany;United Kingdom
686EUCTR2010-019634-26-IE
(EUCTR)
03/05/201115/02/2011Trial of Aeroquin versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis PatientsA Phase 3, Open-Label, Randomized Trial to Evaluate the Safety and Efficacy ofMP-376 Inhalation Solution (Aeroquin™) versus Tobramycin Inhalation Solution(TIS) in Stable Cystic Fibrosis Patients Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Product Name: Aeroquin
Product Code: MP-376
INN or Proposed INN: levofloxacin
Other descriptive name: levofloxacin hemihydrate
Trade Name: TOBI
INN or Proposed INN: TOBRAMYCIN
Mpex Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
330Phase 3France;United States;Canada;Ireland;Israel;Germany;United Kingdom
687NCT01207245
(ClinicalTrials.gov)
May 201121/9/2010Circadian Rhythm In Tobramycin Elimination In Cystic FibrosisCircadian Rhythm In Tobramycin Elimination In Cystic Fibrosis (CRITIC) A Randomized Pharmacokinetic Comparison of Tobramycin in Cystic FibrosisCystic FibrosisOther: Tobramycin time of administrationUniversity of NottinghamNULLCompleted5 YearsN/ABoth18Phase 4United Kingdom
688NCT02295566
(ClinicalTrials.gov)
May 201120/8/2014RATNO, Reducing Antibiotic Tolerance Using Nitric Oxide in CF - a Phase 2 Pilot StudyRATNO (Reducing Antibiotic Tolerance Using NO) Reducing Antibiotic Tolerance Using Low Dose Nitric Oxide in Cystic Fibrosis - a Phase 2 Pilot StudyCystic FibrosisDrug: Nitric Oxide;Drug: ControlUniversity Hospital Southampton NHS Foundation Trust.University of SouthamptonCompleted12 YearsN/ABoth12Phase 2United Kingdom
689EUCTR2011-000192-13-GB
(EUCTR)
28/04/201117/03/2011A 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) studyA 7-day open-label pharmacokinetic study to investigate the systemic absorption of colistimethate sodium after inhalation of dry powder colistimethate sodium for inhalation (Colobreathe® 125mg) in adult, adolescent and paediatric cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa. - Colistin Systemic Exposure (COSY) study cystic fibrosis subjects with chronic pulmonary infection with Pseudomonas aeruginosa
MedDRA version: 13.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 13.1;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: Colobreathe
Product Code: N/A
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colistimethate sodium (BAN, USAN), Colistimethatum natricum, Colistin sodium methanesulfonate
Forest Laboratories UK Ltd.NULLNot RecruitingFemale: yes
Male: yes
28Germany;United Kingdom;Poland
690EUCTR2010-023090-19-IE
(EUCTR)
08/04/201115/02/2011A 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 aeruginosaA double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: OligoG (60 mg/ml)
Product Code: OligoG
INN or Proposed INN: Sodium alginate
Other descriptive name: SODIUM ALGINATE
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Ireland;United Kingdom
691NCT01349192
(ClinicalTrials.gov)
April 20114/5/2011Early 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 AureusDrug: Rifampin;Drug: Trimethoprim/Sulfamethoxazole;Drug: Minocycline;Drug: Mupirocin;Drug: chlorhexidine gluconate oral rinse;Drug: 2% Chlorhexidine solution wipes;Behavioral: Environmental DecontaminationUniversity of North Carolina, Chapel HillCF 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 HospitalTerminated4 Years45 YearsAll47Phase 2United States
692NCT01314716
(ClinicalTrials.gov)
April 201111/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA 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)BronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll274Phase 3United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;United Kingdom
693NCT01313624
(ClinicalTrials.gov)
April 201110/3/2011Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis BronchiectasisA 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 InfectionBronchiectasisDrug: AZLI;Drug: PlaceboGilead SciencesNULLCompleted18 YearsN/AAll266Phase 3United States;Australia;Canada
694EUCTR2010-023090-19-GB
(EUCTR)
29/03/201111/02/2011A 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 aeruginosaA double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosa - A phase II cross-over study of OligoG in subjects with cystic fibrosis Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: OligoG (60 mg/ml)
Product Code: OligoG
INN or Proposed INN: OligoG
Other descriptive name: OligoG-CF5/20, Alginate oligosaccharide (G-block) fragment
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Ireland;United Kingdom
695EUCTR2009-012842-21-BG
(EUCTR)
24/02/201128/09/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86France;Hungary;Belgium;Spain;Poland;Ireland;Romania;Bulgaria;Germany;United Kingdom;Italy
696EUCTR2010-023529-39-GB
(EUCTR)
18/02/201131/12/2010Reducing 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 1.0Reducing 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 FibrosisTrade Name: INOmax 400ppm mol/mol inhalation gas
Product Name: Nitric Oxide
Product Code: NO
Southampton University Hopsitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
Phase 2United Kingdom
697EUCTR2010-020413-90-BE
(EUCTR)
08/02/201115/10/2010Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 16.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
293Phase 2United States;Belgium;Ireland;Australia;Germany;United Kingdom;New Zealand
698EUCTR2009-012842-21-DE
(EUCTR)
13/01/201113/07/2010Treatment of Exocrine Pancreatic Insufficiency in Subjects with Cystic FibrosisRandomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover,Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Aptalis Pharma US Inc.NULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;Italy;United Kingdom
699EUCTR2010-020413-90-DE
(EUCTR)
06/01/201115/10/2010Study of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Cystic Fibrosis (CF) Patients Homozygous or Heterozygous for the F508del-CFTR MutationA Phase 2, Multicenter, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of Lumacaftor Monotherapy, and Lumacaftor and Ivacaftor Combination Therapy in Subjects With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 17.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-809
Product Code: VX-809, VRT-826809
INN or Proposed INN: lumacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Product Name: Lumacaftor/Ivacaftor
Product Code: VX-809/VX-770
INN or Proposed INN: Lumacaftor
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
293Phase 2New Zealand;United Kingdom;Germany;Australia;Belgium;United States
700NCT02163681
(ClinicalTrials.gov)
January 1, 201110/6/2014MRI as a Means to Measure Lung Function: Non-Invasive Imaging in Neonates and ChildrenHealthy;Cystic Fibrosis (CF);Asthma;Bronchopulmonary Dysplasia (BPD)Drug: Hyperpolarized Helium-3 MRI of the chestUniversity of VirginiaXemed LLCCompleted4 Months65 YearsAll77N/AUnited States
701NCT01494909
(ClinicalTrials.gov)
January 201115/12/2011Development Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and FunctionDevelopment Of An Innovative Panel of Methods To Measure Intestinal Macronutrient Digestion, Absorption, and FunctionCystic FibrosisDietary Supplement: Ensure plusTexas A&M UniversityArkansas Children's Hospital Research Institute;University of ArkansasActive, not recruiting10 YearsN/AAll31N/AUnited States
702EUCTR2010-023030-23-GB
(EUCTR)
24/12/201023/11/2010Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis (CRITIC) - a Randomised Pharmacokinetic Comparison of Tobramycin in CF - Circadian Rhythm In Tobramycin Elimination in Cystic Fibrosis CRITIC-1 Cystic fibrosisTrade Name: Nebcin (tobramycin)
Product Name: Tobramycin injection 40mg/1ml
INN or Proposed INN: Tobramcyin
The Univeristy of NottinghamNULLNot Recruiting Female: yes
Male: yes
20 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
703EUCTR2010-022042-24-GB
(EUCTR)
24/12/201025/10/2010A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with PseudomonasA Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in patients with Pseudomonas Aeruginosa - RCT of Atorvastatin in Bronchiectasis in patients with Pseudomonas The aim of this randomized double blind controlled study is to evaluate the efficacy of a 3 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis.
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Lipitor
Product Name: Atorvastatin
INN or Proposed INN: Atorvastatin
Other descriptive name: Lipitor
NHS LothianUniversity of EdinburghNot RecruitingFemale: yes
Male: yes
32Phase 4United Kingdom
704EUCTR2010-022040-20-GB
(EUCTR)
17/12/201021/10/2010A Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in BronchiectasisA Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis - Randomised Controlled Trial of Atorvastatin in Bronchiectasis The aim of this randomised double blind controlled study to evaluate the efficacy of 6 months treatment with atorvastatin versus placebo in patients with clinically significant bronchiectasis
MedDRA version: 14.1;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Trade Name: Lipitor
Product Name: Atorvastatin
INN or Proposed INN: Atorvastatin
Other descriptive name: Lipitor
NHS LothianUniversity of EdinburghNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
705EUCTR2010-019692-30-SE
(EUCTR)
16/12/201011/10/2010Extension study of ataluren in patients with Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden
706EUCTR2010-019802-17-IE
(EUCTR)
15/12/201009/09/2010Tiotropium-bromide in cystic fibrosisA randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic Fibrosis
MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
440Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;United Kingdom;Slovakia;Russian Federation;Czech Republic;Canada;Belgium;Spain;United States;Poland
707EUCTR2010-019802-17-ES
(EUCTR)
29/11/201022/09/2010Ensayo clínico aleatorizado, doble ciego, controlado con placebo, de grupos paralelos para confirmar eficacia y seguridad del tratamiento durante 12 semanas con tiotropio 5mcg una vez al día inhalado via Respimat® en pacientes con fibrosis quística.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 mcg administered once daily via the Respimat® device in patients with cystic fibrosis. - Fibrosis QuísticaCystic Fibrosis Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim España, S.ANULLNot RecruitingFemale: yes
Male: yes
360Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Ireland;Spain;Italy;Austria
708EUCTR2010-019802-17-DE
(EUCTR)
25/11/201004/08/2010Clinical trial to confirm the efficacy and safety of tiotropium 5 microgram administered via Respimat device, in patients with cystic fibrosis.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
INN or Proposed INN: Tiotropium Bromide (monohydrate)
Boehringer Ingelheim Pharma GmbH & Co. KGNULLNot RecruitingFemale: yes
Male: yes
372Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany
709EUCTR2010-019802-17-BE
(EUCTR)
23/11/201011/08/2010Tiotropium-bromide in cystic fibrosicA randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic Fibrosis
MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Australia;South Africa;Germany
710EUCTR2010-019692-30-NL
(EUCTR)
04/11/201024/06/2010Extension study of ataluren in patients with Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden
711NCT01299181
(ClinicalTrials.gov)
November 201021/10/2010A Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis BronchiectasisA Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: AtorvastatinUniversity of EdinburghNHS LothianCompleted18 Years75 YearsBoth60Phase 4United Kingdom
712NCT01299194
(ClinicalTrials.gov)
November 201021/10/2010Atorvastatin in Bronchiectasis in Patients With Pseudomonas AeruginosaA Randomised Controlled Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis in Patients With Pseudomonas AeruginosaBRONCHIECTASISDrug: ATORVASTATINUniversity of EdinburghNHS LothianCompleted18 Years80 YearsAll32Phase 4United Kingdom
713NCT01180634
(ClinicalTrials.gov)
November 201010/8/2010MP-376 (Aeroquin™, Levofloxacin for Inhalation) in Patients With Cystic FibrosisA 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 PatientsCystic FibrosisDrug: MP-376 (Levofloxacin solution for Inhalation);Drug: PlaceboHorizon Pharma USA, Inc.Forest LaboratoriesCompleted12 YearsN/AAll330Phase 3United States;Australia;Canada;Israel;New Zealand
714EUCTR2010-018454-13-DK
(EUCTR)
27/10/201013/08/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
715EUCTR2010-019802-17-GB
(EUCTR)
22/10/201010/08/2010Tiotropium-bromide in cystic fibrosisA randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic Fibrosis
MedDRA version: 14.1;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
471Hungary;Portugal;Germany;Switzerland;France;Ireland;Italy;Austria;South Africa;Australia;Israel;Slovakia;Russian Federation;United Kingdom;Czech Republic;Canada;Belgium;Spain;United States;Poland
716EUCTR2010-019802-17-AT
(EUCTR)
20/10/201009/09/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic Fibrosis
MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
MedDRA version: 12.1;Level: PT;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim RCV GmbH & Co KG,NULLNot RecruitingFemale: yes
Male: yes
Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
717EUCTR2010-020546-96-GB
(EUCTR)
08/10/201017/08/2010Study of the Effect of VX-770 on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects with Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted - Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
16Phase 2United Kingdom;Canada;United States
718EUCTR2010-019692-30-IT
(EUCTR)
06/10/201002/11/2010A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009e-CFA Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009e-CF Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC THERAPEUTICS, INC.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Germany;Netherlands;United Kingdom;Italy;Sweden
719EUCTR2010-019692-30-FR
(EUCTR)
05/10/201017/06/2010A Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Germany;Netherlands;United Kingdom;Italy;Sweden
720EUCTR2010-019802-17-CZ
(EUCTR)
01/10/201016/08/2010Tiotropium-bromide in cystic fibrosicA randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic Fibrosis
MedDRA version: 14.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
360Portugal;United States;Slovakia;Spain;Ireland;Austria;Israel;Russian Federation;Italy;Switzerland;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Australia;South Africa;Germany
721EUCTR2010-019802-17-HU
(EUCTR)
30/09/201023/07/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic fibrosis Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 microgram
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim RCV GmbH & Co KGNULLNot RecruitingFemale: yes
Male: yes
360Portugal;Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
722EUCTR2009-012997-11-DE
(EUCTR)
27/09/201025/06/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
723EUCTR2009-012842-21-GB
(EUCTR)
20/09/201017/06/2010Treatment of Exocrine Pancreatic Insufficiency in subjects with Cystic Fibrosis Randomised, Double-Blind, Active-Controlled, Two-Treatment, Crossover, Multinational, Multicentre Study to Compare Two Pancreatic Enzyme Products in theTreatment of Exocrine Pancreatic Insufficiency in Subjects With Cystic Fibrosis Exocrine pancreatic insufficiency associated with cystic fibrosis
MedDRA version: 14.1;Level: HLGT;Classification code 10015674;Term: Exocrine pancreas conditions;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Trade Name: Kreon 25 000
Product Name: KREON 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: Zenpep
Product Name: EUR-1008
Product Code: EUR-1008
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREASLIPASE
Aptalis Pharma US Inc.NULLNot Recruiting Female: yes
Male: yes
86 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noHungary;Belgium;Bulgaria;Germany;Italy;United Kingdom
724EUCTR2010-019802-17-FR
(EUCTR)
14/09/201023/07/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic FibrosisTrade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer IngelheimNULLNot RecruitingFemale: yes
Male: yes
360Phase 3Ireland;Portugal;France;Czech Republic;Hungary;Slovakia;Spain;Belgium;Austria;Germany;Italy;United Kingdom
725EUCTR2010-019802-17-SK
(EUCTR)
13/09/201003/08/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis.A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. Cystic fibrosisTrade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim RCV GmbH&Co KGNULLNot RecruitingFemale: yes
Male: yes
360Phase 3France;Portugal;Czech Republic;Hungary;Slovakia;Spain;Belgium;Ireland;Austria;Germany;Italy;United Kingdom
726EUCTR2010-019802-17-PT
(EUCTR)
13/09/201007/07/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 µg administered once daily via the Respimat® device in patients with cystic fibrosis. - Cystic Fibrosis Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Product Name: Spiriva Respimat 2.5 mcg
Product Code: Tiotropium Respimat
Other descriptive name: TIOTROPIUM BROMIDE MONOHYDRATE
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
360Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
727EUCTR2010-018454-13-ES
(EUCTR)
06/09/201031/05/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhaladoA Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®Estudio de fase III multicéntrico, doble ciego, aleatorizado y controlado con placebo de la incidencia de recurrencia de las exacerbaciones pulmonares en pacientes con fibrosis quística utilizando dos dosis diferentes de Nacystelyn® inhalado Cystic fibrosisFibrosis quistica
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine- N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine- N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3France;Czech Republic;Hungary;Belgium;Spain;Denmark;Germany;United Kingdom;Italy
728EUCTR2010-018454-13-GB
(EUCTR)
01/09/201018/06/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;Germany;United Kingdom;France;Spain;Italy
729NCT01208285
(ClinicalTrials.gov)
September 201022/9/2010Study of VX-770 in Subjects With Moderate Hepatic Impairment and in Matched Healthy SubjectsA 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 SubjectsIn Development for Cystic FibrosisDrug: VX-770Vertex Pharmaceuticals IncorporatedNULLCompleted18 Years65 YearsBoth24Phase 1Czech Republic;Slovakia
730EUCTR2010-018454-13-DE
(EUCTR)
31/08/201021/05/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
731EUCTR2010-018454-13-CZ
(EUCTR)
27/08/201021/06/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;United Kingdom;Germany;Czech Republic;France;Spain;Italy
732EUCTR2009-012997-11-FR
(EUCTR)
25/08/201027/04/2010An Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSISTAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: VX-770
Product Code: VX-770, VRT-8130077
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217Phase 3France;Czech Republic;Ireland;Germany;United Kingdom
733EUCTR2010-018454-13-HU
(EUCTR)
17/08/201017/06/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
734NCT01140451
(ClinicalTrials.gov)
August 12, 20107/6/2010Extension Study of Ataluren (PTC124) in Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124®) in Subjects With Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: AtalurenPTC TherapeuticsCystic Fibrosis FoundationCompleted6 YearsN/AAll191Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom
735EUCTR2010-019692-30-BE
(EUCTR)
10/08/201025/05/2010Extension study of ataluren in patients with Cystic FibrosisA Phase 3 Extension Study of Ataluren (PTC124) in Subjects with Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;United Kingdom;Italy;Sweden
736EUCTR2009-012842-21-IT
(EUCTR)
10/08/201023/08/2010A randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - NDA randomised, double blind, active-controlled, two-treatment, crossover multinational, multicentre trial to compare two pancreatic enzyme products in the treatment of exocrine pancreatic insufficiency in subjects with cystic fibrosis - ND exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF)
MedDRA version: 9.1;Level: HLGT;Classification code 10015674
MedDRA version: 9.1;Level: LLT;Classification code 10011762
Trade Name: ZENPEP
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Trade Name: CREON 10000 Capsules
INN or Proposed INN: Multienzymes (lipase, protease etc.)
EURAND SPANULLNot RecruitingFemale: yes
Male: yes
86Hungary;Bulgaria;Germany;United Kingdom;Italy
737EUCTR2010-018454-13-FR
(EUCTR)
10/08/201028/05/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetylcysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
738EUCTR2010-019802-17-IT
(EUCTR)
27/07/201020/08/2010A randomised, double-blind, placebo-controlled parallel-group trial to confirm the efficacy after 12 weeks and the safety of tiotropium 5 micrograms administered once daily via the Respimat device in patients with cystic fibrosis. - ND Patients with cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
INN or Proposed INN: Tiotropium bromide
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
440Hungary;Portugal;Czech Republic;United Kingdom;Germany;France;Spain;Ireland;Italy;Austria
739EUCTR2009-016590-15-DE
(EUCTR)
19/07/201015/04/2010A 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 includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862
MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg/5 ml Lösung für einen Vernebler
Product Name: TOBI
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
50France;Egypt;Hungary;Greece;Canada;Argentina;Poland;Romania;Russian Federation;Germany;Switzerland;Italy
740EUCTR2010-018454-13-IT
(EUCTR)
15/07/201015/06/2010A 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 - NDA Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn - ND Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011762
Product Name: Nacystelyn
Product Code: NAL
INN or Proposed INN: L-Lysine N acetylcysteinate
Product Name: Nacystelyn
Product Code: NAL
INN or Proposed INN: L-Lysine N-acetylcysteinate
LABORATOIRES SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3Hungary;Czech Republic;United Kingdom;Germany;France;Spain;Italy
741EUCTR2008-005045-34-IE
(EUCTR)
09/07/201018/05/2010A 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 bronchiectasisA double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis non-CF bronchiectasis (CF = cystic fibrosis)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution
Other descriptive name: colistimethate sodium
Profile Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
260United Kingdom;Ireland
742EUCTR2009-012997-11-GB
(EUCTR)
08/07/201021/06/2010 Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6 and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
217 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
743EUCTR2009-012997-11-IE
(EUCTR)
06/07/201005/05/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX 770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
744EUCTR2009-016734-26-BG
(EUCTR)
01/07/201015/06/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
745EUCTR2009-012997-11-CZ
(EUCTR)
22/06/201012/05/2010Study of long-term VX-770 treatment in Cystic Fibrosis subjects Age 6and OlderAn Open-Label, Rollover Study to Evaluate the Long Term Safety and Efficacy of VX-770 in Subjects with Cystic Fibrosis - PERSIST Cystic Fibrosis
MedDRA version: 16.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: Kalydeco
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
217France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
746EUCTR2009-016590-15-GR
(EUCTR)
15/06/201031/12/2009A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation
MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72France;Hungary;Greece;Poland;Germany;Italy
747EUCTR2010-018738-27-DE
(EUCTR)
02/06/201016/03/2010A Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic FibrosisA Randomized, Double Blind, Parallel Group, Placebo Controlled 28 Day Study to Investigate the Safety, Tolerability and Pharmacodynamics of SB-656933 in Patients with Cystic Fibrosis Cystic fibrosis
MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: SB-656933 Tablets
Product Code: SB-656933-AAA
Product Name: SB-656933 Tablets
Product Code: SB-656933-AAA
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
100Germany
748NCT01149005
(ClinicalTrials.gov)
June 20109/6/2010Cystic Fibrosis (CF) Exacerbation and Insulin TreatmentEvaluation of Glucose Tolerance and Insulin Treatment in Non Diabetic Patients With Cystic Fibrosis During Acute Pulmonary ExacerbationCystic Fibrosis;Impaired Glucose Tolerance;Pulmonary ExacerbationDrug: novorapid / humalog short acting insulin;Drug: Novo Rapid Insulin (Novonordisk)Hadassah Medical OrganizationNULLNot yet recruiting10 YearsN/ABoth30N/AIsrael
749EUCTR2007-001401-15-DK
(EUCTR)
21/05/201014/04/2010Treatment of patients with cystic fibrosis with N-acetylcysteineTreatment of patients with cystic fibrosis with N-acetylcysteine Patients with cystic fibrosis and chronic Pseudomonas lung infection
MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: ACC600Tabs
Product Name: N-acetylcystein
Product Code: R05C B01
INN or Proposed INN: ACETYLCYSTEINE
RigshospitaletNULLNot RecruitingFemale: yes
Male: yes
Phase 4Denmark
750EUCTR2007-006276-11-IT
(EUCTR)
18/05/201007/05/2010A 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) - NDA Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - ND Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763
Product Name: heparin 25mg inhalation powder, hard capsule
Product Code: VR496
VECTURA LIMITEDNULLNot RecruitingFemale: yes
Male: yes
64Phase 1/2Ireland;Italy
751EUCTR2009-016590-15-FR
(EUCTR)
15/04/201014/12/2009A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years.A Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacy and Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P. aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation of Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10068297;Term: Pseudomonas colonisation
MedDRA version: 12.0;Classification code 10068292;Term: Pseudomonas colonization
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Trade Name: TOBI 300mg/5mL nebuliser solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
72Phase 3France;Hungary;Greece;Poland;Germany;Italy
752NCT01082367
(ClinicalTrials.gov)
April 20105/3/2010Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 YearsA 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 YearsTreatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis PatientsDrug: TOBI;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted3 Months6 YearsAll50Phase 3Canada;Egypt;France;Germany;Greece;Hungary;Italy;Romania;Russian Federation;Switzerland;Poland;United States
753NCT01460836
(ClinicalTrials.gov)
April 201025/10/2011Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisIndirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation;Drug: Aztreonam lysine for inhalationNovartis PharmaceuticalsNULLCompleted6 YearsN/ABothN/ANULL
754EUCTR2009-016734-26-LT
(EUCTR)
23/03/201020/01/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
755NCT02198079
(ClinicalTrials.gov)
March 201021/2/2014A Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in FloridaA Prospective, Multicenter, Collaborative Study to Determine the Prevalence of Nontuberculous Mycobacteria (NTM) in Pediatric Patients With Cystic Fibrosis in FloridaCystic Fibrosis;PediatricsBiological: SputumUniversity of MiamiUniversity of FloridaCompletedN/A18 YearsBoth85N/AUnited States
756EUCTR2009-014412-35-GB
(EUCTR)
23/02/201001/10/2009An 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/AAn International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A Non-cystic fibrosis bronchiectasis
MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS
Product Name: Ciprofloxacin for Inhalation
Product Code: None assigned
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
96Germany;United Kingdom
757EUCTR2009-016734-26-LV
(EUCTR)
17/02/201011/01/2010A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
758NCT00889967
(ClinicalTrials.gov)
February 201027/4/2009Safety and Efficacy Study of Ciprofloxacin for Inhalation in Patients With Non-Cystic Fibrosis Bronchiectasis ORBIT-1An 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 BronchiectasisNon-Cystic Fibrosis BronchiectasisDrug: Ciprofloxacin for Inhalation;Drug: PlaceboAradigm CorporationNULLCompleted18 Years80 YearsAll95Phase 2United States;Canada;Germany;United Kingdom
759NCT01069705
(ClinicalTrials.gov)
February 201015/2/2010Second Open Label Extension to Bridging Study CTBM100C2303A 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 AeruginosaDrug: Tobramycin inhalation powderNovartis PharmaceuticalsNULLCompleted6 Years21 YearsAll49Phase 3Bulgaria;Estonia;Latvia;Lithuania;Romania;Russian Federation;South Africa
760EUCTR2009-014412-35-DE
(EUCTR)
27/01/201009/10/2009An 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/AAn International, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Once Daily Administration of Two Strengths of Ciprofloxacin for Inhalation Compared with Placebo for Inhalation in the Management of Pseudomonas aeruginosa in Patients with Non Cystic Fibrosis Bronchiectasis - N/A Non-cystic fibrosis bronchiectasis
MedDRA version: 12.0;Level: LLT;Classification code 10006446;Term: Bronchiectasis NOS
Product Name: Ciprofloxacin for Inhalation
Product Code: None assigned
INN or Proposed INN: CIPROFLOXACIN HYDROCHLORIDE
Aradigm CorporationNULLNot RecruitingFemale: yes
Male: yes
96Phase 2Germany;United Kingdom
761EUCTR2009-013340-36-IT
(EUCTR)
25/01/201031/12/2009PREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - NDPREVENTION OF REPERFUSION INJURY IN HUMAN LUNG TRANSPLANTATION FOR CYSTIC FIBROSIS BY TARGETING IL-8 ACTIVITY - ND cystic fibrosis
MedDRA version: 12.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: reparixin
INN or Proposed INN: Reparixin
IST. DI RICERCHE FARMACOLOG. M. NEGRINULLNot RecruitingFemale: yes
Male: yes
Italy
762EUCTR2007-004277-26-AT
(EUCTR)
21/01/201021/04/2009An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Cayston
Product Name: AZLI
Product Code: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
763EUCTR2009-016734-26-EE
(EUCTR)
08/01/201015/12/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who successfully Completed Participation in Study CTBM100C2303E1. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Lithuania;Bulgaria;Latvia
764NCT00996424
(ClinicalTrials.gov)
January 201015/10/2009The Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung FunctionThe Effect of Inhaled N-Acetylcysteine Compared to Normal Saline on Sputum Rheology and Lung Function.Cystic FibrosisDrug: Acetylcysteine;Drug: normal salineUniversity Hospital, GhentBVSMTerminated6 Years64 YearsBoth19Phase 4Belgium
765NCT01044719
(ClinicalTrials.gov)
January 201014/12/2009Duration of Antibiotics in Infective Exacerbations of Cystic FibrosisWhat Duration of Intravenous Antibiotic Therapy Should be Used in the Treatment of Infective Exacerbations of Cystic Fibrosis Chronically Colonised With Pseudomonas AeruginosaCystic FibrosisDrug: Ceftazidime;Drug: Tobramycin;Drug: MeropenemImperial College LondonNULLNot yet recruiting16 YearsN/ABoth240Phase 4United Kingdom
766EUCTR2009-016590-15-HU
(EUCTR)
29/12/200925/11/2009A 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 includedA Randomized, Double-Blind, Placebo-Controlled, Crossover Multi-Center Study to Assess the Efficacyand Safety of Inhaled Tobramycin Nebuliser Solution (TOBI®) for the Treatment of Early Infections of P.aeruginosa in Cystic Fibrosis Subjects Aged from 3 Months to less than 7 years. Lung colonisation with Pseudomonas aeruginosa in cystic fibrosis patients
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 14.1;Level: LLT;Classification code 10068292;Term: Pseudomonas colonization;System Organ Class: 100000004862
MedDRA version: 14.1;Classification code 10068297;Term: Pseudomonas colonisation;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI 300 mg / 5 mL nebuliser solution
Product Name: TOBI
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
50France;Hungary;Greece;Canada;Poland;Russian Federation;Germany;Italy;Switzerland
767EUCTR2007-006648-23-IE
(EUCTR)
11/12/200915/04/2009An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: XolairNovartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Phase 4Belgium;Ireland;Netherlands;Germany;Italy;United Kingdom
768EUCTR2009-012575-10-GB
(EUCTR)
16/11/200911/09/2009Trial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CFTrial of Optimal Therapy for Pseudomonas Eradication in Cystic Fibrosis - TORPEDO-CF Product Name: Ceftazidime
INN or Proposed INN: Ceftazidime
Other descriptive name: N/A
Product Name: Tobramycin
INN or Proposed INN: Tobramycin
Other descriptive name: N/A
Product Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: N/A
Product Name: Ciprofloxacin
INN or Proposed INN: Ciprofloxacin
Other descriptive name: N/A
University Hospitals Bristol NHS Foundation TrustUniversity of LiverpoolNot Recruiting Female: yes
Male: yes
260 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom;Sweden
769EUCTR2008-008317-20-BE
(EUCTR)
13/11/200921/09/2009The effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung functionThe effect of inhaled N-Acetylcysteine compared to normal saline on sputum rheology and lung function Cystic Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Lysomucil 10 %
Product Name: N-acetylcysteine
INN or Proposed INN: Acetylcysteine
University Hospital GhentNULLNot RecruitingFemale: yes
Male: yes
Belgium
770NCT01499914
(ClinicalTrials.gov)
November 200921/11/2011Cohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza VaccinationCohort Study Evaluating the Clinical Effectiveness, Safety and Immunogenicity to the Pandemic Influenza Vaccination in Patients With Cystic Fibrosis and, Where Applicable, the Clinical Expression of Influenza A (H1N1)Cystic Fibrosis With Gastrointestinal ManifestationBiological: influenza vaccinationAssistance Publique - Hôpitaux de ParisNULLCompleted6 MonthsN/ABoth439Phase 4France
771NCT01018368
(ClinicalTrials.gov)
November 200919/11/2009Study of VX-770 and Rifampin in Healthy Male SubjectsAn Open-Label Phase 1 Study to Examine the Effect of Multiple Doses of Rifampin on the Single-Dose Pharmacokinetics of VX 770 in Healthy SubjectsCystic FibrosisDrug: VX-770;Drug: RifampinVertex Pharmaceuticals IncorporatedNULLCompleted18 Years55 YearsMale24Phase 1United States
772NCT01094704
(ClinicalTrials.gov)
November 200919/3/2010Durability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic FibrosisDurability of Hypertonic Saline for Enhancing Mucociliary Clearance in Cystic FibrosisCystic FibrosisDrug: sodium chloride (7%)University of North Carolina, Chapel HillJohns Hopkins University;Novartis PharmaceuticalsCompleted18 YearsN/AAll16Phase 1United States
773EUCTR2009-009869-34-SE
(EUCTR)
12/10/200929/07/2009Randomized, 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 - Bayq3939Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
MedDRA version: 9.1;Level: PT;Term: Bronchiectasis
Product Name: Cipro Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
122United Kingdom;Germany;Spain;Sweden
774EUCTR2008-003924-52-NL
(EUCTR)
06/10/200905/02/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
775EUCTR2008-007479-26-DE
(EUCTR)
25/09/200926/06/2009Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D MutationA Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 3United States;France;Canada;Ireland;Australia;Germany;United Kingdom
776EUCTR2006-006215-68-FR
(EUCTR)
21/09/200906/08/2009A 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 AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
777EUCTR2009-014050-15-BE
(EUCTR)
18/09/200914/09/2009Conversion 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-XLConversion from a twice-daily tacrolimus (tac) regimen to a once-daily tacorlimus exended-release formulation (TacXL) regimen : Pharamcokinetic studies in stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant - Tac-XL Stable cystic fibrosis (CF) and non-CF patients having received a pulmonary transplant
MedDRA version: 12.0;Level: LLT;Classification code 10025127;Term: Lung transplant
Trade Name: Prograft capsules
Product Name: Tacrolimus capsules
INN or Proposed INN: TACROLIMUS
INN or Proposed INN: TACROLIMUS
INN or Proposed INN: TACROLIMUS
Trade Name: Advagraf prolonged-release hard capsules
Product Name: Tacrolimus prolonged-release hard capsules
Hopital Erasme - Chest serviceNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Belgium
778EUCTR2008-007416-15-FR
(EUCTR)
14/09/200904/06/2009A 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 - REACHA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - REACH cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: VX-770
Product Code: VX-770, VRT-813077
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;Czech Republic;Ireland;Germany;United Kingdom
779NCT00803205
(ClinicalTrials.gov)
September 8, 20094/12/2008Study of Ataluren (PTC124™) in Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: Ataluren;Drug: PlaceboPTC TherapeuticsCystic Fibrosis FoundationCompleted6 YearsN/AAll238Phase 3United States;Belgium;Canada;France;Germany;Israel;Italy;Netherlands;Spain;Sweden;United Kingdom
780EUCTR2008-002318-22-LT
(EUCTR)
07/09/200922/01/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Other descriptive name: TBM100C
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
781EUCTR2008-007479-26-FR
(EUCTR)
07/09/200907/07/2009A 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 - ENVISIONA Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: VX-770
Product Code: VX-770, VRT-813077
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
30Phase 3France;Ireland;Germany;United Kingdom
782EUCTR2008-004764-39-LT
(EUCTR)
07/09/200922/01/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 13.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
783EUCTR2009-009869-34-GB
(EUCTR)
02/09/200909/04/2009Randomized, 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 - Bayq3939Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
MedDRA version: 9.1;Level: PT;Term: Bronchiectasis
Product Name: Cipro Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
122Germany;United Kingdom;Spain;Sweden
784NCT01031706
(ClinicalTrials.gov)
September 200911/12/2009Effect of Hypertonic Saline on Mucus Clearance in Children Ages 5-12 With Cystic FibrosisSustained Impact of Hypertonic Saline on Mucociliary Clearance in Young Children With Cystic FibrosisCystic FibrosisDrug: Hypertonic Saline;Drug: PlaceboUniversity of North Carolina, Chapel HillNational Heart, Lung, and Blood Institute (NHLBI)Completed5 Years12 YearsAll23N/AUnited States
785NCT01710449
(ClinicalTrials.gov)
September 200917/10/2012Evaluation of Regional Ventilation Using 19F MRI of Inert Perfluorinated Gases Mixed With OxygenEvaluation 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 DiseasesDrug: perfluorinated gas/oxygen mixtureHal C CharlesNULLCompleted18 YearsN/ABoth44Phase 1United States
786EUCTR2008-003924-52-GB
(EUCTR)
26/08/200909/04/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot Recruiting Female: yes
Male: yes
208 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
787EUCTR2008-006446-25-NL
(EUCTR)
26/08/200910/03/2009A 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 VX08-809-101A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
90Germany;Netherlands;Belgium
788EUCTR2008-002318-22-BG
(EUCTR)
20/08/200928/08/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Bulgaria;Latvia;Lithuania
789EUCTR2008-004764-39-BG
(EUCTR)
20/08/200928/08/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 12.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Estonia;Bulgaria;Latvia;Lithuania
790EUCTR2008-003924-52-DE
(EUCTR)
17/08/200910/07/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Netherlands;Germany;Italy;United Kingdom;Sweden
791EUCTR2008-007479-26-IE
(EUCTR)
11/08/200914/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D MutationA Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
40Phase 3Germany;United Kingdom;Canada;France;Ireland;United States;Australia
792EUCTR2008-007416-15-IE
(EUCTR)
11/08/200914/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
793EUCTR2008-002740-42-NL
(EUCTR)
10/08/200925/03/2009Long Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inhaled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
794EUCTR2007-006648-23-IT
(EUCTR)
06/08/200922/05/2009An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - NDAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab (Xolair) in cystic fibrosis complicated by allergic bronchopulmonary aspergillosis - ND Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: XOLAIR
INN or Proposed INN: Omalizumab
NOVARTIS FARMANULLNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
795EUCTR2008-007416-15-CZ
(EUCTR)
05/08/200904/06/2009A 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 - STRIVEA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: VX-770
Product Code: VX-770, VRT-813077
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;Czech Republic;Ireland;Germany;United Kingdom
796NCT00982930
(ClinicalTrials.gov)
August 200921/9/2009Open Label Extension to Bridging Study CTBM100C2303A Phase III Open-label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.Pseudomonas Aeruginosa;Cystic FibrosisDrug: Tobramycin inhalation powderNovartis PharmaceuticalsNULLCompleted6 Years21 YearsBoth57Phase 3Estonia;Russian Federation
797EUCTR2008-004764-39-EE
(EUCTR)
30/07/200923/07/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
798EUCTR2008-007416-15-GB
(EUCTR)
27/07/200922/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
100 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
799EUCTR2008-001156-43-IT
(EUCTR)
27/07/200928/07/2009A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosisA randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 micrograms and 5 micrograms) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis cystic fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
INN or Proposed INN: Tiotropium bromide
Product Name: Tiotropium Respimat 1.25 micrograms solution for inhalation
Product Code: NA
INN or Proposed INN: Tiotropium bromide
BOEHRINGER ING.NULLNot RecruitingFemale: yes
Male: yes
600Portugal;France;Belgium;Netherlands;Germany;United Kingdom;Italy
800EUCTR2008-007479-26-GB
(EUCTR)
27/07/200922/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 6 to 11 With the G551D MutationA Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISION Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;United States;Canada;Ireland;Australia;Germany;United Kingdom
801EUCTR2008-006446-25-BE
(EUCTR)
08/07/200912/05/2009A 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 VX08-809-101A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
90Germany;Netherlands;Belgium
802EUCTR2009-009869-34-ES
(EUCTR)
03/07/200906/05/2009 Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística. Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis. Estudio aleatorizado, controlado con placebo, en doble ciego y multicéntrico, para evaluar la seguridad y la eficacia de ciprofloxacino inhalado frente a placebo en pacientes con bronquiectasias no debidas a fibrosis quística. Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of greater than or equal to 35 % and less than or equal to 80 percent of predicted) Bronquiectasias idiopática y post-neumónica no debidas a fibrosis quística en pacientes en situación pulmonar estable (definida como mayor o igual al 35% y menor o igual al 80%)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
MedDRA version: 9.1;Level: PT;Term: Bronchiectasis
Product Name: Cipro Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot Recruiting Female: yes
Male: yes
120 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noSpain;Germany;United Kingdom;Sweden
803NCT00945347
(ClinicalTrials.gov)
July 200923/7/2009Does 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 FibrosisDrug: Miglustat;Drug: PlaceboCliniques universitaires Saint-Luc- Université Catholique de LouvainNULLCompleted14 YearsN/ABoth10Phase 2Belgium
804EUCTR2008-003924-52-IT
(EUCTR)
26/06/200922/06/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009-CFA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis - PTC124-GD-009-CF Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 12.0;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Name: PTC124
Product Name: PTC124
PTC THERAPEUTICS, INC.NULLNot RecruitingFemale: yes
Male: yes
208Phase 3Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
805EUCTR2008-001156-43-PT
(EUCTR)
23/06/200905/05/2009A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
INN or Proposed INN: Tiotropium
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
INN or Proposed INN: Tiotropium
Boehringer Ingelheim Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
596Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy
806EUCTR2008-008314-40-DE
(EUCTR)
22/06/200903/03/2009Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosisRandomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
276Denmark;Germany;United Kingdom;Sweden
807EUCTR2008-004764-39-LV
(EUCTR)
19/06/200908/05/2009A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303.A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder after Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Subjects Who Completed Participation in Study CTBM100C2303. Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
808EUCTR2008-007877-19-DE
(EUCTR)
15/06/200928/05/2009Nasale 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 pilotNasale Inhalation von Colistin mit dem Pari-Sinus-Vernebler bei Patienten mit Mukoviszidose und Pseudomonasnachweis im Nasen-Nasennebenhöhlenbereich.Nasal inhalation of colistin by the Pari Sinus nebulizer im patients with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways. - colistin nasal CF pilot subjects with cystic fibrosis and pseudomonas aeruginosa colonization in the upper airways
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Colistin CF
Product Name: Colistin CF
INN or Proposed INN: Colistimethat-Natrium
University of JenaNULLNot RecruitingFemale: yes
Male: yes
14Germany
809EUCTR2008-003924-52-FR
(EUCTR)
12/06/200917/03/2009A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: not assigned
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
810EUCTR2007-006648-23-NL
(EUCTR)
08/06/200903/09/2008An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: Xolair
INN or Proposed INN: omalizumab
Other descriptive name: Recombinant humanized monoclonal antibody omalizumab to IgE
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
811EUCTR2009-009869-34-DE
(EUCTR)
08/06/200917/03/2009Randomized, 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 - Bayq3939Randomized, placebo-controlled, double-blind, multi center study to evaluate the safety and efficacy of ciprofloxacin inhale compared to placebo in patients with non-cystic fibrosis bronchiectasis - Bayq3939 Idiopathic and post-pneumonic non-Cystic Fibrosis Bronchiectasis in pulmonary stable patients (defined as FEV1 of > 35 % and < 80 percent of predicted)
MedDRA version: 9.1;Level: LLT;Classification code 10006445;Term: Bronchiectasis
MedDRA version: 9.1;Level: PT;Term: Bronchiectasis
Product Name: Cipro Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
122Spain;Germany;United Kingdom;Sweden
812EUCTR2006-003275-12-NO
(EUCTR)
03/06/200927/03/2009Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: Zitromax
Product Code: Zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNAFemale: yes
Male: yes
250Phase 4Denmark;Norway;Sweden
813EUCTR2008-008314-40-DK
(EUCTR)
02/06/200916/04/2009Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosisRandomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
276United Kingdom;Germany;Denmark;Sweden
814NCT00918957
(ClinicalTrials.gov)
June 20094/6/2009A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus PlaceboA Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder From a Modified Manufacturing Process (TIPnew).Cystic FibrosisDrug: Tobramycin Inhalation Powder;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted6 Years21 YearsAll62Phase 3Bulgaria;Egypt;Estonia;India;Latvia;Lithuania;Romania;Russian Federation;South Africa
815NCT00930982
(ClinicalTrials.gov)
June 200930/6/2009Evaluation of Cipro Inhale in Patients With Non-cystic Fibrosis BronchiectasisRandomized, 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 BronchiectasisBronchiectasisDrug: Ciprofloxacin (Cipro, BAYQ3939);Drug: PlaceboBayerNovartisCompleted18 YearsN/AAll124Phase 2United States;Australia;Germany;Spain;Sweden;United Kingdom
816EUCTR2008-008314-40-GB
(EUCTR)
18/05/200909/04/2009Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosisRandomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer Healthcare AGNULLNot RecruitingFemale: yes
Male: yes
276Germany;United Kingdom;Denmark;Sweden
817EUCTR2008-003924-52-ES
(EUCTR)
18/05/200909/03/2009Estudio de fase 3 sobre la eficacia y la seguridad de PTC124 como tratamiento oral para la fibrosis quística mediada por mutación terminadoraEstudio de fase 3 sobre la eficacia y la seguridad de PTC124 como tratamiento oral para la fibrosis quística mediada por mutación terminadora Fibrosis quística mediada por mutación terminadora
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: no asignado
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: no asignado
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: no asignado
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
208Germany;United Kingdom;Netherlands;Belgium;France;Spain;Italy;Sweden
818EUCTR2008-008314-40-SE
(EUCTR)
15/05/200925/03/2009Randomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosisRandomized, double-blind, placebo-controlled, multicenter study to evaluate the safety and efficacy of inhaled ciprofloxacin compared to placebo in subjects with cystic fibrosis Cystic fibrosis
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Product Name: Ciprofloxacin Inhale
Product Code: BAYq3939
INN or Proposed INN: Ciprofloxacin
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
276United Kingdom;Germany;Denmark;Sweden
819EUCTR2008-006446-25-DE
(EUCTR)
14/05/200914/04/2009A 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 VX08-809-101A randomized, double-blind, placebo-controlled, multiple dose study of VX-809 to evaluate safety, pharmacokinetics, and pharmacodynamics of VX-809 in cystic fibrosis subjects homozygous for the deltaF508-CFTR gene mutation - Study VX08-809-101 Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
MedDRA version: 9.1;Classification code 10011764;Term: Cystic fibrosis NOS
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Product Name: VX-809
Product Code: VX-809
Other descriptive name: VRT-826809
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
90Belgium;Netherlands;Germany
820EUCTR2008-002318-22-LV
(EUCTR)
13/05/200928/01/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
821ChiCTR-TRC-13003979
2009-05-072013-10-28Application of roxithromycin in patients with bronchiectasis in stable conditionEffect of low-dose, long-term roxithromycin on airway imflammation and remodeling of stable non-cystic fibrosis bronchiectasis BronchietasisRoxithromycin 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 UniversityNULLCompleted1870BothRoxithromycin group:26;Control group:26;China
822EUCTR2008-002318-22-EE
(EUCTR)
06/05/200927/02/2009A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew).A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Phase III Study in Cystic Fibrosis (CF) Subjects to Assess Efficacy, Safety and Pharmacokinetics of Tobramycin Inhalation Powder from a Modified Manufacturing Process (TIPnew). Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 9.1;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100C
INN or Proposed INN: tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
100Phase 3Bulgaria;Estonia;Latvia;Lithuania
823EUCTR2008-003924-52-SE
(EUCTR)
08/04/200917/12/2008A Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
Product Name: PTC124
Product Code: PTC124
INN or Proposed INN: ataluren
Other descriptive name: PTC-0161480; PTC-124; Compound 1a; RPS 2505; PTC-C124; 291844
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;Spain;Belgium;Germany;Netherlands;Italy;United Kingdom;Sweden
824EUCTR2008-003924-52-BE
(EUCTR)
08/04/200920/02/2009Study of ataluren in patients with Cystic FibrosisA Phase 3 Efficacy and Safety Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic Fibrosis Nonsense-Mutation-Mediated Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
Product Name: ataluren
Product Code: PTC124
INN or Proposed INN: ataluren
PTC Therapeutics, IncNULLNot RecruitingFemale: yes
Male: yes
208Phase 3France;United States;Canada;Spain;Belgium;Israel;Germany;Netherlands;Italy;United Kingdom;Sweden
825EUCTR2007-004277-26-GB
(EUCTR)
12/03/200908/02/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Cayston
Product Name: AZLI
Product Code: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
826EUCTR2008-001530-27-GB
(EUCTR)
11/03/200918/04/2008A 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 FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
INN or Proposed INN: none
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom;Denmark;Sweden
827EUCTR2008-002740-42-FR
(EUCTR)
11/03/200912/03/2009Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;Belgium;Netherlands;Germany
828EUCTR2009-009875-37-NL
(EUCTR)
11/03/200921/01/2009A placebo-controlled trial of insulin therapy with or without adjuvant metformin in patients with cystic fibrosis-related diabetes - Insulin therapy and adjuvant metformin in CFRDA 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 PCHStaf LongziektenNULLNot RecruitingFemale: yes
Male: yes
25Netherlands
829EUCTR2007-006648-23-GB
(EUCTR)
27/02/200909/10/2008An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: Xolair
INN or Proposed INN: Omalizumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60Germany;United Kingdom;Netherlands;Belgium;Ireland;Italy
830EUCTR2008-002740-42-BE
(EUCTR)
13/02/200917/11/2008Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
831EUCTR2008-001530-27-DK
(EUCTR)
02/02/200920/11/2008A 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 FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
INN or Proposed INN: none
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom;Denmark;Sweden
832EUCTR2008-008228-34-GB
(EUCTR)
28/01/200929/07/2010Determination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patientsDetermination of the pharmacokinetics of inhaled mannitol after single and multiple dosing in cystic fibrosis patients Cystic Fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: IDPM: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: MANNITOL
Pharmaxis LtdNULLNot RecruitingFemale: yes
Male: yes
18United Kingdom
833EUCTR2008-001156-43-NL
(EUCTR)
15/01/200915/09/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CFA randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. - Tiotropium in CF Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Other descriptive name: TIOTROPIUM
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
Other descriptive name: TIOTROPIUM
Boehringer Ingelheim bvNULLNot RecruitingFemale: yes
Male: yes
596Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy
834EUCTR2007-001412-23-GB
(EUCTR)
09/01/200919/02/2008Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: IDPM: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: MANNITOL
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
340United Kingdom;Ireland
835EUCTR2008-004699-34-ES
(EUCTR)
16/12/200825/09/2008A Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBERA Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Phase II study to Assess the efficacy of 28 Day Oral Administration of AZD1236 in Adult Patients with Cystic Fibrosis.Estudio fase II de distribución aleatoria, doble ciego, controlado con placebo y de grupos paralelos, para evaluar la eficacia de la administración oral durante 28 días de AZD1236 a pacientes adultos con fibrosis quística - CYBER Cystic FibrosisFibrosis quística
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Code: AZD1236AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Netherlands;Spain
836EUCTR2008-005045-34-GB
(EUCTR)
15/12/200817/10/2008A 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 bronchiectasisA double-blind, vehicle-controlled, multi-centre, clinical study to investigate the efficacy and safety of up to 6 months of therapy with inhaled Promixin in the treatment of patients with non-cystic fibrosis bronchiectasis infected with Pseudomonas aeruginosa susceptible to Promixin - Inhaled Promixin in the treatment of non-CF bronchiectasis non-CF bronchiectasis (CF = cystic fibrosis)
MedDRA version: 14.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Promixin 1 million International Units (IU) Powder for Nebuliser Solution
Other descriptive name: colistimethate sodium
Profile Pharma LtdNULLNot RecruitingFemale: yes
Male: yes
144Phase 3Ukraine;Ireland;Russian Federation;United Kingdom
837EUCTR2007-004277-26-PT
(EUCTR)
12/12/200817/10/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
Product Code: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
838EUCTR2008-002740-42-DE
(EUCTR)
13/11/200831/07/2008Long Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy StudyLong Term Administration of Inahled Mannitol in Cystic Fibrosis - A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: MTT
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
300Germany;Netherlands;Belgium;France
839EUCTR2007-006648-23-DE
(EUCTR)
12/11/200815/08/2008An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: Xolair 150 mg Pulver und Injektionslösung zur Herstellung einer Injektionslösung
Product Name: Xolair
Product Code: IGE025
INN or Proposed INN: Omalizumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
840EUCTR2007-006276-11-IE
(EUCTR)
11/11/200811/02/2008A Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in adults with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in adults with Cystic FibrosisA Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in adults with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in adults with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Heparin 25mg inhalation powder, hard capsule
INN or Proposed INN: HEPARIN SODIUM
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
64Phase 1/2Ireland;Italy
841NCT01112059
(ClinicalTrials.gov)
November 200820/4/2010Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult Cystic Fibrosis (CF) PatientsA Randomized Trial of Doxycycline to Reduce Sputum MMP-9 Activity in Adult CF Patients Hospitalized for Pulmonary ExacerbationsCystic FibrosisDrug: Doxycycline;Other: placeboUniversity of Alabama at BirminghamCystic Fibrosis Foundation TherapeuticsCompleted19 YearsN/AAll40N/AUnited States
842NCT00800579
(ClinicalTrials.gov)
November 200821/11/2008Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male VolunteersA Randomised, Double-blind, Placebo-controlled Trial to Assess the Safety, Tolerability and Pharmacokinetics of GS-9411 in Healthy Male VolunteersCystic FibrosisDrug: GS-9411;Drug: PlaceboGilead SciencesNULLCompleted18 Years45 YearsMale12Phase 1Australia
843NCT00803179
(ClinicalTrials.gov)
November 20084/12/2008Growth Hormone Therapy for Wasting in Cystic FibrosisGrowth Hormone Therapy for Wasting in Cystic FibrosisCystic FibrosisDrug: Nutropin AQUniversity of Massachusetts, WorcesterNULLTerminated18 YearsN/AAll5Phase 1United States
844NCT00787917
(ClinicalTrials.gov)
November 20087/11/2008An 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 AspergillosisDrug: Omalizumab;Drug: Placebo;Drug: ItraconazoleNovartis PharmaceuticalsNULLTerminated12 YearsN/AAll14Phase 4Belgium;Germany;Italy;Netherlands;United Kingdom
845NCT00846573
(ClinicalTrials.gov)
November 200816/2/2009Hyperpolarized Noble Gas MR Imaging for Pulmonary DisordersHyperpolarized Noble Gas MR Imaging for Pulmonary DisordersCOPD;Cystic Fibrosis;Asthma;HealthyDrug: Hyperpolarized Helium-3University of Massachusetts, WorcesterNULLTerminated5 YearsN/AAll14N/AUnited States
846NCT00794586
(ClinicalTrials.gov)
November 200818/11/2008Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung InfectionA Phase 2, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Fosfomycin/Tobramycin for Inhalation in Patients With Cystic Fibrosis and Pseudomonas AeruginosaCystic FibrosisDrug: FTI, AZLI;Drug: Placebo, AZLIGilead SciencesNULLCompleted18 YearsN/ABoth120Phase 2United States
847NCT00809094
(ClinicalTrials.gov)
November 200815/12/2008NAC 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 PatientsA 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 PatientsCystic FibrosisDrug: N-acetylcysteine (NAC);Drug: PlaceboStanford UniversityCystic Fibrosis Foundation TherapeuticsCompleted7 YearsN/AAll70Phase 2United States
848NCT00789867
(ClinicalTrials.gov)
November 200811/11/2008Single Dose of pGM169/GL67A in CF PatientsEvaluation of Safety and Gene Expression With a Single Dose of pGM169/GL67A Administered to the Nose and Lung of Individuals With Cystic FibrosisCystic FibrosisDrug: pGM169/GL67AImperial College LondonRoyal Brompton & Harefield NHS Foundation Trust;University of Oxford;University of Edinburgh;Cystic Fibrosis Trust;University of PennsylvaniaCompleted16 Years70 YearsAll35Phase 1/Phase 2United Kingdom
849EUCTR2008-004699-34-NL
(EUCTR)
28/10/200829/08/2008A 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. - CYBERA 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: AZD1236AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
50Phase 2Netherlands;Spain
850EUCTR2008-001156-43-DE
(EUCTR)
15/10/200818/07/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
INN or Proposed INN: tiotropium bromide monohydrate
Product Name: Tiotropium Respimat 1.25 microgram, solution for inhalation
Product Code: N/A
INN or Proposed INN: tiotropium bromide monohydrate
Boehringer Ingelheim Pharma GmbH & Co.KGNULLNot RecruitingFemale: yes
Male: yes
596Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom
851EUCTR2007-004277-26-DE
(EUCTR)
14/10/200829/05/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebulizer Solution (AZLI) versus Tobramycin Nebulizer Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen in Subjects with Cystic Fibrosis Followed by an Open-Label, Single-Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Cayston
Product Name: AZLI
Product Code: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
852NCT00934362
(ClinicalTrials.gov)
October 20086/7/2009Effect of Lucinactant on Mucus Clearance in Cystic Fibrosis Lung DiseaseA Double Blind, Cross-Over Study Comparing Aerosolized Lucinactant and Vehicle on Mucociliary Clearance for Cystic Fibrosis Lung DiseaseCystic FibrosisDrug: Lucinactant first;Drug: Placebo firstUniversity of North Carolina, Chapel HillCystic Fibrosis Foundation Therapeutics;Windtree TherapeuticsCompleted14 YearsN/AAll16Phase 2United States
853EUCTR2007-006648-23-BE
(EUCTR)
30/09/200828/08/2008An exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosisAn exploratory, randomized, double-blind, placebo controlled study to assess the efficacy of multiple doses of omalizumab in cystic fibrosis complicated with allergic bronchopulmonary aspergillosis Patients with cystic fibrosis complicated by allergic bronchopulmonary aspergillosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10000244;Term: ABPA
Trade Name: Xolair
INN or Proposed INN: omalizumab
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
60United Kingdom;Germany;Netherlands;Belgium;Ireland;Italy
854EUCTR2008-001769-27-GB
(EUCTR)
29/09/200809/10/2008Microbiological 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) - PREPACMicrobiological assessment of prophylactic ciprofloxacin therapy for children with cystic fibrosis during viral respiratory viral infection to prevent Pseudomonas aeruginosa colonisation – a randomised control study (Prevent Pseudomonas Aeruginosa Colonisation- PREPAC) - PREPAC Cystic FibrosisSpecifically the trial will include children aged 2-14 years with a diagnosis of cystic fibrosis and not chronically infected with pseudomonas aeruginosa in their lungs.Trade Name: Ciproxin Suspension
Product Name: Ciproxin
Product Code: PL 0010/0211
Southampton University Hospital TrustNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
45United Kingdom
855EUCTR2008-001156-43-FR
(EUCTR)
19/09/200813/06/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Other descriptive name: TIOTROPIUM
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
Other descriptive name: TIOTROPIUM
Boehringer Ingelheim FranceNULLNot RecruitingFemale: yes
Male: yes
596Phase 2Portugal;France;Belgium;Netherlands;Germany;Italy;United Kingdom
856EUCTR2007-004050-85-GB
(EUCTR)
15/09/200813/10/2008Evaluation 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 patientsEvaluation of safety and gene expression with a single dose of pGM169/GL67A administered to the nose and lung of individuals with cystic fibrosis - Single dose of pGM169/GL67A in CF patients Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: pGM169/GL67A
Product Code: pGM169/GL67A
Imperial CollegeNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
857EUCTR2008-001156-43-GB
(EUCTR)
11/09/200814/10/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Other descriptive name: TIOTROPIUM
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
Other descriptive name: TIOTROPIUM
Boehringer Ingelheim LimitedNULLNot RecruitingFemale: yes
Male: yes
596Portugal;Germany;United Kingdom;Netherlands;Belgium;France;Italy
858EUCTR2007-006276-11-GB
(EUCTR)
01/09/200826/11/2007A 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 FibrosisA Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Heparin 25mg inhalation powder, hard capsule
INN or Proposed INN: HEPARIN SODIUM
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
64Phase 1/2Ireland;Italy;United Kingdom
859EUCTR2007-004956-35-GB
(EUCTR)
27/08/200826/11/2007The 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 WardsThe effect of intensive blood glucose control with insulin on markers of short and medium term outcomes in patients hospitalised with acute exacerbations of chronic lung disease. Pilot Study to test feasibility and safety of a clinical protocol for intensive blood glucose control with insulin on medical wards - Pilot of Intensive Blood Glucose Control with Insulin on Medical Wards Acute exacerbations of chronic obstructive pulmonary disease. Stress hyperglycaemia. Insulin-induced hypoglycaemia. Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10010953;Term: COPD exacerbation
MedDRA version: 9.1;Classification code 10060439;Term: Stress induced hyperglycaemia
MedDRA version: 9.1;Classification code 10022484;Term: Insulin hypoglycaemia
MedDRA version: 9.1;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Actrapid 100 IU/ml, Solution for injection in a vial
Trade Name: Levemir 100 U/ml solution for injection in a cartridge, Levemir 100 U/ml solution for injection in a pre-filled pen
Trade Name: NovoRapid 100 U/ml, solution for injection in a vial. NovoRapid Penfill 100 U/ml, solution for injection in a cartridge. NovoRapid FlexPen 100 U/ml, solution for injection in a pre-filled pen.
Trade Name: Lantus® 100 Units/ml solution for injection in a vial. Lantus® 100 Units/ml solution for injection in a cartridge. Lantus® 100 Units/ml solution for injection in a pre-filled pen
St George's, University of LondonNULLNot RecruitingFemale: yes
Male: yes
United Kingdom
860EUCTR2008-001728-30-DE
(EUCTR)
26/08/200807/05/2008A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis PatientsA Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: MP-376
Product Code: MP-376
INN or Proposed INN: levofloxacin
Mpex Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
190Phase 2Netherlands;Germany
861EUCTR2007-004277-26-ES
(EUCTR)
25/08/200824/01/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quísticaAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisEnsayo de fase III, abierto, aleatorizado para evaluar la eficacia y seguridad de aztreonam lisina para inhalación frente a una solución de tobramicina para nebulizador en un régimen intermitente de antibiótico en aerosol en pacientes con fibrosis quística Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection. Pacientes adultos y pediátricos con fibrosis quística (FQ) con infección pulmonar por Pseudomonas aeruginosa (PA).
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;France;Belgium;Spain;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
862EUCTR2006-006215-68-ES
(EUCTR)
22/08/200827/06/2008ENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSAENSAYO CLÍNICO MULTICÉNTRICO, MULTINACIONAL, ABIERTO, ALEATORIZADO, CON GRUPOS PARALELOS DE TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMICINA SOLUCIÓN PARA NEBULIZACIÓN, 300 mg DOS VECES AL DÍA EN VIALES UNIDOSIS DE 4 ML) EN COMPARACIÓN CON TOBI® EN EL TRATAMIENTO DE PACIENTES CON FIBROSIS QUÍSTICA E INFECCIÓN CRÓNICA POR PSEUDOMONAS AERUGINOSA Infección pulmonar crónica por P. aeruginosa en pacientes con fibrosis quística
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramicina
Trade Name: Tobi 300mg/5ml Solución para inhalación por nebulizador.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
863EUCTR2007-004507-36-DE
(EUCTR)
19/08/200819/10/2007A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects.A multicenter, open label, 2 period cross-over study to evaluate the Pharmacokinetics of an 8 week continuous treatment with 1x300mg/d and 2x300mg/d TOBI® inhaled with the PARI eFlow® rapid in Cystic Fibrosis (CF) Subjects. patients with cystic fibrosis and chronical infection with Pseudomonas aeruginosa
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: Tobi
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
Germany
864EUCTR2008-001728-30-NL
(EUCTR)
18/08/200830/05/2008A Phase 2, Multi-center, Randomized, Double-blind, Placebo-controlled Study toEvaluate the Safety, Tolerability and Efficacy of Three Dosage Regimens of MP-376 Solution for Inhalation Given for 28 Days to Stable Cystic Fibrosis Patients - Pseudomonas aeruginosa infection in patients suffering from stable Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
MedDRA version: 9.1;Classification code 10021860;Term: Infection pseudomonas aeruginosa
Product Name: MP-376
Product Code: MP-376
INN or Proposed INN: levofloxacin
Mpex Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
190Phase 2Germany;Netherlands
865EUCTR2006-006215-68-DE
(EUCTR)
14/08/200818/12/2008A 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 AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320France;Hungary;Czech Republic;Spain;Germany
866EUCTR2008-000164-17-DE
(EUCTR)
13/08/200826/05/2008Nasale 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 pilotNasale 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 airwaysTrade Name: Gernebcin 80 mg
Product Name: Gernebcin 80 mg
INN or Proposed INN: tobramycin
University of JenaNULLNot RecruitingFemale: yes
Male: yes
14Germany
867EUCTR2006-006215-68-HU
(EUCTR)
13/08/200825/06/2008A 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 AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Hungary;Germany;Czech Republic;France;Spain
868EUCTR2008-002352-20-BE
(EUCTR)
11/08/200817/07/2008Single 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 mutationSingle center, double-blind, randomized, placebo-controlled, two-period/two-treatment crossover study investigating the effect of miglustat on the nasal potential difference in patients with cystic fibrosis homozygous for the F508del mutation Cystic fibrosis homozygous for the F508del mutation
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Zavesca
INN or Proposed INN: miglustat
Actelion Pharmaceuticals LtdNULLNot RecruitingFemale: yes
Male: yes
Belgium
869EUCTR2008-001530-27-SE
(EUCTR)
06/08/200817/06/2008A 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 FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
INN or Proposed INN: none
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
70Phase 2Germany;United Kingdom;Denmark;Sweden
870NCT00744250
(ClinicalTrials.gov)
August 200828/8/2008Intraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo ControlIntraduodenal Aspiration Study to Assess the Bioavailability of Oral Pancrecarb® Compared to Placebo Control in Patients With Pancreatic InsufficiencyExocrine Pancreatic Insufficiency;Chronic Pancreatitis;Cystic FibrosisDrug: PancrelipaseDigestive Care, Inc.University of North Carolina, Chapel HillTerminated18 YearsN/ABoth3Phase 4United States
871NCT00639626
(ClinicalTrials.gov)
August 200814/3/2008Use of Levemir® Improves Metabolic and Clinical Status in Cystic Fibrosis-related Diabetes (CFRD)Use of Levemir® Improves Metabolic and Clinical Status in CFRDCystic Fibrosis Related DiabetesDrug: insulin detemir [rDNA origin] injectionNationwide Children's HospitalNovo Nordisk A/STerminated16 Years45 YearsAll6Phase 2/Phase 3United States
872EUCTR2006-006215-68-CZ
(EUCTR)
29/07/200816/06/2008A 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 AERUGINOSAA MULTICENTRE,MULTINATIONAL, OPEN-LABEL, RANDOMISED, PARALLEL GROUP CLINICAL TRIAL OF TOBRINEB®/ACTITOB®/ BRAMITOB® (TOBRAMYCIN SOLUTION FOR NEBULISATION, 300 MG TWICE DAILY IN 4 ML UNIT DOSE VIALS) COMPARED TO TOBI® IN THE TREATMENT OF PATIENTS WITH CYSTIC FIBROSIS AND CHRONIC INFECTION WITH PSEUDOMONAS AERUGINOSA cystic fibrosis and P. aeruginosa chronic infection
MedDRA version: 9.1;Level: LLT;Classification code 10057582;Term: Lung infection pseudomonal
MedDRA version: 9.1;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Bramitob
Product Name: Tobrineb/Bramitob
INN or Proposed INN: tobramycin
Trade Name: Tobi 300mg/5ml Nebuliser solution.
Product Name: Tobi
INN or Proposed INN: tobramycin
Chiesi Farmaceutici S.p.ANULLNot RecruitingFemale: yes
Male: yes
320Phase 3France;Hungary;Czech Republic;Spain;Germany
873EUCTR2007-004063-21-NL
(EUCTR)
24/07/200831/10/2007An open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency. - N/AAn open label, exploratory study on the effect of rhBSSL on the fat absorption in patients with cystic fibrosis and pancreatic insufficiency. - N/A Cystic fibrosis and pancreatic insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: rhBSSL
Product Code: rhBSSL
INN or Proposed INN: Bucelipase alfa
Trade Name: Nexium 20
Product Name: Nexium
INN or Proposed INN: Esomeprazole
Biovitrum ABNULLNot RecruitingFemale: yes
Male: yes
18Netherlands
874EUCTR2008-001156-43-BE
(EUCTR)
22/07/200816/06/2008A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis.A randomized, double-blind, placebo-controlled parallel group study to investigate the safety and efficacy of two doses of tiotropium bromide (2.5 µg and 5 µg) administered once daily via the Respimat device for 12 weeks in patients with cystic fibrosis. Cystic fibrosis.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Spiriva Respimat 2.5 microgram, solution for inhalation
Other descriptive name: TIOTROPIUM
Product Name: Tiotropium Respimat 1.25 microgram solution for inhalation
Other descriptive name: TIOTROPIUM
SCS Boehringer Ingelheim Comm.VNULLNot RecruitingFemale: yes
Male: yes
596Portugal;United Kingdom;Germany;Netherlands;Belgium;France;Italy
875EUCTR2006-006693-24-CZ
(EUCTR)
16/07/200809/05/2007A 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 FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
876EUCTR2008-001530-27-DE
(EUCTR)
08/07/200826/05/2008A 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 FibrosisA Phase II, Randomised, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Efficacy of 28 Day Oral Administration of AZD9668 in Patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZD9668
Product Code: AZD9668
INN or Proposed INN: none
AstraZeneca ABNULLNot RecruitingFemale: yes
Male: yes
65Phase 2United Kingdom;Germany;Denmark;Sweden
877EUCTR2007-006204-37-GB
(EUCTR)
03/07/200809/05/2008Glutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CFGlutamine supplementation for cystic fibrosis: a parallel group randomized controlled trial - Glutamine and CF Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Glutamine
Product Code: none
Other descriptive name: L-Glutamine
University of NottinghamNULLNot Recruiting Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
878NCT00706004
(ClinicalTrials.gov)
July 200825/6/2008Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic FibrosisShort Term Safety and Efficacy of Lubiprostone in Adults With Cystic FibrosisConstipation;Cystic FibrosisDrug: lubiprostoneUniversity of ArkansasTakeda Pharmaceuticals North America, Inc.Completed18 YearsN/AAll9N/AUnited States
879EUCTR2007-004277-26-IE
(EUCTR)
19/06/200827/02/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Spain;Ireland;Italy;Austria
880EUCTR2007-004277-26-NL
(EUCTR)
10/06/200829/05/2008An 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 ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open-Label, Single Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
881EUCTR2005-003772-37-GR
(EUCTR)
03/06/200821/01/2008A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE IIA Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - ASPIRE II Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder (TIP)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Trade Name: TOBI
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Greece;Spain;Ireland;Germany;Italy;United Kingdom
882NCT00645788
(ClinicalTrials.gov)
May 200826/3/2008Study to Evaluate the Safety and Efficacy of Ciprofloxacin (Inhaled) in Patients With Cystic FibrosisRandomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Safety and Efficacy of Inhaled Ciprofloxacin Compared to Placebo in Subjects With Cystic FibrosisCystic FibrosisDrug: Ciprofloxacin (Cipro Inhale, BAYQ3939);Drug: PlaceboBayerNovartisCompleted12 YearsN/AAll288Phase 2United States;Australia;Canada;Denmark;Germany;Israel;Norway;Sweden;United Kingdom
883EUCTR2007-004277-26-FR
(EUCTR)
30/04/200821/01/2008An Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic FibrosisAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam Lysine for Inhalation versus Tobramycin Nebuliser Solution in an Intermittent Aerosolized Antibiotic Regimen in Patients with Cystic Fibrosis Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
884EUCTR2007-004277-26-BE
(EUCTR)
29/04/200820/12/2007An 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 ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
885EUCTR2007-004277-26-IT
(EUCTR)
23/04/200817/06/2008An open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - NDAn open-label, randomised, phase 3 trial to evaluate the efficacy and safety of Aztreonan LYsine for inhalation versus Tobramycin nebuliser solution in an intermittent aerosolized antibiotic regimen in patients with cystic fibrosis. - ND Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: aztreonan lysine
Product Code: AZLI
INN or Proposed INN: Aztreonam
Trade Name: TOBI*NEBUL 56F 1D 300MG/5ML
INN or Proposed INN: Tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
200Phase 3Portugal;Germany;United Kingdom;Netherlands;Denmark;Belgium;France;Ireland;Spain;Italy;Austria
886EUCTR2007-004277-26-DK
(EUCTR)
16/04/200812/03/2008An 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 ExtensionAn Open-Label, Randomized, Phase 3 Trial to Evaluate the Efficacy and Safety of Aztreonam 75 mg Powder and Diluent for Nebuliser Solution (AZLI) versus Tobramycin Nebuliser Solution (TNS) in an Intermittent Aerosolized Antibiotic Regimen, in subjects with Cystic Fibrosis followed by an Open Label, Single Arm Extension Adult and paediatric cystic fibrosis (CF) patients with pulmonary Pseudomonas aeruginosa (PA) infection.
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: AZLI
INN or Proposed INN: aztreonam lysine
Trade Name: TOBI
INN or Proposed INN: tobramycin
Gilead Sciences IncNULLNot RecruitingFemale: yes
Male: yes
273Phase 3Portugal;France;Spain;Belgium;Ireland;Austria;Denmark;Netherlands;Germany;Italy;United Kingdom
887NCT01323101
(ClinicalTrials.gov)
April 200815/2/2011Doxycycline Effects on Inflammation in Cystic FibrosisEffect of Doxycycline on Sputum Biomarkers of Inflammation and Lung Epithelial Repair in Patients With Cystic Fibrosis.Cystic FibrosisDrug: Doxycycline;Other: No doxycyclineUniversity of Southern CaliforniaNULLCompleted18 YearsN/AAll21Phase 4United States
888NCT00700050
(ClinicalTrials.gov)
April 200816/6/2008Modulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis AirwaysModulation by Sex Hormones of Inflammation and Susceptibility to Pseudomonas Aeruginosa in Cystic Fibrosis Airways - A Pilot StudyCystic FibrosisDrug: Hypertonic salineThe Hospital for Sick ChildrenUnity Health TorontoActive, not recruiting14 Years28 YearsAll80Canada
889NCT00635141
(ClinicalTrials.gov)
March 20084/3/2008The Effect of Hypertonic Saline on the Lung Clearance Index in Patients With Cystic FibrosisThe Effect of Inhaled Hypertonic Saline (7%) Versus Normal Saline (0.9%) on the Lung Clearance Index in Patients With Cystic FibrosisCystic FibrosisDrug: hypertonic saline (7 %) and isotonic saline (0.9%)The Hospital for Sick ChildrenCanadian Cystic Fibrosis FoundationCompleted6 Years18 YearsBoth20Phase 3Canada
890NCT00762918
(ClinicalTrials.gov)
March 200826/9/2008Vitamin D3 for the Treatment of Low Vitamin D in Cystic FibrosisVitamin D and Its Non-Classic Roles in Cystic FibrosisCystic Fibrosis;Vitamin D DeficiencyDietary Supplement: cholecalciferolChildren's Hospital of PhiladelphiaNULLWithdrawn10 Years25 YearsBoth0Phase 3United States
891EUCTR2007-004004-12-BG
(EUCTR)
28/02/200805/02/2008A STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMYA STUDY TO INVESTIGATE THE EFFECT OF PANCRELIPASE DELAYED RELEASE CAPSULES ON MALDIGESTION IN PATIENTS WITH EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY Pancreatic enzyme replacement therapy is the cornerstone of nutritional management of pancreatic exocrine insufficiency (PEI) due to e.g. cystic fibrosis, chronic pancreatitis, partial or complete pancreatectomy or gastrectomy. Without pancreatic enzyme replacement the patients suffer from severe symptoms of maldigestion as manifested by steatorrhea, abdominal pain, body weight loss etc.
MedDRA version: 9.1;Level: LLT;Classification code 10009093;Term: Chronic pancreatitis
MedDRA version: 9.1;Classification code 10033596;Term: Pancreatectomy
Trade Name: Creon 10000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Trade Name: Creon 25000
Product Name: Pancrelipase Delayed Release Capsule
Other descriptive name: Pancrelipase/Pancreas Powder
Solvay Pharmaceuticals GmbHNULLNot RecruitingFemale: yes
Male: yes
52Bulgaria
892NCT00634192
(ClinicalTrials.gov)
February 20084/3/2008Pharmacokinetic Evaluation of an 8 -Week Treatment With Inhaled TobramycinA 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) SubjectsPseudomonas InfectionsDrug: tobramycinNovartisNULLCompleted6 YearsN/AAll50Phase 3Germany
893EUCTR2006-006693-24-IT
(EUCTR)
31/01/200812/11/2007A 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 - NDA randomized, double blind, placebo controlled, dose-finding study to evaluate the efficacy and safety of aerosolized Moli1901 in adolescents (12 years of age or older) and adults with cystic fibrosis - ND Cystic fibrosis
MedDRA version: 6.1;Level: PT;Classification code 10011763
Product Name: DURAMYCIN
Product Code: MOLI 1901
AOP ORPHAN PHARMACEUTICALSNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
894EUCTR2006-006693-24-ES
(EUCTR)
21/01/200814/09/2007Estudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y la seguridad de Moli1901 aerosol en adolescentes (12 años de edad o más) y adultos con fibrosis quística - MOLIEstudio aleatorizado, doble ciego, controlado con placebo, de búsqueda de dosis, para evaluar la eficacia y la seguridad de Moli1901 aerosol en adolescentes (12 años de edad o más) y adultos con fibrosis quística - MOLI La FQ es la enfermedad hereditaria mortal más frecuente en la población caucásica, afectando a unos 4 de cada 10.000 niños. En la fibrosis quística, el transporte de cloro a través del epitelio respiratorio es deficiente, de manera que la mucosidad contiene menos agua y su viscosidad está aumentada de manera anormal. Se puede suponer que Moli1901 corrige el transporte anormal de cloro y agua en los pulmones y de ese modo reduce la formación de tapones de mucosidad y aumenta el aclaramiento.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
895EUCTR2007-000171-41-IT
(EUCTR)
31/12/200707/01/2008A 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 - NDA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - ND Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency.
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTUS-135
Product Code: ALTUS-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
ALTUS PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
176Phase 3Italy
896EUCTR2007-000178-21-IT
(EUCTR)
31/12/200707/01/2008An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - NDAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency. - ND Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: Multienzymes (lipase, protease etc.)
ALTUS PHARMACEUTICALS INCNULLNot RecruitingFemale: yes
Male: yes
200Italy
897EUCTR2007-005346-20-GB
(EUCTR)
04/12/200728/11/2007Does nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICFDoes nebulised tobramycin (TOBI) via e-flow delivery systems cause a raised peak serum tobramycin level in children with Cystic Fibrosis? - TOBICF Children with cystic fibrosisTrade Name: Tobi 300 mg/5 ml Nebuliser Solution
Product Name: TOBI
INN or Proposed INN: tobramycin
Leeds Teaching Hospitals NHS TrustNULLNot RecruitingFemale: yes
Male: yes
30United Kingdom
898NCT00484263
(ClinicalTrials.gov)
December 20077/6/2007The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis BronchiectasisThe Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non-cystic Fibrosis Bronchiectasis.BronchiectasisDrug: Hypertonic saline 6% -The AlfredNULLCompleted18 YearsN/ABoth40Phase 3Australia
899EUCTR2007-003628-39-IT
(EUCTR)
22/11/200708/04/2008Pilot 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 - NDPilot study to evaluate the local tollerability and efficacy of a new tobramycin 3% nasal spray formulation to reduce the bacterial density of Pseudomonas aeruginosa and/or Staphylococcus aureus, in patients affected by Cystic Fibrosis with rhinosinusal infection - ND Rhinosinusal infection by Pseudomonas a. e/o Staphylococcus a. in patients with Cystic Fibrosis
MedDRA version: 9.1;Level: HLGT;Classification code 10024970;Term: Respiratory tract infections
Product Code: TNSE
INN or Proposed INN: TOBRAMYCIN
ECUPHARMA S.R.L.NULLNot RecruitingFemale: yes
Male: yes
Italy
900EUCTR2005-003772-37-HU
(EUCTR)
08/11/200703/07/2007A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder (TIP)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Trade Name: TOBI
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Germany;United Kingdom;Spain;Italy;Greece
901NCT00510484
(ClinicalTrials.gov)
November 20071/8/2007Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic FibrosisA 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 FibrosisCystic FibrosisDrug: Pancrelipase Delayed Release;Drug: Placebo ComparatorSolvay PharmaceuticalsNULLCompleted12 YearsN/AAll35Phase 3United States;Hungary;Israel;South Africa;Spain
902NCT00537602
(ClinicalTrials.gov)
November 200728/9/2007Miglustat / OGT 918 in the Treatment of Cystic FibrosisSingle 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 MutationCystic FibrosisDrug: miglustat;Drug: placeboActelionNULLTerminated12 YearsN/ABoth6Phase 2Spain
903EUCTR2007-002912-24-DE
(EUCTR)
30/10/200705/09/2007Study 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 yearsStudy to evaluate the safety and pharmacokinetics of ciprofloxacin following inhalation of ciprofloxacin dry powder for inhalation administered to pediatric patients with cystic fibrosis aged 12-17 years long term treatment of chronic lung infections caused by Pseudomonas aeruginosa in patients with cystic fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Ciprofloxacin
Product Code: BAY q 3939
INN or Proposed INN: CIPROFLOXACIN
Other descriptive name: 1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-7-[1-piperazinyl]-3-quinoline carboxylic acid
Bayer HealthCare AGNULLNot RecruitingFemale: yes
Male: yes
16Germany
904EUCTR2007-002657-23-DE
(EUCTR)
01/10/200709/07/2007A 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 G551DA Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study of VX-770 to Evaluate Safety, Pharmacokinetics, and Biomarkers of CFTR Activity in Cystic Fibrosis (CF) Subjects with Genotype G551D cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: NA
Other descriptive name: VRT-813077
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: NA
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
36Phase 2Germany
905EUCTR2007-001412-23-IE
(EUCTR)
27/09/200711/07/2007Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
250United Kingdom;Ireland
906EUCTR2007-000724-40-BE
(EUCTR)
27/09/200727/04/2007A Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisA 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: PTC124PTC Therapeutics, Inc.NULLNot RecruitingFemale: yes
Male: yes
30Phase 2Belgium
907EUCTR2006-006693-24-DE
(EUCTR)
29/08/200729/05/2007A 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 FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
908EUCTR2006-006693-24-FR
(EUCTR)
23/08/200716/05/2007A 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 FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In Cystic Fibrosis chloride transport accross the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli 1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli 1901 (2622U90, duramycin)
Product Code: Moli 1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Phase 2;Phase 3France;Hungary;Czech Republic;Poland;Spain;Austria;Germany;Italy;Sweden
909EUCTR2006-006693-24-SE
(EUCTR)
16/08/200702/07/2007A 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 FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
910EUCTR2007-000959-33-DE
(EUCTR)
16/08/200704/04/2007Randomized, open labelled, cross over deposition study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS® in subjects with CFRandomized, 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 infectionProduct Name: Tobramycin 100 PARI
Product Code: T100 PARI
INN or Proposed INN: Tobramycin
Trade Name: TOBI®
INN or Proposed INN: Tobramycin
PARI GmbHNULLNot RecruitingFemale: yes
Male: yes
25Germany
911NCT01018303
(ClinicalTrials.gov)
August 200719/11/2009Safety and Efficacy of an Antioxidant-rich Multivitamin Supplement in Cystic FibrosisSafety and Efficacy of a Novel Antioxidant-rich Multivitamin Supplement for Persons With Cystic FibrosisCystic FibrosisDietary Supplement: AquADEKUniversity of Colorado, DenverCystic Fibrosis Foundation Therapeutics;Yasoo Health;National Institutes of Health (NIH)Completed10 Years40 YearsBoth17Phase 1/Phase 2United States
912EUCTR2006-006693-24-HU
(EUCTR)
27/07/200718/06/2007A 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 FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
913EUCTR2007-000178-21-SK
(EUCTR)
16/07/200710/04/2008An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovakia;Italy
914EUCTR2007-000171-41-SK
(EUCTR)
16/07/200710/04/2008A 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 InsufficiencyA Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of ALTU-135 Treatment in Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011766;Term: Cystic fibrosis pancreatic
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals IncNULLNot RecruitingFemale: yes
Male: yes
176Phase 3Slovakia;Italy
915NCT01293084
(ClinicalTrials.gov)
July 20079/2/2011Hypertonic Saline and Mucociliary Clearance in ChildrenAcute Inhalation of Hypertonic Saline Does Not Improve Mucociliary Clearance in All Children With Cystic FibrosisCystic FibrosisDrug: 0.12% saline;Drug: 7% salineJohns Hopkins UniversityCystic Fibrosis Foundation TherapeuticsCompleted7 Years12 YearsAll17Phase 2NULL
916NCT00506688
(ClinicalTrials.gov)
July 200724/7/2007Efficacy and Safety Study of Inhaled Glutathione in Cystic Fibrosis PatientsRandomized, Placebo-controlled, Double-blinded Study to Investigate the Efficacy and Safety of a 24-week Inhalation Treatment With Glutathione in Cystic Fibrosis PatientsCystic FibrosisDrug: reduced glutathione sodium salt;Drug: 0.9% normal saline (control)Mukoviszidose Institut gGmbHCystic Fibrosis Foundation TherapeuticsCompleted8 YearsN/ABoth153Phase 2Germany
917NCT00506792
(ClinicalTrials.gov)
July 200722/7/2007Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of QAU145 in Patients With Cystic FibrosisA 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 FibrosisCystic FibrosisDrug: QAU145;Drug: PlaceboNovartis PharmaceuticalsNULLCompleted18 Years50 YearsBoth9Phase 2United States
918EUCTR2007-002707-40-BE
(EUCTR)
28/06/200704/06/2007The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients The effect of inhalation with hypertonic saline (7%) on lung function and sputum rheology in Cystic Fibrosis patients Mucoviscidose
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Hypertonic saline solution
INN or Proposed INN: Sodium Chloride
Product Name: Normal saline solution
INN or Proposed INN: Sodium Chloride
University Hospital GhentNULLNot RecruitingFemale: yes
Male: yes
60Belgium
919EUCTR2006-006980-22-BE
(EUCTR)
27/06/200719/07/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin sulfate
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Hungary;Belgium
920EUCTR2006-006980-22-HU
(EUCTR)
14/06/200703/04/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Hungary;Belgium
921EUCTR2006-003275-12-DK
(EUCTR)
23/05/200717/04/2007Scandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin StudyScandinavian Cystic Fibrosis Azithromycin StudySupplementary oral azithromycin in treatment of intermittent Pseudomonas aeruginosa colonization in CF-patients with inhaled colistin and oral ciprofloxacin; postponing next isolate of pseudomonas and prevention of chronic infection. A prospective, double-blinded, placebo-controlled scandinavian multi-centre study. A investigator initiated study - Scandinavian Cystic Fibrosis Azithromycin Study Cystic fibrosis with intermittent colonization of the airways with pseudomonas aeruginosa.
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Trade Name: Zitromax
Product Name: zitromax
Product Code: zitromax
INN or Proposed INN: AZITHROMYCIN
Copenhagen CF-centreNULLNot RecruitingFemale: yes
Male: yes
250Phase 4Denmark
922EUCTR2006-006980-22-SK
(EUCTR)
17/05/200723/04/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)Transave, Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noHungary;Slovakia;Poland;Belgium
923EUCTR2006-006693-24-AT
(EUCTR)
09/05/200711/01/2007A 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 FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
160Hungary;Germany;Czech Republic;France;Spain;Italy;Austria;Sweden
924EUCTR2006-006362-41-GB
(EUCTR)
05/04/200728/03/2007An open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CFAn open study on the pharmacokinetics and safety of oral voriconazole in adult patients with cystic fibrosis - Voriconazole in CF Adult patients with cystic fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Vfend
Product Name: Vfend
INN or Proposed INN: VORICONAZOLE
Leeds Teaching Hospital NHS TrustNULLNot Recruiting Female: yes
Male: yes
12 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
925NCT00458341
(ClinicalTrials.gov)
March 23, 20076/4/2007A Study of Ataluren in Pediatric Participants With Cystic FibrosisA Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: AtalurenPTC TherapeuticsNULLCompleted6 Years18 YearsAll30Phase 2Belgium;France;Israel
926EUCTR2006-004078-28-GB
(EUCTR)
14/03/200715/02/2012Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 14.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Product Name: IDPM: Inhaled Dry Powder Mannitol
Product Code: IDPM
INN or Proposed INN: MANNITOL
Pharmaxis UK LimitedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United Kingdom
927NCT00431964
(ClinicalTrials.gov)
February 20072/2/2007Effect of Azithromycin on Lung Function in 6-18 Year-olds With Cystic Fibrosis (CF) Not Infected With P. AeruginosaMulti-center, Multi-national, Randomized, Placebo-Controlled Trial of Azithromycin in Subjects With Cystic Fibrosis 6-18 Years Old, Culture Negative for Pseudomonas AeruginosaCystic FibrosisDrug: azithromycin 250 mg tablets;Drug: placebo tabletsCF Therapeutics Development Network Coordinating CenterCystic Fibrosis Foundation TherapeuticsCompleted6 Years18 YearsAll263Phase 4United States;Canada
928EUCTR2006-005180-25-DE
(EUCTR)
15/12/200631/10/2006A study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group designA study investigating the safety, tolerability and pharmacodynamics of bacterial lipase in patients with cystic fibrosis and pancreatic insufficiencyRandomized, double-blind, placebo-controlled, single period, parallel group design Caucasian males aged between 18 and 50 years of age (inclusive) with cystic fibrosis and pancreatic insufficiency able to discontinue their standard pancreatic enzyme therapy during the treatment phase of the study.
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Code: LU 70274Nordmark Arzneimittel GmbHNULLNot RecruitingFemale: no
Male: yes
20Germany
929NCT00351078
(ClinicalTrials.gov)
December 200611/7/2006PTC124 for the Treatment of Cystic FibrosisA Phase 2b Extension Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: PTC124PTC TherapeuticsNULLCompleted18 YearsN/AAll19Phase 2Israel
930EUCTR2006-001254-27-FR
(EUCTR)
30/11/200625/08/2006Open randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitusOpen randomised prospective comparative multi-centre intervention study of patients with cystic fibrosis and early diagnosed diabetes mellitus Patients atteints de mucoviscidose, chez lesquels un diagnostic de diabète a été fait par hyperglycémie provoquée orale (HGPO)
MedDRA version: 8.1;Level: PT;Classification code 10012594;Term: DIABETES
Trade Name: NovoNorm 0.5 mg
Product Name: NovoNorm 0.5 mg
INN or Proposed INN: Répaglinide
Trade Name: Actrapid Penfill 100UI/ml
Product Name: Actrapid Penfill 100UI/ml
INN or Proposed INN: Insuline humaine recombinante
Trade Name: NovoNorm 1 mg
Product Name: NovoNorm 1 mg
INN or Proposed INN: Répaglinide
Trade Name: NovoNorm 2 mg
Product Name: NovoNorm 2 mg
INN or Proposed INN: Répaglinide
ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
France
931NCT00450073
(ClinicalTrials.gov)
November 200619/3/2007Improving Vitamin D Status In Cystic FibrosisDesktop Tanning Unit to Improve Vitamin D Status in Patients With Cystic Fibrosis and Short Bowel Syndrome: A Pilot StudyCystic FibrosisDrug: ergocalciferol (vitamin D2);Device: Sperti Del Sol Lamp;Drug: Vitamin D3Atlanta VA Medical CenterEmory UniversityCompleted18 Years60 YearsAll30N/AUnited States
932NCT00763412
(ClinicalTrials.gov)
November 200629/9/2008Pilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic FibrosisPilot and Feasibility Study for the Treatment of Pre-diabetes in Patients With Cystic FibrosisCystic Fibrosis Related Diabetes;Pancreatic InsufficiencyDrug: placebo;Drug: repaglinideArbelaez, Ana MariaWashington University School of Medicine;National Institutes of Health (NIH);Novo Nordisk A/S;National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Completed12 Years24 YearsAll31N/AUnited States
933NCT00405665
(ClinicalTrials.gov)
November 200628/11/2006The Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic FibrosisPilot Study of the Short Term Safety and Efficacy of Inhaled L-arginine in Patients With Cystic FibrosisCystic FibrosisDrug: L-arginineThe Hospital for Sick ChildrenNULLCompleted14 YearsN/ABoth20Phase 2Canada
934NCT00408317
(ClinicalTrials.gov)
November 20064/12/2006Safety 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 InsufficiencyDrug: Ultrase® MT20;Drug: PlaceboForest LaboratoriesNULLCompleted7 YearsN/AAll36Phase 3United States
935EUCTR2005-003870-88-DE
(EUCTR)
20/10/200628/08/2006Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4Randomized, placebo-controlled, double-blind study to investigate the efficacy and safety of a 24-week inhalation treatment with glutathione in cystic fibrosis patients - GSH-4 Cystic fibrosis (CF) is the most common autosomal recessive lethal hereditary disorder in Caucasians. The majority of cystic fibrosis patients die as a result of progressive pulmonary disease. Airway inflammation, characterized by an excessive and persistent neutrophilic infiltration, is key for the pathogenesis of CF lung disease, and ultimately leads to lung destruction.Product Name: GSH (Glutathione)
Product Code: TAD 600
INN or Proposed INN: Glutathione
Other descriptive name: reduced glutathione
Mukoviszidose Institut gGmbH i. G.NULLNot RecruitingFemale: yes
Male: yes
160Germany
936EUCTR2006-002259-33-DE
(EUCTR)
10/10/200611/07/2006Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study -Protocol for a Phase II-studyAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo - a randomised, double-blinded, placebo-controlled, cross over study - CF-patients develop a chronic pulmonary infection with Pseudomonas aeruginosa (P. aeruginosa). At present it is unknown why CF-patients are highly sensitive to P. aeruginosa infections and, most important, no curative treatment for cystic fibrosis is available. This Study should provide a novel anti-inflammatory treatment for cystic fibrosis, which reduces pulmonary complications, progression of the disease and may possibly increase the life-expectance of the patients.Trade Name: Amitriptylin-ct Tabletten
Product Name: Amitriptyline
INN or Proposed INN: AMITRIPTYLINE
Trade Name: Amitriptylin-ct Tabletten
Product Name: Amitriptyline
INN or Proposed INN: AMITRIPTYLINE
Trade Name: Amitriptylin-ct Tabletten
Product Name: Amitriptyline
INN or Proposed INN: AMITRIPTYLINE
Paediatrisches Sekretariat fuer Klinische StudienNULLNot RecruitingFemale: yes
Male: yes
18Phase 2Germany
937NCT01463371
(ClinicalTrials.gov)
October 200628/10/2011Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With BronchiectasisEffects of Long-Term Azithromycin Treatment on Airway Oxidative Stress Markers in Patients With Stable Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: AzithromycinInstituto de Investigacion Sanitaria La FeSociedad Valenciana de NeumologíaCompleted16 Years80 YearsBoth30N/ASpain
938NCT00671723
(ClinicalTrials.gov)
October 200630/4/2008Dornase Alpha Versus Hypertonic Saline for Lung Atelectasis in Non-Cystic Fibrosis PatientsDornase Alpha Versus Hypertonic Saline for Lung AtelectasisAtelectasisDrug: Normal saline:;Drug: Hypertonic Saline;Drug: Dornase alphaUniversity of OklahomaNULLCompleted18 Years90 YearsAll33N/AUnited States
939EUCTR2005-005594-29-SK
(EUCTR)
14/09/200611/08/2006A 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 FibrosisA 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 FibrosisProduct Name: Moli1901
Product Code: Moli1901
Other descriptive name: Duramycin, 2622U90
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
360Phase 2;Phase 3Czech Republic;Hungary;Slovakia
940EUCTR2006-000945-20-GB
(EUCTR)
22/08/200618/09/2006To 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 FibrosisTo investigate the effect of vitamin K supplementation on markers of bone turnover and bone density in adolescents and adults with cystic fibrosis - Vitamin K supplementation in Cystic Fibrosis Cystic Fibrosis
MedDRA version: 8.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Trade Name: Menadiol Diphosphate
Product Name: Menadiol Diphosphate
Product Code: Menadiol Diphosphate
INN or Proposed INN: Menadiol sodium diphosphate
Barts and the London NHS TrustNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom
941EUCTR2005-002997-31-GB
(EUCTR)
10/08/200609/11/2005A multi-centre randomised trial of insulin detemir in pre-diabetes associated with cystic fibrosis. - Randomized trial of insulin detemir in CF associated pre-diabetesA 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 PenfillSheffield Children's NHS TrustNULLNot Recruiting Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
942NCT00572975
(ClinicalTrials.gov)
August 200611/12/2007Malabsorption Blood Test:Toward a Novel Approach to Quantify SteatorrheaMALABSORPTION BLOOD TEST: Toward a Novel Approach to Quantify SteatorrheaCystic Fibrosis;Pancreatic InsufficiencyOther: Pentadecanoic acid (PA) and Triheptadecanoin (THA)Children's Hospital of PhiladelphiaSolvay PharmaceuticalsCompleted8 YearsN/ABoth9Phase 4United States
943EUCTR2005-004344-30-HU
(EUCTR)
10/05/200623/12/2005An 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 DiseaseAn Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli1901 (2622U90, duramycin)
Product Code: EU Orphan Designation Number EU/3/02/120
Other descriptive name: Duramycin, 2622U90
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
18Hungary
944EUCTR2005-004103-10-DE
(EUCTR)
03/05/200630/01/2006Randomized, 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 infectionsRandomized, open labeled, multi center, active controlled, parallel 28 days safety and bioavailability study of Tobramycin 100 PARI nebulized with eFlow® versus TOBI® nebulized with PARI LC PLUS in cystic fibrosis patients with Pseudomonas Aeruginosa infections Cystic Fibrosis with Pseudomoas aeuriginosa infection
MedDRA version: 8.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Tobramycin 100 PARI
Product Code: T100 PARI
INN or Proposed INN: Tobramycin
Trade Name: Tobi
Product Name: TOBI®
INN or Proposed INN: Tobramycin
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Germany
945NCT00399945
(ClinicalTrials.gov)
May 200614/11/2006Tobramycin Inhalation Solution Administered by eFlow Rapid Nebulizer: Scintigraphy StudyA 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 FibrosisCystic FibrosisDrug: TobramycinNovartisNULLCompleted18 Years65 YearsBoth12Phase 1United Kingdom
946NCT00420836
(ClinicalTrials.gov)
April 200610/1/2007Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic StudyCrossover 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 SubjectsCystic FibrosisDrug: TobramycinNovartisNULLCompleted6 YearsN/ABoth20Phase 1NULL
947EUCTR2005-003772-37-IT
(EUCTR)
28/02/200623/06/2006A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003A randomized, open label, multicentre, phase 3 trial to assess the safety of Tobramycin Inhalation Powder compared to TOBI in cystic fibrosis subjects - TIP003 Cystic Fibrosis with presence of Pseudomonas aeruginosa infection
MedDRA version: 6.1;Level: PT;Classification code 10011763
INN or Proposed INN: Tobramycin
Product Name: Tobramycin Inhalation Powder TIP delivered by the T-326 Inhaler
Product Code: T-326
INN or Proposed INN: Tobramycin
CHIRON CORPORATION LIMITEDNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Germany;United Kingdom;Spain;Italy;Greece
948EUCTR2005-003772-37-ES
(EUCTR)
09/02/200620/01/2006A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística.A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Estudio aleatorizado, abierto, multicéntrico, fase III para evaluar la seguridad de Tobramicina polvo inhalatorio comparado con TOBI en pacientes con fibrosis quística. Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder
Product Code: TIP
INN or Proposed INN: Tobramycin
Trade Name: TOBI 300mg/5mL Nebuliser Solution
Product Name: TOBI
INN or Proposed INN: Tobramycin
Chiron Corporation LtdNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Greece;Spain;Germany;Italy;United Kingdom
949NCT00388505
(ClinicalTrials.gov)
February 200616/10/2006Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic FibrosisA Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis SubjectsCystic FibrosisDrug: Tobramycin Inhalation Powder;Drug: Tobramycin Solution for InhalationNovartis PharmaceuticalsNULLCompleted6 YearsN/AAll517Phase 3United States;Australia;Canada;Chile;Colombia;France;Germany;Hungary;Israel;Italy;Mexico;Netherlands;Spain;United Kingdom
950NCT00298922
(ClinicalTrials.gov)
February 20062/3/2006Azithromycin in Patients With CF, Infected With Burkholderia Cepacia ComplexPhase II, Randomized, Double Blind, Placebo-Controlled Trial of Azithromycin in Patients With CF, Chronically Infected With Burkholderia Cepacia ComplexCystic FibrosisDrug: Azithromycin;Drug: PlaceboSt. Michael's Hospital, TorontoCystic Fibrosis Foundation Therapeutics;PfizerActive, not recruiting19 YearsN/ABoth45Phase 2Canada
951EUCTR2005-003772-37-GB
(EUCTR)
06/01/200609/11/2005A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects - TIP003 Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder (TIP)
Product Code: TBM100C
INN or Proposed INN: Tobramycin
Trade Name: TOBI
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;Greece;Spain;Germany;Italy;United Kingdom
952EUCTR2005-004389-17-HU
(EUCTR)
28/12/200524/10/2005SAFETY AND TOLERABILITY STUDY OF SLIT AMIKACIN 500 MG ONCE DAILY FOR 14 DAYS BY INHALATION IN CYSTIC FIBROSIS STUDY SUBJECTS CHRONICALLY INFECTED WITH PSEUDOMONAS AERUGINOSASAFETY 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 aeruginosaProduct Name: SLIT Amikacin
Product Code: TR02
INN or Proposed INN: amikacin
Other descriptive name: amikin, amiklin, amicacin, BB-K8, Biklin, Fabianol, Kaminax, Mikavir, Novamin, Pierami
Transave, IncNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
15Hungary
953EUCTR2005-004899-21-BE
(EUCTR)
22/12/200512/01/2006Safety 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. - NASafety 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 FibrosisProduct Name: SLIT(TM) Amikacin
Product Code: TR02
INN or Proposed INN: Amikacin
Other descriptive name: amikin®, amiklin, amicacin, BB-K8, Biklin®, Fabianol®, Kaminax, Mikavir, Novamin®, Pierami
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
15Belgium
954NCT00237380
(ClinicalTrials.gov)
November 30, 20057/10/2005Safety and Efficacy of Ataluren (PTC124) for Cystic FibrosisA Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: AtalurenPTC TherapeuticsNULLCompleted18 YearsN/AAll24Phase 2Israel
955EUCTR2005-000311-98-GB
(EUCTR)
09/11/200514/09/2005A 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 studyA 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 fibrosisProduct Name: Boots High Strength Garlic Odour Controlled
Product Code: SE10599
University of NottinghamNULLNot Recruiting Female: yes
Male: yes
30 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
956NCT00117208
(ClinicalTrials.gov)
November 200530/6/2005Comparison of Inhaled Mannitol and rhDNase in Children With Cystic FibrosisA Cross-Over Comparative Study of Inhaled Mannitol, Alone and in Combination With Daily rhDNase, in Children With Cystic FibrosisCystic FibrosisDrug: mannitol;Drug: mannitol + pulmozyme;Drug: Dornase alphaPharmaxisNULLCompleted8 Years18 YearsBoth20Phase 2United Kingdom
957EUCTR2005-004344-30-AT
(EUCTR)
31/10/200526/09/2005An 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 DiseaseAn Evaluation of the Safety and Tolerability of Multiple Dose Regimens of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis and Stable Lung Disease Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10,000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride ans water in the lungs thereby reducing the formation of mucus plugs and improving clearance.Product Name: Moli1901 (2622U90, duramycin)
Product Code: EU Orphan Designation Number EU/3/02/120
Other descriptive name: Duramycin, 2622U90
AOP Orphan Pharmaceuticals AGNULLNot RecruitingFemale: yes
Male: yes
18Hungary;Austria
958EUCTR2004-003675-36-BE
(EUCTR)
27/10/200513/10/2005A 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 infectionA randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.Product Name: Colobreathe
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colomycin
Trade Name: TOBI 300 mg/5 ml Nebuliser Solution
Product Name: TOBI®
INN or Proposed INN: Tobramycin
Other descriptive name: TOBI®
Forest Laboratories UK LtdNULLNot RecruitingFemale: yes
Male: yes
360Denmark;Belgium
959EUCTR2005-003837-42-GB
(EUCTR)
26/09/200524/08/2005CIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosisCIPROFLOXACIN-INDUCED PHOTOTOXICITY IN PATIENTS WITH CYSTIC FIBROSIS - ciprofloxacin phototoxicity cystic fibrosis infection - ciprofloxacin is used to treat various infections, for example respiratory tract infections, ear, nose and throat infections, eye infections, urinary tract infections. The main indication that is relevant to this application is its use in the treatment of chest infections in patients with cystic fibrosis. I have included the ICD classification for chest infection below.Trade Name: Ciprofloxacin (ciproxin)
Product Name: N/A
Product Code: N/A
Belfast City Hospital TrustNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
960EUCTR2005-002035-28-LT
(EUCTR)
19/09/200524/08/2005A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) SubjectsA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) Subjects pulmonary P aeruginosa infection in patient with cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Tobramycin Inhalation Powder
Product Code: TIP
INN or Proposed INN: Tobramycine
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
220Phase 3Lithuania
961NCT00125346
(ClinicalTrials.gov)
September 200528/7/2005Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis SubjectsA Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 3 Trial to Assess the Efficacy and Safety of Tobramycin Inhalation Powder (TIP) in Cystic Fibrosis (CF) SubjectsCystic FibrosisDrug: Tobramycin Inhalation PowderNovartisNULLTerminated6 Years21 YearsBoth98Phase 3United States;Argentina;Brazil;Bulgaria;Canada;Chile;Lithuania;Mexico;Former Serbia and Montenegro
962NCT00234663
(ClinicalTrials.gov)
September 20055/10/2005PTC124 for Cystic FibrosisA Phase 2 Study of PTC124 as an Oral Treatment for Nonsense-Mutation-Mediated Cystic FibrosisCystic FibrosisDrug: PTC124PTC TherapeuticsCystic Fibrosis Foundation Therapeutics;FDA Office of Orphan Products DevelopmentCompleted18 YearsN/ABoth24Phase 2United States
963EUCTR2004-002341-12-BE
(EUCTR)
05/08/200525/08/2005Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis PatientsMulticenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients Cystic fibrosis
MedDRA version: 7.0;Level: PT;Classification code 10011762
Product Name: Depelestat
Product Code: EPI-hNE4 DX-890
INN or Proposed INN: Depelestat
Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase
INN or Proposed INN: Depelestat
Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase
Debiopharm SANULLNot RecruitingFemale: yes
Male: yes
90United Kingdom;Germany;Belgium;Italy
964NCT00687466
(ClinicalTrials.gov)
August 200527/5/2008Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical DecayPhase 3 Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical DecayCystic Fibrosis;Glucose IntoleranceDrug: InsulinFondazione per la ricerca sulla Fibrosi CisticaNULLActive, not recruiting10 Years70 YearsBoth70Phase 3Italy
965EUCTR2005-002135-27-IT
(EUCTR)
06/07/200528/06/2005Glargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deteriorationGlargine insulin efficacy in Cystic Fibrosis patients with glucose intolerance and clinical deterioration Cystic Fibrosis patients with glucose intolerance
MedDRA version: 6.1;Level: PT;Classification code 10011762
Trade Name: LANTUS*SC 5CAR3ML100UI/ML
Product Name: NA
Product Code: NA
INN or Proposed INN: Insulin glargine
ISTITUTO GIANNINA GASLININULLNot RecruitingFemale: yes
Male: yes
Italy
966EUCTR2004-005019-28-GB
(EUCTR)
09/05/200519/04/2005Diabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucoseDiabetes therapy to improve body mass index pulmoanry function in cystic fibrosis subjects with abnormal blood glucose Cystic fibrosis related diabetes mellitusTrade Name: NovoRapid Aspartate
INN or Proposed INN: Novo Rapid
Trade Name: Rapeglinide
INN or Proposed INN: Rapeglinide
Papworth Hospital NHS Foundation TrustNULLNot Recruiting Female: yes
Male: yes
6 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesUnited Kingdom
967EUCTR2004-003675-36-DK
(EUCTR)
28/04/200506/12/2004A 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 infectionA randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.Product Name: Colobreathe
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colomycin
Product Name: TOBI®
INN or Proposed INN: Tobramycin
Other descriptive name: TOBI®
Forest Laboratories UK LtdNULLNot RecruitingFemale: yes
Male: yes
360Belgium;Denmark
968EUCTR2004-003675-36-AT
(EUCTR)
19/04/200515/03/2005A 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 infectionA randomised, open label study to compare the efficacy and safety of a dry powder formulation of inhaled Colistimethate Sodium and nebulised TNSFI (Tobramycin nebuliser solution for inhalation, TOBI®) in cystic fibrosis patients with pseudomonas aeruginosa lung infection Pseudomonas aeruginosa (PA) infection in patients with cystic fibrosis.Product Name: Colobreathe
INN or Proposed INN: Colistimethate sodium
Other descriptive name: Colomycin
Trade Name: TOBI 300 mg/5 ml Nebuliser Solution
Product Name: TOBI®
INN or Proposed INN: Tobramycin
Other descriptive name: TOBI®
Forest Laboratories UK LtdNULLNot RecruitingFemale: yes
Male: yes
360Belgium;Denmark;Austria
969EUCTR2004-002341-12-GB
(EUCTR)
15/04/200510/02/2005Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis PatientsMulticenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients Cystic fibrosis
MedDRA version: 7.0;Level: PT;Classification code 10011762
Product Name: Depelestat
Product Code: EPI-hNE4 DX-890
INN or Proposed INN: Depelestat
Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase
INN or Proposed INN: Depelestat
Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase
Debiopharm SANULLNot RecruitingFemale: yes
Male: yes
90Phase 2Belgium;Germany;Italy;United Kingdom
970EUCTR2005-000313-35-GB
(EUCTR)
13/04/200517/03/2005A 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 StudyA Phase I/II Study to Investigate the Efficacy and Safety of AER 002 in Cystic Fibrosis Given at 3 mg, 10 mg, and 30 mg Doses in Single then Multiple Ascending Doses and to Determine Efficacy of the Highest Tolerable Dose in a 4-Week Proof of Concept Study Cystic Fibrosis
MedDRA version: 7.1;Level: LLT;Classification code 10011762
Product Name: Recombinant truncated SPINT2 protease inhibitor
Product Code: AER002
Aerovance IncNULLNot RecruitingFemale: yes
Male: yes
106Phase 1;Phase 2United Kingdom
971EUCTR2004-004334-13-IE
(EUCTR)
08/04/200506/12/2004A Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Talniflumate in Cystic Fibrosis SubjectsA Phase 2 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of Talniflumate in Cystic Fibrosis Subjects Cystic FibrosisTrade Name: Somalgen
Product Name: Talniflumate
Product Code: MSI-1995
INN or Proposed INN: Talniflumate
Genaera CorporationNULLNot RecruitingFemale: yes
Male: yes
220Phase 2Ireland
972EUCTR2004-002341-12-DE
(EUCTR)
14/02/200524/09/2004Multicenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis PatientsMulticenter, 8-week, Randomised, Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients Cystic fibrosis
MedDRA version: 7.0;Level: PT;Classification code 10011762
Product Name: Depelestat
Product Code: EPI-hNE4 DX-890
INN or Proposed INN: Depelestat
Other descriptive name: Engineered Protein Inhibitor of human Neutrophil Elastase
INN or Proposed INN: Depelestat
Other descriptive name: Engineerd Protein Inhibitor of human Neutrophil Elastase
Debiopharm SANULLNot RecruitingFemale: yes
Male: yes
90United Kingdom;Germany;Belgium;Italy
973EUCTR2004-002341-12-IT
(EUCTR)
12/01/200516/03/2005Multicenter, 8-week, Randomised,Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis PatientsMulticenter, 8-week, Randomised,Double-Blind, Placebo Controlled Study of Two Doses of Depelestat in Cystic Fibrosis Patients cystic fibrosis
MedDRA version: 6.1;Level: PT;Classification code 10011762
Product Name: DEPELESTAT
Product Code: DX-890
INN or Proposed INN: Other respiratory system products
Product Name: DEPELESTAT
Product Code: DX-890
INN or Proposed INN: Other respiratory system products
DEBIOPHARM S.A.NULLNot RecruitingFemale: yes
Male: yes
90United Kingdom;Germany;Belgium;Italy
974EUCTR2004-001888-21-GB
(EUCTR)
03/12/200422/02/2005A cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic FibrosisA cross-over comparative study of inhaled mannitol, alone and in combination with daily rhDNase, in children with cystic fibrosis - Inhaled Mannitol in Cystic Fibrosis Cystic fibrosis (CF)Product Name: DP Mannitol
INN or Proposed INN: Mannitol
Trade Name: Pulmozyme (dornase alfa)
Product Name: Pulmozyme (dornase alfa)
INN or Proposed INN: Dornase alfa
Other descriptive name: rhDNAse
Pharmaxis LtdNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom
975NCT00823238
(ClinicalTrials.gov)
July 200429/12/2008Comparison of Antibiotics for Pseudomonas in Early CFComparison of Antibiotics for Pseudomonas in Early CFCystic FibrosisDrug: ceftazidime and tobramycin;Drug: inhaled tobramycinUniversity of North Carolina, Chapel HillCystic Fibrosis Foundation TherapeuticsCompleted3 Months16 YearsBoth21Phase 1United States
976NCT00163852
(ClinicalTrials.gov)
February 200412/9/2005Treatment of Metabolic Alkalosis in Acute Exacerbations of Cystic FibrosisSalt Replacement for Metabolic Alkalosis in Acute Exacerbations of Cystic FibrosisCystic FibrosisDrug: Normal saline IV, salt tabletsBayside HealthNational Health and Medical Research Council, Australia;Monash University;Cystic Fibrosis AustraliaRecruiting18 Years75 YearsBoth40Phase 2/Phase 3Australia
977NCT00728715
(ClinicalTrials.gov)
January 200431/7/2008Efficacy of Budesonide-Formoterol in BronchiectasisClinical Efficacy and Safety of Budesonide and Formoterol in the Management of Non-Cystic Fibrosis BronchiectasisBronchiectasisDrug: budesonide-formoterol single inhaler;Drug: High dose of budesonide;Drug: A;Drug: BHospital General de RequenaEsteve Labs (Grant)Completed18 Years80 YearsBoth40N/ASpain
978NCT00633191
(ClinicalTrials.gov)
November 20034/3/2008Anti-pseudomonas IgY to Prevent Infections in Cystic FibrosisPost Marketing Study of Anti-pseudomonas IgY in Prevention of Recurrence of Pseudomonas Aeruginosa Infections Infections in Cystic Fibrosis (CF) PatientsCystic Fibrosis;Infection;Pseudomonas AeruginosaDrug: Anti-pseudomonas IgY gargleImmunsystem ABNULLCompletedN/AN/ABoth14Phase 1/Phase 2Sweden
979NCT00391976
(ClinicalTrials.gov)
November 200319/10/2006Efficacy and Safety of 28 or 56 Day Treatment for Pseudomonas Aeruginosa in Children With Cystic FibrosisThe 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 FibrosisCystic FibrosisDrug: Tobramycin solution for inhalation 300 mgNovartisNULLCompleted6 MonthsN/AAll123Phase 3NULL
980NCT00157183
(ClinicalTrials.gov)
March 20039/9/2005Non-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen DesaturationNon-invasive Ventilation and Oxygen Therapy in Cystic Fibrosis Patients With Nocturnal Oxygen DesaturationCystic FibrosisDevice: Nocturnal oxygen , nocturnal bi-level positive pressure ventilationBayside HealthNational Health and Medical Research Council, Australia;Monash University;Cystic Fibrosis AustraliaCompleted18 Years75 YearsBoth59Phase 1/Phase 2Australia
981NCT00662714
(ClinicalTrials.gov)
September 200117/4/2008Early Diagnosis of Diabetes Mellitus in Patients With Cystic FibrosisOpen Randomised Prospective Comparative Multi-centre Intervention Study of Patients With Cystic Fibrosis and Early Diagnosed Diabetes MellitusCystic Fibrosis;Diabetes MellitusDrug: Repaglinide;Drug: short-acting Insulin (Actrapid)Mukoviszidose Institut gGmbHNovo Nordisk A/S;Mucoviscidose-ABCF2;Assistance Publique - Hôpitaux de ParisCompleted10 YearsN/ABoth73Phase 3Austria;France;Germany;Italy
982NCT00274391
(ClinicalTrials.gov)
July 20019/1/2006Efficacy of Amiloride and Hypertonic Saline in Cystic FibrosisEfficacy of Amiloride and Hypertonic Saline in Cystic FibrosisCystic FibrosisDrug: 7% NaCl;Drug: Amiloride HClUniversity of North CarolinaCystic Fibrosis Foundation TherapeuticsCompleted14 YearsN/ABoth24Phase 2United States
983NCT00072904
(ClinicalTrials.gov)
June 200112/11/2003Diabetes Therapy to Improve BMI and Lung Function in CFDiabetes Therapy to Improve BMI and Lung Function in CFCystic Fibrosis;Diabetes MellitusDrug: Insulin Asparte;Drug: RepaglinideNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Cystic Fibrosis Foundation Therapeutics;Novo Nordisk A/SCompleted16 YearsN/ABoth108Phase 3United States;Canada
984NCT00004489
(ClinicalTrials.gov)
October 199818/10/1999Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related OsteoporosisOsteoporosis;Cystic FibrosisDrug: alendronate sodium;Drug: calcium carbonate;Drug: cholecalciferolUniversity of North CarolinaNULLCompleted18 Years45 YearsBoth60N/AUnited States
985NCT00004705
(ClinicalTrials.gov)
September 199624/2/2000Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic FibrosisCystic FibrosisDrug: amiloride;Drug: uridineFDA Office of Orphan Products DevelopmentUniversity of North CarolinaCompleted4 YearsN/ABothN/ANULL
986NCT00004315
(ClinicalTrials.gov)
November 199518/10/1999Phase 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 DiseaseCystic Fibrosis;Gastrointestinal Diseases;CholestasisDrug: ursodiolNational Center for Research Resources (NCRR)Children's Hospital Medical Center, CincinnatiActive, not recruiting4 MonthsN/ABoth20Phase 2United States
987EUCTR2017-000571-85-PL
(EUCTR)
08/05/2017Study of Oral Liprotamase Therapy Of Non-Porcine OriginA Phase 3, Randomized, Open-Label, Assessor-Blind, Non-Inferiority, Active-Comparator Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency - RESULT: Reliable, Emergent Solution Using Liprotamase Treatment Pancreatic Exocrine Insufficiency due to Cystic Fibrosis;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: liprotamase
INN or Proposed INN: not assigned
Other descriptive name: LIPASE
INN or Proposed INN: not assigned
Other descriptive name: PROTEASE
INN or Proposed INN: not assigned
Other descriptive name: AMYLASE
Trade Name: PANCREAZE®
Product Name: PANCREAZE®
INN or Proposed INN: not assigned
Other descriptive name: PANCREATIN
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Hungary;Spain;Poland;Lithuania;Israel;United Kingdom
988EUCTR2019-004511-31-FR
(EUCTR)
01/04/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - oral suspension 40 mg/ml
Product Name: Noxafil
Trade Name: Noxafil 100 mg
Product Name: Noxafil
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
989EUCTR2018-000185-11-FR
(EUCTR)
24/01/2019A Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination TherapyA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous or Heterozygous for the F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100 mg VX-445/50 mg TEZ /75 mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: VX-445
Other descriptive name: VX-445
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNA Female: yes
Male: yes
460 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
990EUCTR2021-005320-38-BE
(EUCTR)
05/01/2022Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
991EUCTR2021-005320-38-DE
(EUCTR)
16/12/2021Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
992EUCTR2021-000694-85-BE
(EUCTR)
21/10/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
993EUCTR2017-002968-40-DE
(EUCTR)
05/04/2018A study lasting 96 weeks to assess a combined treatment called Tezacaftor and Ivacaftor in children aged 6to 11 years who have Cystic FibrosisA Phase 3, Open-label, Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Tezacaftor in Combination With Ivacaftor in Subjects With Cystic Fibrosis Aged 6 Years and Older, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Symdeko
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symkevi
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Symdeko
Product Name: Ivacaftor 75 mg
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor 150 mg
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
121Phase 3France;United States;Canada;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
994EUCTR2021-003277-55-AT
(EUCTR)
27/07/2021COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CFCOVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF - CAR-CF COVID-19 vaccine Antibody response from natural infection or after vaccination in patients with Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: LLT;Classification code 10021433;Term: Immunization;System Organ Class: 100000004865
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Trade Name: Comirnaty concentrate for dispersion for injection
Product Name: Comirnaty
INN or Proposed INN: Tozinameran
Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)
Trade Name: Vaxzevria suspension for injection COVID-19 Vaccine (ChAdOx1-S
Product Name: Vaxzevria
INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant])
Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)
Trade Name: COVID-19 Vaccine Moderna dispersion for injection
Product Name: COVID-19 Vaccine Moderna
INN or Proposed INN: Elasomeran
Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)
Trade Name: COVID-19 Vaccine Janssen suspension for injection
Product Name: COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant])
INN or Proposed INN: COVID-19 vaccine (Ad26.COV2-S [recombinant])
Other descriptive name: Ad26.COV2-S.02
Medical University of Innsbruck, University Clinic for Pediatrics IIINULLNAFemale: yes
Male: yes
5000Phase 4United States;European Union;Canada;Ireland;Austria;United Kingdom
995EUCTR2015-001997-16-DE
(EUCTR)
24/04/2017A study to assess the safety, pharmacokinetics, and pharmacodynamics of ivacaftor in children less than 24 months of age with cystic fibrosis (a rare hereditary disease that affects the lungs, digestive system and other organs).A Phase 3, 2-Part, Open-label Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Ivacaftor in Subjects With Cystic Fibrosis Who Are Less Than 24 Months of Age at Treatment Initiation and Have a CFTR Gating Mutation Cystic Fibrosis
MedDRA version: 19.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
35 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Ireland;Germany;United Kingdom
996EUCTR2020-001762-11-DE
(EUCTR)
17/09/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3Serbia;Portugal;United States;Slovakia;Greece;Spain;Austria;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Poland;Belgium;Romania;Bulgaria;Netherlands;Germany;Sweden
997EUCTR2017-004133-82-DE
(EUCTR)
08/03/2018A Study Evaluating Safety and Efficacy of VX-659 Combination Therapy in Subjects With Cystic FibrosisA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-659 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del Mutation (F/F) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-659/Tezacaftor/Ivacaftor
Product Code: VX-659/TEZ/IVA
INN or Proposed INN: VX-659
Other descriptive name: VX-659
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Product Name: Tezacaftor/Ivacaftor/100mg/150mg
Product Code: VX-661/VX-770 (TEZ/IVA)
INN or Proposed INN: TEZACAFTOR
INN or Proposed INN: IVACAFTOR
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3United States;Spain;Ireland;Australia;Germany;United Kingdom
998EUCTR2011-000442-38-PL
(EUCTR)
01/08/2011Efficacy, safety and tolerability of Arikace™ compared to placebo in Cystic Fibrosis patients with chronic infection due to Pseudomonas AeruginosaRandomized, placebo-controlled, double-blind, multicenter study to assess the efficacy, safety and tolerability of Arikace™ in Cystic Fibrosis patients with chronic infection due to Pseudomonas Aeruginosa Pseudomonas aeruginosa pulmonary infection / colonisation in patientswith cystic fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: Amikacin Sulfate
Insmed IncorporatedNULLNot RecruitingFemale: yes
Male: yes
300Phase 3France;United States;Serbia;Macedonia, the former Yugoslav Republic of;Spain;Poland;Ukraine;Australia;Bulgaria;New Zealand;Sweden
999EUCTR2018-001695-38-IE
(EUCTR)
28/08/2019Evaluation of VX-445/TEZ/IVA in Cystic Fibrosis Subjects 6 Through 11 YearsA Phase 3 Study Evaluating the Pharmacokinetics, Safety, and Tolerability of VX-445/TEZ/IVA Triple Combination Therapy in Cystic Fibrosis Subjects 6 Through 11 Years of Age Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
Product Name: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
56Phase 3United States;Canada;Ireland;Australia;United Kingdom
1000EUCTR2018-000378-30-IE
(EUCTR)
26/06/2019A dose finding study of OligoG in patients with CF.A randomised, double-blind, dose finding study of inhaled alginate oligosaccharide (OligoG) vs placebo in patients with Cystic Fibrosis (CF). Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: OligoG CF-5/20 - 17.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20 - 27.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
Product Name: OligoG CF/20 - 37.5 mg
INN or Proposed INN: OLIGOG CF-5/20
Other descriptive name: OLIGOG CF-5/20
AlgiPharma ASNULLNot RecruitingFemale: yes
Male: yes
168Phase 2Poland;Ireland;Austria;Germany;United Kingdom
1001EUCTR2008-007416-15-DE
(EUCTR)
29/05/2009Study of VX-770 in Cystic Fibrosis Subjects Age 12 and Older With the G551D MutationA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of VX 770 in Subjects with Cystic Fibrosis and the G551D Mutation - STRIVE Cystic Fibrosis
MedDRA version: 14.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: VX-770
Product Code: VX-770, VRT-813077
INN or Proposed INN: ivacaftor
Other descriptive name: VRT-813077
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
100Phase 3France;United States;Czech Republic;Canada;Ireland;Australia;Germany;United Kingdom
1002EUCTR2010-019267-11-DE
(EUCTR)
19/10/2010AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI)AN OPEN-LABEL, MULTICENTER, RANDOMIZED, CROSS-OVER STUDY TO COMPARE THE SAFETY AND EFFICACY OF PANZYTRAT® 25 000 TO KREON® 25 000 IN THE CONTROL OF STEATORRHEA IN SUBJECTS AGED 7 YEARS AND OLDER WITH CYSTIC FIBROSIS (CF) AND EXOCRINE PANCREATIC INSUFFICIENCY (EPI) Correction of steathorrea associated with chronic exocrine pancreatic insufficiency in cystic fibrosis
MedDRA version: 13.1;Level: PT;Classification code 10033628;Term: Pancreatic insufficiency;System Organ Class: 10017947 - Gastrointestinal disorders
MedDRA version: 13.1;Level: LLT;Classification code 10041968;Term: Steatorrhea;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
Trade Name: PANZYTRAT 25000
Product Name: PANZYTRAT 25000
INN or Proposed INN: Pancreas Powder
Other descriptive name: PANCREATIN
Trade Name: KREON 25000
Product Name: KREON 25000
Other descriptive name: PANCREATIN
Axcan Pharma Inc.NULLNot RecruitingFemale: yes
Male: yes
68Germany
1003EUCTR2010-023235-41-PL
(EUCTR)
28/01/2011A comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BEA comparative, randomised, two period, multi-center, cross-over 14 weeksbioequivalence study of Tobramycin PARI (T100) versus TOBI® (Novartis) incystic fibrosis patients with bronchopulmonary chronic Pseudomonasaeruginosa infection - T-100 BE Cystic fibrosis with bronchopulmonary chronic Pseudomonas aeruginosa infection
MedDRA version: 12.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Tobramycin
Product Code: T100
INN or Proposed INN: Tobramycin
Other descriptive name: Tobramycinum
Trade Name: TOBI®
INN or Proposed INN: TOBRAMYCIN
PARI Pharma GmbHNULLNot RecruitingFemale: yes
Male: yes
60Phase 1Poland
1004EUCTR2006-006980-22-PL
(EUCTR)
22/08/2007MULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSAMULTIDOSE SAFETY AND TOLERABILITY STUDY OF DOSE ESCALATION OF LIPOSOMAL AMIKACIN FOR INHALATION (ARIKACE™) IN CYSTIC FIBROSIS PATIENTS WITH CHRONIC INFECTIONS DUE TO PSEUDOMONAS AERUGINOSA Cystic fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Liposomal Amikacin (Arikace™)
INN or Proposed INN: AMIKACIN SULFATE
Transave, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Hungary;Slovakia;Belgium;Poland
1005EUCTR2021-005320-38-AT
(EUCTR)
07/01/2022Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
1006EUCTR2015-004841-13-FR
(EUCTR)
23/06/2016A Study to Evaluate the Safety and Efficacy of VX-371 in Subjects With Cystic Fibrosis Who Are Homozygous for the F508del-CFTR MutationA Phase 2a, Randomized, Double-blind, Placebo-controlled, Incomplete Block, Crossover Study to Evaluate the Safety and Efficacy of VX-371 in Subjects Aged 12 Years or Older With Cystic Fibrosis, Homozygous for the F508del-CFTR Mutation, and Being Treated With Orkambi Cystic Fibrosis
MedDRA version: 19.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Code: VX-371 in hypertonic saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Product Code: VX-371 in saline
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-371
Trade Name: Orkambi
Product Name: lumacaftor/ivacaftor 200mg/125mg tablets
Product Code: VX-809/VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: Ivacaftor
INN or Proposed INN: Lumacaftor
Other descriptive name: LUMACAFTOR
Product Name: Hypertonic saline
INN or Proposed INN: 4.2% NaCl/inhalation solution
Vertex Pharmaceuticals Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;France;Czech Republic;Ireland;United Kingdom
1007EUCTR2021-000694-85-AT
(EUCTR)
27/10/2021A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
1008EUCTR2016-002749-42-IE
(EUCTR)
26/07/2017Study of Aztreonam for Inhalation in Children with Cystic Fibrosis and New Infection of the Airways by Pseudomonas aeruginosa bacteriaRandomized, Double-Blind, Phase 3B Trial to Evaluate the Safety and Efficacy of 2 Treatment Regimens of Aztreonam 75 mg Powder and Solvent for Nebulizer Solution / Aztreonam for Inhalation Solution (AZLI) in Pediatric Subjects with Cystic Fibrosis (CF) and New Onset Respiratory Tract Pseudomonas aeruginosa (PA) Infection/Colonization - ALPINE2 (Aztreonam Lysine for Pseudomonas Infection Eradication 2) Cystic fibrosis and new onset lower respiratory tract culture positive for Pseudomonas aeruginosa
MedDRA version: 20.1;Level: LLT;Classification code 10068288;Term: Cystic fibrosis pulmonary exacerbation;System Organ Class: 100000004862 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Cayston
Product Code: AZLI
INN or Proposed INN: AZTREONAM
Gilead Sciences, Inc.NULLNot Recruiting Female: yes
Male: yes
140 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Spain;Ireland;Austria;Israel;United Kingdom;Italy;France;Belgium;Denmark;Germany;Netherlands
1009EUCTR2016-004786-80-DE
(EUCTR)
30/06/2017Tolerability and Efficacy of Anakinra in patients with cystic fibrosis.A phase IIa, randomized, placebo-controlled, double-blind, cross-over study to evaluate safety and efficacy of subcutanous administration of anakinra in patients with cystic fibrosis. - ANAKIN Cystic fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10028141;Term: Mucoviscidosis;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Kineret
INN or Proposed INN: ANAKINRA
Ruprecht-Karls-University Heidelberg, Medical FacultyNULLNA Female: yes
Male: yes
52 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noGermany
1010EUCTR2012-002699-14-FR
(EUCTR)
20/09/2012Trial of inhaled mannitol in children with cystic fibrosisA randomised, multicentre, double-blind, placebo-controlled, crossover trial determining the efficacy of dry powder mannitol in improving lung function in subjects with Cystic Fibrosis aged six to seventeen years - DPM-CF-204 mannitol in CF aged 6-17 years Cystic fibrosis in children aged 6 to 17 years
MedDRA version: 15.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Bronchitol
Product Name: Bronchitol
Product Code: N/A
INN or Proposed INN: mannitol
Other descriptive name: N/A
Pharmaxis Ltd.NULLNot Recruiting Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;Canada;Argentina;Belgium;Spain;Austria;Netherlands;Germany;Italy;United Kingdom
1011EUCTR2007-001548-36-DE
(EUCTR)
27/07/2009Nasale 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-cfNasale 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 rhinosinusitisTrade Name: Pulmozyme
Product Name: Pulmozyme
INN or Proposed INN: Dornase alfa
Other descriptive name: recombiant human Desoxyribonuclease ( rhDNase)
University of JenaNULLNot RecruitingFemale: yes
Male: yes
16Phase 3Germany
1012EUCTR2019-004511-31-GB
(EUCTR)
06/10/2020Prospective validation and clinical evaluation of a new posaconazole dosingregimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus Infection
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: Noxafil - oral suspension 40 mg/ml
Product Name: Noxafil - oral suspension 40 mg/ml
Trade Name: Noxafil 100 mg
Product Name: Noxafil 100 mg
Bambino Gesù Children's HospitalNULLNAFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czech Republic;Greece;Spain;Ireland;Netherlands;Germany;Switzerland;Italy;United Kingdom;Sweden
1013EUCTR2014-003023-22-FR
(EUCTR)
22/06/2015Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study)Open trial with randomized withdrawal of treatment, to evaluate the efficacy of azithromycin in the treatment of bronchiectasis excluding cystic fibrosis in children (AZI-STOP study) - AZI-STOP study bronchiectasis excluding cystic fibrosis in children;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Trade Name: ZITHOMAX 40 mg/ml ENFANTS
Product Name: zithromax
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
Trade Name: ZITHROMAX 250 mg
Product Name: ZITHROMAX
INN or Proposed INN: AZITHROMYCIN DIHYDRATE
ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLENULLNot RecruitingFemale: yes
Male: yes
100Phase 3France
1014EUCTR2020-001762-11-AT
(EUCTR)
10/08/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance Study of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3United States;Serbia;Portugal;Slovakia;Greece;Spain;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Bulgaria;Germany;Sweden
1015EUCTR2016-004479-35-IE
(EUCTR)
19/02/2018A Study to Evaluate Efficacy and Safety of TEZ/IVA in Subjects Aged 6 through 11 Years With Cystic FibrosisA Phase 3, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Tezacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous or Heterozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-661/ivacaftor 50 mg/ 75 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: VX-661/ivacaftor 100 mg/ 150 mg
INN or Proposed INN: TEZACAFTOR
Other descriptive name: VRT-893661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Product Name: Ivacaftor
Product Code: VX-770, VRT-813077
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
65 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Poland;Belgium;Ireland;Denmark;Australia;Germany;United Kingdom;Switzerland
1016EUCTR2019-001827-11-GB
(EUCTR)
11/12/2019Evaluation of Long-term Safety and Efficacy of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and OlderA Phase 3, Open-label Study Evaluating the Long-term Safety and Efficacy of VX-445/TEZ/IVA Combination Therapy in Subjects With Cystic Fibrosis Who Are 6 Years of Age and Older Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445 / TEZ / IVA
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: IVACAFTOR
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Product Name: VX-445 / TEZ / IVA FDC
Product Code: VX-445 / TEZ / IVA
Vertex Pharmaceuticals IncorporatedNULLNA Female: yes
Male: yes
56 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited Kingdom;Australia;Ireland;Canada;United States
1017EUCTR2016-002851-92-PL
(EUCTR)
02/08/2016NAAn Open-Label Study Evaluating the Efficacy and Safety of Liprotamase in Subjects with Exocrine Pancreatic Insufficiency due to Cystic Fibrosis - EASY: Extended Access to Sollpura over Years Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency;Therapeutic area: Diseases [C] - Immune System Diseases [C20]Product Name: Liprotamase
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: LIPASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: PROTEASE
INN or Proposed INN: NOT ASSIGNED
Other descriptive name: AMYLASE
ANTHERA Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Czech Republic;Hungary;Canada;Spain;Poland;Israel
1018EUCTR2007-000178-21-PL
(EUCTR)
04/09/2007An Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic InsufficiencyAn Open-Label Clinical Study Evaluating the Long-Term Safety of ALTU-135 for the Treatment of Patients with Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency Cystic Fibrosis-Related Exocrine Pancreatic Insufficiency
MedDRA version: 9.1;Level: LLT;Classification code 10011765;Term: Cystic fibrosis pancreas
Product Name: ALTU-135
Product Code: ALTU-135
INN or Proposed INN: NA
Other descriptive name: Lipase CLEC
INN or Proposed INN: NA
Other descriptive name: Amylase
INN or Proposed INN: NA
Other descriptive name: Protease
Altus Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
200Phase 3Slovakia;Poland;Italy
1019EUCTR2007-001412-23-DE
(EUCTR)
26/01/2009Long Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy StudyLong Term Administration of Inhaled Dry Powder Mannitol In Cystic Fibrosis – A Safety and Efficacy Study Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Product Name: Inhaled dry powder mannitol
Product Code: IDPM
INN or Proposed INN: Mannitol
Trade Name: Aridol or Osmohale
INN or Proposed INN: Mannitol
Pharmaxis Pharmaceuticals LimitedNULLNot RecruitingFemale: yes
Male: yes
340Phase 3Ireland;Germany;United Kingdom
1020EUCTR2006-006693-24-PL
(EUCTR)
11/10/2007A 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 FibrosisA Randomized, Double-Blind, Placebo-Controlled, Dose-finding Study to Evaluate the Efficacy and Safety of Aerosolized Moli1901 in Adolescents (12 Years of Age or Older) and Adults with Cystic Fibrosis Cystic fibrosis is the most common fatal inherited disease in the Caucasian population, affecting about 4 in 10.000 children. In cystic fibrosis chloride transport across the respiratory epithelium is deficient, so the mucus contains less water and its viscosity is abnormally increased. Moli1901 corrects the abnormal transport of chloride thereby reducing the formation of mucus plugs and improving clearance.
MedDRA version: 9.1;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Moli1901 (2622U90, duramycin)
Product Code: Moli1901
INN or Proposed INN: Not available
Other descriptive name: 2622U90 Duramycin
AOP Orphan Pharmaceuticals AGNULLNAFemale: yes
Male: yes
160Phase 2France;Hungary;Czech Republic;Spain;Poland;Austria;Germany;Italy;Sweden
1021EUCTR2015-004143-39-FR
(EUCTR)
30/03/2017Saline hypertonic in preschoolers and lung structure as measured by computed tomography.A Phase 3 randomised, double-blind, controlled trial of inhaled 7% hypertonic saline versus 0.9% isotonic saline for 48 weeks in patients with Cystic Fibrosis at 3-6 years of age in parallel with the North American SHIP clinical trial - Ship-CT study Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011763;Term: Cystic fibrosis lung;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Hypertonic saline 7%
INN or Proposed INN: SODIUM CHLORIDE
Other descriptive name: SODIUM CHLORIDE PH. EUR.
Product Name: Isotonic saline 0.9%
INN or Proposed INN: SODIUM CHLORIDE
Other descriptive name: SODIUM CHLORIDE PH. EUR.
Erasmus MCNULLNot RecruitingFemale: yes
Male: yes
120Phase 3United States;France;Spain;Belgium;Denmark;Australia;Netherlands;Italy
1022EUCTR2018-002624-16-FR
(EUCTR)
21/11/2018NA Validation of respiratory epithelial functional assessment to predict clinical efficacy of Orkambi®. Pathway to personalized therapy in Cystic Fibrosis PREDICT-CF - PREDICT-CF Homozygous F508del patient aged 12 years or older
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: Orkambi®
Product Name: Orkambi®
ASSISTANC-PUBLIQUE-HOPITAUX DE PARIS (AP-HP)NULLNA Female: yes
Male: yes
104 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): yesFrance
1023EUCTR2008-002673-13-DE
(EUCTR)
27/08/2008Anti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and PlaceboAnti-inflammatory pulmonal therapy of CF-patients with Amitriptyline and Placebo Deficiency of the Cftr-molecule results in accumulation of ceramide in respiratory epithelial cells. Ceramide triggers a pro-inflammatory and -apoptotic status in cystic fibrosis patients. Amitriptyline reduces ceramide levels in the lung tissue, normalises the activity of cytokines and prevents constitutive cell death of epithelial cells. Amitriptyline prevents pulmonary infections of CF-mice with P. aeruginosa. Amitriptyline may result in an improved lung function of cystic fibrosis patients.Trade Name: Amitriptylin-CT
Product Name: Amitriptyline
INN or Proposed INN: Amitriptyline
PSKSNULLNot RecruitingFemale: yes
Male: yes
Phase 2Germany
1024EUCTR2019-004511-31-IE
(EUCTR)
21/05/2021Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection.Prospective validation and clinical evaluation of a new posaconazole dosing regimen for children and adolescents with cystic fibrosis and Aspergillus infection. - cASPerCF Cystic Fibrosis and Aspergillus infection.
MedDRA version: 20.0;Level: LLT;Classification code 10003488;Term: Aspergillosis;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: NOXAFIL - 40 mg/ml oral suspension
Product Name: Noxafil
INN or Proposed INN: POSACONAZOLE
Other descriptive name: POSACONAZOLE
Trade Name: Noxafil 100 mg Tablets Gastro-Resistant
Product Name: Noxafil
INN or Proposed INN: POSACONAZOLE
Other descriptive name: POSACONAZOLE
Bambino Gesù Children's HospitalNULLNot RecruitingFemale: yes
Male: yes
135Phase 2;Phase 3Portugal;France;Czechia;Greece;Spain;Ireland;Netherlands;Germany;United Kingdom;Switzerland;Italy;Sweden
1025EUCTR2018-002835-76-BE
(EUCTR)
25/07/2019A Phase 3 Study of VX-445 Combination Therapy in Cystic Fibrosis (CF) Subjects Heterozygous for F508del and a Gating or Residual Function Mutation (F/G and F/RF Genotypes)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Gating or Residual Function Mutation (F/G and F/RF Genotypes) Cystic fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
250Phase 3United States;France;Canada;Spain;Belgium;Ireland;Denmark;Australia;Netherlands;Germany;United Kingdom;Italy
1026EUCTR2007-006276-11-PL
(EUCTR)
06/05/2009A 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 FibrosisA Phase I/II randomised, placebo-controlled, double blind trial to assess the safety, tolerability, pharmacodynamics and exploratory efficacy of heparin 25 mg inhalation powder in patients with Cystic Fibrosis (CF) - VR496/005- Orally inhaled heparin in patients with Cystic Fibrosis Cystic Fibrosis
MedDRA version: 9.1;Level: LLT;Classification code 10011763;Term: Cystic fibrosis lung
Product Name: Heparin 25mg inhalation powder, hard capsule
INN or Proposed INN: HEPARIN SODIUM
Vectura LimitedNULLNot RecruitingFemale: yes
Male: yes
64Phase 2Poland;Ireland;Italy;United Kingdom
1027EUCTR2005-003772-37-DE
(EUCTR)
05/12/2005A Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis SubjectsA Randomized, Open-label, Multicenter, Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to TOBI® in Cystic Fibrosis Subjects Pulmonary pseudomonas aeruginosa infections in patients with cystic fibrosis
Classification code 10011762
Product Name: Tobramycin Inhalation Powder
Product Code: TIP
INN or Proposed INN: Tobramycin
Product Name: TOBI
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
500Phase 3Hungary;United Kingdom;Germany;Spain;Italy;Greece
1028EUCTR2021-000694-85-IE
(EUCTR)
29/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del MutationA Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Homozygous for F508del, Heterozygous for F508del and a Gating (F/G) or Residual Function (F/RF) Mutation, or Have At Least 1 Other Triple Combination Responsive CFTR Mutation and No F508del Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
550Phase 3United States;Greece;Ireland;Austria;Israel;United Kingdom;Switzerland;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Netherlands;Norway;Sweden
1029EUCTR2017-003723-29-FR
(EUCTR)
14/03/2018A study of safety and efficacy of lenabasum in Cystic FibrosisA Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Trial to Evaluate Efficacy and Safety of Lenabasum in Cystic Fibrosis - A Phase 2 safety and efficacy study of Lenabasum in Cystic Fibrosis Cystic Fibrosis (CF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
415Phase 2United States;Serbia;Portugal;Slovakia;Greece;Spain;Réunion;Austria;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Romania;Australia;Bulgaria;Germany;Netherlands;Sweden
1030EUCTR2018-003831-31-PL
(EUCTR)
01/12/2020MS1819-SD phase II clinical trial for Exocrine Pancreatic Insufficiency caused by Cystic Fibrosis.A multicenter, open-label Phase 2 study with escalating doses of MS1819-SD on top of a stable dose of PPEs, to investigate the efficacy and safety of this combination for the compensation of severe exocrine pancreatic insufficiency in CF patients not fully compensated with only PPEs Exocrine Pancreatic Insufficiency due to Cystic Fibrosis
MedDRA version: 20.0;Level: LLT;Classification code 10073392;Term: Pancreatic exocrine insufficiency;System Organ Class: 100000004856
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06]
Product Name: MS1819-SD
INN or Proposed INN: Lipase Lip2 from Yarrowia lipolytica
Other descriptive name: LIPASE LIP2
AzurRx SASNULLNot RecruitingFemale: yes
Male: yes
24Phase 2Hungary;Spain;Poland;Turkey
1031EUCTR2016-004318-82-Outside-EU/EEA
(EUCTR)
15/05/2017A 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 fibrosisTobramycin Inhalation Powder (TIP) Administered Once Daily Continuously Versus TIP Administered BID in 28 Day on / 28 Day Off Cycles Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 20.0;Level: LLT;Classification code 10021860;Term: Infection Pseudomonas aeruginosa;System Organ Class: 100000004862;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Trade Name: TOBI Podhaler
INN or Proposed INN: Tobramycin
Other descriptive name: TOBRAMYCIN
Novartis Pharmaceuticals CorporationNULLNAFemale: yes
Male: yes
200Phase 4United States
1032EUCTR2021-000712-31-CZ
(EUCTR)
23/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Product Name: ivacaftor
Product Code: VX-770
INN or Proposed INN: ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
400Phase 3United States;Portugal;Czechia;Czech Republic;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
1033EUCTR2010-018454-13-BE
(EUCTR)
25/05/2010A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn®A Phase III, Multicentre, Randomised, Placebo-Controlled, Double Blind Study of the Incidence of Recurring Pulmonary Exacerbations in Cystic Fibrosis Patients using Two Different Doses of Inhaled Nacystelyn® Cystic fibrosis
MedDRA version: 12.1;Level: PT;Classification code 10011762;Term: Cystic fibrosis
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate
Other descriptive name: Nacystelyn®
Product Name: Nacystelyn®
Product Code: NAL
INN or Proposed INN: L-Lysine-N-acetyl-L-cysteinate
Other descriptive name: Nacystelyn®
Laboratoires SMB S.A.NULLNot RecruitingFemale: yes
Male: yes
552Phase 3France;Czech Republic;Hungary;Spain;Belgium;Denmark;Germany;United Kingdom;Italy
1034EUCTR2015-000543-16-FR
(EUCTR)
07/07/2015A study in children aged 6 Through 11 Years With Cystic Fibrosis to assess the efficacy and safety of a combination of two experimental drugsA Phase 3, Double Blind, Placebo Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects Aged 6 Through 11 Years With Cystic Fibrosis, Homozygous for the F508del CFTR Mutation Cystic Fibrosis;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]Product Name: lumacaftor/ivacaftor 100mg/125mg tablets
Product Code: VX-809 / VX-770
INN or Proposed INN: LUMACAFTOR
Other descriptive name: LUMACAFTOR
INN or Proposed INN: IVACAFTOR
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
200Phase 3United States;France;Canada;Belgium;Denmark;Australia;Germany;United Kingdom;Sweden
1035EUCTR2018-000183-28-FR
(EUCTR)
12/12/2018A Phase 3 Study of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-445 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for the F508del Mutation and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445/50-mg TEZ/75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: Ivacaftor
INN or Proposed INN: VX-445
Other descriptive name: VX-445
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
360 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Austria;United Kingdom;Italy;France;Czech Republic;Canada;Belgium;Australia;Germany;Netherlands;Sweden
1036EUCTR2016-001840-20-Outside-EU/EEA
(EUCTR)
18/05/2016Study to Validate the Instructions for Use of TOBI® Podhaler™ in Cystic Fibrosis PatientsA 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 PodhalerNovartis Pharmaceuticals CorporationNULLNAFemale: yes
Male: yes
45Phase 4United States
1037EUCTR2021-005320-38-PT
(EUCTR)
02/02/2022Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3France;Portugal;Spain;Belgium;Austria;Netherlands;Germany;Switzerland;Italy
1038EUCTR2021-000712-31-IE
(EUCTR)
29/09/2021A Phase 3 Study of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Heterozygous for F508del and a Minimal Function Mutation (F/MF)A Phase 3, Randomized, Double-blind, Controlled Study Evaluating the Efficacy and Safety of VX-121 Combination Therapy in Subjects With Cystic Fibrosis Who Are Heterozygous for F508del and a Minimal Function Mutation (F/MF)
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: VX-121/tezacaftor/deutivacaftor
Product Code: VX-121/TEZ/D-IVA
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: deutivacaftor
Other descriptive name: D-IVA
INN or Proposed INN: Not yet assigned
Other descriptive name: VX-121
Trade Name: Kaftrio
Product Name: elexacaftor/tezacaftor/ivacaftor
Product Code: ELX/TEZ/IVA
INN or Proposed INN: elexacaftor
Other descriptive name: ELX
INN or Proposed INN: tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: ivacaftor
Other descriptive name: IVA
Trade Name: Kalydeco
Product Name: ivacaftor
Product Code: VX-770
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
400Phase 3Portugal;United States;Czechia;Spain;Ireland;Australia;Israel;Germany;United Kingdom;Sweden
1039EUCTR2019-001735-31-BE
(EUCTR)
08/07/2019A study to evaluate the safety and efficacy of VX-445 / Tezacaftor / Ivacaftor in patients suffering from Cystic FibrosisA Phase 3b, Randomized, Double blind, Controlled Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del - A Study Evaluating the Efficacy & Safety of VX-445/Tezacaftor/Ivacafto in Cystic Fibrosis Subjects Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100-mg VX-445 / 50-mg TEZ / 75-mg IVA FDC
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: ELEXACAFTOR
Other descriptive name: VX-445
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Symkevi 100mg/150mg Film-coated tablets
Product Code: VX-661 / VX-770
INN or Proposed INN: TEZACAFTOR
Other descriptive name: TEZ
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: IVA
Vertex Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
158Phase 3Belgium;Australia;Germany;United Kingdom
1040EUCTR2017-000540-18-FR
(EUCTR)
01/08/2017Study to Evaluate Safety, Efficacy, and Tolerability of TEZ/IVA in Subjects With Cystic Fibrosis (CF) Who Have Previously Discontinued Orkambi Phase 3b, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Assess the Safety, Efficacy, and Tolerability of Tezacaftor/Ivacaftor (TEZ/IVA) in an Orkambi-experienced Population Who Are Homozygous for the F508del-CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: tezacaftor/ivacaftor 100mg/150mg
Product Code: VX-661/VX-770
INN or Proposed INN: tezacaftor
Other descriptive name: VX-661
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Trade Name: Kalydeco 150 mg film-coated tablets
Product Name: Ivacaftor
Product Code: VX-770
INN or Proposed INN: IVACAFTOR
Other descriptive name: VX-770
Vertex Pharmaceuticals IncorporatedNULLNot Recruiting Female: yes
Male: yes
90 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;France;Germany
1041EUCTR2021-005320-38-NL
(EUCTR)
23/02/2022Evaluation of Efficacy and Safety of ELX/TEZ/IVA in Subjects Without an F508del MutationA Phase 3 Double-blind, Randomized, Placebo-controlled Study Evaluating the Efficacy and Safety of ELX/TEZ/IVA in Cystic Fibrosis Subjects 6 Years of Age and Older With a Non-F508del ELX/TEZ/IVA-responsive CFTR Mutation Cystic Fibrosis
MedDRA version: 20.0;Level: PT;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Product Name: 100mg ELX/50mg TEZ /75mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Elexacaftor
Other descriptive name: ELX
INN or Proposed INN: Tezacaftor
Other descriptive name: TEZ
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 150mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 75-mg IVACAFTOR
Product Code: VX-770
INN or Proposed INN: Ivacaftor
Other descriptive name: IVA
Product Name: 50 mg ELX/25 mg TEZ/37.5 mg IVA
Product Code: VX-445/TEZ/IVA
INN or Proposed INN: Ivacaftor
Vertex Pharmaceuticals IncorporatedNULLNAFemale: yes
Male: yes
270Phase 3Portugal;France;Spain;Belgium;Austria;Germany;Netherlands;Switzerland;Italy
1042EUCTR2011-002000-32-FR
(EUCTR)
22/09/2011A clinical study to investigate long term safety of tobramycin inhalation powder (TIP) in patients with Cystic FibrosisA single arm, open-label, multicenter, Phase IV trial toassess long term safety of tobramycin inhalation powder(TIP) in patients with Cystic Fibrosis Pseudomonas aeruginosa infection in cystic fibrosis patients
MedDRA version: 14.0;Level: LLT;Classification code 10021860;Term: Infection pseudomonas aeruginosa;System Organ Class: 10021881 - Infections and infestations;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
Trade Name: TOBI Podhaler
Product Name: TIP (Tobramycin inhalation powder)
Product Code: TBM100
INN or Proposed INN: Tobramycin
Novartis Pharma Services AGNULLNAFemale: yes
Male: yes
150Phase 4United States;France;Hungary;Mexico;Canada;Argentina;Brazil;Spain;Australia;Germany;Italy
1043EUCTR2020-001762-11-SE
(EUCTR)
17/07/2020A research study to collect long term safety information from subjects who have received study treatment from a qualifying lenabasum Corbus trial.An Observational Long-Term Safety Surveillance of Participants from Corbus Sponsored Lenabasum Pivotal Clinical Trials Dermatomyositis (DM) is a rare and serious autoimmune disease.An overactive immune response causes chronic inflammation,which results in growth of scar tissue in the skin,muscles,and many internal organs.Cystic Fibrosis (CF) is a genetic disorder which results in thick mucus formation on the airways leading to increased lung infections,fibrosis of the lungs and digestive tract and abnormal immune function
MedDRA version: 20.0;Level: PT;Classification code 10012503;Term: Dermatomyositis;System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Not possible to specify
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Product Name: Lenabasum
Product Code: JBT-101
INN or Proposed INN: Lenabasum
Other descriptive name: resunab, ajulemic acid, anabasum
Corbus Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
100Phase 2;Phase 3Sweden;Germany;Bulgaria;Romania;Poland;Belgium;Canada;Hungary;Czech Republic;France;Italy;United Kingdom;Russian Federation;Austria;Spain;Greece;Slovakia;Portugal;Serbia;United States
1044EUCTR2019-003052-36-GB
(EUCTR)
28/02/2020Magnetic Resonance Imaging (MRI) in BronchiectasisTriple Modality Functional Magnetic Resonance Lung Imaging in Cystic Fibrosis and Non-CF Bronchiectasis - MRI in Bronchiectasis Cystic fibrosis (CF) Non-CF Bronchiectasis
MedDRA version: 21.0;Level: PT;Classification code 10006445;Term: Bronchiectasis;System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
MedDRA version: 20.0;Classification code 10011762;Term: Cystic fibrosis;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
Trade Name: hyperpolarized xenon-129
Product Name: hyperpolarized xenon-129
The University of NottinghamNULLNA Female: yes
Male: yes
40 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited Kingdom