299. Cystic fibrosis Clinical trials / Disease details


Clinical trials : 1,696 Drugs : 1,644 - (DrugBank : 272) / Drug target genes : 96 - Drug target pathways : 170

  
18 trials found
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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PhaseCountries
1EUCTR2015-004143-39-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
2EUCTR2015-004841-13-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
3EUCTR2015-004841-13-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
4EUCTR2015-004841-13-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
5NCT02141191
(ClinicalTrials.gov)
June 201412/5/2014A Study of Lung Clearance After Hypertonic Saline Delivery Using the tPAD DeviceA Randomized Crossover Mucociliary Clearance Study of Aerosolized 7% NaCl Solution Administered Overnight by the tPAD Device to Subjects With Cystic FibrosisCystic FibrosisDrug: inhaled hypertonic saline (7%)University of PittsburghParion SciencesCompleted18 YearsN/AAll12Phase 1United States
6NCT01417481
(ClinicalTrials.gov)
March 201215/8/2011Effect of Glycine in Cystic FibrosisEvaluation of the Capability of a Glycine Oral Supplement for Diminishing Bronchial Inflammation in Children With Cystic FibrosisCystic FibrosisDietary Supplement: Glycine;Dietary Supplement: PlaceboInstituto Nacional de Enfermedades RespiratoriasHospital Infantil de Mexico Federico Gomez;Instituto Mexicano del Seguro SocialTerminated5 Years15 YearsAll13Phase 2Mexico
7EUCTR2010-018454-13-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
8EUCTR2010-018454-13-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
9EUCTR2010-018454-13-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
10EUCTR2010-018454-13-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
11EUCTR2010-018454-13-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
12EUCTR2010-018454-13-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
13EUCTR2010-018454-13-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
14EUCTR2010-018454-13-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
15NCT00809094
(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
16NCT00274391
(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
17EUCTR2015-004841-13-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
18EUCTR2010-018454-13-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