Clinical trials: Cystic Fibrosis
Cystic Fibrosis
A Study Evaluating the Efficacy and Safety of VX-445/Tezacaftor/Ivacaftor in Cystic Fibrosis Subjects, Homozygous for F508del
This study will evaluate the efficacy, safety, and pharmacodynamics of elexacaftor (ELX, VX-445) in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for…
- Trial name
- NCT04105972
- Testing
- ELX/TEZ/IVA, TEZ/IVA, IVA
- Where
- 35 sites in Australia, Belgium and 2 more
- Volunteers
- 176 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Non-cystic Fibrosis Bronchiectasis
Phase 2a, 28-day Investigational Use Study of ARINA-1 in Non-Cystic Fibrosis Bronchiectasis (NCFBE) With Excess Mucus and Cough
This is a randomized, Phase 2a, double-blind, placebo-controlled study to evaluate the safety and efficacy of ARINA-1 compared to placebo (isotonic saline, 0.9%) in participants with NCFBE.
- Trial name
- NCT05495243
- Testing
- ARINA-1
- Where
- 10 sites in United States
- Volunteers
- 40 people
- Sponsor
- Renovion, Inc.
Fibrosing Colonopathy
Long-term Study in US Cystic Fibrosis Patients Receiving Digestive Enzyme Supplements to Assess Narrowing of the Large Intestine Causing Adverse Intestinal Symptoms (Fibrosing Colonopathy)
This is a long-term study in cystic fibrosis patients who are participating in the Cystic Fibrosis Patient Registry to assess the occurrence and risk factors for a rare bowel disorder called fibrosing colonopathy (narrowing of…
- Trial name
- NCT01652157
- Testing
- ULTRESA, PANCREAZE, CREON
- Where
- 123 sites in United States
- Volunteers
- 17 people
- Sponsor
- AbbVie
Cystic Fibrosis
A Study in Adult and Pediatric Patients With Cystic Fibrosis
The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose…
- Trial name
- NCT00034515
- Testing
- denufosol tetrasodium (INS37217) Inhalation Solution
- Volunteers
- 63 people
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
A Study of Tobramycin Inhalation Powder From a Modified Manufacturing Process Versus Placebo
This study is designed to show how well tobramycin inhalation powder works and how safe it is when produced by a modified manufacturing process
- Trial name
- EDIT (NCT00918957)
- Testing
- Tobramycin Inhalation Powder
- Where
- 24 sites in Bulgaria, Egypt and 7 more
- Volunteers
- 62 people
- Sponsor
- Novartis Pharmaceuticals
Healthy Volunteer
Bioequivalence and Food Effect Bioavailability Study of Lumacaftor Film-Coated Tablets
The objective of this study is to assess bioequivalence of lumacaftor from Lumacaftor 200 mg Film-Coated Tablet Formulation (Qanatpharma) versus the reference commercial product, Lumacaftor 200 mg /Ivacaftor 125 mg Combination…
- Trial name
- NCT05968612
- Testing
- Lumacaftor 200 mg/Ivacaftor 125 mg Film-Coated Tablet, Lumacaftor 200 mg Film-Coated Tablet Formulation
- Where
- Canada
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- Qanatpharma Canada LTD
Cystic Fibrosis
Extension Study of Ataluren in Participants With Nonsense Mutation Cystic Fibrosis
This is an open-label extension study for participants who completed a Phase 3, placebo-controlled study of ataluren in participants with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled aminoglycosides.
- Trial name
- NCT02456103
- Testing
- Ataluren
- Where
- 70 sites in United States, Argentina and 14 more
- Volunteers
- 246 people
- Sponsor
- PTC Therapeutics
Cystic Fibrosis
Phase 3 Study of Aztreonam for Inhalation Solution (AZLI) in a Continuous Alternating Therapy Regimen for the Treatment of Chronic Pseudomonas Aeruginosa Infection in Patients With CF
The primary objective of this study is to evaluate the safety and efficacy of a CAT regimen with aztreonam for inhalation solution (AZLI) and tobramycin inhalation solution (TIS) in adult and pediatric subjects with cystic…
- Trial name
- AZLI CAT (NCT01641822)
- Testing
- AZLI, Tobramycin inhalation solution
- Where
- 71 sites in United States
- Volunteers
- 107 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
A Safety and Tolerability Study OF PUR118 In Subjects With Cystic Fibrosis
The purpose of this study is to determine whether PUR118 is safe and tolerable in a population of subjects with Cystic Fibrosis.
- Trial name
- NCT01543191
- Testing
- PUR118
- Where
- United Kingdom
- Volunteers
- 10 people
- Sponsor
- Pulmatrix Inc.
Cystic Fibrosis
Study of Cavosonstat (N91115) in Patients With CF Homozygous for the F508del-CFTR Mutation
This will be a double-blind, randomized, placebo-controlled, parallel group study. The purpose of this study is to investigate the efficacy and safety of Cavosonstat (N91115) in adult patients with CF who are homozygous for the…
- Trial name
- SNO-6 (NCT02589236)
- Testing
- Cavosonstat
- Where
- 46 sites in United States
- Volunteers
- 138 people
- Sponsor
- Nivalis Therapeutics, Inc.
Cystic Fibrosis
A Study to Evaluate GLPG2222 in Ivacaftor-treated Subjects With Cystic Fibrosis
This clinical study is a phase IIa, multi-center, randomized, double-blind, placebo-controlled, parallel group study to evaluate two doses of orally administered GLPG2222 in adult subjects with a confirmed diagnosis of CF…
- Trial name
- NCT03045523
- Testing
- GLPG2222 150 mg q.d., GLPG2222 300 mg q.d.
- Where
- 22 sites in Australia, Belgium and 4 more
- Volunteers
- 37 people
- Sponsor
- Lakefront Biotherapeutics NV
Bronchiectasis, Lower Respiratory Infection
Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis.
To test whether POL7080 is effective in patients with exacerbation of non-cystic fibrosis bronchiectasis caused by Pseudomonas aeruginosa infection.
- Trial name
- NCT02096315
- Testing
- POL7080
- Where
- 4 sites in Spain, United Kingdom
- Volunteers
- 20 people
- Sponsor
- Polyphor Ltd.
Cystic Fibrosis, Adherence, Medication
Evaluation of the ReX-C System, in Patients Receiving CFTR Modulators for the Treatment of Cystic Fibrosis (CF).
Cystic fibrosis (CF) is a progressive multisystem disorder characterized by abnormalities in the transport of chloride ions in human airway epithelial cells, leading to frequent lung infections, decreased pulmonary function…
- Trial name
- NCT04215796
- Testing
- ReX-C system
- Where
- 2 sites in Israel
- Volunteers
- 10 people
- Sponsor
- Dosentrx Ltd.
Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic
A Double-Blind, Active-Controlled, Multiple-Ascending Dose Study of Aerosolized RSP-1502 in Subjects With CF and Chronic PA Lung Infection
A double-blind, active-controlled, multiple-ascending dose, safety study of aerosolized RSP-1502 in subjects with cystic fibrosis Pseudomonas aeruginosa lung infection.
- Conditions
- Cystic Fibrosis Lung, Respiratory Infections, Recurrent, Chronic, Pseudomonas Aeruginosa
- Trial name
- NCT06016088
- Testing
- RSP-1502, Tobramycin inhalation solution
- Where
- 22 sites in United States, Australia
- Volunteers
- 71 people
- Sponsor
- Respirion Pharmaceuticals Pty Ltd
Cystic Fibrosis
Evaluation of an Airway Clearance System
The aim of this study is to assess the effectiveness of an Airway Clearance System.
- Trial name
- NCT03091062
- Testing
- Vest® Airway Clearance System, Monarch™ System
- Where
- Belgium
- Volunteers
- 9 people
- Sponsor
- Hill-Rom
Pulmonary Cystic Fibrosis
Home Airway Clearance in CF Patients
Regular bronchial clearance is essential in patients with cystic fibrosis for their bronchial health. SIMEOX® (Physio-Assist, Aix en Provence, France) is an innovative medical device for the drainage of the bronchial tree.
- Trial name
- HomeCareSIMEOX (NCT04096664)
- Testing
- SIMEOX
- Where
- 20 sites in France
- Volunteers
- 143 people
- Sponsor
- Physio-Assist
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Assessment of a PERT-free Nutritional Therapeutic Delivery System for Cystic Fibrosis
This is a single center, randomized, double-blind, cross-over trial (with a follow-on single-blind safety evaluation stage), assessing a ready-to-drink nutritional supplement used without PERT ("PERT-free"), nutritional…
- Trial name
- NCT04966897
- Testing
- Standard Nutritional Supplement + PERT
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- GlycosBio, Inc.
Cystic Fibrosis
28 Day Repeat Dose in Cystic Fibrosis Patients
The purpose of this study is to determine whether the safety, tolerability and pharmacodynamics of SB656933 in patients that have cystic fibrosis
- Trial name
- NCT00903201
- Testing
- SB656933
- Where
- 33 sites in United States, Canada and 3 more
- Volunteers
- 146 people
- Sponsor
- GlaxoSmithKline
Cystic Fibrosis
A Study Evaluating the Safety of VX-152 Combination Therapy in Adults With Cystic Fibrosis
This is a Phase 2, randomized, double blind, placebo and active-controlled, parallel group, multicenter study designed to evaluate the safety and tolerability of VX-152 in Triple Combination (TC) with tezacaftor (TEZ; VX-661) and…
- Trial name
- NCT02951195
- Testing
- VX-152, TEZ/IVA, IVA
- Where
- 16 sites in United States
- Volunteers
- 80 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis Patients
This study is designed to assess the safety, tolerability, pharmacokinetics and preliminary pharmacodynamics (proof of concept) of QBW251 in healthy subjects and cystic fibrosis patients following single and multiple doses.
- Trial name
- NCT02190604
- Testing
- QBW251
- Where
- 23 sites in United States, Belgium and 5 more
- Volunteers
- 153 people, healthy volunteers welcome
- Sponsor
- Novartis Pharmaceuticals