Clinical trials: Pulmonary Cystic Fibrosis
Cystic Fibrosis
A Study to Evaluate the Efficacy and Safety of Lumacaftor in Combination With Ivacaftor in Subjects With CF, Homozygous for the F508del-CFTR Mutation
To evaluate the efficacy and safety of lumacaftor in combination with ivacaftor in subjects aged 6 Through 11 years with cystic fibrosis (CF), homozygous for the F508del CF transmembrane conductance regulator (CFTR) mutation
- Trial name
- NCT02514473
- Testing
- VX-809, VX-770
- Where
- 53 sites in United States, Australia and 7 more
- Volunteers
- 206 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cytomegalovirus Infections
A Relative Bioavailability Study of Valcyte (Valganciclovir) in Lung Transplant Recipients With or Without Cystic Fibrosis.
This study will assess the relative bioavailability of ganciclovir from the pro-drug valganciclovir in lung transplant recipients with or without cystic fibrosis.
- Trial name
- NCT00377741
- Testing
- valganciclovir [Valcyte]
- Where
- 5 sites in United States
- Volunteers
- 31 people
- Sponsor
- Hoffmann-La Roche
Cystic Fibrosis, Bronchiectasis
A Study to Test How Well BI 1291583 is Tolerated by People With Cystic Fibrosis Bronchiectasis (Clairafly™)
This study is open to adults aged 18 years and older with cystic fibrosis bronchiectasis. The purpose of this study is to find out whether a medicine called BI 1291583 is tolerated by people with cystic fibrosis bronchiectasis.
- Trial name
- NCT05865886
- Testing
- BI 1291583
- Where
- 24 sites in United States, Belgium and 5 more
- Volunteers
- 22 people
- Sponsor
- Boehringer Ingelheim
Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF)
A Study to Evaluate Safety and Explore Efficacy of New Lipase NHS7108 in Adult Participants With Exocrine Pancreatic Insufficiency.
The purpose of this study is to measure the safety and explore the efficacy of 4 different doses of the new lipase NHS7108 in participants with EPI.
- Conditions
- Exocrine Pancreatic Insufficiency (EPI), Cystic Fibrosis (CF), Pancreatic Enzyme Abnormality, Pancreatic Diseases
- Trial name
- EPIC (NCT07559175)
- Testing
- NHS7108, Zenpep®
- Where
- 39 sites in United States, Bulgaria and 5 more
- Volunteers
- 66 people
- Sponsor
- Aimmune Nestlé Health Science US R&D, LLC
Cystic Fibrosis (CF)
Safety, Tolerability and Pharmacokinetics Study of AIR DNAse Administered by Inhalation to Healthy Adult Volunteers
This study will be performed to assess the safety, tolerability and PK of escalating inhaled AIR-DNase doses administered as a single dose followed by multiple doses for 5 consecutive days in healthy subjects.
- Trial name
- NCT02605590
- Testing
- AIR DNase
- Where
- Israel
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Protalix
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis Patients With P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF2 (NCT00104520)
- Testing
- AZLI 75 mg two times a day (BID)/three times a day (TID)
- Where
- 56 sites in United States
- Volunteers
- 211 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Study Evaluating Fosfomycin/Tobramycin for Inhalation in Cystic Fibrosis Patients With Pseudomonas Aeruginosa Lung Infection
The purpose of this study is to evaluate the safety and efficacy of 2 dose combinations of fosfomycin/tobramycin for inhalation (FTI), following a 28-day course of Aztreonam for Inhalation (AZLI) in patients with cystic fibrosis…
- Trial name
- NCT00794586
- Testing
- FTI, AZLI
- Where
- 36 sites in United States
- Volunteers
- 120 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
A Study to Assess the Safety, Tolerability, and Pharmacokinetics of Brensocatib Tablets in Adults With Cystic Fibrosis
The main objective of the study is to evaluate the pharmacokinetics of brensocatib in participants with cystic fibrosis following once daily oral administration of study drug and to evaluate the safety of brensocatib compared to…
- Trial name
- NCT05090904
- Testing
- Brensocatib
- Where
- 14 sites in United States
- Volunteers
- 29 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of VX-661/Ivacaftor in Pediatric Subjects With Cystic Fibrosis (CF)
This is a Phase 3, 2-part (Part A and Part B), open label, multicenter study evaluating the pharmacokinetic (PK), safety, and tolerability of multiple doses of tezacaftor (TEZ) in combination with ivacaftor (IVA) in subjects 6…
- Trial name
- NCT02953314
- Testing
- TEZ, TEZ/IVA, IVA
- Where
- 33 sites in United States, Canada
- Volunteers
- 83 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
PTC124 for Cystic Fibrosis
In some patients with cystic fibrosis (CF), the disease is caused by a nonsense mutation (premature stop codon) in the gene that makes the cystic fibrosis transmembrane regulator (CFTR) protein.
- Trial name
- NCT00234663
- Testing
- PTC124
- Where
- 5 sites in United States
- Volunteers
- 24 people
- Sponsor
- PTC Therapeutics
Cystic Fibrosis
Safety, Pharmacokinetic and Pharmacodynamic Study of MP-376 in Patients With Cystic Fibrosis
Patients with cystic fibrosis (CF) suffer from chronic infections of the lower respiratory tract that can be caused by one or multiple bacteria, including Pseudomonas aeruginosa, which has been particularly problematic to…
- Trial name
- NCT00503490
- Testing
- MP-376 (Levofloxacin solution for Inhalation)
- Where
- 14 sites in United States
- Volunteers
- 40 people
- Sponsor
- Amgen
Cystic Fibrosis
A Phase 2 Study to Evaluate Efficacy and Safety of VX-561 in Subjects Aged 18 Years and Older With Cystic Fibrosis
The purpose of this study is to evaluate the efficacy, safety, pharmacodynamic (PD) and pharmacokinetic (PK) effect of VX-561.
- Trial name
- NCT03911713
- Testing
- VX-561, IVA
- Where
- 48 sites in United States, Australia and 5 more
- Volunteers
- 77 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study of VX-445 Combination Therapy in CF Subjects Homozygous for F508del (F/F)
This study will evaluate the efficacy of VX-445 in triple combination (TC) with tezacaftor (TEZ) and ivacaftor (IVA) in subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation (F/F)
- Trial name
- NCT03525548
- Testing
- VX-445/TEZ/IVA, TEZ/IVA, IVA
- Where
- 44 sites in United States, Belgium and 2 more
- Volunteers
- 113 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Rollover Study to Evaluate the Safety and Efficacy of Long-term Treatment With Lumacaftor in Combination With Ivacaftor
Study 110 is a Phase 3, multicenter study in subjects aged 6 years and older with cystic fibrosis (CF) who are homozygous for the F508del-CF transmembrane conductance regulator (CFTR) mutation and who participated in Study 109…
- Trial name
- NCT02544451
- Testing
- LUM/IVA
- Where
- 60 sites in United States, Australia and 7 more
- Volunteers
- 246 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Non-Cystic Fibrosis Bronchiectasis, Cystic Fibrosis
A Study to Investigate Safety, Tolerability and Pharmacokinetics of Single and Repeat Doses of CHF6333 in Healthy Subjects
Human Neutrophil Elastase (HNE) plays a pivotal role in innate immunity and in neutrophilic lung inflammation that characterized many diseases.
- Trial name
- CHF6333 FIH (NCT03056326)
- Testing
- CHF6333 (Part 1 - SAD), CHF6333 (Part 2 - MAD)
- Where
- Belgium
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Treatment of Early Pulmonary Infections With P. Aeruginosa in Cystic Fibrosis Patients
Randomized, Controlled Study of CF Patients Between 3 Months and Less Than 7 Years
This study investigated the efficacy of inhaled TOBI treatment for early infections of P. aeruginosa in paediatric patients with cystic fibrosis.
- Trial name
- EARLY (NCT01082367)
- Testing
- TOBI
- Where
- 19 sites in Canada, Egypt and 8 more
- Volunteers
- 50 people
- Sponsor
- Novartis Pharmaceuticals
Cystic Fibrosis
Study Investigating a Delayed-Release Pancrelipase in Patients With Exocrine Pancreatic Insufficiency Due to Cystic Fibrosis
This study will assess the effect of pancrelipase delayed release 24,000 unit capsules on fat and nitrogen absorption in subjects with PEI due to Cystic Fibrosis.
- Trial name
- NCT00510484
- Testing
- Pancrelipase Delayed Release
- Where
- 23 sites in United States, Hungary and 3 more
- Volunteers
- 35 people
- Sponsor
- Solvay Pharmaceuticals
Cystic Fibrosis, Pulmonary
Study of ARO-ENaC in Healthy Volunteers and in Patients With Cystic Fibrosis
The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single doses of ARO-ENaC in healthy adult volunteers; and to evaluate the safety, tolerability, PK and efficacy of multiple doses of…
- Trial name
- NCT04375514
- Testing
- ARO-ENaC
- Where
- 7 sites in Australia, New Zealand
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Open-Label Phase III Long-Term Safety Trial of Liprotamase
This is an open-label, single-arm clinical study investigating the long-term safety of ALTU-135 treatment in patients with cystic fibrosis (CF)-related exocrine pancreatic insufficiency (PI).
- Trial name
- DIGEST (NCT00449904)
- Testing
- Liprotamase
- Where
- 39 sites in United States
- Volunteers
- 214 people
- Sponsor
- Anthera Pharmaceuticals
Cystic Fibrosis
Rollover Study of VX-770 in Cystic Fibrosis Subjects
The primary objective of the study was to evaluate the safety of long-term VX-770 treatment in participants with cystic fibrosis (CF).
- Trial name
- NCT01117012
- Testing
- Ivacaftor
- Where
- 58 sites in United States, Australia and 6 more
- Volunteers
- 192 people
- Sponsor
- Vertex Pharmaceuticals Incorporated