Clinical trials: Pulmonary Fibrosis
Cystic Fibrosis
Study of N91115 in Patients With Cystic Fibrosis Homozygous F508del-CFTR Mutation
This Phase 1b study in F508del-CFTR homozygous CF patients is being conducted to assess the safety of N91115 as the sole cystic fibrosis transmembrane conductance regulator (CFTR) modulator at doses near the expected therapeutic…
- Trial name
- SNO4 (NCT02275936)
- Testing
- N91115
- Where
- 19 sites in United States
- Volunteers
- 51 people
- Sponsor
- Nivalis Therapeutics, Inc.
Cystic Fibrosis
Tobramycin Administered by eFlow Rapid Nebulizer: Pharmacokinetic Study
This study assesses the aerosol delivery characteristics (measured by nebulization time, serum and sputum tobramycin pharmacokinetic parameters) and safety of tobramycin administered for inhalation by PARI eFlow rapid electronic…
- Trial name
- NCT00420836
- Testing
- Tobramycin
- Volunteers
- 20 people
- Sponsor
- Novartis
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
A Study to Evaluate the Mode of Administration and Safety of EUR-1008 (APT-1008) in Infants 1 to 12 Months of Age
A study to determine the safety, effectiveness, and acceptability of 2 methods of administration of EUR-1008 (APT-1008) (Zenpep® [pancrelipase] delayed release capsule) 3,000 lipase units capsule, a pancreatic enzyme product…
- Trial name
- NCT01100606
- Testing
- EUR-1008 (APT-1008)
- Where
- 6 sites in United States
- Volunteers
- 15 people
- Sponsor
- Forest Laboratories
Idiopathic Pulmonary Fibrosis
A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40 years old. People taking standard medicines for IPF, including antifibrotic medicines, can continue taking them throughout the study.
- Trial name
- NCT04419506
- Testing
- BI 1015550
- Where
- 75 sites in United States, Argentina and 20 more
- Volunteers
- 147 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
A Study Evaluating Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor in Subjects 6 Through 11 Years of Age With Cystic Fibrosis and F/MF Genotypes
This study will evaluate the efficacy and safety of elexacaftor (ELX) / tezacaftor (TEZ) / ivacaftor (IVA) triple combination (TC) in subjects 6 through 11 years of age with cystic fibrosis (CF) who are heterozygous for F508del…
- Trial name
- NCT04353817
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 34 sites in Australia, Canada and 8 more
- Volunteers
- 121 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
Rollover Study of Ivacaftor in Subjects With Cystic Fibrosis and a Non G551D CFTR Mutation
The purpose of this study is to evaluate the safety of long-term ivacaftor treatment in participants with cystic fibrosis (CF) from Studies 110 (NCT01614457), 111 (NCT01614470), and 113 (NCT01685801).
- Trial name
- KONTINUE (NCT01707290)
- Testing
- Ivacaftor
- Where
- 38 sites in United States, Belgium and 2 more
- Volunteers
- 125 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
A Study of Inhaled KB407 for the Treatment of Cystic Fibrosis
The Sponsor is developing KB407, a replication-defective, non-integrating herpes simplex virus type 1 (HSV-1)-derived vector engineered to deliver functional full-length human Cystic Fibrosis Transmembrane Conductance Regulator…
- Trial name
- NCT05095246
- Testing
- KB407 (Nebulization)
- Where
- Australia
- Sponsor
- Krystal Biotech, Inc.
Idiopathic Pulmonary Fibrosis
Study of Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of VAY736 in Patients With Idiopathic Pulmonary Fibrosis
The purpose of this study was to investigate the safety, tolerability and efficacy of VAY736 as potential therapy for the treatment of idiopathic pulmonary fibrosis (IPF).
- Trial name
- NCT03287414
- Testing
- VAY736, Standard of Care (SoC)
- Where
- 16 sites in United States, Canada and 4 more
- Volunteers
- 30 people
- Sponsor
- Novartis Pharmaceuticals
Idiopathic Pulmonary Fibrosis
A Phase 1b Study of IV PRM151 in Patients With Idiopathic Pulmonary Fibrosis (IPF)
The aims of the study are to assess safety, tolerability, the pharmacokinetic profile, and the pharmacodynamic profile of multiple doses of PRM-151 administered IV to IPF patients.
- Trial name
- PRM151F-12GL (NCT01254409)
- Testing
- PRM-151
- Where
- 3 sites in United States, Netherlands
- Volunteers
- 21 people
- Sponsor
- Hoffmann-La Roche
Idiopathic Pulmonary Fibrosis
Cough Reduction in IPF With Nalbuphine ER
The main purpose of the study is to evaluate the effect of NAL ER on 24-hour cough frequency using objective digital cough monitoring and to assess safety and tolerability of NAL ER.
- Trial name
- CORAL (NCT05964335)
- Testing
- NAL ER
- Where
- 59 sites in Australia, Canada and 8 more
- Volunteers
- 165 people
- Sponsor
- Trevi Therapeutics
Cystic Fibrosis
Safety and Pharmacokinetic Study of Lumacaftor/Ivacaftor in Participants 1 to Less Than 2 Years of Age With Cystic Fibrosis, Homozygous for F508del
This study will evaluate the safety and pharmacokinetics (PK) of lumacaftor (LUM) and ivacaftor (IVA) in participants 1 to less than 2 years of age with cystic fibrosis (CF), homozygous for F508del (F/F).
- Trial name
- NCT03601637
- Testing
- LUM, IVA
- Where
- 27 sites in United States, Canada
- Volunteers
- 61 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis.
- Trial name
- NCT00737100
- Testing
- Tiotropium bromide 5 mcg, tiotropium bromide-low dose-2.5mcg
- Where
- 107 sites in United States, Australia and 9 more
- Volunteers
- 510 people
- Sponsor
- Boehringer Ingelheim
Healthy, Cystic Fibrosis
Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics
The study is carried out to evaluate the safety, tolerability and pharmacokinetics of AeroVanc inhalation powder in healthy volunteers, and in patients with cystic fibrosis.
- Trial name
- NCT01537666
- Testing
- AeroVanc, IV vancomycin hydrochloride
- Where
- 2 sites in Australia
- Volunteers
- 25 people, healthy volunteers welcome
- Sponsor
- Savara Inc.
Idiopathic Pulmonary Fibrosis
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Repeated Doses of Inhaled CHF10073 in Participants With Idiopathic Pulmonary Fibrosis
The objective of the study is to assess the safety and tolerability of repeated doses of CHF10073 and to characterise cough-related safety outcomes associated with CHF10073 administration.
- Trial name
- NCT07876284
- Testing
- CHF10073 low dose, CHF10073 high dose
- Volunteers
- 18 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Idiopathic Pulmonary Fibrosis
Nintedanib Twice Daily vs Placebo in Patients Diagnosed With Idiopathic Pulmonary Fibrosis (IPF)
This is an 6 month multi-centre, prospective, randomized, placebo controlled, double blind clinical trial followed by conversion of each arm to active nintedanib for an additional 6 months comparing the effect of nintedanib 150mg…
- Trial name
- NCT01979952
- Testing
- Nintedanib
- Where
- 25 sites in United States, Canada and 1 more
- Volunteers
- 113 people
- Sponsor
- Boehringer Ingelheim
Cystic Fibrosis
Safety/Tolerability Study of Arikayce™ in Cystic Fibrosis Patients With Chronic Infection Due to Pseudomonas Aeruginosa
This is a study to determine the safety and tolerability of 28 days of daily dosing of 560 mg of Arikayce™ versus placebo and daily dosing of 70 mg and 140 mg of Arikayce™ versus placebo in patients who have Cystic fibrosis (CF)…
- Trial name
- NCT00558844
- Testing
- Arikayce™ 560 mg, Arikayce™ 70 mg, Arikayce™ 140 mg
- Where
- 19 sites in United States
- Volunteers
- 41 people
- Sponsor
- Insmed Incorporated
Idiopathic Pulmonary Fibrosis
A Clinical Study to Test How Effective and Safe GLPG1690 is for Subjects With Idiopathic Pulmonary Fibrosis (IPF) When Used Together With Standard of Care
The main purpose of this study was to see how GLPG1690 works together with your current standard treatment on your lung function and IPF disease in general.
- Trial name
- ISABELA1 (NCT03711162)
- Testing
- GLPG1690
- Where
- 132 sites in United States, Australia and 13 more
- Volunteers
- 525 people
- Sponsor
- Lakefront Biotherapeutics NV
Cystic Fibrosis
Study of Ivacaftor in Subjects With Cystic Fibrosis (CF) Who Have a Non-G551D CF Transmembrane Conductance Regulator (CFTR) Gating Mutation
The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following…
- Trial name
- KONNECTION (NCT01614470)
- Testing
- Ivacaftor
- Where
- 12 sites in United States, Belgium and 1 more
- Volunteers
- 39 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Pulmonary Fibrosis
Study of the Effects of High-dose N-acetylcysteine (NAC) in Idiopathic Pulmonary Fibrosis (IPF)
The purpose of this study is to determine whether NAC added to prednisone, and azathioprine has a better effect on lung function, radiology and clinical condition than placebo + prednisone in combination with azathioprine after 6…
- Trial name
- IFIGENIA (NCT00639496)
- Testing
- n-acetylcysteine
- Where
- 7 sites in Belgium, France and 5 more
- Volunteers
- 184 people
- Sponsor
- Zambon SpA