Clinical trials: Cystic Fibrosis
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
Pharmacokinetic Bioequivalence Study of Nebcinal® 150mg/3ml Administered by Aeroneb® Idehaler® Versus Tobi® 300mg/5ml Administered by Pari LC Plus® /Pulmoaid® in Patients With Cystic Fibrosis
Cystic fibrosis (CF) is a genetic disease characterized by mutations in CFTR (Cystic Fibrosis Transmembrane conductance Regulator) gene.
- Trial name
- RM/NEB-03-10 (NCT01337219)
- Testing
- Tobramycin
- Where
- France
- Volunteers
- 36 people
- Sponsor
- Erempharma
Cystic Fibrosis
Evaluation of Efficacy and Safety of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis Subjects Without an F508del Mutation
This study evaluated the efficacy, pharmacodynamics (PD) and safety of ELX/TEZ/IVA in participants 6 years of age and older with a non-F508del ELX/TEZ/IVA-responsive cystic fibrosis transmembrane conductance regulator gene (CFTR)…
- Trial name
- NCT05274269
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 90 sites in Austria, Belgium and 13 more
- Volunteers
- 307 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
Study Assessing PTI-428 Safety, Tolerability, Pharmacokinetics and Effect in Subjects With Cystic Fibrosis
The study population is comprised of adult subjects with cystic fibrosis (CF) who are homozygous for the F508del mutation and are currently receiving background treatment with tezacaftor/ivacaftor for a minimum of 1 month prior…
- Trial name
- NCT03591094
- Testing
- PTI-428
- Where
- 26 sites in United States
- Volunteers
- 40 people
- Sponsor
- Proteostasis Therapeutics, Inc.
Cystic Fibrosis, Lung Infection
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Patients With Cystic Fibrosis, Mild Lung Disease, and P. Aeruginosa
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF), mild lung disease (forced expiratory volume in 1 second…
- Conditions
- Cystic Fibrosis, Lung Infection, Pseudomonas Aeruginosa
- Trial name
- AIR-CF4 (NCT00712166)
- Testing
- AZLI 75 mg three times daily (TID)
- Where
- 40 sites in United States, Australia and 1 more
- Volunteers
- 160 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
A Study Evaluating the Long-term Safety of VX-445 Combination Therapy
This study evaluated the long-term safety and tolerability of elexacaftor (ELX), tezacaftor (TEZ), and ivacaftor (IVA) triple combination (TC) treatment in participants with cystic fibrosis (CF).
- Trial name
- NCT04043806
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 97 sites in United States, Australia and 9 more
- Volunteers
- 458 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
"Safety, Tolerability and Pharmacokinetics of MP-376 Administered for 14 Days to Stable Pediatric (CF) Patients"
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
- NCT00840333
- Testing
- MP-376 (Levofloxacin solution for Inhalation)
- Where
- 6 sites in United States
- Volunteers
- 27 people
- Sponsor
- Amgen
Cystic Fibrosis
MP-376 (Aeroquin™, Levofloxacin for Inhalation) 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
- NCT01180634
- Testing
- Aeroquin
- Where
- 112 sites in United States, Australia and 3 more
- Volunteers
- 330 people
- Sponsor
- Amgen
Cystic Fibrosis
Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease
The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.
- Trial name
- NCT00103714
- Testing
- denufosol tetrasodium (INS37217)
- Volunteers
- 72 people
- Sponsor
- Merck Sharp & Dohme LLC
Cystic Fibrosis
A Study of VX-445 in Healthy Subjects and Subjects With Cystic Fibrosis
This is a first-in-human and proof-of-concept study of VX-445. The study includes 6 parts. Parts A, B, and C were conducted in healthy subjects.
- Trial name
- NCT03227471
- Testing
- IVA, TEZ/IVA, VX-445
- Where
- 38 sites in United States, Australia and 2 more
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Study of Pancreatic Enzyme Product in Pediatric Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This is an open-label study to evaluate the efficacy and safety of Aptalis' (formerly Eurand) pancreatic enzyme product (PEP) microtabs in pediatric participants under age 7 with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00981214
- Testing
- EUR-1008 (APT-1008)
- Where
- 14 sites in United States
- Volunteers
- 19 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
Long Term Administration of Inhaled Mannitol in Cystic Fibrosis
The purpose of this study is to examine the efficacy and safety of 26 weeks treatment with inhaled mannitol in subjects with cystic fibrosis.
- Trial name
- NCT00630812
- Testing
- inhaled mannitol
- Where
- 53 sites in United States, Argentina and 5 more
- Volunteers
- 318 people
- Sponsor
- Syntara
Pseudomonas Aeruginosa Infection
Study to Evaluate Arikayce™ in CF Patients With Chronic Pseudomonas Aeruginosa Infections
A major factor in the respiratory health of Cystic Fibrosis (CF) participants is the prevalence of chronic Pseudomonas aeruginosa (Pa) infections.
- Trial name
- NCT01315678
- Testing
- Liposomal amikacin for inhalation (Arikayce™) using the PARI Investigational eFlow® Nebulizer., Tobramycin inhalation solution using a PARI LC® Plus nebulizer.
- Where
- 62 sites in Austria, Belgium and 16 more
- Volunteers
- 302 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis
Efficacy and Safety of Inhaled Nitric Oxide (NO) in Cystic Fibrosis (CF) Patients
Prospective, randomized, placebo controlled, phase II clinical study of subjects crossing over from an approved inhaled antibiotic to inhaled nitric oxide as compared to a placebo control arm.
- Trial name
- NCT02498535
- Testing
- Nitric Oxide 160 ppm
- Where
- 7 sites in United States, Canada
- Volunteers
- 49 people
- Sponsor
- Novoteris, LLC
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
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
Cystic Fibrosis
A Study Evaluating the Long-Term Safety of Elexacaftor Combination Therapy
This study evaluate the long-term safety and tolerability of elexacaftor (ELX)/tezacaftor (TEZ)/ ivacaftor (IVA) triple combination (TC) in participants with cystic fibrosis (CF) who are homozygous for F508del.
- Trial name
- NCT04362761
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 29 sites in Australia, Belgium and 2 more
- Volunteers
- 172 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis, Pseudomonas Aeruginosa Airway Infection
Aztreonam Lysine for Inhalation in Patients With Cystic Fibrosis and Pseudomonas Aeruginosa Airway Infection
The primary objective of this program is to provide expanded access to aztreonam lysine for inhalation (AZLI) 75 mg prior to its commercial availability to patients with cystic fibrosis (CF) and chronic P.
- Trial name
- NCT00499720
- Testing
- Aztreonam Lysine for Inhalation
- Where
- 65 sites in United States, Puerto Rico
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Study Assessing PTI-428 Safety, Tolerability, and Pharmacokinetics in Subjects With Cystic Fibrosis on KALYDECO® as Background Therapy
The trial will consist of a single treatment group enrolling adult subjects with CF on background therapy with KALYDECO®. Approximately 16 subjects will be enrolled.
- Trial name
- NCT03258424
- Testing
- PTI-428
- Where
- 2 sites in United Kingdom
- Volunteers
- 15 people
- Sponsor
- Proteostasis Therapeutics, Inc.
Cystic Fibrosis
Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients
The purpose of this study is to determine whether AeroVanc treatment is safe and effective in reducing the number of MRSA colony forming units in the lungs of cystic fibrosis patients.
- Trial name
- NCT01746095
- Testing
- Vancomycin hydrochloride inhalation powder
- Where
- 38 sites in United States
- Volunteers
- 87 people
- Sponsor
- Savara Inc.