Clinical trials: Cystic Fibrosis (CF)
Bronchiectasis
Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE)
The purpose of this study is to evaluate if the time to first pulmonary exacerbation of bronchiectasis or its frequency can be prolonged by inhalation of ciprofloxacin for 28 days every other 28 days or for 14 days every other 14…
- Trial name
- RESPIRE 2 (NCT02106832)
- Testing
- Ciprofloxacin (BAYQ3939) dry powder for inhalation
- Where
- 207 sites in United States, Argentina and 23 more
- Volunteers
- 521 people
- Sponsor
- Bayer
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
A Study to Assess the Effect of ELX/TEZ/IVA on Glucose Tolerance in Participants With Cystic Fibrosis (CF)
This study was evaluate the effect of elexacaftor (ELX)/tezacaftor (TEZ)/ivacaftor (IVA) on glucose tolerance in CF participants, 12 years of age and older who are heterozygous for the F508del mutation and a minimal function…
- Trial name
- NCT04599465
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 41 sites in Australia, Belgium and 5 more
- Volunteers
- 69 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Exocrine Pancreatic Insufficiency, Cystic Fibrosis
Control of Steatorrhea in Participants With Cystic Fibrosis and Exocrine Pancreatic Insufficiency
This study by Aptalis (formerly Axcan) assesses the efficacy and safety of Panzytrat® 25,000 compared to Kreon® 25,000 in the control of steatorrhea in participants with cystic fibrosis (CF) and exocrine pancreatic insufficiency…
- Trial name
- NCT01327703
- Testing
- Panzytrat® 25,000, Kreon® 25,000
- Where
- 13 sites in Germany, Poland
- Volunteers
- 87 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis, Exocrine Pancreatic Insufficiency
Safety and Efficacy Study of ULTRASE® MT20 in Participants With Cystic Fibrosis (CF) and Exocrine Pancreatic Insufficiency (PI)
The purpose of this study is to assess the safety and efficacy of Ultrase® MT20 compared to placebo for the correction of fat and protein malabsorption in participants with cystic fibrosis (CF) and exocrine pancreatic…
- Trial name
- NCT00408317
- Testing
- Ultrase® MT20
- Where
- 4 sites in United States
- Volunteers
- 36 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis, Motor Neuron Disease
MN4000 for Treatment of CF and MND Patients in the Home Setting
The study was a non-randomized open label pilot study. It was an observational design conducted at one (1) site in the US. All enrolled subjects received treatment with the MN4000.
- Conditions
- Cystic Fibrosis, Motor Neuron Disease, Airway Clearance Impairment
- Trial name
- NCT03797677
- Testing
- MN 4000
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Hill-Rom
Cystic Fibrosis
Phase 1b Safety, Tolerability, and PK Study to Assess GS-5737 in Subjects With CF
This study will determine the safety, tolerability, and pharmacokinetics of a single dose of GS-5737 administered with a 2.8% saline solution vehicle in adult subjects with CF.
- Trial name
- NCT01840735
- Testing
- GS-5737
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
Safety and Efficacy Study of Aztreonam for Inhalation Solution (AZLI) in Cystic Fibrosis (CF) Patients With Pseudomonas Aeruginosa (PA)
The purpose of this study was to evaluate the safety and efficacy of multiple courses of AZLI in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).
- Trial name
- AIR-CF3 (NCT00128492)
- Testing
- AZLI 75 mg two times a day (BID)/ three times a day (TID)
- Where
- 65 sites in United States, Australia and 2 more
- Volunteers
- 274 people
- Sponsor
- Gilead Sciences
Mycobacterium Infections, Nontuberculous, Cystic Fibrosis (CF)
Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection
A study to evaluate the efficacy of inhaled molgramostim administered open-label to adult cystic fibrosis (CF) subjects with chronic pulmonary nontuberculous mycobacterial (NTM) infection, with or without ongoing…
- Trial name
- ENCORE (NCT03597347)
- Testing
- Molgramostim nebulizer solution, PARI eFlow nebulizer system
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Savara Inc.
Cystic Fibrosis
PK Study of N91115 in Cystic Fibrosis Patients
This Phase 1 study in F508del-CFTR homozygous CF patients is being conducted to assess the pharmacokinetics and absorption dynamics of N91115 compared with healthy subjects in order to identify an initial starting dose for Phase…
- Trial name
- SNO3 (NCT02227888)
- Testing
- N91115
- Where
- 3 sites in United States
- Volunteers
- 6 people
- Sponsor
- Nivalis Therapeutics, Inc.
Cystic Fibrosis, Bronchiectasis
Safety, Tolerability and Efficacy of S-1226 in Cystic Fibrosis and Non CF Bronchiectasis
This is a single center, open label, Phase IIa, multiple-ascending dose study in which subjects with mild to moderate Cystic Fibrosis and non CF bronchiectasis (n≤12) will be enrolled.
- Trial name
- NCT03903913
- Testing
- S-1226
- Where
- 3 sites in Canada
- Volunteers
- 12 people
- Sponsor
- SolAeroMed Inc.
Cystic Fibrosis
BI 443651 Multiple Rising Dose in Healthy Volunteers Followed by a Cross-over in CF Subjects
The objective of this study is to investigate the safety, tolerability, and pharmacokinetics of BI 443651 in male and female healthy volunteers and subjects with Cystic Fibrosis (CF).
- Trial name
- NCT02976519
- Testing
- BI 443651
- Where
- 5 sites in Germany, United Kingdom
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Boehringer Ingelheim
Chronic Pseudomonas Aeruginosa Infection, Cystic Fibrosis
Nebulized Bacteriophage Therapy in Cystic Fibrosis Patients With Chronic Pseudomonas Aeruginosa Pulmonary Infection
This is a Phase 1b/2a study with the primary objective to determine if BX004-A is safe and tolerable. Exploratory objectives include whether BX004-A reduces sputum Pseudomonas aeruginosa (PsA) bacterial load in CF subjects with…
- Trial name
- NCT05010577
- Testing
- BX004-A
- Where
- 28 sites in United States, Czechia and 3 more
- Volunteers
- 43 people
- Sponsor
- BiomX, Inc.
Chronic Lung Infection With Pseudomonas Aeruginosa in Cystic Fibrosis
Evaluation of Lung Clearance Index in Cystic Fibrosis (CF) Patients, Infected With P.Aeruginosa
The purpose of the study was to evaluate lung clearance index (LCI) by a standardized procedure in a well characterized study setting and to assess feasibility of LCI as a more sensitive method than forced expiratory volume at 1…
- Trial name
- ELIXIR (NCT02248922)
- Testing
- TIS or TIP
- Where
- 6 sites in Germany
- Volunteers
- 17 people
- Sponsor
- Novartis Pharmaceuticals
Bronchiectasis
Inhalation Flow Rate-study
Study should show feasibility of the device for drug delivery into the lung independently of the severity of impaired lung function.
- Trial name
- NCT02563197
- Testing
- T-326 Inhaler
- Where
- 10 sites in Germany
- Volunteers
- 33 people
- Sponsor
- Bayer
Cystic Fibrosis
Study of Ataluren in Nonsense Mutation Cystic Fibrosis (ACT CF)
This is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, efficacy and safety study of ataluren in patients with nonsense mutation cystic fibrosis (nmCF) not receiving chronic inhaled…
- Trial name
- NCT02139306
- Testing
- Ataluren (PTC124®)
- Where
- 88 sites in United States, Argentina and 14 more
- Volunteers
- 279 people
- Sponsor
- PTC Therapeutics
Cystic Fibrosis
Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis
Study of Urinary Predictors of Exacerbations by Biomarkers in Cystic Fibrosis
- Trial name
- SUPERB-CF (NCT04297709)
- Where
- United Kingdom
- Volunteers
- 29 people
- Sponsor
- Mologic Ltd
Cystic Fibrosis, Pancreatic Insufficiency
Efficacy and Safety of Ultrase® MT20 in Improving the Coefficient of Fat Absorption (CFA) in Children With Cystic Fibrosis (CF) and Pancreatic Insufficiency (PI)
This is a Phase III, multicenter, open-label study, that will evaluate the improvement of nutrient absorption when participants will receive Ultrase® MT20. This study is sponsored by Aptalis (formerly Axcan).
- Trial name
- NCT00513682
- Testing
- Ultrase® MT20
- Where
- 3 sites in United States
- Volunteers
- 9 people
- Sponsor
- Forest Laboratories
Cystic Fibrosis
Extension Study of Liposomal Amikacin for Inhalation in Cystic Fibrosis (CF) Patients With Chronic Pseudomonas Aeruginosa (Pa) Infection
The purpose of this study is to evaluate the long term safety and tolerability of Liposomal Amikacin for Inhalation (LAI) 590 mg once daily (QD) in Cystic Fibrosis patients with chronic infection due to pseudomonas aeruginosa.
- Trial name
- NCT01316276
- Testing
- Liposomal amikacin for inhalation
- Where
- 50 sites in Austria, Belgium and 15 more
- Volunteers
- 206 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