Clinical trials: Cystic Fibrosis, completed
Cystic Fibrosis
Evaluation of Elexacaftor/Tezacaftor/Ivacaftor (ELX/TEZ/IVA) in Cystic Fibrosis (CF) Participants 12 to Less Than 24 Months of Age
The study evaluates the pharmacokinetics (PK), safety, tolerability, pharmacodynamics (PD), and efficacy of ELX/TEZ/IVA in CF participants 2 to less than (<) 24 months of age.
- Trial name
- NCT05882357
- Testing
- ELX/TEZ/IVA, IVA
- Where
- 19 sites in Australia, Canada and 5 more
- Volunteers
- 67 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Cystic Fibrosis
STaph Aureus Resistance-Treat Early and Repeat (STAR-TER)
To evaluate the micro-biologic efficacy and safety of a streamlined treatment for early onset methicillin-resistant staphylococcus aureus (MRSA) in patients with cystic fibrosis.
- Trial name
- STAR-TER (NCT03489629)
- Testing
- Trimethoprim Sulfamethoxazole (TMP/SMX), Minocycline, Mupirocin
- Where
- 9 sites in United States
- Volunteers
- 49 people
- Sponsor
- University of North Carolina, Chapel Hill
Cystic Fibrosis
Sildenafil Exercise: Role of PDE5 Inhibition
Exercise intolerance is an understudied phenomenon in people with CF. The investigators hypothesized that vascular dysfunction plays a significant role, and can be partially reversed by administration of the phosphodiesterase…
- Trial name
- NCT04039087
- Testing
- Sildenafil 40mg oral capsule
- Where
- 2 sites in United States
- Volunteers
- 31 people
- Sponsor
- National Jewish Health
Cystic Fibrosis
Trikafta in Cystic Fibrosis Patients
This clinical study will enroll 42 participants without the F508del mutation, carrying partial function or N1303K mutations not approved for Trikafta, and who are not expected to be approved for CFTR modulator treatment in the…
- Trial name
- NCT03506061
- Testing
- Trikafta
- Where
- 2 sites in United States
- Volunteers
- 42 people
- Sponsor
- Emory University
Sickle Cell Disease, Chronic Kidney Diseases
Peer i-Coaching for Activated Self-Management Optimization in Adolescents and Young Adults With Chronic Conditions
The purpose of this study is to test the efficacy of a peer support coaching intervention to improve activated chronic illness self-management versus an attention control group in 225 adolescents and young adults with childhood…
- Conditions
- Sickle Cell Disease, Chronic Kidney Diseases, Systemic Lupus Erythematosus, Childhood Cancer
- Trial name
- PiCASO (NCT03938324)
- Testing
- PiCASO Intervention Group
- Where
- United States
- Volunteers
- 222 people
- Sponsor
- Duke University
Ototoxicity
SPI-1005 for Prevention and Treatment of Tobramycin Induced Ototoxicity
The primary objective of this study is to determine the safety and efficacy of SPI-1005 treatment in CF patients with active pulmonary exacerbation that are receiving an IV course of tobramycin, determined by comparing hearing…
- Trial name
- NCT02819856
- Testing
- SPI-1005 Ebselen 200mg Capsule x1, SPI-1005 Ebselen 200mg Capsule x2, SPI-1005 Ebselen 200mg Capsule x3
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- Sound Pharmaceuticals, Incorporated
Bacterial Disease Carrier, Cystic Fibrosis
A Phase 1b/2 Trial of the Safety and Microbiological Activity of Bacteriophage Therapy in Cystic Fibrosis Subjects Colonized With Pseudomonas Aeruginosa
This is a phase 1b/2 study of a single dose of intravenous (IV) bacteriophage in males and non-pregnant females, at least 18 years old, diagnosed with Cystic Fibrosis (CF).
- Trial name
- NCT05453578
- Testing
- WRAIR-PAM-CF1
- Where
- 19 sites in United States
- Volunteers
- 73 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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
Safety and Efficacy of Sildenafil in Cystic Fibrosis (CF) Lung Disease
The purpose of this study is to determine whether sildenafil can decrease inflammation in CF lung disease.
- Trial name
- NCT00659529
- Testing
- sildenafil
- Where
- United States
- Volunteers
- 36 people
- Sponsor
- National Jewish Health
Cystic Fibrosis
Pharmacokinetics of Omadacycline in Cystic Fibrosis
The purpose of this study is to characterize the pharmacokinetics of intravenous and oral omadacycline in patients with cystic fibrosis.
- Trial name
- NCT04460586
- Testing
- Omadacycline Injection [Nuzyra], Omadacycline Oral Tablet [Nuzyra]
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Paul Beringer
Cystic Fibrosis
Intrapulmonary Percussive Ventilation for Sputum Induction in Adults With Cystic Fibrosis
This is a small pilot study with the goal of identifying a superior sputum collection method in Cystic Fibrosis patients unable to produce a sputum.
- Trial name
- NCT06311292
- Testing
- Volara System
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Daniel J. Weiner
Cystic Fibrosis
IV Colistin for Pulmonary Exacerbations: Improving Safety and Efficacy
The purpose of this study is to find the safest and most effective way to administer IV antibiotics to treat acute pulmonary exacerbations (APEs) in patients with cystic fibrosis (CF) that are caused by pathogens, like…
- Trial name
- NCT02918409
- Testing
- Colistin, Tobramycin
- Where
- United States
- Volunteers
- 51 people
- Sponsor
- National Jewish Health
Exocrine Pancreatic Insufficiency
Phase 1 Study to Assess Safety and Efficacy of ANG003
Randomized, parallel, active-treatment Phase 1 study of a single dose of orally administered ANG003 with a test meal in adult subjects with cystic fibrosis-related exocrine pancreatic insufficiency.
- Trial name
- NCT06052293
- Testing
- ANG003
- Where
- 20 sites in United States
- Volunteers
- 57 people
- Sponsor
- Anagram Therapeutics, Inc.
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
Study to Evaluate the Safety & Tolerability of MRT5005 Administered by Nebulization in Adults With Cystic Fibrosis
This Phase 1/2, first-in-human study evaluated the safety and tolerability of single and multiple escalating doses of MRT5005 administered by nebulization to the respiratory tract of adult subjects with cystic fibrosis (CF).
- Trial name
- RESTORE-CF (NCT03375047)
- Testing
- MRT5005, Normal saline
- Where
- 16 sites in United States
- Volunteers
- 42 people
- Sponsor
- Sanofi
Cystic Fibrosis, Cystic Fibrosis-related Diabetes
Semaglutide in CFRD
This open label, single arm pilot study, will examine the safety and tolerability of GLP-1RA semaglutide as an add-on therapy to insulin for overweight/obese adult patients with cystic fibrosis related diabetes (CFRD).
- Trial name
- NCT05788965
- Testing
- Semaglutide
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- University of Minnesota
Cystic Fibrosis
Inhaled Mannitol on Mucociliary Clearance in Moderate to Severe Cystic Fibrosis
This study will provide important mechanistic information regarding the effect of inhaled mannitol (Bronchitol) in people with cystic fibrosis (PwCF) with moderate to severe disease who are already using…
- Trial name
- NCT05740618
- Testing
- Mannitol Inhalant Product
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University of North Carolina, Chapel Hill
Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa
Study to Evaluate the Safety, Phage Kinetics, and Efficacy of Inhaled AP-PA02 in Subjects With Non-Cystic Fibrosis Bronchiectasis and Chronic Pulmonary Pseudomonas Aeruginosa Infection
A phase 2, multi-center, double-blind, randomized, placebo-controlled study to evaluate the safety, phage kinetics, and efficacy of inhaled AP-PA02 administered in subjects with non-cystic fibrosis bronchiectasis and chronic…
- Conditions
- Non-cystic Fibrosis Bronchiectasis, Pseudomonas Aeruginosa, Lung Infection
- Trial name
- Tailwind (NCT05616221)
- Testing
- AP-PA02
- Where
- 23 sites in United States
- Volunteers
- 48 people
- Sponsor
- Armata Pharmaceuticals, Inc.
Non-Cystic Fibrosis Bronchiectasis
A Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib in Participants With Non-Cystic Fibrosis Bronchiectasis
The primary objective of this study is to evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period.
- Trial name
- ASPEN (NCT04594369)
- Testing
- Brensocatib 10 mg, Brensocatib 25 mg
- Where
- 373 sites in United States, Argentina and 34 more
- Volunteers
- 1,767 people
- Sponsor
- Insmed Incorporated
Cystic Fibrosis-related Diabetes
Comparison of Meal-Time Dosing of Insulin in Cystic Fibrosis Related Diabetes
The aim of this study is to assess the utility of CGMs to determine the optimal method to dose meal-time insulin. The investigators will examine glucose excursions in patients with CF who will dose meal-time rapid-acting insulin…
- Trial name
- NCT04533646
- Testing
- Insulin, Continuous glucose monitor (CGM)
- Where
- United States
- Volunteers
- 13 people
- Sponsor
- Jagdeesh Ullal