Clinical trials: Cystic Fibrosis (CF)
Cystic Fibrosis
Evaluation of Lung T1-MRI in Pediatric Cystic Fibrosis Patients
In this observational study, the investigators evaluate the sensitivity of T1-MRI to identify lung perfusion changes in pediatric patients with CF (age = 6-11) before and after initiating FDA-approved Trikafta therapy.
- Trial name
- NCT04994301
- Testing
- Lung T1 MRI
- Where
- 3 sites in United States
- Volunteers
- 48 people
- Sponsor
- University Hospitals Cleveland Medical Center
Cystic Fibrosis
Effect of Acid Blockade on Microbiota and Inflammation in Cystic Fibrosis (CF)
Mucus in the airways of patients with CF represents an area for bacteria proliferation, microbial infection and inflammation. Similar to the lung, the esophagus provides an environment for bacterial to grow.
- Trial name
- NCT02769637
- Testing
- PPI treatment
- Where
- 2 sites in United States
- Volunteers
- 2 people
- Sponsor
- University of Colorado, Denver
Cystic Fibrosis
IL-17 Neutrophils in CF Lung Inflammation
The purpose of this study is to determine whether IL-17 polymorphonuclear leukocytes (PMNs) are central to the disease pathology in CF.
- Trial name
- NCT02025829
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- University Hospitals Cleveland Medical Center
Cystic Fibrosis, Pneumonia
Population Pharmacokinetics of Prolonged Infusion Meropenem in Cystic Fibrosis (CF) Children
This study will determine the concentrations of the antibiotic meropenem when administered as a 3 hour prolonged infusion in children with cystic fibrosis who are hospitalized with an acute pulmonary exacerbation.
- Conditions
- Cystic Fibrosis, Pneumonia, Pseudomonas Aeruginosa Infection
- Trial name
- NCT01429259
- Testing
- meropenem
- Where
- 7 sites in United States
- Volunteers
- 30 people
- Sponsor
- Joseph Kuti
Cystic Fibrosis
A Phase 1/2 Trial of SP-101 for the Treatment of Cystic Fibrosis (CF)
This is a Phase 1/2 multicenter, open-label, single dose trial of SP-101 investigational gene therapy in adults with CF who are ineligible for or intolerant to CFTR modulator therapy.
- Trial name
- SAAVe (NCT06526923)
- Testing
- SP-101 and doxorubicin Cohort 1, SP-101 and doxorubicin Cohort 2
- Where
- 4 sites in United States
- Volunteers
- 15 people
- Sponsor
- Spirovant Sciences, Inc.
Cystic Fibrosis
Safety Study of Ivacaftor in Subjects With Cystic Fibrosis
The purpose of this study was to evaluate the safety and tolerability of ivacaftor in patients with cystic fibrosis (CF) who were aged 18 years or older and have a G551D mutation in the cystic fibrosis transmembrane conductance…
- Trial name
- NCT00457821
- Testing
- Ivacaftor 25 mg/75 mg, Ivacaftor 75 mg/150 mg, Ivacaftor 150 mg or 250 mg
- Where
- 15 sites in United States, Canada and 1 more
- Volunteers
- 39 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
COVID-19, Cystic Fibrosis
COVID-19 ANtibody Responses in Cystic Fibrosis: CAR-CF
The coronavirus disease 2019 (COVID-19) which is caused by the virus SARS-CoV-2 has resulted in an ongoing global pandemic. It is unclear whether the relatively low number of reported cases of COVID-19 in people with CF (pwCF) is…
- Trial name
- CAR-CF (NCT05745948)
- Where
- Spain
- Volunteers
- 75 people
- Sponsor
- Hospital Universitari Vall d'Hebron Research Institute
Cystic Fibrosis, Pseudomonas Aeruginosa
Safety of AZLI in Children With Cystic Fibrosis (CF) and Chronic Pseudomonas Aeruginosa in the Lower Airways
This was an open-label, multicenter study in children ≤ 12 years of age with cystic fibrosis (CF) and chronic Pseudomonas aeruginosa (PA) infection in the lower airways using three 28-day courses of Aztreonam for Inhalation…
- Trial name
- PALS (NCT01404234)
- Testing
- AZLI
- Where
- 29 sites in United States, France and 4 more
- Volunteers
- 61 people
- Sponsor
- Gilead Sciences
Cystic Fibrosis
CHaractErizing CFTR Modulated Changes in Sweat Chloride and Their Association With Clinical Outcomes
This is a multicenter, cross-sectional, cohort study which will collect contemporary sweat chloride (SC) values from approximately 5000 Cystic Fibrosis (CF) patients prescribed and currently receiving commercially approved Cystic…
- Trial name
- CHEC-SC (NCT03350828)
- Where
- 52 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Nicole Hamblett
Cystic Fibrosis
Monitoring Response to Orkambi in Cystic Fibrosis Lung Disease by Inhaled Xenon MRI
This is an observational study for children with Cystic Fibrosis (CF) who are eligible based on their CF gene type. One group will be called the treatment group because they have the gene type (homozygous F508del) that makes them…
- Trial name
- NCT02848560
- Testing
- Hyperpolarized Xenon
- Where
- United States
- Volunteers
- 38 people
- Sponsor
- Children's Hospital Medical Center, Cincinnati
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
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
A Trial of Pulmozyme Withdrawal on Exercise Tolerance in Cystic Fibrosis Subjects With Severe Lung Disease (TOPIC)
This was a multicenter, randomized, double-blind, placebo-controlled study of patients with severe, though stable, cystic fibrosis (CF) whose routine treatment included Pulmozyme.
- Trial name
- NCT00434278
- Testing
- Dornase alfa
- Where
- 40 sites in United States
- Volunteers
- 27 people
- Sponsor
- Genentech, Inc.
Cystic Fibrosis
Effect of Sulforaphane in Broccoli Sprouts on Nrf2 Activation
The purpose of this study to investigate the effect of sulforaphane from macerated broccoli sprouts in humans and to evaluate less invasive methods of assessing potential anti-inflammatory drugs in CF.
- Trial name
- NCT01315665
- Testing
- Broccoli sprouts
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University Hospitals Cleveland Medical Center
Cystic Fibrosis, Quality of Life
Pragmatic Implementation Trial of a CF Primary Palliative Care Intervention
Five Cystic Fibrosis (CF) centers, key stakeholders, and a palliative care institute have collaborated to create a novel primary palliative care intervention for patients with CF, "Improving Life with CF: A Primary Palliative…
- Trial name
- NCT04923880
- Testing
- Implementation of Primary Palliative Care Intervention in CF Centers
- Where
- 5 sites in United States
- Volunteers
- 643 people
- Sponsor
- Massachusetts General Hospital
Cystic Fibrosis (CF)
Group Cognitive Behavioural Therapy for Adults With Cystic Fibrosis
The overall goal of this clinical trial is to: a) explore the feasibility, acceptability, and participant experiences with the group version of CF-CBT; b) examine the effectiveness of the virtual delivery of a group version of…
- Trial name
- NCT06645782
- Testing
- Virtual, Group CF-CBT
- Where
- 2 sites in Canada
- Volunteers
- 21 people
- Sponsor
- University of Regina
Cystic Fibrosis (CF)
Gender Disparity and Hormones in Cystic Fibrosis
The objective of this study is to investigate the impact of hormones on lung disease in Cystic Fibrosis (CF) patients. Due to improved therapies, CF patients are living longer and healthier lives than they did 20 years ago.
- Trial name
- NCT02036879
- Testing
- Loestrin (norethindrone acetate and ethinyl estradiol)
- Where
- 2 sites in United States
- Volunteers
- 55 people
- Sponsor
- University of Texas Southwestern Medical Center
Cystic Fibrosis
Cystic Fibrosis and Endothelial Function: At Rest and During Exercise
Perhaps one of the most disturbing aspects of Cystic Fibrosis (CF) is the associated premature death. Oxidative stress has been observed in patients with CF and exercise intolerance has been shown to predict mortality in patients…
- Trial name
- NCT01772758
- Testing
- BH4 5mg, BH4 20mg, Antioxidant Cocktail
- Where
- United States
- Volunteers
- 64 people, healthy volunteers welcome
- Sponsor
- Augusta University
Cystic Fibrosis
PTC124 for the Treatment of 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
- NCT00351078
- Testing
- PTC124
- Where
- Israel
- Volunteers
- 19 people
- Sponsor
- PTC Therapeutics
Cystic Fibrosis, Mucociliary Clearance Defect
Symptom Based Performance of Airway Clearance After Starting Highly Effective Modulators for Cystic Fibrosis (SPACE-CF)
Cystic Fibrosis (CF) is an autosomal recessive disease cause by a mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) manifesting in multiple organs, the most common cause of morbidity and mortality…
- Trial name
- SPACE-CF (NCT05392855)
- Testing
- Symptom driven performance of airway clearance, Continuous daily performance of airway clearance
- Where
- United States
- Volunteers
- 6 people
- Sponsor
- University of Missouri-Columbia