Cystic Fibrosis
Conditions
Keywords
losartan
Brief summary
The goal of this clinical trial is to test use of losartan in those with cystic fibrosis (CF) on modulator therapy. The main question it aims to answer is if treatment with losartan improves response of the CF transmembrane conductance regulator (CFTR) channel to modulator therapy. Participants will be asked take losartan or placebo for twelve weeks and will have changes in sweat chloride levels measured as a marker of CFTR function.
Detailed description
This is a randomized, placebo-controlled, parallel group clinical trial in those those with CF on elexacaftor/tezacaftor/ivacaftor to determine if treatment with losartan improves response to modulator therapy using sweat chloride as an marker of CFTR function.
Interventions
DRUGLosartan
Treatment with losartan through week 12
DRUGPlacebo
Treatment with placebo through week 12
Sponsors
University of Kansas Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Established diagnosis of cystic fibrosis * Age 12 years and older * Stable use of elexacaftor/tezacaftor/ivacaftor for 90 days prior to enrollment * Sweat chloride concentration 50 mmol/L or greater while on elexacaftor/tezacaftor/ivacaftor
Exclusion criteria
* Prior lung transplant * BMI \<18 * CF pulmonary exacerbation requiring hospitalization or intravenous antibiotics in the preceding 30 days * Systemic corticosteroid or regular non-steroidal anti-inflammatory use in the preceding 30 days * Chronic use of angiotensin receptor blockers or angiotensin converting enzyme inhibitors * Concomitant use of medications known to interact with losartan, including aliskiren * Chronic renal insufficiency (creatinine clearance \<45 ml/min) * Pregnancy or lactation * Inability or unwillingness to comply with approved contraceptive method during the study period (females of childbearing age) * In the opinion of the investigator any severe or acute or chronic condition or laboratory abnormality that may increase the risk associated with trial participation or make the participant inappropriate for enrollment * Participation in another interventional trial that, in the opinion of the investigator, has the potential to affect the primary outcome
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sweat chloride | Baseline through week 12 | Change in sweat chloride concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function - relative | Baseline through week 12 | Relative change in ppFEV1 |
| Transforming growth factor (TGF)-beta1 - airway | Baseline through week 12 | Change in nasal fluid levels of TGF-beta1 |
| TGF-beta1 - systemic | Baseline through week 12 | Change in plasma levels of TGF-beta1 |
| Lung function - absolute | Baseline through week 12 | Absolute change in percent predicted forced expiratory volume in one second (ppFEV1) |
| Inflammatory mediators - systemic | Baseline through week 12 | Change in plasma levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha) |
| CFQ-R | Baseline through week 12 | Change in CF questionnaire revised (CFQ-R); scale 0-100 with higher scores indicating better quality of life |
| Adverse events | Baseline through week 12 | Cumulative incidence of adverse events |
| Inflammatory mediators - airway | Baseline through week 12 | Change in concentration nasal fluid levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha) |
Countries
United States
Contacts
Primary ContactHeidi Hellwig
Backup ContactCarolina Aguiar
Outcome results
None listed