Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
- Registration Number
- NCT06364176
- Lead Sponsor
- University of Kansas Medical Center
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 42
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo twice daily through week 12 Losartan Losartan Losartan 25mg twice daily for one week followed by 50mg twice daily through week 12.
- Primary Outcome Measures
Name Time Method Sweat chloride Baseline through week 12 Change in sweat chloride concentration
- Secondary Outcome Measures
Name Time Method Inflammatory mediators - systemic Baseline through week 12 Change in plasma levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha)
Lung function - relative Baseline through week 12 Relative change in ppFEV1
TGF-beta1 - systemic Baseline through week 12 Change in plasma levels of TGF-beta1
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
Lung function - absolute Baseline through week 12 Absolute change in percent predicted forced expiratory volume in one second (ppFEV1)
Transforming growth factor (TGF)-beta1 - airway Baseline through week 12 Change in nasal fluid levels of TGF-beta1
Inflammatory mediators - airway Baseline through week 12 Change in concentration nasal fluid levels of inflammatory mediators (interleukin-1beta, interleukin-8, tumor necrosis factor-alpha)
Trial Locations
- Locations (1)
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States