Actively Recruiting
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
Led by University of Kansas Medical Center · Updated on 2025-05-02
42
Participants Needed
1
Research Sites
173 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- Prior lung transplant
- BMI less than 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 less than 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
H
Heidi Hellwig
CONTACT
C
Carolina Aguiar
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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