RecruitingPhase 2NCT06364176

Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.

Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis

Sponsor

University of Kansas Medical Center

Enrollment

42 participants

Start Date

Jun 3, 2024

Study Type

INTERVENTIONAL

Conditions

Cystic Fibrosis

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.

Eligibility

Min Age: 12 Years

Inclusion Criteria4

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 Criteria11

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