Losartan for Cystic Fibrosis on Modulator Therapy

This study is testing if a medication called losartan can improve how well current cystic fibrosis (CF) treatments, specifically elexacaftor/tezacaftor/ivacaftor, work. You might be able to join if you are 12 years or older, have CF, and have been taking elexacaftor/tezacaftor/ivacaftor stably for at least 90 days. You also need to have a sweat chloride level of 50 mmol/L or higher while on your current CF medication. The study will measure changes in your sweat chloride levels to see if losartan helps. The goal is to enroll 42 participants, but the current recruitment status is unclear.

Study design
This is a randomized, placebo-controlled study, meaning some participants will receive losartan and others a placebo (an inactive substance). It aims to enroll 42 participants.
What's involved
Participants will take either losartan or a placebo for twelve weeks. Your sweat chloride levels will be measured from the beginning of the study through week 12.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for changes in sweat chloride levels through week 12.

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NCT06364176

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

Recruiting
PHASE2Ages 12+InterventionalTreatment
University of Kansas Medical Center
~42 participants
Updated 2025-05-02 on ClinicalTrials.gov
What's tested:LosartanPlacebo

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Sweat chloride
Measured over Baseline through week 12
Cystic Fibrosis
1 sites across 1 states
Kansas1
  • Charles Bengtson, MD, MSc · PRINCIPAL_INVESTIGATOR · University of Kansas Medical Center

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Eligibility criteria

Inclusion

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

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
  • Sweat chlorideBaseline through week 12

    Change in sweat chloride concentration