Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Losartan, Placebo.
- Who it may be relevant to
- Registry conditions: Cystic Fibrosis. Basic parameters: from 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis
Overview
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
- Drug Losartan
Treatment with losartan through week 12 - Drug Placebo
Treatment with placebo through week 12
Primary outcome measures
- Sweat chloride [Time frame: Baseline through week 12]
Secondary outcome measures (8)
- Lung function - absolute [Time frame: Baseline through week 12]
- Lung function - relative [Time frame: Baseline through week 12]
- Transforming growth factor (TGF)-beta1 - airway [Time frame: Baseline through week 12]
- TGF-beta1 - systemic [Time frame: Baseline through week 12]
- Inflammatory mediators - airway [Time frame: Baseline through week 12]
- Inflammatory mediators - systemic [Time frame: Baseline through week 12]
- CFQ-R [Time frame: Baseline through week 12]
- Adverse events [Time frame: Baseline through week 12]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Kansas Medical Center — Kansas City
Identifiers
NCT: NCT06364176 · STUDY00149479