NCT06364176 · University of Kansas Medical Center
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis.
What this study 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.
View original scientific description
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.
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
Change in sweat chloride concentration
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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
Where
- Kansas City, Kansas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 2, 2025 · Source of record for eligibility and locations