Using losartan to enhance cystic fibrosis treatment response
Targeting Inflammation With Losartan to Improve Response to Modulator Therapy in Cystic Fibrosis
PHASE2 · University of Kansas Medical Center · NCT06364176
This study is testing if adding losartan to the treatment of people with cystic fibrosis already on modulator therapy can help them feel better by improving their sweat chloride levels.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Ages | 12 Years and up |
| Sex | All |
| Sponsor | University of Kansas Medical Center (other) |
| Locations | 1 site (Kansas City, Kansas) |
| Trial ID | NCT06364176 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of losartan on patients with cystic fibrosis who are already receiving modulator therapy. It is a randomized, placebo-controlled study that will last for twelve weeks, during which participants will either receive losartan or a placebo. The primary outcome measure will be changes in sweat chloride levels, which serve as an indicator of CFTR channel function. The goal is to determine if losartan can improve the efficacy of existing treatments for cystic fibrosis.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 12 years and older with a confirmed diagnosis of cystic fibrosis who have been stable on specific modulator therapy for at least 90 days.
Not a fit: Patients who have had a lung transplant or those with certain health conditions, such as chronic renal insufficiency or recent pulmonary exacerbations, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly enhance the effectiveness of modulator therapies for cystic fibrosis patients.
How similar studies have performed: While the approach of using losartan in this context is novel, other studies have explored the role of inflammation in cystic fibrosis treatment, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kansas City, Kansas
- University of Kansas Medical Center — Kansas City, Kansas, United States (RECRUITING)
Study contacts
- Principal investigator: Charles Bengtson, MD, MSc — University of Kansas Medical Center
- Study coordinator: Heidi Hellwig
- Email: hhellwig@kumc.edu
- Phone: 9135886045
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Cystic Fibrosis, losartan