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

NCT ID: NCT06364176

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-03
• Study Completion Date: 2027-10-31

Brief 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.

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.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Losartan

Losartan 25mg twice daily for one week followed by 50mg twice daily through week 12.

Group Type: EXPERIMENTAL

Losartan

Intervention Type: DRUG

Treatment with losartan through week 12

Placebo

Placebo twice daily through week 12

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Treatment with placebo through week 12

Interventions

Losartan

Treatment with losartan through week 12

Intervention Type: DRUG

Placebo

Treatment with placebo through week 12

Intervention Type: DRUG

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charles Bengtson, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Heidi Hellwig

Role: CONTACT

hhellwig@kumc.edu

9135886045

Carolina Aguiar

Role: CONTACT

caguiar@kumc.edu

9139459295

Facility Contacts

Charles Bengtson, MD, MSc

Role: primary

913-588-6000

Carolina Aguiar

Role: backup

9139459295

Other Identifiers

STUDY00149479

Identifier Type: -

Identifier Source: org_study_id