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

NCT06364176 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00149479
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Keywords

losartan

Outcome Measures

Primary Outcomes (1)

• Sweat chloride

  Change in sweat chloride concentration

  Baseline through week 12

Secondary Outcomes (8)

• Lung function - absolute

  Baseline through week 12

• Lung function - relative

  Baseline through week 12

• Transforming growth factor (TGF)-beta1 - airway

  Baseline through week 12

• TGF-beta1 - systemic

  Baseline through week 12

• Inflammatory mediators - airway

  Baseline through week 12

Study Arms (2)

Losartan

EXPERIMENTAL

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

Drug: Losartan

Placebo

PLACEBO COMPARATOR

Placebo twice daily through week 12

Drug: Placebo

Interventions

Losartan DRUG

Treatment with losartan through week 12

Losartan

Placebo DRUG

Treatment with placebo through week 12

Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Losartan

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrazoles

Study Officials

• Charles Bengtson, MD, MSc

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Heidi Hellwig

CONTACT

9135886045; hhellwig@kumc.edu

Carolina Aguiar

CONTACT

9139459295; caguiar@kumc.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: April 15, 2024
• Study Start: June 3, 2024
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: May 2, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)