Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240

NCT03435939 | Completed Early Phase 1 DMC FDA Drug

• 1 other identifier: STUDY00146945
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to execute a small clinical proof of concept trial: To examine the effects of losartan on mucociliary clearance (MCC) in patients not eligible for CFTR rescue therapies

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

• Improvement of mucociliary clearance ( MCC) and cough clearance (CC)

  Losartan (100 mg for \>12 weeks) will improve MCC+CC clearance in CF patients not on CFTR augmentation therapy in % of baseline

  12 weeks treatment

Secondary Outcomes (4)

• Improvement on pulmonary function tests (in %predicted)

  12 weeks of treatment

• Improvement on pulmonary function tests (in L)

  12 weeks of treatment

• Decrease of inflammatory markers

  12 weeks

• Nasal cytokine changes

  12 weeks

Study Arms (1)

losartan

EXPERIMENTAL

a daily dose of 50 mg losartan for 7 days (for tolerability). Then, the losartan dose will be increased to 100 mg daily for 12 weeks.

Drug: Losartan

Interventions

Losartan DRUG

50 mg/day for 7 days followed by 100 mg/day for 12 weeks

Also known as: Cozaar

losartan

Eligibility Criteria

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

You may qualify if:

• CF patients with any known mutation combination not on CFTR augmentation therapy
• ≥18 years of age
• Severity of the Disease: Suitable patients will have mild to moderate lung disease, as defined by:
• Pulmonary Function: Each patient must have an FEV1 ≥40% of predicted at the screening visit.
• Hemoglobin saturation: Patients must have an oxygen saturation of \>92% on room air as determined by pulse oximetry at the screening visit.
• Produces sputum regularly (daily basis, at minimum)
• FEV1 ≥ 40% of predicted at screening visit
• Able to sign Informed consent
• Negative COVID-19 test within 72 hours prior to MCC testing

You may not qualify if:

• When enrolling female patients
• Not willing to adhere to strict birth control (combination of two methods)
• If female, patient must be non-pregnant and non-lactating, and those of childbearing potential must be using an acceptable method of birth control (i.e., an Intrauterine Contraceptive Device with a failure rate of \<1%, hormonal contraceptives or a barrier method). If a female patient is abstinent, she must agree to use one of the acceptable methods if she becomes sexually active.
• Unstable lung disease: As defined by a change in medical regimen during the preceding 2 weeks or an FEV1 ≥15% below value within 3 months
• Received an investigational drug or therapy during the preceding 30 days
• Active or former smokers with less than 1 year since quitting, or \>10 pack-year smoking history
• Unable to adequately complete study measures, including spirometry
• Intolerance to angiotensin receptor blockers (ARB)
• Treatment with angiotensin converting enzyme (ACE) inhibitor
• Regular use of NSAIDs or potassium supplementation, treatment with aliskiren, on anticoagulation
• Oral corticosteroid use within 6 weeks
• Exacerbation requiring treatment within 6 weeks
• Treatment of mycobacterial infections
• Significant hypoxemia (oxygen saturation \<92% on room air and rest or use of continuous oxygen treatment), chronic respiratory failure by history (pCO2 \> 45 mmHg), clinical evidence of cor pulmonale
• Untreated arterial hypertension (systolic blood pressure \>140 mm Hg, diastolic blood pressure \> 90 mmHg)

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

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

• Matthias Salathe, MD

  University of Kansas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairperson-Professor- Internal Medicine

Study Record Dates

• First Submitted: February 5, 2018
• First Posted: February 19, 2018
• Study Start: February 15, 2022
• Primary Completion: September 3, 2025
• Study Completion: March 31, 2026
• Last Updated: May 1, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)