Losartan for Cystic Fibrosis

Overseen By Matthias Salathe, MD

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: University of Kansas Medical Center

Must not be taking: ACE inhibitors, NSAIDs, Anticoagulants, Corticosteroids

Disqualifiers: Unstable lung disease, Smoking history, Hypertension, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 14 weeks

16 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing losartan, a blood pressure medication, to see if it can help clear mucus from the lungs of cystic fibrosis patients who can't use current treatments. These patients need alternative treatments because they don't respond to existing options. Losartan may reduce lung inflammation, making it easier for them to breathe.

Research Team

Matthias Salathe, MD

Principal Investigator

University of Kansas

Eligibility Criteria

Adults over 18 with cystic fibrosis not treated with CFTR therapy can join. They should have mild to moderate lung disease, be able to produce sputum daily, and have an FEV1 ≥40% of predicted. Participants need a negative COVID-19 test before testing, must not smoke or have quit for at least a year, and females must use strict birth control.

Inclusion Criteria

My lung condition is considered mild to moderate.

You need to have a negative COVID-19 test within 3 days before the test for the clinical trial.

You need to have a certain level of lung function, called FEV1, to be eligible for the study.

Exclusion Criteria

You are not able to do the breathing tests required for the study.

I regularly use NSAIDs, potassium supplements, aliskiren, or am on anticoagulation therapy.

I am a current or former smoker who quit less than a year ago or have smoked more than 10 pack-years.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants receive a daily dose of 50 mg losartan for 7 days, followed by 100 mg daily for 12 weeks

14 weeks

1 safety visit after 7 days, regular monitoring visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Losartan

Trial Overview The trial is studying the effect of Losartan on mucociliary clearance in cystic fibrosis patients ineligible for CFTR therapies. It's a small-scale proof of concept study designed to understand how this medication might help clear mucus from the lungs.

Participant Groups

Group I: losartan Experimental Treatment 1 Intervention

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.

Losartan is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Stroke prevention in hypertension and left ventricular hypertrophy

Approved in European Union as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Heart failure

Approved in Canada as Cozaar for:

• Hypertension
• Diabetic nephropathy
• Heart failure

Who Is Running the Clinical Trial?

University of Kansas Medical Center

Lead Sponsor

Trials

527

Recruited

181,000+