What is the mechanism of action of this treatment?

Common treatments for Cystic Fibrosis (CF) target various aspects of the disease. Antibiotics are used to manage pulmonary infections, reducing bacterial load and inflammation. Azithromycin, a macrolide antibiotic, not only fights infections but also has anti-inflammatory properties, which help in reducing lung damage. Hypertonic saline improves mucociliary clearance, aiding in the removal of thick mucus from the airways. Gene therapy aims to correct the underlying genetic defect by introducing functional CFTR genes into the affected cells. Losartan, an Angiotensin II Receptor Blocker, is being studied for its potential to improve mucociliary clearance, which could offer an additional therapeutic avenue for CF patients. These treatments are crucial as they address both the symptoms and the root causes of CF, improving quality of life and potentially extending lifespan.

What side effects are associated with this type of intervention?

Common treatments for Cystic Fibrosis include antibiotics like azithromycin, which can cause gastrointestinal disturbances and potential liver enzyme elevation. Inhaled therapies such as tobramycin may lead to bronchospasm and voice alteration. Anti-inflammatory agents like ibuprofen can cause gastrointestinal bleeding and renal impairment. While Losartan, an Angiotensin II Receptor Blocker, is not commonly used for CF, its side effects in other conditions include dizziness, hyperkalemia, and renal function impairment.

What prior FDA approvals exist?

The FDA has approved several treatments for cystic fibrosis, primarily focusing on managing chronic pulmonary infections and improving lung function. Inhaled antibiotics like tobramycin and aztreonam lysine are commonly used to treat chronic Pseudomonas aeruginosa infections. Additionally, azithromycin has been approved for its anti-inflammatory properties and ability to reduce pulmonary exacerbations. While Losartan, an Angiotensin II Receptor Blocker, is being studied for its potential effects on mucociliary clearance in CF, there is no specific FDA approval for ARBs in the treatment of cystic fibrosis as of now.

What other types of research exist?

Promising novel alternatives to Losartan for Cystic Fibrosis patients include CFTR modulators such as ivacaftor, tezacaftor-ivacaftor, and elexacaftor-tezacaftor-ivacaftor. These therapies have shown potential in improving pancreatic function and overall health outcomes in CF patients. Additionally, ongoing research into tyrosine kinase inhibitors like bosutinib and other targeted therapies may offer new treatment options in the near future.

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Angiotensin II Receptor Blocker

Losartan for Cystic Fibrosis

Phase < 1

Waitlist Available

Led By Matthias Salathe, MD

Research Sponsored by University of Kansas Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

CF patients with any known mutation combination not on CFTR augmentation therapy

≥18 years of age

Must not have

Treatment with angiotensin converting enzyme (ACE) inhibitor

Subjects with prior thoracic surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Losartan may cause dizziness due to low blood pressure, increased potassium levels which can affect heart rhythm, kidney function changes, or allergic reactions if there's intolerance to ARBs (angiotensin receptor blockers).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have cystic fibrosis and am not on CFTR therapy.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication for my blood pressure.

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I have had surgery in my chest area before.

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

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I am being treated for a mycobacterial infection.

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My blood pressure is high and untreated.

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I have severe breathing issues, need oxygen, or have heart problems due to lung condition.

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I needed treatment for a sudden worsening of my condition within the last 6 weeks.

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I have a lung condition other than cystic fibrosis.

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I have been diagnosed with narrowed arteries in my kidneys.

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I am using birth control or am not of childbearing potential.

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My lung condition has been stable, without treatment changes in the last 2 weeks.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Decrease of inflammatory markers

Improvement on pulmonary function tests (in %predicted)

Improvement on pulmonary function tests (in L)

+1 more

Side effects data

From 2021 Phase 4 trial • 227 Patients • NCT02188121

43%

Laboratory values outside normal range

23%

Psychiatric Hospitalization

Medical Hospitalization

Elevated creatine kinase level

Muscle pain

Hypotension

Dehydration

Leukemia

Placed on Lithium while on Losartan

100%

80%

60%

40%

20%

Study treatment Arm

Statin and/or Angiotensin Receptor Blocker

Usual Treatment

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: losartanExperimental Treatment1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Losartan

2003

Completed Phase 4

~3000

0 / 13Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Cystic Fibrosis (CF) target various aspects of the disease. Antibiotics are used to manage pulmonary infections, reducing bacterial load and inflammation. Azithromycin, a macrolide antibiotic, not only fights infections but also has anti-inflammatory properties, which help in reducing lung damage. Hypertonic saline improves mucociliary clearance, aiding in the removal of thick mucus from the airways. Gene therapy aims to correct the underlying genetic defect by introducing functional CFTR genes into the affected cells. Losartan, an Angiotensin II Receptor Blocker, is being studied for its potential to improve mucociliary clearance, which could offer an additional therapeutic avenue for CF patients. These treatments are crucial as they address both the symptoms and the root causes of CF, improving quality of life and potentially extending lifespan.

Targeting the Root Cause of Cystic Fibrosis.Gene therapy for cystic fibrosis.Exploring the mechanisms of macrolides in cystic fibrosis.