Status:
ACTIVE_NOT_RECRUITING
Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240
Lead Sponsor:
University of Kansas Medical Center
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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
Detailed Description
CF is the most common inherited disease causing a shortened life span, affecting \~30,000 people in the United States with annual health care costs of at least $1.8 billion. The median age of predicte...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
- Blood pressure less than 90 mm Hg systolic while standing
- Cardiac, renal (creatinine 1.5 times normal limit), hepatic (LFTs \> 3x normal upper limit), neurological, psychiatric, endocrine or neoplastic diseases that are judged to interfere with participation in study
- Known renal artery stenosis
- Concomitant airway disorders other than CF, such as ABPA
- Subjects with prior thoracic surgery
- Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with trial participation or may interfere with the interpretation of trial results and, in the judgment of the PI, would make the subject inappropriate for enrollment.
- Patients using intermittent inhaled or oral antibiotics will be allowed to participate in this trial. Patients on chronic, cycling antibiotics will be required to have completed at least 2 full cycles of the prescribed antibiotic prior to enrollment and should be studied during the same phase of treatment (on or off) during each study period.
- Have had radiation exposure within the past year that would cause them to exceed Federal Regulations by participating in this study.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2026
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03435939
Start Date
February 15 2022
End Date
February 28 2026
Last Update
October 28 2025
Active Locations (1)
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1
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160