Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240 (NCT03435939) | Clinical Trial Compass
CompletedEarly Phase 1
Effect of Losartan in Cystic Fibrosis (CF)-NIH Grant #133240
United States13 participantsStarted 2022-02-15
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
* Unabl…
What they're measuring
1
Improvement of mucociliary clearance ( MCC) and cough clearance (CC)