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 range
18 Years
Sex
ALL
See this in plain English?
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Improvement of mucociliary clearance ( MCC) and cough clearance (CC)