Losartan and Inflammation in Cystic Fibrosis
NCT03206788 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2020-11-27
Summary
The purpose of the study is to examine if a specific drug called losartan (Cozaar ®), generally used to treat high blood pressure and to protect kidneys from damage in patients suffering from Diabetes Mellitus, will have any effect on the nasal inflammation in patients with cystic fibrosis (CF). The study will be performed at the Pulmonary Division at the University of Miami, Cincinnati Children's Medical Hospital Center, University of Kansas Medical Center and University of Alabama-Birmingham.
Conditions
Interventions
- DRUG
-
Losartan
25 mg or 50 mg (based on patient's weight) Losartan tablets taken by mouth daily in the morning for week 1 followed by twice daily (one in the morning and one in the evening) on Weeks 2-12.
- DRUG
-
Placebo tablets, matching the Losartan intervention, taken by mouth daily in the morning for week 1 followed by twice daily (one in the morning and one in the evening) on Weeks 2-12.
Sponsors & Collaborators
-
University of Alabama at Birmingham
collaborator OTHER -
Children's Hospital Medical Center, Cincinnati
collaborator OTHER -
University of Kansas Medical Center
collaborator OTHER -
Cystic Fibrosis Foundation
collaborator OTHER -
University of Miami
lead OTHER
Principal Investigators
-
Matthias Salathe, MD · University of Miami
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-11-11
- Primary Completion
- 2019-10-24
- Completion
- 2019-12-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
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