Losartan and Inflammation in Cystic Fibrosis

NCT03206788 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2020-11-27

Study results available
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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

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03206788 on ClinicalTrials.gov