Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD)...
Date First Received: July 18, 2008
Last Updated: July 18, 2008
Verified by: National Heart, Lung, and Blood Institute (NHLBI), July 2008
Clinical Trial Phase: Phase 4 | Start Date: July 2008
Overall Status: Recruiting
Estimated Enrollment: 120
Brief Summary
Official Title: “Efficacy of Losartan in Preventing Progression of COPD”
Condition Keyword(s):
Intervention(s):
Evidence in animals shows that losartan can prevent or reverse inflammation and lung damage due to smoking. The goal of this study is to determine whether this drug which is also used to treat hypertension can stabilize or improve lung function in people who have from chronic obstructive pulmonary disease (COPD).
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Study Primary Completion Date: August 2012
Detailed Clinical Trial Description
Participants will be given either losartan in a dose of 50-100 mg per day for a period of one year. During that time, they will have lung function tests, breathing tests, and computed tomograms of the chest. These tests will determine whether there is inflammation in the lung and whether there is progressive involvement of the lung with COPD.
Intervention(s) in this Clinical Trial
- Drug: Losartan
- Losartan 100 mg daily
- Drug: Placebo
- Placebo pill daily
Arms, Groups and Cohorts in this Clinical Trial
- Experimental: 1
- Losartan 100 mg daily
- Placebo Comparator: 2
- Placebo 1 pill daily
Outcome Measures for this Clinical Trial
Primary Measures
- Extent of emphysema on CT scan
- Time Frame: Measured at Month 12
Safety Issue?: No
- Time Frame: Measured at Month 12
Secondary Measures
- Pulmonary function testing
- Time Frame: Measured at Month 12
Safety Issue?: No
- Time Frame: Measured at Month 12
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Adults with COPD who are either active or former smokers
Exclusion Criteria:
- Clinical requirement or history of intolerance of angiotensin receptor blockers, serious heart, liver, kidney, neurological disease.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 40 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Overall Clinical Trial Officials and Contacts
Robert A. Wise, MD Principal Investigator Johns Hopkins University
Overall Contact: Gwen Leatherman, RN 410 550-0800 gleathe@jhmi.edu
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00720226
Study ID Number: 1 P50 HL084945
ClinicalTrials.gov Identifier: NCT00720226
Health Authority: United States: Federal Government
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