Efficacy of Losartan in Preventing Progression of COPD

Verified by: National Heart, Lung, and Blood Institute (NHLBI), July 2008
First Received: July 18, 2008 | Last Updated: July 18, 2008 | Phase: Phase 4 | Start Date: July 2008
Overall Status: Recruiting | Estimated Enrollment: 120
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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)...

Brief Summary

Official Title: “Efficacy of Losartan in Preventing Progression of COPD”

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: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
  • 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

Secondary Measures

  • Pulmonary function testing
    • Time Frame: Measured at Month 12
      Safety Issue?: No

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 Investigator Information

Lead Investigator: National Heart, Lung, and Blood Institute (NHLBI) NIH

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 February 12, 2012

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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