Official Title: “Effect of Losartan on Airway Parameters in COPD”

Losartan, an angiotensin receptor blocker, has been effective in preventing the development of emphysema and lung inflammation in animal models of COPD. Moreover, there is epidemiologic evidence that suggests that this drug may be effective in reducing COPD morbidity and mortality.

This study will provide treatment with either losartan or placebo for a period of 12 months to determine whether there is progression of COPD as measured by high-resolution CT scans, lung function, or blood tests for inflammation.

Study Type: Interventional

Study Design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Study Primary Completion Date: June 2012

Intervention(s) in this Clinical Trial

• Drug: Losartan
  • 50-100 mg daily by mouth
• Drug: Placebo
  • Similar placebo

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Losartan 50-100mg daily
• Placebo Comparator: 2
  • Placebo tablet daily

Primary Measures

• Progression of emphysema and airway wall thickness by HRCT
  • Time Frame: Measured at Month 12
    Safety Issue?: No

Secondary Measures

• Pulmonary function
  • Time Frame: Measured at Month 12
    Safety Issue?: No
• Measures of serum biomarkers of inflammation
  • Time Frame: Measured at Months 6 and 12
    Safety Issue?: No
• Inflammatory cells and biomarkers in bronchoalveolar lavage in selected subset of patients
  • Time Frame: Measured at Month 2
    Safety Issue?: No

Inclusion Criteria:

• Evidence of COPD by pulmonary function testing

Exclusion Criteria:

• Clinical indication for angiotensin receptor blockers or ACE inhibitors
• Significant kidney disease or heart disease
• History of intolerance to losartan or similar drugs

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?: Accepts Healthy Volunteers

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

Overall Clinical Trial Officials and Contacts

Robert A Wise, M.D. Principal Investigator Johns Hopkins University  

Overall Contact: Marie Daniel 410 550-0800 mdaniel@jhmi.edu

Information obtained from ClinicalTrials.gov on March 18, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00720044

Study ID Number: 1 P50 HL084945-A

ClinicalTrials.gov Identifier: NCT00720044

Health Authority: United States: Federal Government