Effect of Losartan on Chronic Obstructive Pulmonary Disease (COPD)

Condition(s) targeted: COPD; Emphysema; Chronic Obstructive Pulmonary Disease; Chronic Bronchitis

Intervention: Losartan (Drug); Placebo (Drug)

Phase: Phase 2/Phase 3

Status: Recruiting

Sponsored by: National Heart, Lung, and Blood Institute (NHLBI)

Official(s) and/or principal investigator(s):
Robert A Wise, M.D., Principal Investigator, Affiliation: Johns Hopkins University

Overall contact:
Marie Daniel, Phone: 410 550-0800, Email: mdaniel@jhmi.edu

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.

Official title: Effect of Losartan on Airway Parameters in COPD

Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Primary outcome: Progression of emphysema and airway wall thickness by HRCT

Secondary outcome:

Pulmonary function

Measures of serum biomarkers of inflammation

Inflammatory cells and biomarkers in bronchoalveolar lavage in selected subset of patients

Minimum age: 40 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Marie Daniel, Phone: 410 550-0800, Email: mdaniel@jhmi.edu

Johns Hopkins Hospital, Baltimore, Maryland 21205, United States; Recruiting
Teresa Concordia, Phone: 410-550-2449, Email: tconcor1@jhmi.edu
Gregory Diette, M.D., Sub-Investigator

Starting date: May 2008
Ending date: September 2012
Last updated: July 18, 2008