Efficacy of Losartan in Preventing Progression of COPD

Phase 4

Completed

• Conditions: Emphysema; COPD; Chronic Bronchitis; Smoking
• Interventions: Drug: Placebo; Drug: Losartan

• Registration Number: NCT00720226
• Lead Sponsor: Johns Hopkins University

Brief Summary

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).

Detailed 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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-18
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-22
• Primary Completion: 2014-08
• Study Completion: 2016-08
• Results First Submitted: 2017-01-24
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Results First Posted: 2017-04-25
• Last Update Posted: 2017-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo 1 pill daily
Losartan	Losartan	Losartan 100 mg daily

Primary Outcome Measures

Name	Time	Method
Change in Percent Emphysema on CT Scan	Change between baseline and month 12.	Percent emphysema calculated as percent of CT voxels less than -950 HU measured at TLC. Analysis limited to patients with 5-35% emphysema on CT scan at baseline.

Secondary Outcome Measures

Name	Time	Method
Change in FEV1 (L)	Measured at Baseline and Month 12	Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.

Trial Locations

Locations (1)

Johns Hopkins Asthma and Allergy Center; 🇺🇸 Baltimore, Maryland, United States