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Efficacy of Losartan in Preventing Progression of COPD

Primary Purpose

COPD, Emphysema, Chronic Bronchitis

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Losartan
Placebo
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, emphysema, angiotensin receptor blocker

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Johns Hopkins Asthma and Allergy Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Losartan

Placebo

Arm Description

Losartan 100 mg daily

Placebo 1 pill daily

Outcomes

Primary Outcome Measures

Change in Percent Emphysema on CT Scan
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

Change in FEV1 (L)
Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.

Full Information

First Posted
July 18, 2008
Last Updated
March 14, 2017
Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Merck Sharp & Dohme LLC
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1. Study Identification

Unique Protocol Identification Number
NCT00720226
Brief Title
Efficacy of Losartan in Preventing Progression of COPD
Official Title
Efficacy of Losartan in Preventing Progression of COPD
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Johns Hopkins University
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), Merck Sharp & Dohme LLC

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD, Emphysema, Chronic Bronchitis, Smoking
Keywords
COPD, emphysema, angiotensin receptor blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Losartan
Arm Type
Experimental
Arm Description
Losartan 100 mg daily
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo 1 pill daily
Intervention Type
Drug
Intervention Name(s)
Losartan
Other Intervention Name(s)
Cozaar
Intervention Description
Losartan 100 mg daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
"Sugar pill"
Intervention Description
Placebo pill daily
Primary Outcome Measure Information:
Title
Change in Percent Emphysema on CT Scan
Description
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.
Time Frame
Change between baseline and month 12.
Secondary Outcome Measure Information:
Title
Change in FEV1 (L)
Description
Change in FEV1 (L) post-bronchodilator from baseline to 12 months. Analysis includes only participants with 5-35% emphysema at baseline.
Time Frame
Measured at Baseline and Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert A. Wise, MD
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins Asthma and Allergy Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Limited dataset available to qualified investigators with data use agreement.

Learn more about this trial

Efficacy of Losartan in Preventing Progression of COPD

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