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Efficacy of Losartan in Preventing Progression of COPD

NCT ID: NCT00720226

Last Updated: 2017-04-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-07-31

Study Completion Date

2016-08-31

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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COPD Emphysema Chronic Bronchitis Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Losartan

Losartan 100 mg daily

Group Type EXPERIMENTAL

Losartan

Intervention Type DRUG

Losartan 100 mg daily

Placebo

Placebo 1 pill daily

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo pill daily

Interventions

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Losartan

Losartan 100 mg daily

Intervention Type DRUG

Placebo

Placebo pill daily

Intervention Type DRUG

Other Intervention Names

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Cozaar "Sugar pill"

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Johns Hopkins University

OTHER

Sponsor Role lead

Responsible Party

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Robert A. Wise

Professor of Medicine (Pulmonary and Critical Care)

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert A. Wise, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

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Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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1P50HL084945

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1P50HL084945

Identifier Type: NIH

Identifier Source: org_study_id

View Link

NCT00720044

Identifier Type: -

Identifier Source: nct_alias

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