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OpenTrials
Completed

NCT Number: NCT00720226

Efficacy of Losartan in Preventing Progression of COPD

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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Key information

Conditions

COPD Behavior Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Bronchitis Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections Smoking

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21205, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Losartan

Drug

Losartan 100 mg daily

Other names: Cozaar

Placebo

Drug

Placebo pill daily

Other names: "Sugar pill"

Primary outcomes

  1. Change in Percent Emphysema on CT Scan

    Time frame: 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 outcomes

  1. Change in FEV1 (L)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • Merck Sharp & Dohme LLC
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start
2008
Primary completion
2014
Study completion
2016
First posted
Jul 22, 2008
Registry last updated
Apr 25, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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