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Efficacy of Losartan in Preventing Progression of COPD

This study has been completed.
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert A. Wise, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00720226
First received: July 18, 2008
Last updated: March 14, 2017
Last verified: March 2017
  Purpose
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).

Condition Intervention Phase
COPD Emphysema Chronic Bronchitis Smoking Drug: Losartan Drug: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Losartan in Preventing Progression of COPD

Resource links provided by NLM:


Further study details as provided by Robert A. Wise, Johns Hopkins University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 106
Study Start Date: July 2008
Study Completion Date: August 2016
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Losartan
Losartan 100 mg daily
Drug: Losartan
Losartan 100 mg daily
Other Name: Cozaar
Placebo Comparator: Placebo
Placebo 1 pill daily
Drug: Placebo
Placebo pill daily
Other Name: "Sugar pill"

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.
  Eligibility

Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720226

Locations
United States, Maryland
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
National Heart, Lung, and Blood Institute (NHLBI)
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Robert A. Wise, MD Johns Hopkins University
  More Information

Responsible Party: Robert A. Wise, Professor of Medicine (Pulmonary and Critical Care), Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00720226     History of Changes
Obsolete Identifiers: NCT00720044
Other Study ID Numbers: 1P50HL084945 ( U.S. NIH Grant/Contract )
Study First Received: July 18, 2008
Results First Received: January 24, 2017
Last Updated: March 14, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Limited dataset available to qualified investigators with data use agreement.

Keywords provided by Robert A. Wise, Johns Hopkins University:
COPD
emphysema
angiotensin receptor blocker

Additional relevant MeSH terms:
Emphysema
Pulmonary Emphysema
Bronchitis
Bronchitis, Chronic
Pathologic Processes
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Respiratory Tract Infections
Losartan
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 22, 2017