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Efficacy of Losartan in Preventing Progression of COPD

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ClinicalTrials.gov Identifier: NCT00720226
Recruitment Status : Completed
First Posted : July 22, 2008
Results First Posted : April 25, 2017
Last Update Posted : April 25, 2017
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Robert A. Wise, Johns Hopkins University

July 18, 2008
July 22, 2008
January 24, 2017
April 25, 2017
April 25, 2017
July 2008
August 2014   (Final data collection date for primary outcome measure)
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.
Extent of emphysema on CT scan [ Time Frame: Measured at Month 12 ]
Complete list of historical versions of study NCT00720226 on ClinicalTrials.gov Archive Site
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.
Pulmonary function testing [ Time Frame: Measured at Month 12 ]
Not Provided
Not Provided
 
Efficacy of Losartan in Preventing Progression of COPD
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).
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.
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • COPD
  • Emphysema
  • Chronic Bronchitis
  • Smoking
  • Drug: Losartan
    Losartan 100 mg daily
    Other Name: Cozaar
  • Drug: Placebo
    Placebo pill daily
    Other Name: "Sugar pill"
  • Experimental: Losartan
    Losartan 100 mg daily
    Intervention: Drug: Losartan
  • Placebo Comparator: Placebo
    Placebo 1 pill daily
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
120
August 2016
August 2014   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
40 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00720226
1P50HL084945( U.S. NIH Grant/Contract )
1P50HL084945 ( U.S. NIH Grant/Contract )
Yes
Not Provided
Plan to Share IPD: Yes
Plan Description: Limited dataset available to qualified investigators with data use agreement.
Robert A. Wise, Johns Hopkins University
Johns Hopkins University
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Merck Sharp & Dohme Corp.
Principal Investigator: Robert A. Wise, MD Johns Hopkins University
Johns Hopkins University
March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP