Efficacy of Losartan in Preventing Progression of COPD

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
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: April 1, 2013
Last verified: April 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 Johns Hopkins University:

Primary Outcome Measures:
  • Extent of emphysema on CT scan [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pulmonary function testing [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: July 2008
Estimated Study Completion Date: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Losartan 100 mg daily
Drug: Losartan
Losartan 100 mg daily
Other Name: Cozaar
Placebo Comparator: 2
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
Genders Eligible for Study:   Both
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
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
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Robert A. Wise, MD Johns Hopkins University
  More Information

No publications provided

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: 1 P50 HL084945, 1P50HL084945
Study First Received: July 18, 2008
Last Updated: April 1, 2013
Health Authority: United States: Federal Government

Keywords provided by Johns Hopkins University:
COPD
emphysema
angiotensin receptor blocker

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

ClinicalTrials.gov processed this record on April 15, 2014