Efficacy of Losartan in Preventing Progression of COPD - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) Merck
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00720226

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 IV

MedlinePlus related topics: Bronchitis Emphysema Smoking

Drug Information available for: Losartan Losartan potassium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Efficacy of Losartan in Preventing Progression of COPD

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

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 2012
Estimated Primary Completion Date:	August 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Losartan 100 mg daily	Drug: Losartan Losartan 100 mg daily
2: Placebo Comparator Placebo 1 pill daily	Drug: Placebo Placebo pill daily

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

Contacts

Contact: Gwen Leatherman, RN	410 550-0800	gleathe@jhmi.edu
Contact: Marie Daniels	410 550-0800	mdaniel@jhmi.edu

Locations

United States, Maryland
Johns Hopkins Asthma and Allergy Center	Recruiting
Baltimore, Maryland, United States, 21205
Contact: Teresa Concordia, RN 410-283-5728 tconcor1@jhmi.edu
Principal Investigator: Robert A. Wise, MD
Sub-Investigator: Enid Neptune, MD
Sub-Investigator: Nadia Hansel, MD
Sub-Investigator: Gregory Diette, MD
Sub-Investigator: M. Bradley Drummond, MD

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Merck

Investigators

Principal Investigator:

Robert A. Wise, MD

Johns Hopkins University

More Information

Responsible Party:	Johns Hopkins University School of Medicine / Bloomberg School of Public Health ( Robert A. Wise, MD )
Study ID Numbers:	1 P50 HL084945, 1 P50 HL084945
Study First Received:	July 18, 2008
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00720226
Health Authority:	United States: Federal Government

Keywords provided by National Heart, Lung, and Blood Institute (NHLBI):

COPD
emphysema
angiotensin receptor blocker

Study placed in the following topic categories:

Emphysema
Losartan
Disease Progression
Angiotensin II
Pulmonary Emphysema
Bronchitis, Chronic
Smoking

Lung Diseases, Obstructive
Respiratory Tract Diseases
Respiratory Tract Infections
Lung Diseases
Bronchitis
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Angiotensin II Type 1 Receptor Blockers
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Therapeutic Uses

Cardiovascular Agents
Anti-Arrhythmia Agents
Antihypertensive Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009