Effect of Losartan on Chronic Obstructive Pulmonary Disease (COPD) - Full Text View

Sponsor:	National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00720044

Purpose

Losartan, an angiotensin receptor blocker, has been effective in preventing the development of emphysema and lung inflammation in animal models of COPD. Moreover, there is epidemiologic evidence that suggests that this drug may be effective in reducing COPD morbidity and mortality.

This study will provide treatment with either losartan or placebo for a period of 12 months to determine whether there is progression of COPD as measured by high-resolution CT scans, lung function, or blood tests for inflammation.

Condition	Intervention	Phase
COPD Emphysema Chronic Obstructive Pulmonary Disease Chronic Bronchitis	Drug: Losartan Drug: Placebo	Phase II Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Effect of Losartan on Airway Parameters in COPD

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Chronic Bronchitis Emphysema

Drug Information available for: Losartan Losartan potassium

U.S. FDA Resources

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

Primary Outcome Measures:

Progression of emphysema and airway wall thickness by HRCT [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Pulmonary function [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
Measures of serum biomarkers of inflammation [ Time Frame: Measured at Months 6 and 12 ] [ Designated as safety issue: No ]
Inflammatory cells and biomarkers in bronchoalveolar lavage in selected subset of patients [ Time Frame: Measured at Month 2 ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	May 2008
Estimated Study Completion Date:	September 2012
Estimated Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Losartan 50-100mg daily	Drug: Losartan 50-100 mg daily by mouth Other Name: Cozaar
Placebo Comparator: 2 Placebo tablet daily	Drug: Placebo Similar placebo Other Name: "sugar pill"

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Evidence of COPD by pulmonary function testing

Exclusion Criteria:

Clinical indication for angiotensin receptor blockers or ACE inhibitors
Significant kidney disease or heart disease
History of intolerance to losartan or similar drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720044

Contacts

Contact: Marie Daniel	410 550-0800	mdaniel@jhmi.edu
Contact: Gwen Leatherman	410 550-0800	gleathe@jhmi.edu

Locations

United States, Maryland
Johns Hopkins Hospital	Recruiting
Baltimore, Maryland, United States, 21205
Contact: Teresa Concordia 410-550-2449 tconcor1@jhmi.edu
Sub-Investigator: Gregory Diette, M.D.

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

Principal Investigator:

Robert A Wise, M.D.

Johns Hopkins University

More Information

No publications provided

Responsible Party:	Robert A. Wise, MD, Johns Hopkins University School of Medicine / Bloomberg School of Public Health
ClinicalTrials.gov Identifier:	NCT00720044 History of Changes
Other Study ID Numbers:	1 P50 HL084945-A, 1 P50 HL084945
Study First Received:	July 18, 2008
Last Updated:	July 18, 2008
Health Authority:	United States: Federal Government

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

Lung function
Biomarkers
Emphysema
COPD

Additional relevant MeSH terms:

Bronchitis
Bronchitis, Chronic
Emphysema
Pulmonary Emphysema
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Pathologic Processes
Losartan
Anti-Arrhythmia Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012