Macrolide Azithromycin to Prevent Rapid Worsening of Symptoms Associated With Chronic Obstructive Pulmonary Disease

NCT00325897 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1142

Last updated 2019-11-18

Study results available
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Summary

The purpose of this study is to determine if long-term administration of a macrolide antibiotic will reduce worsening of symptoms among individuals with chronic obstructive pulmonary disease (COPD).

Conditions

  • Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

Macrolide Antibiotic (Azithromycin)

Azithromycin (daily capsule, 250 mg for 12 months)

DRUG

Placebo

Placebo taken on a daily basis

Sponsors & Collaborators

Principal Investigators

  • Richard K. Albert, MD · Denver City-County Health/Hospitals Department

  • William C. Bailey, MD · University of Alabama at Birmingham

  • Richard Casaburi, MD, PhD · Harbor-UCLA Research & Education Institute

  • John E. Connett, PhD · University of Minnesota

  • Gerard J. Criner, MD · Temple University

  • Stephen C. Lazarus, MD · University of California at San Francisco

  • Fernando J. Martinez, MD · University of Michigan

  • Dennis E. Niewoehner, MD · Minnesota Veterans Medical Research and Education Foundation

  • John J. Reilly, MD · Brigham and Women's Hospital

  • Steven M. Scharf, MD, PhD · University of Maryland, Baltimore

  • Frank Sciurba, MD · University of Pittsburgh

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2010-06-30
Completion
2010-07-31

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00325897 on ClinicalTrials.gov