At a glance
ClinicalIndex Comparison RecordN/ACompleted· 1,142 enrolled
Drug / intervention
Macrolide Antibiotic (Azithromycin) +1 moredrug
Likely dose
Azithromycin 250 mg orally once daily for 12 monthsAI-extracted
Key inclusion· 7
- ✓Post-bronchodilator FEV1/FVC ratio <70%
- ✓Post-bronchodilator FEV1 <80% predicted
- ✓≥10 pack-year smoking history
- ✓Current or prior supplemental oxygen use
Key exclusion· 9
- ✕Diagnosis of asthma
- ✕Macrolide hypersensitivity
- ✕QTc interval >440 ms on electrocardiogram
- ✕Taking cisapride, ergot derivatives, pimozide, disopyramide, cyclosporin, tacrolimus, nelfinavir, bromocriptine, or hexobarbital
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Effect of Chronic Macrolide Administration on the Frequency and Severity of COPD Exacerbations
In Brief
A clinical study evaluating Macrolide Antibiotic (Azithromycin) and Placebo for Pulmonary Disease, Chronic Obstructive. Completed, enrolled 1,142 participants across 10 sites.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Disease, Chronic Obstructive
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI)
Timeline
N/ACompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMar 2006
First PostedMay 2006
Primary CompletionJun 2010
Study CompletionJul 2010
TodayJul 2026
First PostedMay 15, 2006
Enrollment StartMar 1, 2006
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 20.1 years ago
Interventions
Macrolide Antibiotic (Azithromycin)drug
Azithromycin (daily capsule, 250 mg for 12 months)
Placebodrug
Placebo taken on a daily basis