Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease

• Status: Terminated
• Trial end date: 2006-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether macrolide therapy is effective in treating patients hospitalized with asthma exacerbations or chronic obstructive pulmonary disease (COPD)exacerbations. We hypothesize that compared to placebo, maintenance therapy with macrolides, when added to usual care, a) improves respiratory symptoms, b) improves quality of life, c) reduces airway inflammation, d) reduces airflow obstruction, and e) decreases the rate of re-exacerbations.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Treatments: Azithromycin

Criteria

Inclusion Criteria:

• Physician-diagnosis of asthma, COPD exacerbation, or undifferentiated asthma/COPD exacerbation

• Admitted to the inpatient medical service at Johns Hopkins Hospital or Johns Hopkins Bayview Medical Center

• Evidence of airflow obstruction on spirometry (FEV1/FVC<70%)

• Age 18 years or older

Exclusion Criteria:

• History of allergy or other contraindication to macrolides (azithromycin, erythromycin, clarithromycin)

• Treatment with any macrolide in the 4 weeks prior to study entry

• Elevated AST or ALT (2 or more times the upper limit of normal) on current admission

• Elevated alkaline phosphatase (>1.25 times the upper limit of normal) on current admission

• Elevated total serum bilirubin (more than upper limit of normal) on current admission

• Previous participation in this study

• Patients prescribed digoxin (azithromycin may increase digoxin levels)

• Patients prescribed warfarin (azithromycin may increase INR in patients on warfarin)

• Patients prescribed pimozide (azithromycin may increase risk of arrhythmias)

• Patient unable to provide consent (e.g., language difficulty or history of dementia)

• Patient to be discharged to a location other than home (e.g., other hospital, long-term care facility)