Macrolides to Prevent Exacerbations of Asthma and Chronic Obstructive Pulmonary Disease
Stopped early · Phase 2
Conditions studied: Asthma, Chronic Obstructive Pulmonary Disease
In brief
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.
Key facts
- Study ID
- NCT00181272
- Run by
- Johns Hopkins University
- People needed
- 18
- Starts
- 2005-09-01
- Expected to finish
- 2006-07-01
- Last updated by the study team
- 2013-05-13
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- Johns Hopkins Hospital — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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