AZMATICS: AZithroMycin/Asthma Trial In Community Settings
Status:
Completed
Trial end date:
2010-11-01
Target enrollment:
Participant gender:
Summary
The purpose of this study is to assess the effectiveness of the azalide macrolide
azithromycin in adults with persistent asthma.
Research Question: Will a 12-week treatment with the antibiotic, azithromycin, result in a
statistically significant and clinically meaningful improvement in overall asthma symptoms
and other patient-oriented asthma outcomes one year after initiation of treatment of adult
primary care patients with asthma?
Experimental Design: The investigators propose a one-year randomized, placebo-controlled,
blinded (investigator, patient, data collector, data analyst) trial of 12 weekly doses of
azithromycin/placebo as adjunctive therapy (in addition to usual care) along with a parallel
observational cohort who will participate 'open label' in 100 adult asthma patients recruited
from practice-based research networks (e.g., Wisconsin Research and Education Network (WREN)
and others). This "practical clinical trial" will (1) enroll a representative sample of
asthma patients encountered in the practices of primary care physicians, (2) employ standard
clinical trial methodology to ensure internally valid results and (3) measure outcomes
important to patients, so that the results will be valid and applicable to the kinds of
asthma patients encountered by family physicians and other primary care providers.
Active study sites -
- Wisconsin: Augusta, Cross Plains, La Crosse, Marshfield, Milwaukee, Madison,
- Mauston, Rice Lake, Tomah, Wausau
- Colorado: Monument
- Illinois: Peoria
- Nevada: Reno
- North Carolina: Granite Falls
- North Dakota: Minot
- Ohio: Cleveland, Berea
- Oklahoma: Ardmore, Claremore, Edmond, Lawton, Oklahoma City, Stroud, Tulsa, Weatherford
- Rhode Island: East Providence
Phase:
Phase 3
Details
Lead Sponsor:
University of Wisconsin, Madison
Collaborators:
American Academy of Family Physicians Dean Foundation Pfizer