Study:
AZMATICS: Azithromycin Asthma Trial In Community Settings
Rationale:
n/a
Purpose:
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) 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
Study Status: Completed
Recruiting:
n/a
| Condition |
Intervention |
Phase |
|
Asthma |
Drug: Azithromycin
Drug: Placebo |
Phase 3 |
Verified by
University of Wisconsin, Madison
January, 2013
Sponsored by: University of Wisconsin, Madison
Information provided by: University of Wisconsin, Madison
ClinicalTrials.gov identifier: NCT00266851
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
RAP - Cleveland Clinic
Cleveland, Ohio 44130
United States
David L Hahn, MD, MS., Principal Investigator