AZMATICS: AZithroMycin/Asthma Trial In Community Settings
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 Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||AZMATICS: Azithromycin Asthma Trial In Community Settings|
- Overall asthma symptoms, as measured by a 5-point scale [ Time Frame: 2006-2010 ] [ Designated as safety issue: No ]
- Asthma control [ Time Frame: 2006-2010 ] [ Designated as safety issue: No ]
- Asthma-specific quality-of-life [ Time Frame: 2006-2010 ] [ Designated as safety issue: No ]
- Asthma exacerbations [ Time Frame: 2006-2010 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2006|
|Study Completion Date:||November 2010|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Azithromycin
Active adjunctive treatment
600 mg x 3 days, then 600 mg weekly x 11 weeks
Other Name: Zithromax
Placebo Comparator: Placebo
1.0 PROTOCOL SYNOPSIS
Approximately 100 eligible adult patients with physician-diagnosed asthma will be randomized to 12-week treatment with azithromycin, a widely marketed azalide antibiotic with an excellent safety profile, or identical placebo as adjunctive therapy for usual care for asthma. The following patient-reported data will be collected via Zoomerang™ (a commercially-available data collection tool) periodically until one year after randomization: (1) study medication adherence and side effects weekly until 12 weeks, (2) asthma control and exacerbations every 6 weeks until 12 months, and (3) asthma quality of life and asthma controller medication changes every 3 months until 12 months. The primary hypothesis is that azithromycin will significantly improve asthma control (decrease symptoms and medication use) by 3 months (end treatment) and the improvement will continue to 12 months (end study). The primary outcome variable is overall asthma symptoms. Secondary outcomes are asthma medication use, quality of life and exacerbations. We will examine the predictive value of baseline patient characteristics including age, sex, smoking, co-morbid respiratory diagnoses and degree of airflow limitation. We will also examine for any imbalances between study groups in controller medication use, other antibiotic prescriptions and acute respiratory illnesses during the one-year study period.
We will enroll subjects from the practices of Wisconsin Research and Education Network (WREN) members, UW Department of Family Medicine physicians, Dean Medical Center primary care physicians, and from other practice-based research networks (PBRNs), medical group practices and individual primary care practices throughout North America.
Patients with physician-diagnosed asthma aged 18 and older will be identified at point-of-service (office, urgent care, emergency room or hospital), by administrative data base review, or by physician recall. Most subjects will be the patients of study physicians. Other physicians in the group practice may refer subjects. Subjects also may be self-referred after responding to posters placed in the clinics. Some sites may elect to identify cases by medical record or database review, in which case only the personal physician may initiate patient contacts.
Treatment is azithromycin tablets, 600 milligrams orally once daily for 3 days, then 600 milligrams once weekly for an additional 11 weeks (total dose 8400 milligrams) or identical placebo, in addition to usual care for asthma.
|United States, Illinois|
|Peoria, Illinois, United States, 61602|
|United States, Kansas|
|AAFP National Research Network|
|Kansas City, Kansas, United States, 66211|
|United States, Ohio|
|RAP - Cleveland Clinic|
|Cleveland, Ohio, United States, 44130|
|United States, Oklahoma|
|University of Oklahoma Health Sciences Center (OUHSC) and Oklahoma Physicians Resource/Research Network (OKPRN)|
|Oklahoma City, Oklahoma, United States, 73104|
|United States, Wisconsin|
|Wisconsin Research and Education Network (WREN)|
|Madison, Wisconsin, United States, 53713|
|Principal Investigator:||David L Hahn, MD, MS||Wisconsin Research and Education Network (WREN)|