AZMATICS: AZithroMycin/Asthma Trial In Community Settings
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|ClinicalTrials.gov Identifier: NCT00266851|
Recruitment Status : Completed
First Posted : December 19, 2005
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Asthma||Drug: Azithromycin Drug: Placebo||Phase 3|
1.0 PROTOCOL SYNOPSIS
Approximately 100 eligible adult patients with physician-diagnosed asthma will either be randomized to 12-week treatment with azithromycin or an identical placebo, or join an observational open-label azithromycin cohort. Azithromycin is a widely marketed azalide antibiotic with an excellent safety profile. Azithromycin or placebo will be adjunctive therapy for usual asthma care. 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||2 arms are randomized, placebo-controlled, double-blinded, 1 arm was added as an open-label observational cohort|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||AZMATICS: Azithromycin Asthma Trial In Community Settings|
|Study Start Date :||January 2006|
|Actual Primary Completion Date :||November 2010|
|Actual Study Completion Date :||November 2010|
Active Comparator: Azithromycin
Active adjunctive treatment
600 mg x 3 days, then 600 mg weekly x 11 weeks
Other Name: Zithromax
Placebo Comparator: Placebo
Eligible participants who declined randomization, offered enrollment in parallel, open-label azithromycin treatment arm
600 mg x 3 days, then 600 mg weekly x 11 weeks
Other Name: Zithromax
- Change in Overall Asthma Symptoms From Baseline [ Time Frame: Within the past 24 hours; measured every 1.5 months for one year ]5-point scale: 0=none, 1=mild, 2=moderate, 3=severe, 4=worst ever, the lower scores indicate improvement in asthma symptoms
- Change in Asthma Control Over Baseline [ Time Frame: Within the past week; every 3 months ]Mini-Juniper Asthma Control Questionnaire without pulmonary function. This is a 6-item survey scored on a 7 point scale where 0 is none, or no symptoms and 6 is severe or symptoms all of the time. Answers are averaged for a final score of 0-6. Data are reported as a change from baseline.
- Change is Asthma-specific Quality-of-Life (AQL) [ Time Frame: Within the past 2 weeks; every three months ]Juniper Asthma Quality of Life Questionnaire is a 32-item survey, recall of the past 2 weeks, scored on a 7 point Likert scale where 1 is severely impaired, and 7 is not impaired at all. Scores are averaged for a final range of 1-7. Change from Baseline is reported here.
- Asthma Exacerbations [ Time Frame: up to 12 months ]A steroid burst, an unscheduled or emergency visit and/or a hospitalization for asthma, reported at Weeks 0, 6, 12, 18, 24, 30, 36, 42, 48, and any time during follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00266851
|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)|