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| Sponsor: | University of Wisconsin, Madison |
|---|---|
| Collaborators: |
American Academy of Family Physicians Wisconsin Academy of Family Physicians (WAFP) Dean Foundation Pfizer |
| Information provided by: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT00266851 |
Purpose
The purpose of this study is to determine whether an emerging body of evidence suggests that half of adult asthma cases may be caused by chronic infection that is treatable with antibiotics.
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 600 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 | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Azithromycin Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | AZMATICS: Azithromycin Asthma Trial In Community Settings |
| Estimated Enrollment: | 200 |
| Study Start Date: | January 2006 |
| Estimated Study Completion Date: | November 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Azithromycin: Active Comparator
Active adjunctive treatment
|
Drug: Azithromycin
600 mg x 3 days, then 600 mg weekly x 11 weeks
|
|
Placebo: Placebo Comparator
Adjunctive placebo
|
Drug: Placebo
Matching placebo
|
1.0 PROTOCOL SYNOPSIS
Approximately 200 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Age 18 and older (and at least 50 kg/110 pounds)
At the time of randomization, eligible subjects must either:
Documentation of objective evidence of reversible airway obstruction, either spontaneously or after treatment, is required prior to randomization. This requirement can be met by documentary evidence, within 2 years of randomization, of either:
Exclusion Criteria:
Specified co-morbidities likely to interfere with study assessments or follow up. Excluded comorbidities include:
Specified medications for which close monitoring has been recommended in the setting of macrolide administration Patients taking digoxin, theophylline, warfarin, ergotamine or dihydroergotamine, triazolam, carbamazepine, cyclosporine, hexobarbital or phenytoin are excluded.
The intent of this protocol is to enroll a broadly generalizable sample of adult patients with physician-diagnosed asthma, either stable persistent or in exacerbation.
Contacts and Locations| Contact: David L Hahn, MD, MS | (608) 260-6343 | dlhahn@wisc.edu |
| Contact: Michael Grasmick, PhD | (608) 265-4597 | Michael.Grasmick@fammed.wisc.edu |
| United States, Illinois | |
| ANSR | Recruiting |
| Peoria, Illinois, United States, 61602 | |
| Principal Investigator: Gregg Stoner, MD | |
| United States, Kansas | |
| AAFP National Research Network | Recruiting |
| Kansas City, Kansas, United States, 66211 | |
| Principal Investigator: Deborah Graham, MSPH | |
| United States, Ohio | |
| RAP - Cleveland Clinic | Recruiting |
| Cleveland, Ohio, United States, 44130 | |
| Principal Investigator: James Werner, PhD | |
| United States, Oklahoma | |
| University of Oklahoma Health Sciences Center (OUHSC) and Oklahoma Physicians Resource/Research Network (OKPRN) | Recruiting |
| Oklahoma City, Oklahoma, United States, 73104 | |
| Principal Investigator: James Mold, MD MPH | |
| United States, Wisconsin | |
| Wisconsin Research and Education Network (WREN) | Recruiting |
| Madison, Wisconsin, United States, 53713 | |
| Principal Investigator: David L Hahn, MD, MS | |
| Sub-Investigator: Michael Grasmick, PhD | |
| Principal Investigator: | David L Hahn, MD, MS | Wisconsin Research and Education Network (WREN) |
More Information
| Responsible Party: | Dean Medical Center ( David L Hahn ) |
| Study ID Numbers: | H-2005-0258 |
| Study First Received: | December 15, 2005 |
| Last Updated: | January 23, 2009 |
| ClinicalTrials.gov Identifier: | NCT00266851 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Randomized clinical trial Asthma Adults Azithromycin |
|
Anti-Infective Agents Bronchial Diseases Immune System Diseases Asthma Pharmacologic Actions Anti-Bacterial Agents Lung Diseases, Obstructive |
Hypersensitivity Respiratory Tract Diseases Lung Diseases Azithromycin Therapeutic Uses Hypersensitivity, Immediate Respiratory Hypersensitivity |