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AZMATICS: AZithroMycin/Asthma Trial In Community Settings

NCT00266851 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2019-09-06

Study results available
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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

Conditions

Interventions

DRUG

Azithromycin

600 mg x 3 days, then 600 mg weekly x 11 weeks

DRUG

Placebo

Matching placebo

Sponsors & Collaborators

  • American Academy of Family Physicians

    collaborator OTHER

  • Dean Foundation

    collaborator OTHER

  • Pfizer

    collaborator INDUSTRY

  • University of Wisconsin, Madison

    lead OTHER

Principal Investigators

  • David L Hahn, MD, MS · Wisconsin Research and Education Network (WREN)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2006-01-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00266851 on ClinicalTrials.gov