CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 97 enrolled
Drug / intervention
Azithromycin +1 moredrug
Likely dose
Azithromycin 600 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00266851
NCT00266851Phase 3Completed

AZMATICS: Azithromycin Asthma Trial In Community Settings

University of Wisconsin, Madison·interventional·Posted Dec 19, 2005·Updated Sep 6, 2019

In Brief

A Phase 3 clinical trial evaluating Azithromycin and Placebo for Asthma. Completed, enrolled 97 participants across 5 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 19, 2005
Enrollment StartJan 1, 2006
Primary CompletionNov 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 20.5 years ago

Interventions

Azithromycindrug

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

Placebodrug

Matching placebo