At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 109 enrolled
Drug / intervention
Azithromycin 250 mg +1 moredrug
Likely dose
Azithromycin 250 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.
The AZIthromycin in Severe ASThma (AZISAST) Study: a Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Evaluating the Efficacy, Safety and Cost-effectiveness of Azithromycin as add-on Therapy in Adult Subjects With Severe Persistent Asthma, Who Remain Inadequately Controlled Despite GINA (2006) Step 4 or 5 Therapy
In Brief
A Phase 4 clinical trial evaluating Azithromycin 250 mg and Placebo for Asthma. Completed, enrolled 109 participants across 7 sites.
Detailed Summary
The purpose of this study is to evaluate the efficacy, safety and cost-effectiveness of azithromycin as add-on therapy in adult subjects with severe persistent asthma, who remain inadequately controlled despite GINA (2006) step 4 or 5 therapy.
Study Details
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedSep 2008
Enrollment StartMar 2009
Primary CompletionFeb 2011
Study CompletionSep 2011
TodayJul 2026
First PostedSep 26, 2008
Enrollment StartMar 1, 2009
Primary CompletionFeb 1, 2011
Study CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 17.8 years ago
Interventions
Azithromycin 250 mgdrug
Azithromycin 250 mg three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks
Placebodrug
Placebo three times a week during treatment period (6 months); run-in period of 2 weeks; wash-out period of 4 weeks