Vol.57 No.1 January 2009
Multicenter, open-label study of the sustained-release formulation of azithromycin (azithromycin SR) for treatment of acute bronchitis and secondary infection of chronic respiratory disease
1)Second Department of Internal Medicine, Nagasaki University School of Medicine and Dentistry, 1-7-1 Sakamoto, Nagasaki, Japan
2)Department of Internal Medicine, Shinrakuen Hospital
3)Department of Clinical Infectious Diseases, School of Medicine, Showa University
4)Research Division for Development of Anti-Infective Agents, Institute of Development, Aging and Cancer, Tohoku University
Abstract
A phase 3 multicenter open-label study was conducted to confirm the efficacy and safety of a single 2.0 g dose of a new formulation of a macrolide antibiotic azithromycin, i.e., the sustained-release formulation for oral suspension (azithromycin SR), in patients with acute bronchitis or secondary infection in chronic respiratory disease.
Clinical efficacy on day 8, evaluated as the primary end point in the clinical per protocol set, was 93.3% (42/45 subjects) for the entire population. Clinical efficacy by disease was 97.0% (32/33 subjects) in acute bronchitis and 83.3% (10/12 subjects) in secondary infection in chronic respiratory disease. Clinical efficacy for the entire population was 97.7% (42/43 subjects) on day 15 and 95.5% (21/22 subjects) on day 29.
The bacteriological response (eradication) in the "bacteriologic per protocol set" was 78.9% on day 4, 84.2% on day 8, and 100% on days 15 and 29 for the entire population. Eradication by disease ranged from 83.3% to 100% for acute bronchitis and from 71.4% to 100% for secondary infection in chronic respiratory disease throughout the study.
In safety, the incidence of treatment-related adverse events was 53.1% (34/64 subjects). The most frequent adverse event was diarrhea, for which all cases were confirmed to have recovered. No severe adverse events or deaths were reported during the study.
Based on these results, we concluded that azithromycin SR administered as a single 2.0 g oral dose is highly effective and well tolerated in the treatment of acute bronchitis and secondary infection in chronic respiratory disease. Azithromycin SR is therefore considered very useful for treating of respiratory tract infection in clinical practice from various aspects, including drug compliance.
Key word
azithromycin, single-dose, extended release, acute bronchitis, chronic respiratory disease
Received
August 8, 2008
Accepted
November 10, 2008
Jpn. J. Chemother. 57 (1): 15-25, 2009
