Single-dose azithromycin microspheres versus 5day moxifloxacin in acute exacerbation of chronic bronchitis
Abstract number: O212
Zhang Y., Zhu D., Atienza T.C., Ong M.L.
Objectives: Azithromycin microspheres formulation (AZM) was developed to enable a higher dosage of 2 g to be administered as a single oral dose without decreasing the safety profile. This study compared AZM with moxifloxacin (MOX) aimed at confirming the efficacy and safety of AZM in acute exacerbations of chronic bronchitis (AECB).
Methods: This prospective, multicentre, randomised, double-blind, double dummy study compared AZM 2 g single dose with MOX 400 mg once daily for 5 days, enrolled AECB patients 50 years old and above, with Anthonisen Type 1 exacerbations, and with at least 2 exacerbations of AECB in the past 12 months. Subjects were to have a history of smoking of at least 20 pack-years and documented forced expiratory volume in 1 second (FEV1) less than 80% of predicted. They were followed up for up to 9 months.
Results: A total of 396 patients were treated (198 in each of the treatment groups) The distribution of the age, and mean FEV1 were similar for the 2 treatment groups. Pathogens were isolated from 62.9% of the patients (61.1% of patients on AZM and 62.9% of patients on MOX).
The clinical success (signs and symptoms related to the acute infection had returned to the subject's normal baseline level, or clinical improvement was such that no additional antibiotics were deemed necessary) rate for the Per Protocol Population at Test of Cure (TOC) at Day 1219 was 93.0% for AZM and 94.2% for MOX group (95% CI -5.8, 3.9). Bacterial eradication rate (Bacteriologic Pre Protocol population) at TOC was 96.0% for AZM group and 96.7% for MOX group (95% CI -4.5, 3.3). Although the study population had history of at least 2 exacerbation in the past 12 months, less than half of the subjects experienced a recurrence during the follow-up, and there was no statistically significant treatment difference in time taken to first occurrence of AECB.
Both treatments were well tolerated. The incidence of treatment related adverse events was low, being reported by 17% of subjects receiving AZM and 12% of subjects receiving MOX. Most AEs were mild or moderate in severity. The most common AEs were gastrointestinal disorders, being reported by 14% of subjects receiving AZM and 8% of subjects receiving MOX.
Conclusions: A single oral dose of AZM was as effective as a 5-day course of MOX in the treatment of AECB and was well tolerated.
|Session name:||19th European Congress of Clinical Microbiology and Infectious Diseases|
|Location:||Helsinki, Finland, 16 - 19 May 2009|
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