Abstract
OBJECTIVE: Acute exacerbation of chronic bronchitis (AECB) is a commonly encountered problem and those suspected to be due to bacterial infections require antibiotic therapy. This randomized, controlled trial was designed to evaluate the effectiveness and safety of gemifloxacin, a new fluoroquinolone, versus cefpodoxime, an oral third-generation cephalosporin, for the treatment of mild to moderately severe cases of AECB. MATERIALS AND METHODS: Adult subjects diagnosed with chronic bronchitis with clinical symptoms suggestive of an Anthonisen type II acute exacerbation (any two of the following criteria - increased dyspnea, cough, sputum purulence) were eligible and those fulfilling the subject selection criteria were randomized to receive either gemifloxacin 320 mg once daily or cefpodoxime 200 mg twice daily orally for 7 days. The primary outcome measure was clinical success rate at day 14 visit and the secondary outcome measures were changes in Clinical Global impression (CGI) scales and incidence of adverse events (AEs). Fifty-two subjects were enrolled: 26 in gemifloxacin group and 24 in the other and 2 were lost to follow-up. RESULTS: The clinical success rates were comparable (84.6% in gemifloxacin group versus 83.3% in cefpodoxime group) and no statistically significant difference was observed between the groups. AEs were mild, self-limiting and few (two in gemifloxacin and three in cefpodoxime arm) and tolerability was also good. CONCLUSION: The results of this randomized, single-blind trial demonstrated that a 7-day course of gemifloxacin is therapeutically comparable to cefpodoxime in terms of both clinical effectiveness and safety for the treatment of type II Anthonisen category AECB patients.