Gemifloxacin versus amoxicillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis. The 070 Clinical Study group.

Six hundred patients were evaluated in this randomized, double-blind, double-dummy, multicenter, parallel-group study comparing the efficacy and safety of gemifloxacin (320 mg once-daily for 5 days) and amoxicillin/clavulanate (500/125 mg three-times daily for 7 days) for the treatment of acute exacerbations of chronic bronchitis (AECB). Of note, more than 90% of study participants had stage 2 disease at study entry. The two drugs were found to be equally effective, with clinical success rates of 93.6% for gemifloxacin and 93.2% on amoxicillin/clavulanate (95% CI -3.9 to 4.6). Bacteriological success rates favored gemifloxacin (90.9% compared with 79.5% for amoxicillin/clavulanate; 95% CI -3.3 to 26.0); however, this difference was not statistically significant. Gemifloxacin and amoxicillin/clavulanate were both well tolerated. In summary, gemifloxacin was found to be well tolerated and effective for the treatment of AECB, suggesting it is well suited for empirical treatment of this common respiratory condition in the current clinical environment.