Fleroxacin versus amoxicillin in the treatment of acute exacerbation of chronic bronchitis

Abstract

The objective of this double-blind, multicenter study was to compare the efficacy and safety of oral fleroxacin, 400 mg once daily for 7 days, with amoxicillin, 500 mg administered every 8 hours for 7 days, in the treatment of acute exacerbation of chronic bronchitis. Adult male or female inpatients or outpatients were included. Patients gave informed consent and underwent a physical examination. Appropriate sputum specimens were collected, gramstained, and cultured before and 3-9 days after therapy. Complete blood count, serum chemistry, and urinalysis were performed before and 3-9 days after therapy. Of the 625 enrolled patients, 286 (148 in the fleroxacin group and 138 in the amoxicillin group) were evaluable for efficacy. The rate of bacteriologic cure was 96% (142 of 148) among patients in the fleroxacin group and 83% (114 of 138) among patients in the amoxicillin group, showing a statistically significant superiority for fleroxacin. The rate of clinical cure in the patients evaluable for this parameter was 90% (131 of 145) in the fleroxacin group and 82% (111 of 136) in the amoxicillin group. The differences were not significant, but the trend supported the bacteriologic results. Adverse clinical events related to the trial medication were reported by 61 (19%) of 313 patients receiving fleroxacin and by 27 (9%) of 310 patients treated with amoxicillin. The rates of bacteriologic cure and clinical success for fleroxacin were higher than those for amoxicillin. While the overall rate of adverse events was higher in the fleroxacin group, the proportions of patients with severe adverse events was higher in the fleroxacin group, the proportions of patients with severe adverse events were similar in the two groups. Most of the reported events were not serious or severe and were generally well tolerated, as reflected by the low proportion of premature withdrawals for this reason.