Randomized, Double-Blind Study Comparing 5- and 7-Day Regimens of Oral Levofloxacin in Patients with Acute Exacerbation of Chronic Bronchitis

Abstract

Translated and Reprinted with permission from «International Journal of Antimicrobial Agents» 2001;18:503-13.

A randomized, double-blind, multicentre study was conducted in adult patients with acute exacerbation of chronic bronchitis (AECB), to compare the efficacy of a 5-day course of levofloxacin 500 mg once daily, with the standard 7-day regimen at the same dose. Five hundred and thirty-two patients from 48 centers in 10 countries were randomized to receive levofloxacin: 268 and 264 received the 5- and 7-day courses, respectively. The primary efficacy analysis was the clinical response at 7-10 days post-treatment in the per-protocol (PP) population. Clinical success rates in the primary PP analysis of 482 patients were 82,8% (¹⁹⁷⁄₂₃₈) for the 5-day group and 84,8% (²⁰⁷⁄₂₄₄) for the 7-day group. The difference in success rates was - 2,1% with 95% CI (of - 9,1 to 4,9%). The bacteriological response showed eradication rates of 82,1% (⁹²⁄₁₁₂) and 83,2% (⁸⁴⁄₁₀₁) in the 5- and 7-day groups, respectively. Both treatments were well tolerated. These results show that for patients with AECB levofloxacin 500 mg once daily for 5 days provides equivalent clinical and bacteriological success to the same dose given for 7 days irrespective of the patients age, the frequency of exacerbations or the presence of co-existing cardiopulmonary or chronic obstructive airways disease.