Efficacy and tolerance of two oral dosages of Augmentin® 1 g/125 mg twice a day versus 500 mg/125 mg thrice a day in acute exacerbations of chronic bronchitis.: A multicenter comparative randomized double blind study.

Objective - The authors had for aim to assess and to compare the clinical efficacy and tolerance of co-amoxiclav 1 g/125 mg, twice a day (group I), versus the reference formulation of co-amoxiclav 500 mg/125 mg thrice a day (group 2) in the treatment of acute exacerbation of chronic obstructive bronchitis. Material and methods - A multicenter randomized double blind clinical trial, included 355 patients, 173 in group 1, and 182 in group 2. Results - There was no significant difference within groups according clinical findings at inclusion: FEV1/VC was below 70% in 77.4%, and 71.4% of patients of group 1 and 2 respectively. The acute exacerbation of chronic bronchitis was Anthonisen type I in 73.4% and 68.4% of patients, respectively, and 37.9% and 28.4% of patients exhibited more than four exacerbation episodes in the past year: In both groups, the duration of therapy was 8 to 10 days. The success rate evaluated at the end of treatment on an intention-to-treat basis was 98.2% in group 1 g and 97.2% in group 2. The success rate at the end of the study reached 93.3% and 93.2% respectively. There was no significant difference between the clinical efficacy of both dosages of co-amoxiclav whether evaluated at the end of therapy or at the end of the study. Frequency and kind of side effects assessed in 352 patients were comparable within groups. Comments - The new formulation of co-amoxiclav can be suggested in the treatment of patients with acute exacerbation of chronic obstructive bronchitis, when antibiotherapy is indicated. (C) 2000 Editions scientifiques et medicales Elsevier SAS.