A multinational, multicentre, non-blinded, randomized study of moxifloxacin oral tablets compared with co-amoxiclav oral tablets in the treatment of acute exacerbation of chronic bronchitis.

The aim of this study was to compare the efficacy and safety of once daily dosing wit moxifloxacin (BAY 12-8039) with that of co-amoxiclay given three times dally for the treatment of acute exacerbation of chronic bronchitis (AECB). Moxifloxacin (ane 400 mg tablet dally) was administered orally for 5 days and co-amoxiclav (three 625 mg tablets dally) was given orally for 7 days. The study was randomized, non-blinded, multinational (12 countries) and multi-centre (68 centres). A total of 575 patients, all with clear signs of AECB, were treated, 292 with moxifloxacin and 283 with co-amoxiclav. Of these, 512 patients were evaluable for efficacy (261 in the moxifloxacin group and 251 in the co-amoxiclav group). The primary efficacy parameter was clinical response at 14 days in the evaluable population. A clinical success was classified as resolution or improvement of symptoms. Variobles used to assess clinical response included wheeze. cough, dyspnoea, sputurn volume, rales and rhonchi. The success rate for moxifloxacin in the evaluable patients was 96.2% and that for co-amoxiclav was 91.6%. The 95% confidence intervals for this difference (0.4%; 8.7%) indicate equivalence in the treatments. Spatum samples were taken from potients and 140 of these contained a pathogen. Haemophilus influenzae being the most frequently isolated Maraxella caturrhalis and Streptococcus pneumoniae were also commonly isolated pathogens. The eradication rate at 14 days in the evaluable patients was 87.7% in the moxifioxacin group and 89.6% in the co-amoxiclov group. Both drugs were well tolecated with no significant differences in the numbers of drug-related adverse events or the numbers of patients withdrawing because of on adverse event. These results and the broad spectrum of antibacterial activity make moxifloxacin a promising and safe alternative to conventional therapy for the empirical treatment of AECB.