Daily-practice treatment of acute exacerbations of chronic bronchitis with moxifloxacin in a large cohort in Germany

Objective: To monitor the efficacy and safety of moxifloxacin in respiratory tract infections (RTIs) focussing on acute exacerbations of chronic bronchitis (AECB). Methods: Patients with RTIs could be enrolled in this open-label, prospective, non-controlled post-marketing surveillance study from October 2001 until June 2002 unless moxifloxacin was contraindicated. At the initial visit, data were recorded on patient demographics, diagnosis and clinical symptoms. Two follow-up examinations could be performed to determine cure or improvement based on clinical symptoms, and to record adverse events. Clinical symptoms including fever, cough and purulent sputum were assessed individually. Efficacy, tolerability and patient acceptance were assessed globally at the final visit. Results: Of 9036 enrolled patients, 4328 had AECB, most of whom were treated with moxifloxacin at a daily dose of 400mg. Mean +/- SD time to clinical improvement was 3.4 +/- 1.5 days, and mean +/- SD time to clinical cure was 6.6 +/- 2.4 days. Cure rates were 39.4% at day 5 and 94.3% at day 10. By day 6, the proportion of patients with severe cough decreased from 85.4% at the initial visit to 6.9%, and those with severe dyspnoea from 22.5% to 1.2%. Purulent sputum was absent within 4 days in the majority of cases. Physicians rated efficacy, tolerability and patient acceptance as 'very good' or 'good' in approximately 95% of patients. There were 59 adverse events in 44 (1.0%) patients, most frequently gastrointestinal and nervous system disorders. Conclusions: This study further confirms that AECB patients treated with moxifloxacin benefit from more rapid symptom relief and that this therapy option is well accepted in general practice.