Using an innovative study design we compared oral moxifloxacin (MXF) 400 mg QD for 5 days with amoxicillin, clarithromycin or cefuroxime-axetil (CMP) at recommended doses for 7 days to treat acute exacerbations of chronic bronchitis (AECB).
This multicenter, double-blind study included outpatients aged > 45 years with stable CB, history of smoking of ≥20 packs/year, ≥2 documented AECB in the previous year, and FEV1 < 85% of predicted value. Patients with Anthonisen type 1 AECB within 12 months of enrolment were randomised. Patients were assessed at screening, end of treatment and 7-10 days after treatment, and contacted monthly until new AECB occurred or up to 9 months. Clinical cure was defined as return to pre-AECB status, and clinical success as cure and improvement combined. Other measures were bacteriological treatment success, need for further antimicrobials and time to next AECB.
730 ITT patients received MXF (n=354) or CMP (n=376). Cure rates were 70.9% with MXF and 62.8% with CMP in the ITT population (95% CI 1.4, 14.9; p=0.05), and 68.7% vs. 62.1% in the per protocol population (95% CI 0.3, 15.6; p=0.02). Clinical success was seen in 83.0-87.6% of ITT patients across treatment arms and populations with a significant difference in favor of MXF in patients not receiving steroids (p<0.01). In the per protocol population, 91.5% of patients on MXF and 81.0% on CMP showed bacteriological success (95% CI 0.4, 22.1). A significantly lower proportion of patients required additional antimicrobials in the moxifloxacin arm (9.5% vs. 15.1%, p=0.045). Mean times to new AECB in patients not requiring further antibiotics were 132.8 days for MXF and 118.0 days for CMP (p=0.03).CONCLUSIONS: There was a significantly greater response to MXF for cure rates, rates of bacteriological eradication, need for additional antimicrobials and time to next exacerbation.
The excellent clinical outcomes for MXF support the use of MXF in AECB and should be considered in future treatment guidelines.DISCLOSURE: A. Anzueto, None.