PT  - JOURNAL ARTICLE
AU  - Robert Wilson
AU  - Antonio Anzueto
AU  - Marc Miravitlles
AU  - Pierre Arvis
AU  - Jeff Alder
AU  - Daniel Haverstock
AU  - Mila Trajanovic
AU  - Sanjay Sethi
TI  - Late-breaking abstract: Moxifloxacin (MXF) vs amoxicillin/clavulanic acid (AMC) in acute exacerbations of COPD (AECOPD): Results of a large clinical trial with a novel endpoint
DP  - 2011 Sep 01
TA  - European Respiratory Journal
PG  - 195
VI  - 38
IP  - Suppl 55
4099  - http://erj.ersjournals.com/content/38/Suppl_55/195.short
4100  - http://erj.ersjournals.com/content/38/Suppl_55/195.full
SO  - Eur Respir J2011 Sep 01; 38
AB  - Introduction: Evidence-based therapy of AECB/COPD is limited by a lack of appropriate trials. MAESTRAL compares antibiotic therapies for AECOPDs in patients with moderate-to-severe disease at risk of poor outcomes.Method: This was a multiregional, prospective, randomised, double-blind study of patients ≥60 years, FEV1<60% predicted, with an Anthonisen type 1 exacerbation and ≥2 exacerbations in the last year. Patients were stratified by systemic steroid use and received MXF 400 mg PO qd (5 days) or AMC 875/125 mg PO bd (7 days). The primary endpoint was clinical failure 8 weeks post-therapy (PP) and the study was powered for superiority (ITT).Results: At 8-weeks post-therapy MXF was non-inferior to AMC (Table). In microbiologically confirmed AECOPD, MXF resulted in lower clinical failure and higher bacterial eradication (Table). Steroid-treated patients had worse outcomes overall; this effect was lower for MXF vs AMC. Clinical cure at 8 weeks post-therapy was significantly higher in MXF patients with eradication vs persistence at EOT (P<0.0001) but not in AMC patients (P=0.149) (Table).Conclusion: Both drugs had good efficacy. At the 8-week endpoint, MXF was superior to AMC in microbiologically confirmed AECOPD. Bacterial eradication and clinical success were strongly correlated. The results may help physicians optimise antibiotic therapy in moderate-to-severe AECOPD.