%0 Journal Article %A Jadwiga A. Wedzicha %A Gavin Donaldson %A Ferran Chuecos %A Esther Garcia Gil %T Effect of aclidinium bromide on exacerbations in patients with moderate-to-severe COPD: Pooled analysis of phase III studies %D 2014 %J European Respiratory Journal %P 1888 %V 44 %N Suppl 58 %X BackgroundThis analysis investigated the effect of twice-daily aclidinium 400 µg on exacerbation rates in patients with COPD.MethodsAclidinium 400 µg and placebo data from five randomised, double-blind, Phase III studies were analysed by GOLD 2013 groups. Prior exacerbation was not an inclusion criterion. Exacerbations (reported and unreported) were assessed by healthcare resource utilisation (symptom increase on ≥2 consecutive days requiring treatment change).ResultsOf 2521 patients, 2459 were classified by GOLD group (A=8.1%; B=47.9%, C=2.6% and D=41.4% [82.5% of D had FEV1 <50% predicted]. Aclidinium 400 µg significantly reduced the rate of any (rate ratio [RR]=0.79; p<0.05) and moderate-to-severe exacerbations (see table) vs placebo. The rate reduction was mainly in symptomatic patients (Groups B+D), both any (RR=0.78; p<0.05) and moderate-to-severe (see table) vs Group A+C (any: RR=1.017; p=0.97). Time to first exacerbation (any) was delayed with aclidinium 400 µg vs placebo for all patients (hazard ratio [HR]=0.79; p<0.05) and in Group B+D (HR=0.79; p<0.05) but not Group A+C (HR=0.99; p=0.97). There was also a delay in time to first moderate-to-severe exacerbation in Group B+D patients (p=0.073).ConclusionAclidinium significantly reduced the rate of moderate-to-severe and exacerbations of any severity vs placebo for all patients and particularly those in GOLD Group B+D. %U