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Pulmonary rehabilitation
P189 Reduced COPD Exacerbations Associated with Aclidinium Bromide Versus Placebo: A Pooled Analysis of Phase III Data
  1. Paul W Jones1,
  2. Dave Singh2,
  3. Edward Kerwin3,
  4. Rosa Lamarca4,
  5. Cynthia Caracta5,
  6. Esther Garcia Gil4
  1. 1St George’s, University of London, London, UK
  2. 2Medicines Evaluation Unit Ltd, Manchester, UK
  3. 3Clinical Research Institute, Medford, USA
  4. 4Almirall SA, Barcelona, Spain
  5. 5Forest Research Institute, Jersey City, New Jersey, USA

Abstract

Introduction and objective Aclidinium bromide is a novel, long-acting, inhaled muscarinic antagonist indicated for the treatment of chronic obstructive pulmonary disease (COPD). COPD is characterised by periodic worsening of symptoms (exacerbations) that are associated with increased morbidity and mortality. Here, we report the results of a pooled analysis of aclidinium on exacerbations.

Methods Data from two Phase III studies (3-month ACCORD COPD I and 6-month ATTAIN) were included in this analysis. Both were designed to evaluate the efficacy and safety of aclidinium 200 µg and 400 µg (metered dose) BID versus placebo (primary endpoint: change from baseline in FEV1). Adults (aged ≥40 years) with moderate-to-severe COPD, who were current/former smokers with a smoking history ≥10 pack-years, were included. Exacerbations (additional endpoint) were assessed in both studies using healthcare resource utilisation (HCRU) criteria (increase in symptoms for ≥2 consecutive days that required increased medication use or other medical intervention) and, in ATTAIN only, with the Exacerbations of Chronic Pulmonary Disease Tool (EXACT [daily diary card data with exacerbations defined according to the developer’s criteria]). Neither study was individually powered to assess treatment differences in exacerbation frequency. In this pooled analysis, exacerbation rate ratios (per patient/year for aclidinium versus placebo) were analyzed using a Poisson regression model corrected for over-dispersion; 95% confidence intervals and p-values were calculated.

Results Data for 1378 patients were included; the majority (62%) were male with a mean age of approximately 63 years. At baseline, >60% of patients were classed as GOLD stage II (moderate), and 31% reported ≥1 exacerbations in the previous 12 months. In both studies, there was a trend towards relative reduction (approximately 30%) in the rate of moderate or severe exacerbations (requiring antibiotic or corticosteroid treatment, or hospitalisation) with both aclidinium doses versus placebo (Figure). A significant reduction in moderate or severe exacerbation rate was observed with aclidinium 400 µg versus placebo when data from both studies were pooled (0.31 vs 0.44; rate ratio 0.71, p=0.01).

Conclusions This pooled analysis provides evidence to support a reduction in moderate or severe COPD exacerbations with aclidinium 200 µg and 400 µg BID compared with placebo.

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