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Randomised clinical trials in COPD
S51 Efficacy of Aclidinium Bromide Compared with Tiotropium and Placebo in Patients with Moderate to Severe COPD: A Phase IIIb Study
  1. Jutta Beier1,
  2. Anne Marie Kirsten2,
  3. Robert Mroz3,
  4. Rosa Segarra4,
  5. Ferran Chuecos4,
  6. Cynthia Caracta5,
  7. Esther Garcia Gil4
  1. 1Insaf Respiratory Research, Wiesbaden, Germany
  2. 2Pulmonary Research Institute at Hospital Grosshansdorf, Grosshansdorf, Germany
  3. 3ISPL Centrum Medyczne, Białystok, Poland
  4. 4Almirall, R&D Centre, Barcelona, Spain
  5. 5Forest Research Institute, Jersey City, New Jersey, USA

Abstract

Introduction and Objective Aclidinium bromide is a novel, long-acting, muscarinic antagonist indicated as a maintenance treatment for chronic obstructive pulmonary disease (COPD). Maintaining significant bronchodilation throughout the 24-hour day is important to improve outcomes for patients with COPD. This study evaluated daily bronchodilatory symptom control with twice-daily (BID) aclidinium in patients with stable, moderate-to-severe COPD.

Methods In this 6-week, randomised, double-blind, Phase IIIb study, patients received aclidinium 400 µg (metered dose; equivalent to aclidinium 322 µg delivered dose) BID, tiotropium bromide 18 µg once daily or placebo. Change from baseline in normalised forced expiratory volume in 1 second (FEV1) area under the curve over the 24-hour period immediately following morning treatment (AUC0–24) at Week 6 was the primary endpoint. Other endpoints included change from baseline in normalised FEV1 AUC12–24 and AUC0–12, pre-dose (trough) FEV1 and peak FEV1. Daily symptoms were recorded each evening using the 11-item EXAcerbations of Chronic pulmonary disease Tool-Respiratory Symptoms (EXACT-RS) and a total score was calculated (range 040: more severe symptoms indicated by higher score). Additional daily symptoms, including presence of morning symptoms and night-time symptom severity (5point scale: 0=none; 4=very severe), were recorded using electronic diaries.

Results In total, 414 patients were randomised: mean age was 62.3±8.1 years (mean±SD); 54.1% were current smokers; baseline FEV1 was 1.484±0.51 L At Week 6, aclidinium 400 µg BID and tiotropium 18 µg QD significantly improved lung function from baseline compared with placebo (Table). Compared with placebo, aclidinium and tiotropium significantly reduced EXACT-RS total scores from baseline (–2.1 and –1.3 versus –0.1; p<0.0001 and p<0.05, respectively), and increased percentage of days without morning symptoms from baseline (6.7% and 3.4%, respectively, versus 2.2%; p<0.05 for both) at Week 6. Night-time symptom severity scores were significantly reduced from baseline with aclidinium (–0.16) versus placebo (–0.02) at Week 6 (p<0.05) but improvements with tiotropium (–0.09) did not reach statistical significance.

Conclusions Aclidinium 400 µg BID provided significant 24-hour bronchodilation and daily symptom improvement throughout the study. The bronchodilatory effect of aclidinium was similar to tiotropium, with numerically greater improvement in morning and night-time symptoms among aclidinium-treated patients.

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Abstract S51 Table 1

Spirometric variables at Week 6

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