Chronic Obstructive Pulmonary Disease
ATS 2016. A6817 – Improvement in Lung Function and Symptom Control with Aclidinium Bromide Versus Tiotropium and Placebo in Symptomatic Patients with COPD: Post-Hoc Analysis of a Phase IIIb Study
J. Beier, et al.
Results: Overall, 277/414 symptomatic patients were included in the analyses (mean age 62.1 years; 65.0% male; 54.5% current smokers; baseline FEV1 1.41±0.48 L). Aclidinium 400 μg BID improved FEV1 over 24 hours from baseline at Week 6 compared with placebo. Additionally, improvements in FEV1 from baseline during the nighttime period were observed for aclidinium 400 μg BID versus tiotropium. Aclidinium 400 μg BID demonstrated improvements in trough FEV1 from baseline versus tiotropium and placebo at Week 6. Over the 6-week treatment period, aclidinium 400 μg BID improved early-morning and nighttime symptom severity, limitation of early-morning activities caused by COPD symptoms, and also improved E-RS total score and domain scores (at Week 6) versus tiotropium (except for E-RS Chest symptoms) and placebo. Tolerability (reported previously; Beier et al. 2013) showed similar incidence of adverse events (AEs) in each arm, with few anticholinergic AEs or serious AEs; aclidinium was well tolerated.
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CONCLUSIONS: IN SYMPTOMATIC PATIENTS WITH MODERATE TO SEVERE COPD, ACLIDINIUM 400 ΜG BID IMPROVED BRONCHODILATION (PARTICULARLY DURING THE NIGHTTIME PERIOD), AND ALSO IMPROVED EARLY-MORNING, DAYTIME, AND NIGHTTIME SYMPTOMS, AND EARLY-MORNING LIMITATION OF ACTIVITY COMPARED WITH EITHER TIOTROPIUM 18 ΜG QD OR PLACEBO.
CARE™ FACULTY PERSPECTIVE: A number of clinical trials indicated that the long-acting, inhaled muscarinic antagonist (LAMA) aclidinium bromide reduces the frequency of COPD exacerbations compared with placebo and that these effects are greater in symptomatic patients. Aclidinium therefore offers an alternative to long-acting beta-agonist or anticholinergic bronchodilators. Aclidinium bromide is available in Canada as single drug or in combination with formoterol fumarate (LABA-LAMA).