Abstract
Introduction: Aclidinium bromide is a long-acting muscarinic antagonist in clinical development for chronic obstructive pulmonary disease (COPD).
Aims: To assess the safety and tolerability of aclidinium 200 μg and 400 μg twice-daily (BID) in patients with COPD.
Methods: This 24-week, double-blind, Phase III study (NCT01001494) randomised patients to receive aclidinium 200 μg, 400 μg or placebo BID (1:1:1). Adverse events (AEs), clinical laboratory measures, vital signs and electrocardiograms (ECGs) were assessed.
Results: Baseline demographics were similar across all groups (safety population, N=819). The incidence of treatment-emergent AEs (TEAEs) was similar for placebo, aclidinium 200 μg and 400 μg (57.1%, 54.5%, 53.5%, respectively). COPD exacerbation was the most frequently reported TEAE in all groups (placebo, 20.5%; 200 μg, 15.9%; 400 μg, 14.1%). TEAEs reported by ≥2% of patients and with a higher incidence in the aclidinium groups were: headache, nasopharyngitis, diarrhoea, cough and toothache. The incidence of TEAEs leading to discontinuation was similar across the groups (3-4%); COPD exacerbation was the most frequent reason (placebo, n=5; 200 μg, n=3; 400 μg, n=4). The incidence of anticholinergic AEs (<2.5% for each group) and of general serious AEs (4.3-5.5%, all groups) was low in all treatment arms. Changes in laboratory tests, vital signs and ECGs were similar between groups.
Conclusions: Aclidinium 200 μg and 400 μg were well tolerated with an incidence of AEs similar to placebo. There were no differences in the safety profiles between the aclidinium doses.
This study was supported by Almirall S.A., Barcelona, Spain, and Forest Laboratories, Inc, New York, USA.
- © 2011 ERS
