PT  - JOURNAL ARTICLE
AU  - Anthony D'Urzo
AU  - Barry Make
AU  - Edward Kerwin
AU  - Ludmyla Rekeda
AU  - Esther Garcia Gil
AU  - Cynthia Caracta
AU  - Brian Maurer
TI  - ACCORD COPD I: Safety and tolerability of twice daily aclidinium bromide in COPD patients
DP  - 2011 Sep 01
TA  - European Respiratory Journal
PG  - p3998
VI  - 38
IP  - Suppl 55
4099  - http://erj.ersjournals.com/content/38/Suppl_55/p3998.short
4100  - http://erj.ersjournals.com/content/38/Suppl_55/p3998.full
SO  - Eur Respir J2011 Sep 01; 38
AB  - Introduction: Aclidinium bromide is a long-acting muscarinic antagonist in development for COPD. Safety and tolerability of aclidinium 200 μg and 400 μg BID in moderate to severe COPD patients were assessed in this Phase III study.Methods: In this 12-week, double-blind study, COPD patients were randomised to aclidinium 200 μg, 400 μg, or placebo BID (1:1:1). Safety was assessed via adverse events (AEs), clinical laboratory measures, vital signs, and electrocardiograms (ECGs).Results: Baseline demographics were similar across treatment groups (N=561). The number (%) of patients with a treatment-emergent AE (TEAE) was comparable between aclidinium 400 μg, 200 μg, and placebo [85 (44.7), 93 (50.5), 97 (52.2), respectively]. COPD exacerbation was the most frequently reported TEAE in all groups (12.4%, placebo; 9.2%, 200 μg; 7.4%, 400 μg). Incidence of serious AEs was low (2.2%-4.3% for all groups). Incidence of potential anticholinergic AEs (eg, constipation and dry mouth) was low (n≤3) in both aclidinium groups and comparable to placebo. The most frequently reported AEs resulting in discontinuation were COPD exacerbation (n=7, placebo; n=4, 200 μg; n=1, 400 μg) and dyspnea (n=2 each, placebo and 400 μg). One patient in the aclidinium 400 μg group died due to metastatic lung cancer but this was not considered to be related to treatment. Changes from baseline in laboratory tests, vital signs, and ECGs, were similar across all groups.Conclusions: Aclidinium 200 μg and 400 μg BID were safe and well tolerated throughout this 12-week study with a low incidence of systemic anticholinergic adverse events, similar to placebo. There were no differences in safety profiles between the two aclidinium doses.