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• W2389349820 abstract "Background and Objectives Aclidinium bromide is a long-acting muscarinic antagonist approved for the longterm maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD). This 12-week phase III study evaluated efficacy and tolerability of aclidinium 200 or 400 lg in patients with moderate-tosevere COPD. Methods In this double-blind study, 544 patients with COPD were randomized to placebo or twice-daily aclidinium 200 or 400 lg administered by Genuair/Pressair. Lung function, health status [measured by the St. George’s Respiratory Questionnaire (SGRQ)], dyspnea [measured using the Transition Dyspnea Index (TDI)], and safety were assessed throughout the study. Results Mean changes from baseline in morning trough forced expiratory volume in 1 s (FEV1) at week 12 (primary endpoint) were significantly higher for aclidinium than for placebo (200 lg, 51 mL; 400 lg, 72 mL; both p 0.05). Aclidinium also significantly improved other lung function outcomes. At week 12, improvements from baseline were observed with aclidinium in SGRQ total score (200 lg, -6.0; 400 lg, -5.4) and TDI focal score (200 lg, 1.0; 400 lg, 1.3). Furthermore, clinically important improvements in SGRQ total and TDI focal scores were achieved by 45 and 51 % of patients, respectively, who received aclidinium 400 lg, with a significant difference versus placebo for TDI (p 0.05). Anticholinergic-related adverse events (e.g., dry mouth) were infrequent, occurring 2 % for any event in any treatment group. Both aclidinium doses were well tolerated. Conclusion This study demonstrates efficacy and safety of aclidinium in COPD patients. Unexpected baseline imbalances between treatment groups may have impacted the aclidinium treatment benefit in this study." @default.
• W2389349820 created "2016-06-24" @default.
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• W2389349820 date "2013-01-01" @default.
• W2389349820 modified "2023-09-27" @default.
• W2389349820 title "ACCORD COPD II: A Randomized Clinical Trial to Evaluate the 12-Week Efficacy and Safety of Twice-Daily Aclidinium Bromide in Chronic Obstructive Pulmonary Disease Patients Stephen I. RennardPaul D. ScanlonGary T. Ferguson •" @default.
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