RT Journal Article SR Electronic T1 ACCORD COPD I: Improvements in nighttime symptoms and rescue medication use in COPD with twice-daily aclidinium bromide JF European Respiratory Journal JO Eur Respir J FD European Respiratory Society SP p873 VO 38 IS Suppl 55 A1 Edward Kerwin A1 Stephen Rennard A1 Arthur Gelb A1 Ludmyla Rekeda A1 Esther Garcia Gil A1 Cynthia Caracta YR 2011 UL http://erj.ersjournals.com/content/38/Suppl_55/p873.abstract AB Introduction: Nighttime symptoms in COPD patients can reduce quality of life. In this Phase III study, nighttime symptoms and rescue medication use were assessed during twice-daily (BID) treatment with aclidinium bromide, a long-acting muscarinic antagonist in development for COPD.Methods: In this 12-week, double-blind study, COPD patients (FEV1/FVC <70%) were randomised (1:1:1) to aclidinium 200 μg, 400 μg, or placebo. Nighttime symptoms were recorded daily using electronic diaries via a COPD Nighttime Symptoms Questionnaire, which assessed frequency and severity of symptoms and their impact on activity and sleep. Rescue medication use was also assessed.Results: Of 561 randomised patients, 467 completed the study. At Week 12, aclidinium 200 μg and 400 μg reduced nighttime COPD symptom frequency vs placebo (p<0.05 and p<0.005, respectively). Both aclidinium doses reduced severity and impact of nighttime breathlessness and cough on morning activities vs placebo (p<0.01 and p<0.05, respectively). Severity of early morning breathlessness and activity restriction due to breathlessness were reduced with aclidinium 200 μg (p<0.01) and 400 μg (p<0.001) vs placebo. Compared to placebo, 24-h sputum production was significantly reduced with the 200 μg (p<0.05) and 400 μg (p<0.01) doses at Week 12 but not sputum production during sleep. Aclidinium 400 μg improved the severity and impact of breathing symptoms on sleep vs placebo at 12 weeks (p<0.01). Both aclidinium doses reduced total daily rescue medication use vs placebo (p≤0.001 for both).Conclusions: Aclidinium 200 μg and 400 μg BID significantly reduced nighttime/early morning symptoms and daily rescue medication use.