Morning and nighttime symptoms in COPD and efficacy of aclidinium/formoterol in symptomatic vs asymptomatic patients

Background: Morning and nighttime symptoms of COPD impair patient quality of life. Methods: Data were pooled from two 24-week, randomised, placebo-controlled, Phase III studies of twice-daily aclidinium/formoterol fixed-dose combination (FDC) in moderate to severe COPD (NCT01462942 u0026 NCT01437397). Morning and nighttime symptom prevalence was assessed, and patient characteristics and efficacy of FDC 400/12 µg were compared for symptomatic (cough, wheezing, dyspnoea and phlegm, both morning and night at baseline) vs asymptomatic patients (no symptoms at baseline either morning or night). Results: Data were analysed for 3339 patients. Symptoms were common in the morning (cough 81.5%; dyspnoea 77.6%; wheeze 63.4%; phlegm 48.6%) and at night (cough 72.7%; dyspnoea 67.2%; wheeze 59.3%; phlegm 44.0%). Compared with asymptomatic patients, symptomatic patients were more likely to be male, smokers, with more severe COPD and lower predicted FEV 1 , and to have had exacerbations in the last year. FDC 400/12 µg improved FEV 1 and TDI (dyspnoea related to daily activities) in both symptomatic and asymptomatic patients, and E-RS (symptoms) in symptomatic patients (Table). Conclusion: Morning and nighttime COPD symptoms are common in moderate to severe COPD. Aclidinium/formoterol FDC 400/12 µg significantly improved symptoms vs placebo, and improved dyspnoea and lung function in symptomatic and asymptomatic patients.