Abstract
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 & 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 FEV1, and to have had exacerbations in the last year. FDC 400/12 µg improved FEV1 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.
- Copyright ©ERS 2015
