Background: Physical activity limitation is common in chronic obstructive pulmonary disease (COPD), and is\nassociated with worse health status, and increased hospitalisation and mortality. Long-acting bronchodilators, either\nalone or in combination, have been shown to improve exercise intolerance. However, none of these studies were\ndesigned with physical activity as primary outcome.\nThis study assessed the effect of indacaterol/glycopyrronium fixed dose combination (IND/GLY) 110/50 Ã?¼g once\ndaily (OD) versus placebo on lung hyperinflation (inspiratory capacity [IC]) and physical activity in patients with\nmoderate-to-severe COPD.\nMethods: In this multicentre, randomised, double-blind, placebo-controlled crossover study, patients received\nIND/GLY or placebo OD in two 21-day treatment periods (14-day washout between periods). Eligible patients\nwere ââ?°Â¥40 years of age, current or ex-smokers (smoking history ââ?°Â¥10 pack-years), with post-salbutamol forced\nexpiratory volume in 1 s (FEV1) 40ââ?¬â??80 % predicted, and FEV1:forced vital capacity <0.70.\nThe co-primary endpoints were peak IC after 21 days and average daily activity-related energy expenditure. Key\nsecondary endpoints were average number of steps per day and the duration of at least moderate activity per\nday. Peak IC and FEV1 on Day 1, and trough IC and FEV1 after 21 days were other secondary endpoints.\nResults: A total of 194 patients were randomised (65.5 % male, mean age 62.8 years, mean FEV1 61.6 %\npredicted), with 183 (94.3 %) completing the study.\nCompared with placebo, IND/GLY significantly increased peak IC after 21 days (difference 202 mL, p < 0.0001),\nactivity-related energy expenditure (difference 36.7 kcal/day, p = 0.040), and the average number of steps per day\n(difference 358, p = 0.029), with a trend towards an improvement in the duration of at least moderate activity\n(difference 4.4 min, p = 0.264). IND/GLY was associated with statistically significant improvements versus placebo\nin peak IC and FEV1 on Day 1, and trough IC and FEV1 after 21 days. The incidence of treatment-emergent\nadverse events was 22.8 % with IND/GLY and 22.9 % with placebo.\nConclusions: In this study, compared with placebo, IND/GLY reduced hyperinflation, and, despite no patient\neducation or lifestyle advice, improved daily physical activity levels. This suggests that IND/GLY has the potential\nto impact two of the main clinical concerns in the care of patients with COPD.
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