Rationale Indacaterol/glycopyrronium (IND/GLY, QVA149) is a combination of a long-acting beta-2 agonist and a muscarinic receptor antagonist for the once-daily treatment of COPD. Here we assessed the effects of indacaterol/glycopyrronium on lung function and physical activity compared with placebo.

Methods We performed a randomised, two-period, cross-over study (21 days of treatment separated by a wash-out period of 14 days) with IND/GLY 110 µg/50 µg or matching placebo. Lung function was measured by slow and forced spirometry. Physical activity was measured by an activity monitor (Bodymedia SenseWear Armband) over the last week of each treatment period. The primary endpoint was peak inspiratory capacity (IC) at the end of each treatment period (i.e., on Day 21). The co-primary endpoint was physical activity level as defined by daily activity-related energy expenditure (kcal/day). Secondary endpoints included number of steps per day, duration of at least moderate activity per day, peak IC and FEV₁ on Day 1, trough IC on Day 1, and trough IC and FEV₁ on Day 21.

Results 194 patients (mean age 63 years; mean postbronchodilator FEV₁ 61.6% predicted), were randomised; 183 patients completed the study. Peak IC on Day 21 was 0.202 L greater with IND/GLY compared to placebo (p < 0.001; Table 1). In addition, superiority of indacaterol/glycopyrronium over placebo with regard to other parameters of lung function was demonstrated (Table 1). Compared with placebo, indacaterol/glycopyrronium significantly increased the change from baseline in average physical activity level with a difference of 36.7 kcal/day. Further, IND/GLY -treated patients completed significantly more steps per day with a difference between the two treatment groups of 358.0 steps per day (Table 1).

Conclusion Compared with placebo, IND/GLY improved lung function and physical activity in patients with moderate to severe COPD.