Outcomes and Assessments

The primary objective was to evaluate the safety and tolerability of IND/GLY (27.5/15.6 or 27.5/31.2 µg) versus IND (75 µg) in terms of adverse event (AE)-reporting rates in patients with moderate-to-severe COPD over 52 weeks. Secondary objectives were to evaluate the bronchodilator effect of IND/GLY (27.5/15.6 or 27.5/31.2 µg) versus IND (75 µg) on the mean FEV₁ at pre-dose 15 and 45 minutes (pre-dose trough FEV₁) at Week 52 and on FEV₁ and FVC at all post-baseline time points (including post-dose 1 h). Other secondary objectives were to evaluate the safety and tolerability of IND/GLY (27.5/15.6 or 27.5/31.2 µg) versus IND (75 µg) in terms of vital signs, electrocardiogram (ECG), laboratory evaluations, and treatment discontinuation and the effect of IND/GLY (27.5/15.6 or 27.5/31.2 µg) versus IND (75 µg) on time to first moderate or severe exacerbation, COPD symptoms reported, and the number of puffs/day of rescue medication during the 52-week treatment.