Two replicate; double-blind; 6-week; incomplete-crossover studies (MORACTO 1 and 2) assessed the effects of tiotropium/olodaterol on inspiratory capacity and exercise endurance time in patients with moderate to severe chronic obstructive pulmonary disease.For each patient; four of five treatments were administered once daily for 6xe2x80x85weeks; with a 21-day washout between treatments: tiotropium/olodaterol 2.5/5xe2x80x85xc2xb5g or 5/5xe2x80x85xc2xb5g; tiotropium 5xe2x80x85xc2xb5g; olodaterol 5xe2x80x85xc2xb5g or placebo; all via the Respimat inhaler. Primary outcomes were inspiratory capacity prior to exercise and exercise endurance time during constant work-rate cycle ergometry to symptom limitation at 75% of peak incremental work rate after 6xe2x80x85weeks (2xe2x80x85h post-dose).295 and 291 patients were treated in MORACTO 1 and 2; respectively. Tiotropium/olodaterol 2.5/5 and 5/5xe2x80x85xc2xb5g provided significant improvements in inspiratory capacity versus placebo and monotherapies (p<0.0001); and significant improvements in exercise endurance time versus placebo (p<0.0001). Intensity of breathing discomfort was reduced following both doses of tiotropium/olodaterol versus placebo (p<0.0001).Once-daily tiotropium/olodaterol yielded improvements in lung hyperinflation versus placebo and statistically significant improvements versus monotherapies. Tiotropium/olodaterol also showed improvements in dyspnoea and exercise tolerance versus placebo but not consistently versus monotherapies.
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