The once-daily fixed-dose combination of olodaterol and tiotropium in the management of COPD: current evidence and future prospects.

That 21% improvement in endurance time with TIO/OLO 5/5 μg after 12 weeks just failed to reach statistical significance versus placebo ( p = 0.055), although it numerically reached clinical significance. 6 The MORACTO studies With their double-blind, incomplete crossover design, the replicate MORACTO studies compared the effects of TIO/OLO 5/5 μg with those of TIO 5 μg, OLO 5 μg and placebo on EET during CWRCE after 6 weeks. 5 A total of 586 patients were randomized and 571 were included in the full analysis. 73% of the included patients were GOLD stage 2 and 21% GOLD stage 3, with a mean FEV 1 of 58%.

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In the placebo-controlled studies, the OLO arm had a numerically higher odds ratio (OR) for death, a finding that, however, did not reach statistical significance (OR: 1.31; 95% CI: 0.90, 1.89).

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The increase in dyspnoea (Borg scale) during exercise [(end of exercise Borg score minus pre-exercise Borg score)/per time unit] was numerically lower for TIO/OLO 5/5 μg compared with placebo at weeks 6 and 12 but failed to reach statistical significance. 6 In the ESWT substudy, the common baseline mean EET was 311 ± 14 s.

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