SPIOLTO® Respimat® (tiotropium + olodaterol) delivers statistically significant improvements in lung function (measured by FEV1 AUC0-3h and trough FEV1 response) vs SPIRIVA® Respimat (tiotropium)1,2
Mean change in FEV1 AUC0–3h (measured at 12 weeks)
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SPIOLTO Respimat significantly improved mean trough FEV1 (difference of 37mL; p<0.01) vs SPIRIVA Respimat.
AUC0–3h, area under the curve 0–3 hours; FEV1, forced expiratory volume in one second.
Study design
OTEMTO: Two replicate, randomised, double-blind, placebo-controlled, phase IIIb trials comparing SPIOLTO Respimat with SPIRIVA Respimat (tiotropium) and placebo Respimat over 12 weeks in 1,621 adult patients with moderate to severe COPD. The primary endpoints were SGRQ total score, and lung function measured as FEV1 AUC0–3h and trough FEV1 response in each individual trial.
References: 1. Singh D, et al. European Respiratory Society International Congress, Amsterdam, The Netherlands, 26–30 September 2015; PA2958; 2. Singh D, et al. Respir Med. 2015;109:1312-1319 and supplementary materials.