Tiotropium plus Olodaterol ( Europe: Spiolto Respimat; US: Stiolto Respimat ) improves lung function and symptoms compared to monotherapies in chronic obstructive pulmonary disease ( COPD ).
The OTEMTO 1 and 2 studies investigated the effects of Tiotropium plus Olodaterol on lung function and health-related quality of life compared to placebo in patients with moderate to severe COPD.
In these two replicate, double-blind, parallel-group, placebo-controlled trials, patients were randomised to receive Tiotropium plus Olodaterol 5/5 mcg, 2.5/5 mcg, Tiotropium 5 mcg or placebo for 12 weeks, via the Respimat inhaler.
Primary end points were St George's Respiratory Questionnaire ( SGRQ ) total score, forced expiratory volume in 1 s ( FEV1 ) area under the curve from 0 to 3 h ( AUC0-3 ) response and trough FEV1 response.
In OTEMTO 1 and 2, Tiotropium plus Olodaterol 5/5 mcg improved SGRQ total score by 4.89 ( 95% confidence interval [CI] -6.90, -2.88 ) and 4.56 ( 95% CI -6.50, -2.63 ) units versus placebo ( both p less than 0.0001 ), and 2.49 ( 95% CI -4.47, -0.51; p less than 0.05 ) and 1.72 ( 95% CI -3.63, 0.19 ) units versus Tiotropium 5 mcg.
Tiotropium plus Olodaterol 2.5/5 mcg significantly improved SGRQ score compared to placebo.
Both doses significantly improved FEV1 AUC0-3 response compared to placebo and Tiotropium 5 mcg.
Tiotropium plus Olodaterol 5/5 and 2.5/5 mcg also significantly improved trough FEV1 response compared to placebo ( both studies ) and separated from Tiotropium 5 mcg in OTEMTO 2.
Adverse-event incidence was similar between treatment groups.
In conclusion, Tiotropium plus Olodaterol improved lung function and quality of life compared to placebo and Tiotropium 5 mcg. ( Xagena )
Singh D et al, Respir Med 2015;109:1312-1319