Tiotropium+Olodaterol Fixed Dose Combination (FDC) in Chronic Obstructive Pulmonary Disease (OTEMTO 2)

Summary

The objective of this study is to assess the efficacy and safety of 12 weeks once daily treatment with orally inhaled tiotropium + olodaterol FDC (delivered by the Respimat inhaler) compared with tiotropium and placebo in patients with COPD.

Timeline

Start

2013-11

Primary completion

2014-10

Completion

2014-11

Outcome

Met primary endpoint

registry analysis (superiority or other test); Placebo vs Tiotropium 5 μg + Olodaterol 5 μg; p <0.0001; Mean Difference (Final Values) 0.299 (95% CI 0.261 to 0.336); NCT02006732 ↗

registry analysis (superiority or other test); Placebo vs Tiotropium 5 μg + Olodaterol 5 μg; p <0.0001; Mean Difference (Final Values) 0.166 (95% CI 0.129 to 0.203); NCT02006732 ↗

registry analysis (superiority or other test); Placebo vs Tiotropium 5 μg + Olodaterol 5 μg; p <0.0001; Mean Difference (Final Values) -4.564 (95% CI -6.499 to -2.629); NCT02006732 ↗

registry analysis (superiority or other test); Placebo vs Tiotropium 5 μg + Olodaterol 5 μg; p <0.0001; Mean Difference (Final Values) -4.668 (95% CI -6.060 to -3.276); NCT02006732 ↗

release “Further published data from the 1,600 patient OTEMTO® 1&2 trials ( NCT01964352 / NCT02006732 ) in COPD show STIOLTO RESPIMAT provides significant improvements in lung function” prnewswire.com ↗

Publications

• Buhl R, de la Hoz A, Xue W, Singh D, Ferguson GT. Efficacy of Tiotropium/Olodaterol Compared with Tiotropium as a First-Line Maintenance Treatment in Patients with COPD Who Are Naive to LAMA, LABA and ICS: Pooled Analysis of Four Clinical Trials. Adv Ther. 2020 Oct;37(10):4175-4189. doi: 10.1007/s12325-020-01411-0. Epub 2020 Jul 15.
• Buhl R, Singh D, de la Hoz A, Xue W, Ferguson GT. Benefits of Tiotropium/Olodaterol Compared with Tiotropium in Patients with COPD Receiving only LAMA at Baseline: Pooled Analysis of the TONADO(R) and OTEMTO(R) Studies. Adv Ther. 2020 Aug;37(8):3485-3499. doi: 10.1007/s12325-020-01373-3. Epub 2020 May 27.
• Singh D, Gaga M, Schmidt O, Bjermer L, Gronke L, Voss F, Ferguson GT. Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO(R) studies. Respir Res. 2016 Jun 18;17(1):73. doi: 10.1186/s12931-016-0387-7.
• Singh D, Ferguson GT, Bolitschek J, Gronke L, Hallmann C, Bennett N, Abrahams R, Schmidt O, Bjermer L. Tiotropium + olodaterol shows clinically meaningful improvements in quality of life. Respir Med. 2015 Oct;109(10):1312-9. doi: 10.1016/j.rmed.2015.08.002. Epub 2015 Aug 12.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Olodaterol	Small molecule	5 ug	Inhaled
Subject	Tiotropium	Other / unclassified	2.5 ug	Inhaled
Subject	Tiotropium	Other / unclassified	5 ug	Inhaled

Indications