Trial Profile
A Randomised, Double-blind, Placebo- and Active-controlled Parallel Group Study to Assess the Efficacy of 12 Weeks of Once Daily Treatment of Two Doses of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (Delivered by the Respimat Inhaler) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 26 Nov 2021
Price :
$35
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At a glance
- Drugs Olodaterol/tiotropium bromide (Primary) ; Tiotropium bromide
- Indications Chronic obstructive pulmonary disease
- Focus Registrational; Therapeutic Use
- Acronyms OTEMTO1; TOviTO
- Sponsors Boehringer Ingelheim Pharmaceuticals
Most Recent Events
- 15 Jul 2020 Results of post hoc pooled analysis comparing the efficacy of tiotropium/olodaterol versus tiotropium as maintenance therapy in patients with COPD published in the Advances in Therapy
- 27 May 2020 Results of a pooled post-hoc analysis from four clinical studies: TONADO 1, TONADO 2, OTEMTO 1 and OTEMTO 2 focused on sub-group of patients assessing changes from baseline and responder rates published in the Advances in Therapy
- 29 Mar 2016 According to a Boehringer Ingelheim media release, the US FDA has approved an sNDA for olodaterol/tiotropium-bromide (STIOLTO RESPIMAT) that adds data showing improvement in health-related quality of life among people with chronic obstructive pulmonary disease (COPD) to the product labelling. The label expansion is based on data from the OTEMTO 1 and 2 and TONADO 1 and 2 trials.