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)
Phase of Trial: Phase III
Latest Information Update: 24 Mar 2017
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
- 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.
- 28 Oct 2015 Post-hoc analysis data presented at the American College of CHEST Physicians Annual Meeting in Montreal, as per Boehringer media release.
- 27 Oct 2015 Pooled analysis results as well as individual study result published in Boehringer media release.
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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History