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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)

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: 22 May 2019

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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

    • 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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