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A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 microg / 5 microg; 5 microg / 5 microg) (Delivered by the Respimat Inhaler) Compared With the Individual Components (2.5 microg and 5 microg Tiotropium, 5 microg Olodaterol) (Delivered by the Respimat Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]

Trial Profile

A Randomised, Double-blind, Parallel Group Study to Assess the Efficacy and Safety of 52 Weeks of Once Daily Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5 microg / 5 microg; 5 microg / 5 microg) (Delivered by the Respimat Inhaler) Compared With the Individual Components (2.5 microg and 5 microg Tiotropium, 5 microg Olodaterol) (Delivered by the Respimat Inhaler) in Patients With Chronic Obstructive Pulmonary Disease (COPD) [TOnado TM 2]

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 12 Jan 2022

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At a glance

  • Drugs Olodaterol/tiotropium bromide (Primary) ; Olodaterol; Tiotropium bromide
  • Indications Chronic obstructive pulmonary disease
  • Focus Registrational; Therapeutic Use
  • Acronyms TOnado 2
  • Sponsors Boehringer Ingelheim Pharmaceuticals
  • Most Recent Events

    • 19 May 2021 Results of pooled analysis from six studies (TONADO 1-2, DYNAGITO, WISDOM, UPLIFT and TIOSPIR) comparing the time to all-cause mortality with LAMA/LABA/ICS versus LAMA+LABA in a population of patients with predominantly moderate-to-severe COPD and a predominantly lower exacerbation risk, presented at the 117th International Conference of the American Thoracic Society.
    • 19 Nov 2020 Data from (TONADO and DYNAGITO trials) were used to assess cost effectiveness of Tiotropium+Olodaterol Versus Tiotropium and Laba/Ics presented at the 23rd Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research
    • 11 Nov 2020 Results of post hoc analysis (n=2055) from NCT01431274 and NCT01431287, comparing long acting muscarinic antagonist/long-acting agonist combination therapy with tiotropium/olodaterol versus tiotropium alone using a composite endpoint for CID, published in the Advances in Therapy
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