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A Randomised, Double-blind, Cross-over Study to Evaluate the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Compared With Tiotropium (5 µg), Both Delivered by the Respimat® Inhaler, on Breathlessness During the Three Minute Constant Speed Shuttle Test (3min CSST) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [OTIVATO TM]

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Trial Profile

A Randomised, Double-blind, Cross-over Study to Evaluate the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (5/5 µg) Compared With Tiotropium (5 µg), Both Delivered by the Respimat® Inhaler, on Breathlessness During the Three Minute Constant Speed Shuttle Test (3min CSST) in Patients With Chronic Obstructive Pulmonary Disease (COPD). [OTIVATO TM]

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 07 Apr 2022

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At a glance

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

    • 17 Jan 2019 Primary endpoint (The change from baseline in intensity of breathlessness measured using the Modified Borg Scale (MBS-S) at the end of the 3 minute Constant Speed Shuttle Test) has been met, according to the results published in the European Respiratory Journal.
    • 17 Jan 2019 Results published in the European Respiratory Journal
    • 23 May 2018 Results presented at the 114th International Conference of the American Thoracic Society

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