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A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 mcg and 5/5 mcg) Delivered by the Respimat Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]

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Trial Profile

A Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Determine the Effect of 12 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (2.5/5 mcg and 5/5 mcg) Delivered by the Respimat Inhaler, on Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD)[Torracto (TM)]

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2021

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At a glance

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

    • 24 May 2017 Results (n=162) assessing reproducibility of EET during CWRCE and ESWT, presented at the 113th International Conference of the American Thoracic Society
    • 23 Jul 2016 Primary endpoint (Adjusted Mean Endurance Time During Constant Work Rate Cycle Ergometry (CWRCE) After 12 Weeks (Tio+Olo 5.0 / 5.0 µg versus Tio+Olo 2.5 / 5.0 µg) has not been met as per the results published in trial registry.
    • 23 Jul 2016 Planned locations also included Ireland.
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