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An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Trial Profile

An Exploratory, 12 Week, Randomised, Partially Double-blinded, Placebo-controlled Parallel Group Trial to Explore the Effects of Once Daily Treatments of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination or Tiotropium (Both Delivered by Respimat Inhaler), Supervised Exercise Training and Behavior Modification on Exercise Capacity and Physical Activity in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Status: Completed
Phase of Trial: Phase III/IV

Latest Information Update: 17 Apr 2018

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At a glance

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

    • 17 Apr 2018 Primary endpoint (Endurance time [sec] during Endurance Shuttle Walk Test to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption after 8 weeks of treatment) has not been met as per the results published in the American Journal of Respiratory and Critical Care Medicine.
    • 17 Apr 2018 Results published in the American Journal of Respiratory and Critical Care Medicine
    • 05 Sep 2016 According to a Primary Endurance time [sec] during Endurance Shuttle Walk Test to symptom limitation at walking speed corresponding to 85% of predicted maximum oxygen consumption after 8 weeks of treatment [ Time Frame: 8 weeks ] [ Designated as safety issue: No ] endpoint has been met.
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