A Randomised, Double-blind, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 mcg; and 5 / 5 mcg) (Delivered by the Respimat Inhaler) Compared With Tiotropium (5 mcg), Olodaterol (5 mcg ) and Placebo (Delivered by the Respimat Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 2]

Trial Profile

A Randomised, Double-blind, 5 Treatment Arms, 4-period, Incomplete Cross-over Study to Determine the Effect of 6 Weeks Treatment of Orally Inhaled Tiotropium + Olodaterol Fixed Dose Combination (FDC) (2.5 / 5 mcg; and 5 / 5 mcg) (Delivered by the Respimat Inhaler) Compared With Tiotropium (5 mcg), Olodaterol (5 mcg ) and Placebo (Delivered by the Respimat Inhaler) on Lung Hyperinflation and Exercise Endurance Time During Constant Work Rate Cycle Ergometry in Patients With Chronic Obstructive Pulmonary Disease (COPD) [MORACTO TM 2]

Completed
Phase of Trial: Phase III

Latest Information Update: 01 Apr 2017

At a glance

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

    • 01 Apr 2017 Combined results of two identical phase III studies (MORACTO 1 and 2; n=586), published in the European Respiratory Journal
    • 01 Nov 2013 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov
    • 31 Oct 2013 Planned end date changed from 1 Oct 2013 to 1 Nov 2013 as reported by ClinicalTrials.gov.
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