Randomized, double-blind, double-dummy, active-controlled, 4 period complete cross-over study to compare the effect on lung function of 6 weeks once daily treatment with orally inhaled tiotropium+olodaterol fixed dose combination delivered by the Respimat inhaler vs. 6 weeks twice daily treatment with fluticasone propionate+salmeterol fixed dose combination delivered by the Accuhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

Trial Profile

Randomized, double-blind, double-dummy, active-controlled, 4 period complete cross-over study to compare the effect on lung function of 6 weeks once daily treatment with orally inhaled tiotropium+olodaterol fixed dose combination delivered by the Respimat inhaler vs. 6 weeks twice daily treatment with fluticasone propionate+salmeterol fixed dose combination delivered by the Accuhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

Completed
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2016

At a glance

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

    • 09 Feb 2016 Results published in Journal of Chronic Obstructive Pulmonary Disease (COPD), as per Boehringer Ingelheim media release.
    • 09 Feb 2016 Results published in Boehringer Ingelheim media release.
    • 28 Sep 2015 Primary endpoint has been met (FEV1 AUC0-12h - change from baseline after 6 weeks of treatment), according to a Boehringer Ingelheim media release.
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