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)
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History