Pulmonary Disease, Chronic Obstructive Clinical Trial
Official title:
A Randomized, Double-blind, Double-dummy, Active-controlled, Multi-center, Parallel Group Study to Show the Superiority in Lung Function of 12 Weeks Once Daily Treatment With Orally Inhaled Tiotropium+Olodaterol Fixed Dose Combination Delivered by the Respimat® Inhaler vs. 12 Weeks Twice Daily Treatment With Fluticasone Propionate+Salmeterol Fixed Dose Combination Delivered by the Diskus® in Patients With Chronic Obstructive Pulmonary Disease (COPD) [ENERGITO® 2]
The primary objective of the trial is to show superiority in lung function of once daily (2
inhalations) treatment with orally inhaled tiotropium+olodaterol fixed dose combination to
twice daily (one inhalation) treatment with fluticasone propionate+salmeterol fixed dose
combination over 12 weeks in patients with Chronic Obstructive Pulmonary Disease (COPD).
A Digital Health (DH) exploratory study has been integrated into the main study as a site
specific study. The DH exploratory study will be performed at a single site; the site is also
participating in the main study. The DH exploratory study site will enter (randomize)
approximately 20 patients (subjects) (in addition to the patients to be enrolled in the main
study at this site). The patients enrolled in the DH exploratory study are not considered to
be part of the main study (i.e. data collected in the DH exploratory study will be analyzed
separately from the data collected in the main study).
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