Active Controlled Trial of CHF5993 Pressurized Metered-dose Inhaler ( pMDI) vs Symbicort�Turbuhaler� in Patients With Chronic Obstructive Pulmonary Disease ( COPD) (TRIVERSYTI)

The purpose of this study is to demonstrate the superiority of CHF 5993 pMDI (fixed combination of extrafine beclometasone dipropionate plus formoterol fumarate plus glycopyrronium bromide) over Symbicort® Turbuhaler® in terms of pulmonary function, as well as to assess its safety.


Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 990 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 24-week, Double Blind, Double Dummy, Randomized, Multinational, Multicentre, 2-arm Parallel Group,Active Controlled Clinical Trial of Fixed Combination of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide Administered Via pMDI (CHF 5993) Versus the Fixed Combination of Budesonide Plus Formoterol Fumarate (Symbicort® Turbuhaler®) in Patients With Chronic Obstructive Pulmonary Disease
Actual Study Start Date: December 13, 2016
Estimated Primary Completion Date: September 30, 2019
Estimated Study Completion Date: September 30, 2019

Arm:
- Experimental: CHF 5993 100/6/12.5 µg
- Active Comparator: Symbicort Turbuhaler 160/4.5 µg