A Study Comparing Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination CHF 5993 With the Fixed Dose Dual Combination CHF 1535 in Subjects With COPD (TRITON)

Sponsor Name: Chiesi Farmaceutici S.p.A.
Regulatory Agency Identifier Numbers: CLI-05993AA3-06; 2020-002389-16 (EudraCT Number)
Protocol Title: A phase III, 52-week, multinational, multicenter, randomized, double-blind, 2-arm parallel group study comparing efficacy, safety and tolerability of the fixed dose triple combination of beclomethasone dipropionate plus formoterol fumarate plus glycopyrronium bromide (CHF 5993) with the fixed dose dual combination of beclomethasone dipropionate plus formoterol fumarate (CHF 1535), both administered via pMDI in subjects with chronic obstructive pulmonary disease (COPD)
Brief Summary: The purpose of this study is to compare CHF 5993 with CHF 1535 in improving lung function, reducing moderate and severe COPD exacerbations, and other clinical efficacy and safety outcomes in the target subject population.

https://clinicaltrials.gov/study/NCT04320342?term=CLI-05993AA3-06&rank=1