drugset / Trial / NCT02467452

Non Inferiority of Fixed Combination of Beclomethasone Dipropionate (BDP) + Formoterol Fumarate (FF) + Glycopyrronium Bromide (GB) Versus Combination of Fluticasone Furoate (FlF)/Vilanterol (VI) + Tiotropium Bromide in Chronic Obstructive Pulmonary Disease (COPD)

NCT02467452

Phase 3 Completed 1479 enrolled Chiesi Farmaceutici S.p.A.
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to demonstrate the triple combination of beclometasone dipropionate + formoterol fumarate + glycopyrronium bromide is effective in term of quality of life in COPD patients (Chronic Obstructive Pulmonary Disease).

Timeline

Start
2015-05
Primary completion
2017-01
Completion
2017-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Fluticasone Furoate Other / unclassified 100 ug Inhaled
Subject Formoterol Other / unclassified 6 ug Inhaled
Subject Glycopyrronium Unknown 12 ug Inhaled
Comparator Tiotropium Other / unclassified 18 ug Inhaled
Comparator Vilanterol Other / unclassified 25 ug Inhaled
Subject beclomethasone dipropionate Other / unclassified 100 ug Inhaled