drugset / Trial / NCT05097014

CHF5993 and CHF1535 pMDI on Lung Hyperinflation and Exercise Endurance Time in Subjects With COPD

NCT05097014

Phase 4 Completed 106 enrolled Chiesi Farmaceutici S.p.A.
RandomizedCrossoverQuadruple-blindTreatment

Summary

Double Blind, Multinational, Multicentre, Randomised, Placebo-Controlled, 3-Way Cross-Over Study To Evaluate The Effect Of A Triple Combination Of Beclometasone Dipropionate And Formoterol Fumarate Plus Glycopyrronium (CHF5993) And A Dual Combination Of Beclometasone Dipropionate Plus Formoterol Fumarate (CHF1535) Both Administered Via pMDI On Lung Hyperinflation And Exercise Endurance Time In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Timeline

Start
2021-10-28
Primary completion
2023-02-24
Completion
2023-02-24

Drugs

EvaluationDrugModalityDoseRoute
Comparator CHF 5993 Other / unclassified Inhaled
Comparator CHF1535 Unknown Inhaled