Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists
brief summary
This is a study comparing CHF 5993 pMDI HFA-152a with CHF 1535 pMDI HFA-134a in Chinese patients with asthma uncontrolled on medium doses of ICS+LABA.
detailed description
The study will be conducted at sites in China. The study will be composed of a run-in period with CHF 1535 pMDI HFA-134a (reference product) followed by a 24-week randomised treatment period when CHF 5993 pMDI HFA-152a (test product) or the reference product will be administered. Total study duration is 27 weeks. AEs and SAEs will be monitored from the informed consent signature until the subject's study participation ends, including AEs of particular interest such as cough. Serial spirometry will be performed both for subjects under study treatment as well as for subjects that discontinued the study treatments but continued the study using a different medication
official title
A 24 Week, Randomised, Double Blind, Multicentre, Active Controlled, 2-arm, Parallel Group Trial Comparing Efficacy and Safety of CHF 5993 100/6/12.5 μg HFA-152a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 100/6 μg HFA-134a pMDI (Fixed Combination of Extrafine Beclometasone Dipropionate Plus Formoterol Fumarate) in Patients With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists