Asthma Clinical Trial
Official title:
A 26 Week, Randomized, Double Blind, Multinational, Multicenter, Active Controlled, 2-arm Parallel Group Trial Comparing CHF 5993 100/6/12.5 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate Plus Glycopyrronium Bromide) to CHF 1535 200/6 μg pMDI (Fixed Combination of Extrafine Formulation of Beclometasone Dipropionate Plus Formoterol Fumarate) in Subjects With Asthma Uncontrolled on Medium Doses of Inhaled Corticosteroids in Combination With Long-Acting β2-Agonists.
The purpose of this phase IV Study is to compare the efficacy of CHF5993 (BDP/FF/GB 100/6/12.5 pMDI) on uncontrolled asthma subjects, versus CHF1535 (BDP/FF 200/6 pMDI). The open label extension part aims to assess the proportion of subjects whose asthma remains or becomes adequately controlled..
The study consists in two phases: The study population includes 1400 subjects that are randomly assigned to two treatment arms. Each participant will be followed for 26 weeks to assess the efficacy of CHF5993 (BDP/FF/GB 100/6/12.5 pMDI). The study population of the extension part includes 800 subjects who opt to enroll into this extension and receive either CHF5993 (BDP/FF/GB 100/6/12.5 pMDI) or CHF5993 (BDP/FF/GB 200/6/12.5 pMDI) depending on their asthma control status at the end of the main phase. ;
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