[Translation] A 24-week clinical trial comparing beclomethasone dipropionate/formoterol fumarate with budesonide/formoterol fumarate in the treatment of COPD
主要目的:证明CHF1535pMDI治疗COPD患者在肺功能方面(第24周的早晨用药前一秒用力呼气量(FEV1)较基线变化)非劣效于信必可都保。 次要目的:评估CHF1535pMDI对其它肺功能参数和患者报告的结局(PRO)的影响。评估研究治疗的安全性和耐受性。
[Translation] Primary objective: To demonstrate the non-inferiority of CHF1535pMDI to Symbicort in lung function (change from baseline in forced expiratory volume in one second (FEV1) before morning dosing at week 24) in patients with COPD. Secondary objectives: To assess the effect of CHF1535pMDI on other lung function parameters and patient-reported outcomes (PROs). To assess the safety and tolerability of the study treatment.