[Translation] A 24-week clinical trial comparing beclomethasone propionate/formote 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] Main objective: To demonstrate that CHF1535pMDI is non-inferior to Symbicort in lung function (change from baseline in forced expiratory volume in one second (FEV1) in the morning at week 24) in COPD patients. Secondary objective: To assess the effect of CHF1535pMDI on other pulmonary function parameters and patient-reported outcomes (PROs). Assess the safety and tolerability of the study treatment.