[Translation] Randomized, open, positive drug parallel control, multi-center clinical trial design, ciclesonide aerosol, marketing re-evaluation clinical trial
为了确保更换抛射剂辅料后的气雾剂质量,同时根据CFDA要求进行上市后临床试验,对更换抛射剂后的安徽威尔曼制药有限公司研发的环索奈德气雾剂(MDI)治疗支气管哮喘的临床安全性及疗效进行客观评价。
[Translation] In order to ensure the quality of aerosol after the propellant excipients were replaced, post-market clinical trials were conducted according to CFDA requirements, and the clinical safety and efficacy of ciclesonide aerosol (MDI) for the treatment of bronchial asthma developed by Anhui Wellman Pharmaceutical Co., Ltd. after the propellant was replaced were objectively evaluated.