A 24 Week Randomised, Double Blind and Placebo Controlled Study to Evaluate the Efficacy and Safety of 62.5 mcg Umeclidinium Inhalation Powder Delivered Once Daily Via a Novel Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
收藏DataCite Commons2024-12-02 更新2026-05-07 收录
下载链接:
https://search.vivli.org/doiLanding/studies/00005910/isLanding
下载链接
链接失效反馈官方服务:
资源简介:
Studies to date provides substantial evidence for the effectiveness for UMEC 62.5 microgram (mcg) as a long term maintenance therapy for the treatment of COPD; this study further evaluates the efficacy and safety of UMEC 62.5 mcg administered once-daily (OD) for 24 weeks via a NDPI compared with placebo in Asian subjects with COPD. Over approximate 27 weeks of entire study duration, 10 study clinic visits will be conducted on an outpatient basis. Pre-screening visit will be conducted for the informed consent form, review demography, COPD history and COPD concomitant medications. Subjects meeting the eligibility criteria at screening will complete a 7 to 14 day Run-in period and will be provided with albuterol/salbutamol as rescue medication on an "as-needed" basis. Further, subjects will be randomized to the UMEC 62.5 mcg or matching placebo in a 1:2 ratio for 24 week treatment period. A follow up for adverse event assessment will be scheduled approximately 7 days after the treatment period or the Early Withdrawal Visit.
提供机构:
Vivli
创建时间:
2020-06-08



