Dataset from A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate/Vilanterol (FF/VI) Inhalation Powder 100/25 mcg Once Daily Compared With Fluticasone Propionate/Salmeterol Inhalation Powder 250/50 mcg Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

This will be a Phase IIIb multicentre, randomized, double-blind, double-dummy, 12-week parallel group study evaluating the effects of once daily in the morning treatment of FF/VI Inhalation Powder versus Fluticasone Propionate/Salmeterol Inhalation Powder twice daily on lung function in COPD subjects. Subjects will be screened and will enter a 2-week, single-blind (placebo), Run-In Period to evaluate the subject's adherence with study treatment, study procedures and assessment of disease stability. At the end of the Run-In Period, subjects will return to the Clinic and who meet all of the Randomization Criteria will be randomized to double-blind study medication (12-week treatment period). Subjects will be randomized to receive either FF/VI 100/25 via NDPI or Fluticasone Propionate/Salmeterol 250/50mcg via ACCUHALER/DISKUS. Matching placebos will be available in NDPI and ACCUHALER/DISKUS. Each morning (approximately 6-10 AM) subjects will take 1 inhalation from the NDPI followed by 1 inhalation from the ACCUHALER/DISKUS. Each evening (approximately 6-10 PM), approximately 12 hours after the morning dose with blinded study medication, subjects will take 1 inhalation from the ACCUHALER/DISKUS. Subjects will return to the clinic at the end of the treatment period. A follow-up phone contact will be performed approximately 7 days after the last clinic visit. The overall study duration (Screening to Follow-up) for each subject is approximately 15 weeks.

本研究为一项IIIb期多中心、随机、双盲、双模拟平行组研究，疗程共12周，旨在评估每日晨起单次给予FF/VI吸入粉剂（FF/VI Inhalation Powder）对比每日两次给予丙酸氟替卡松/沙美特罗（Fluticasone Propionate/Salmeterol）吸入粉剂，对慢性阻塞性肺疾病（Chronic Obstructive Pulmonary Disease, COPD）受试者肺功能的影响。受试者将先接受筛选，并进入为期2周的单盲（安慰剂）导入期，以评估其对研究治疗方案、研究流程的依从性，同时判定疾病稳定性。导入期结束后，受试者将返回临床中心，符合所有随机化标准者将被随机分配至双盲研究药物组，接受12周的治疗。受试者将被随机分为两组，分别通过NDPI吸入装置（NDPI）给予FF/VI 100/25制剂，或通过ACCUHALER/DISKUS吸入装置（ACCUHALER/DISKUS）给予丙酸氟替卡松/沙美特罗250/50μg制剂。配套的NDPI型与ACCUHALER/DISKUS型外观匹配安慰剂均可供使用。受试者需于每日晨起（约6时至10时）分别吸入1次NDPI制剂与1次ACCUHALER/DISKUS制剂；于每日晚间（约6时至10时），即晨起给予盲态研究药物后约12小时，再吸入1次ACCUHALER/DISKUS制剂。治疗期结束后，受试者将返回临床中心。末次临床访视后约7天将进行一次电话随访。每位受试者的总研究周期（从筛选至随访结束）约为15周。