The Efficacy and Safety of Once-daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-daily Budesonide/Formoterol in a Subgroub of Patients from China with Symptomatic COPO at Risk of Exacerbations (FULFIL Trial)
单位：[1]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, Guangdong, China[2]Department of Respiratory Medicine, Xinqiao Hospital, Third Military Medical University, Chongqing, China[3]Department of Respiratory Medicine, Hai Nan Provincial People’s Hospital, Haikou, Hainan, China[4]Department of Respiratory Medicine, General Hospital of Shenyang Military Command, Shenyang, Liaoning, China[5]Respiratory Department, Hangzhou First People’s Hospital, Hangzhou, Zhejiang, China[6]Respiratory Department, Wuxi People’s Hospital, Wuxi, Jiangsu, China[7]Department of Respiratory Medicine, Shengjing Hospital of China Medical University, Shenyang, Liaoning, China中国医科大学附属盛京医院[8]Department of Respiratory Medicine, Beijing Friendship Hospital, Capital Medical University, Beijing, China临床科室呼吸内科呼吸内科首都医科大学附属北京友谊医院[9]GSK, Shanghai, China[10]GSK, Beijing, China[11]GSK, King of Prussia, PA, USA[12]Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA
The FULFIL study evaluated once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100 & micro;g/62.5 mu g/25 mu g versus twice-daily budesonide/formoterol (BUD/FOR) 400 & micro;g/12 mu g in patients with symptomatic COPD at risk of exacerbations. FULFIL demonstrated clinically meaningful and statistically significant improvements at Week 24 in trough forced expiratory volume in 1 second (FEV1), St George's Respiratory Questionnaire (SGRQ) Total scores and reduced exacerbation frequency. Predefined analyses were performed to evaluate treatment effects in a subgroup of patients recruited in China (China subgroup; FF/UMEC/VI, n = 32; BUD/FOR, n = 29). Analyses included treatment by region (China versus non-China) to allow estimated treatment effects in patients from China to be compared with those of the non-China sub-group and the overall FULFIL intent-to-treat (ITT) population. In the China subgroup at Week 24: the mean change from baseline in trough FEV1 was 125 mL (95% confidence interval [CI] 36, 214) for FF/UMEC/VI and -70 mL (95% CI -163, 23) BUD/FOR (between-treatment difference: 195 mL [95% CI 67, 323]; p = 0.003) and in SGRQ Total score was -5.6 units (95% CI -10.5, -0.7) and -0.3 units (95% CI -5.4, 4.7), respectively (between-treatment difference: -5.3 [95% CI -12.3, 1.7]; p = 0.140). Fewer moderate/severe exacerbations occurred with FF/UMEC/VI than BUD/FOR (16% and 28%, respectively). The overall incidence of adverse events was similar between arms (FF/UMEC/VI: 38%; BUD/FOR: 31%). This prespecified subgroup analysis of patients recruited in China to FULFIL demonstrated comparable efficacy and safety to that observed in the non-China and in the overall ITT populations, for FF/UMEC/VI versus BUD/FOR.
第一作者单位：[1]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, Guangdong, China[*1]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, No 151 Yanjiang Road, Guangzhou, Guangdong, 510120, China.
通讯作者：
通讯机构：[1]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, Guangdong, China[*1]State Key Laboratory of Respiratory Disease, National Clinical Research Center for Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, No 151 Yanjiang Road, Guangzhou, Guangdong, 510120, China.
推荐引用方式(GB/T 7714)：
Zheng Jinping,Zhong Nanshan,Wang Changzheng,et al.The Efficacy and Safety of Once-daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-daily Budesonide/Formoterol in a Subgroub of Patients from China with Symptomatic COPO at Risk of Exacerbations (FULFIL Trial)[J].COPD-JOURNAL of CHRONIC OBSTRUCTIVE PULMONARY DISEASE.2018,15(4):334-340.doi:10.1080/15412555.2018.1481022.
APA：
Zheng, Jinping,Zhong, Nanshan,Wang, Changzheng,Huan, Yijiang,Chen, Ping...&Lipson, David A..(2018).The Efficacy and Safety of Once-daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-daily Budesonide/Formoterol in a Subgroub of Patients from China with Symptomatic COPO at Risk of Exacerbations (FULFIL Trial).COPD-JOURNAL of CHRONIC OBSTRUCTIVE PULMONARY DISEASE,15,(4)
MLA：
Zheng, Jinping,et al."The Efficacy and Safety of Once-daily Fluticasone Furoate/Umeclidinium/Vilanterol Versus Twice-daily Budesonide/Formoterol in a Subgroub of Patients from China with Symptomatic COPO at Risk of Exacerbations (FULFIL Trial)".COPD-JOURNAL of CHRONIC OBSTRUCTIVE PULMONARY DISEASE 15..4(2018):334-340
