Jinfang Ma, Fangfang Dou, Wutie Zhou, Liyu Li, Junfei Zhu, Yupeng Zhang, Luqian Zhou, Lin Su, Lu Dong, Yifan He, Ark Ye, David Slade, Jinping Zheng
{"title":"单吸入器糠酸氟替卡松/溴化乌莫克利地铵/维兰特罗治疗中国慢性阻塞性肺疾病(COPD)患者的实际疗效:一项上市后、前瞻性、多中心观察性研究","authors":"Jinfang Ma, Fangfang Dou, Wutie Zhou, Liyu Li, Junfei Zhu, Yupeng Zhang, Luqian Zhou, Lin Su, Lu Dong, Yifan He, Ark Ye, David Slade, Jinping Zheng","doi":"10.1080/03007995.2025.2536600","DOIUrl":null,"url":null,"abstract":"<p><strong>Objective: </strong>To assess the effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) in symptomatic chronic obstructive pulmonary disease (COPD) under real-world settings in China.</p><p><strong>Methods: </strong>In this single-arm, prospective, observational study, participants received 12 weeks of FF/UMEC/VI treatment. The primary outcome was change from baseline (CFB) in COPD Assessment Test (CAT) score at Week 12. Secondary outcomes included CFB in modified Medical Research Council (mMRC) dyspnea scale score and pre-dose forced expiratory volume in one second (FEV<sub>1</sub>), and proportion of CAT responders at Week 12.</p><p><strong>Results: </strong>From 14 October 2022 to 25 June 2023, 460 participants were enrolled; 392 (85.2%) completed the study treatment. After a 12-week treatment, there was a clinically meaningful CFB in CAT score with a mean of -6.81 (95% CI = -7.28-6.33); the proportion of CAT responders (≥2 points reduction from baseline) was 86%; the mean CFB in mMRC score was -0.52 (95% CI = -0.60∼-0.43); and pre-dose FEV<sub>1</sub> showed a clinically meaningful improvement from baseline with a mean of 0.13 L (95% CI = 0.10 ∼ 0.16). During the treatment, 10 (2.2%) participants reported FF/UMEC/VI-related adverse events.</p><p><strong>Conclusion: </strong>In real-world clinical practice in China, FF/UMEC/VI effectively improved symptoms and lung function in patients with symptomatic COPD and was well-tolerated.</p>","PeriodicalId":10814,"journal":{"name":"Current Medical Research and Opinion","volume":" ","pages":"1363-1372"},"PeriodicalIF":2.2000,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-world effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol in Chinese patients with symptomatic chronic obstructive pulmonary disease (COPD): a post-marketing, prospective, multicenter, observational study.\",\"authors\":\"Jinfang Ma, Fangfang Dou, Wutie Zhou, Liyu Li, Junfei Zhu, Yupeng Zhang, Luqian Zhou, Lin Su, Lu Dong, Yifan He, Ark Ye, David Slade, Jinping Zheng\",\"doi\":\"10.1080/03007995.2025.2536600\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Objective: </strong>To assess the effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) in symptomatic chronic obstructive pulmonary disease (COPD) under real-world settings in China.</p><p><strong>Methods: </strong>In this single-arm, prospective, observational study, participants received 12 weeks of FF/UMEC/VI treatment. The primary outcome was change from baseline (CFB) in COPD Assessment Test (CAT) score at Week 12. Secondary outcomes included CFB in modified Medical Research Council (mMRC) dyspnea scale score and pre-dose forced expiratory volume in one second (FEV<sub>1</sub>), and proportion of CAT responders at Week 12.</p><p><strong>Results: </strong>From 14 October 2022 to 25 June 2023, 460 participants were enrolled; 392 (85.2%) completed the study treatment. After a 12-week treatment, there was a clinically meaningful CFB in CAT score with a mean of -6.81 (95% CI = -7.28-6.33); the proportion of CAT responders (≥2 points reduction from baseline) was 86%; the mean CFB in mMRC score was -0.52 (95% CI = -0.60∼-0.43); and pre-dose FEV<sub>1</sub> showed a clinically meaningful improvement from baseline with a mean of 0.13 L (95% CI = 0.10 ∼ 0.16). During the treatment, 10 (2.2%) participants reported FF/UMEC/VI-related adverse events.</p><p><strong>Conclusion: </strong>In real-world clinical practice in China, FF/UMEC/VI effectively improved symptoms and lung function in patients with symptomatic COPD and was well-tolerated.</p>\",\"PeriodicalId\":10814,\"journal\":{\"name\":\"Current Medical Research and Opinion\",\"volume\":\" \",\"pages\":\"1363-1372\"},\"PeriodicalIF\":2.2000,\"publicationDate\":\"2025-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Current Medical Research and Opinion\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1080/03007995.2025.2536600\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2025/7/29 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"MEDICINE, GENERAL & INTERNAL\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Current Medical Research and Opinion","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1080/03007995.2025.2536600","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/7/29 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
Real-world effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol in Chinese patients with symptomatic chronic obstructive pulmonary disease (COPD): a post-marketing, prospective, multicenter, observational study.
Objective: To assess the effectiveness of single-inhaler fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) in symptomatic chronic obstructive pulmonary disease (COPD) under real-world settings in China.
Methods: In this single-arm, prospective, observational study, participants received 12 weeks of FF/UMEC/VI treatment. The primary outcome was change from baseline (CFB) in COPD Assessment Test (CAT) score at Week 12. Secondary outcomes included CFB in modified Medical Research Council (mMRC) dyspnea scale score and pre-dose forced expiratory volume in one second (FEV1), and proportion of CAT responders at Week 12.
Results: From 14 October 2022 to 25 June 2023, 460 participants were enrolled; 392 (85.2%) completed the study treatment. After a 12-week treatment, there was a clinically meaningful CFB in CAT score with a mean of -6.81 (95% CI = -7.28-6.33); the proportion of CAT responders (≥2 points reduction from baseline) was 86%; the mean CFB in mMRC score was -0.52 (95% CI = -0.60∼-0.43); and pre-dose FEV1 showed a clinically meaningful improvement from baseline with a mean of 0.13 L (95% CI = 0.10 ∼ 0.16). During the treatment, 10 (2.2%) participants reported FF/UMEC/VI-related adverse events.
Conclusion: In real-world clinical practice in China, FF/UMEC/VI effectively improved symptoms and lung function in patients with symptomatic COPD and was well-tolerated.
期刊介绍:
Current Medical Research and Opinion is a MEDLINE-indexed, peer-reviewed, international journal for the rapid publication of original research on new and existing drugs and therapies, Phase II-IV studies, and post-marketing investigations. Equivalence, safety and efficacy/effectiveness studies are especially encouraged. Preclinical, Phase I, pharmacoeconomic, outcomes and quality of life studies may also be considered if there is clear clinical relevance