{"title":"布地奈德/甘替溴铵/富马酸福莫特罗计量吸入器对COPD患者症状和生活质量的实际有效性：EBISU研究","authors":"Shigeo Muro , Soichiro Hozawa , Hisatoshi Sugiura , Yuri Yoshida , Naoyuki Makita , Yuki Kato , Takehiro Hirai , Kenichiro Nishida , Tomotaka Kawayama","doi":"10.1016/j.resinv.2025.05.007","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>There are limited real-world data regarding triple therapy with inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β<sub>2</sub>-agonist on symptoms and patient-reported outcomes (PROs) in patients with chronic obstructive pulmonary disease (COPD), without current/history of asthma. We investigated the effects of budesonide/glycopyrronium/formoterol fumarate (BGF) metered dose inhaler (MDI) triple therapy on health status and PROs in patients with COPD in daily clinical practice.</div></div><div><h3>Methods</h3><div>This was a 12-week, prospective, multicenter, observational study (NCT05219630). The primary endpoint was mean change from baseline in the COPD Assessment Test (CAT) over 12 weeks. Secondary and exploratory endpoints included mean change from baseline in the St George's Respiratory Questionnaire (SGRQ) over 12 weeks and CAT score subgroup analyses.</div></div><div><h3>Results</h3><div>In total, 102 patients were analyzed; mean age at baseline was 73.8 years, mean forced expiratory volume in 1 s was 57.7 %, CAT total score was 15.6, and SGRQ score was 33.3. The adjusted mean change from baseline over 12 weeks in CAT was −2.9 (standard error [SE] 0.5) (P < 0.001), and in SGRQ was −2.7 (SE 0.9) (P = 0.004). As early as Week 4, these scores were significantly improved from baseline. In subgroup analyses, CAT scores were improved, regardless of blood eosinophil counts at baseline and exacerbation history in the previous year.</div></div><div><h3>Conclusions</h3><div>Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD who have persistent symptoms without current asthma or a history of asthma.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov (NCT05219630)</div></div>","PeriodicalId":20934,"journal":{"name":"Respiratory investigation","volume":"63 5","pages":"Pages 726-733"},"PeriodicalIF":2.4000,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study\",\"authors\":\"Shigeo Muro , Soichiro Hozawa , Hisatoshi Sugiura , Yuri Yoshida , Naoyuki Makita , Yuki Kato , Takehiro Hirai , Kenichiro Nishida , Tomotaka Kawayama\",\"doi\":\"10.1016/j.resinv.2025.05.007\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>There are limited real-world data regarding triple therapy with inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β<sub>2</sub>-agonist on symptoms and patient-reported outcomes (PROs) in patients with chronic obstructive pulmonary disease (COPD), without current/history of asthma. We investigated the effects of budesonide/glycopyrronium/formoterol fumarate (BGF) metered dose inhaler (MDI) triple therapy on health status and PROs in patients with COPD in daily clinical practice.</div></div><div><h3>Methods</h3><div>This was a 12-week, prospective, multicenter, observational study (NCT05219630). The primary endpoint was mean change from baseline in the COPD Assessment Test (CAT) over 12 weeks. Secondary and exploratory endpoints included mean change from baseline in the St George's Respiratory Questionnaire (SGRQ) over 12 weeks and CAT score subgroup analyses.</div></div><div><h3>Results</h3><div>In total, 102 patients were analyzed; mean age at baseline was 73.8 years, mean forced expiratory volume in 1 s was 57.7 %, CAT total score was 15.6, and SGRQ score was 33.3. The adjusted mean change from baseline over 12 weeks in CAT was −2.9 (standard error [SE] 0.5) (P < 0.001), and in SGRQ was −2.7 (SE 0.9) (P = 0.004). As early as Week 4, these scores were significantly improved from baseline. In subgroup analyses, CAT scores were improved, regardless of blood eosinophil counts at baseline and exacerbation history in the previous year.</div></div><div><h3>Conclusions</h3><div>Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD who have persistent symptoms without current asthma or a history of asthma.</div></div><div><h3>Trial registration</h3><div>ClinicalTrials.gov (NCT05219630)</div></div>\",\"PeriodicalId\":20934,\"journal\":{\"name\":\"Respiratory investigation\",\"volume\":\"63 5\",\"pages\":\"Pages 726-733\"},\"PeriodicalIF\":2.4000,\"publicationDate\":\"2025-06-11\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Respiratory investigation\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S2212534525000711\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"RESPIRATORY SYSTEM\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Respiratory investigation","FirstCategoryId":"1085","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S2212534525000711","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"RESPIRATORY SYSTEM","Score":null,"Total":0}
Real-world effectiveness of budesonide/glycopyrronium/formoterol fumarate metered dose inhaler on symptoms and quality of life in patients with COPD: EBISU study
Background
There are limited real-world data regarding triple therapy with inhaled corticosteroid/long-acting muscarinic antagonist/long-acting β2-agonist on symptoms and patient-reported outcomes (PROs) in patients with chronic obstructive pulmonary disease (COPD), without current/history of asthma. We investigated the effects of budesonide/glycopyrronium/formoterol fumarate (BGF) metered dose inhaler (MDI) triple therapy on health status and PROs in patients with COPD in daily clinical practice.
Methods
This was a 12-week, prospective, multicenter, observational study (NCT05219630). The primary endpoint was mean change from baseline in the COPD Assessment Test (CAT) over 12 weeks. Secondary and exploratory endpoints included mean change from baseline in the St George's Respiratory Questionnaire (SGRQ) over 12 weeks and CAT score subgroup analyses.
Results
In total, 102 patients were analyzed; mean age at baseline was 73.8 years, mean forced expiratory volume in 1 s was 57.7 %, CAT total score was 15.6, and SGRQ score was 33.3. The adjusted mean change from baseline over 12 weeks in CAT was −2.9 (standard error [SE] 0.5) (P < 0.001), and in SGRQ was −2.7 (SE 0.9) (P = 0.004). As early as Week 4, these scores were significantly improved from baseline. In subgroup analyses, CAT scores were improved, regardless of blood eosinophil counts at baseline and exacerbation history in the previous year.
Conclusions
Triple therapy with a BGF MDI significantly improved CAT and SGRQ scores over 12 weeks. BGF MDI could be a suitable option for patients living with COPD who have persistent symptoms without current asthma or a history of asthma.
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