{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T07:52:55Z","timestamp":1790927575961,"version":"4.1.0"},"reference-count":49,"publisher":"The Korean Academy of Tuberculosis and Respiratory Diseases","issue":"4","license":[{"start":{"date-parts":[[2026,6,12]],"date-time":"2026-06-12T00:00:00Z","timestamp":1781222400000},"content-version":"tdm","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","award":["207955"],"award-info":[{"award-number":["207955"]}],"id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/100004330","name":"GlaxoSmithKline","doi-asserted-by":"publisher","award":["219293"],"award-info":[{"award-number":["219293"]}],"id":[{"id":"10.13039\/100004330","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["e-trd.org"],"crossmark-restriction":true},"short-container-title":["Tuberc Respir Dis"],"published-print":{"date-parts":[[2026,10,1]]},"abstract":"<jats:p>Background: Fluticasone furoate\/umeclidinium\/vilanterol (FF\/UMEC\/VI) is a single-inhaler triple therapy administered via the ELLIPTA inhaler (GSK). FF\/UMEC\/VI 100\/62.5\/25 \u03bcg was approved in Korea to treat chronic obstructive pulmonary disease (COPD) in 2018 and asthma in 2022 (100\/62.5\/25 and 200\/62.5\/25 \u03bcg). Safety and efficacy of FF\/UMEC\/VI are well established in global clinical trials, though Korean real-world evidence remains limited.Methods: This Korean multicentre post-marketing surveillance assessed safety and clinical outcomes of FF\/UMEC\/VI 100\/62.5\/25 \u03bcg in COPD (May 2018\u2013May 2024) and safety of FF\/UMEC\/VI in asthma (100\/62.5\/25 \u03bcg: August 2022\u2013May 2024; 200\/62.5\/25 \u03bcg: September 2022\u2013May 2024). Safety was assessed by total, serious, and unexpected adverse event and adverse drug reaction (ADR) incidence. For COPD, physicians assessed within-patient improvement in clinical outcomes (lung function [forced expiratory volume in 1 second, forced vital capacity], exacerbations and symptoms [modified Medical Research Council dyspnoea, COPD Assessment Test]).Results: Overall, 606 patients with COPD and 132 patients with asthma were evaluated. Mean\u00b1standard deviation administration for FF\/UMEC\/VI 100\/62.5\/25 \u03bcg was 254.11\u00b1119.97 days overall; 271.83\u00b1104.99 for COPD; 20.74\u00b110.87 for integrated asthma; 34.17\u00b113.06 days for asthma with FF\/UMEC\/VI 200\/62.5\/25 \u03bcg. ADRs occurred in 2.64% (16\/606) of patients with COPD and 3.79% (5\/132) with asthma. Most ADRs were mild; all serious\/unexpected ADRs resolved. Of 33 patients with COPD who reported pneumonia, all events were considered unlikely to be treatment-related. Physicians determined improvement in 74.87% (283\/378) of patients with COPD post- versus pre-FF\/UMEC\/VI administration.Conclusion: FF\/UMEC\/VI was well tolerated in Korean patients with asthma or COPD, with no new safety concerns identified. In COPD, within-patient improvement was observed in clinical outcomes post-administration. These results support continued FF\/UMEC\/VI use in real-world clinical practice in Korea.<\/jats:p>","DOI":"10.4046\/trd.2025.0158","type":"journal-article","created":{"date-parts":[[2026,6,14]],"date-time":"2026-06-14T23:25:03Z","timestamp":1781479503000},"page":"464-479","update-policy":"https:\/\/doi.org\/10.4046\/crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Real-World Safety of Fluticasone Furoate\/Umeclidinium\/Vilanterol in Patients with Asthma or Chronic Obstructive Pulmonary Disease (COPD), and Clinical Outcomes in COPD: Post-marketing Surveillance in Korea"],"prefix":"10.4046","volume":"89","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-9028-7396","authenticated-orcid":true,"given":"Eun-Bin","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Medical, GSK, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-3639-9004","authenticated-orcid":true,"given":"Jung-Eun","family":"Cho","sequence":"additional","affiliation":[{"name":"Department of Medical, GSK, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eunsun","family":"Kwon","sequence":"additional","affiliation":[{"name":"Department of Medical, GSK, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karam","family":"Ko","sequence":"additional","affiliation":[{"name":"Department of Medical, GSK, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang Heon","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Hanyang University College of Medicine, Seoul, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sang-Ha","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"2481","reference":[{"key":"ref1","doi-asserted-by":"publisher","DOI":"10.2500\/aap.2011.32.3479","type":"journal-article"},{"key":"ref2","first-page":"425","volume-title":"Global, regional, and national burden of asthma and atopic dermatitis, 1990-2021, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021","year":"2025","type":"journal-article"},{"key":"ref3","first-page":"439","type":"journal-article","volume-title":"Economic burden of chronic obstructive pulmonary disease (COPD): a systematic literature review","author":"Iheanacho","year":"2020"},{"key":"ref4","doi-asserted-by":"publisher","DOI":"10.1111\/resp.12660","type":"journal-article"},{"key":"ref5","doi-asserted-by":"publisher","DOI":"10.4046\/trd.2023.0052","type":"journal-article"},{"key":"ref6","doi-asserted-by":"publisher","DOI":"10.4046\/trd.2018.0029","type":"journal-article"},{"key":"ref7","volume-title":"Global strategy for asthma management and prevention [Internet]","year":"2025","type":"web-resource"},{"key":"ref8","volume-title":"Korean guideline for asthma 2021 [Internet]","year":"2021","type":"web-resource"},{"key":"ref9","volume-title":"Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease [Internet]","year":"2026","type":"web-resource"},{"key":"ref10","volume-title":"COPD treatment guidelines 2024 revision [Internet]","year":"2024","type":"web-resource"},{"key":"ref11","doi-asserted-by":"publisher","DOI":"10.1038\/s41533-023-00336-9","type":"journal-article"},{"key":"ref12","doi-asserted-by":"publisher","DOI":"10.1038\/s41533-021-00222-2","type":"journal-article"},{"key":"ref13","volume-title":"Trelegy ELLIPTA (fluticasone furoate\/umeclidinium\/vilanterol) product information [Internet]","year":"2018","type":"web-resource"},{"key":"ref14","volume-title":"Trelegy 200 ELLIPTA inhalation (fluticasone furoate\/umeclidinium\/vilanterol) product information [Internet]","year":"2022","type":"web-resource"},{"key":"ref15","doi-asserted-by":"publisher","DOI":"10.1016\/s2213-2600(20)30389-1","type":"journal-article"},{"key":"ref16","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201703-0449oc","type":"journal-article"},{"key":"ref17","doi-asserted-by":"publisher","DOI":"10.1056\/nejmoa1713901","type":"journal-article"},{"key":"ref18","doi-asserted-by":"publisher","DOI":"10.2147\/copd.s427770","type":"journal-article"},{"key":"ref19","doi-asserted-by":"publisher","DOI":"10.3389\/fphar.2024.1460407","type":"journal-article"},{"key":"ref20","doi-asserted-by":"publisher","DOI":"10.3390\/jcm14082566","type":"journal-article"},{"key":"ref21","volume-title":"Safety of medicines: a guide to detecting and reporting adverse drug reactions. 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