{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T22:58:25Z","timestamp":1789513105779,"version":"build-2803163510"},"reference-count":40,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2025,11,28]],"date-time":"2025-11-28T00:00:00Z","timestamp":1764288000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"},{"start":{"date-parts":[[2025,11,28]],"date-time":"2025-11-28T00:00:00Z","timestamp":1764288000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by-nc\/4.0"}],"funder":[{"name":"GSK","award":["214953"],"award-info":[{"award-number":["214953"]}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Adv Ther"],"published-print":{"date-parts":[[2026,1]]},"DOI":"10.1007\/s12325-025-03421-2","type":"journal-article","created":{"date-parts":[[2025,11,28]],"date-time":"2025-11-28T06:29:15Z","timestamp":1764311355000},"page":"317-332","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":1,"title":["Real-World Safety and Effectiveness of Fluticasone Furoate\/Umeclidinium\/Vilanterol in Patients with Asthma: Final Analysis of a Post-Marketing Surveillance in Japan"],"prefix":"10.1007","volume":"43","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-8400-863X","authenticated-orcid":false,"given":"Kazuhisa","family":"Asai","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yoriko","family":"Morioka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0009-0006-6820-0561","authenticated-orcid":false,"given":"Risako","family":"Ito","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masaki","family":"Komatsubara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hiroki","family":"Maruoka","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,11,28]]},"reference":[{"key":"3421_CR1","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1016\/j.alit.2020.08.001","volume":"69","author":"Y Nakamura","year":"2020","unstructured":"Nakamura Y, Tamaoki J, Nagase H, et al. Japanese guidelines for adult asthma 2020. Allergol Int. 2020;69:519\u201348.","journal-title":"Allergol Int"},{"key":"3421_CR2","doi-asserted-by":"publisher","first-page":"405","DOI":"10.1016\/j.resinv.2025.03.009","volume":"63","author":"J Tamaoki","year":"2025","unstructured":"Tamaoki J, Nagase H, Sano H, et al. Practical guidelines for asthma management (PGAM): digest edition. Respir Investig. 2025;63:405\u201321.","journal-title":"Respir Investig"},{"key":"3421_CR3","volume-title":"Asthma prevention and management guidelines 2024","author":"Asthma Prevention and Management Guidelines 2024 WG","year":"2024","unstructured":"Asthma Prevention and Management Guidelines 2024 WG. Asthma prevention and management guidelines 2024. Tokyo: Kyowa Planning Co; 2024."},{"key":"3421_CR4","unstructured":"Pharmacauticals and Medical Devices Agency. List of approved products April 2004 to December 2024. 2024. Accessed 26 March 2025 https:\/\/www.pmda.go.jp\/english\/review-services\/reviews\/approved-information\/drugs\/0002.html."},{"key":"3421_CR5","doi-asserted-by":"publisher","first-page":"1657","DOI":"10.1080\/03007995.2021.1944849","volume":"37","author":"Y Nakamura","year":"2021","unstructured":"Nakamura Y, Hozawa S, Sagara H, et al. Efficacy and safety of once-daily, single-inhaler fluticasone furoate\/umeclidinium\/vilanterol versus fluticasone furoate\/vilanterol in Japanese patients with inadequately controlled asthma: the CAPTAIN study. Curr Med Res Opin. 2021;37:1657\u201365.","journal-title":"Curr Med Res Opin"},{"key":"3421_CR6","doi-asserted-by":"publisher","first-page":"809","DOI":"10.2147\/JAA.S305918","volume":"14","author":"S Hozawa","year":"2021","unstructured":"Hozawa S, Ohbayashi H, Tsuchiya M, et al. Safety of once-daily single-inhaler triple therapy with fluticasone Furoate\/Umeclidinium\/Vilanterol in Japanese patients with asthma: a long-term (52-week) phase III open-label study. J Asthma Allergy. 2021;14:809\u201319.","journal-title":"J Asthma Allergy"},{"key":"3421_CR7","unstructured":"European Medicines Agency. Trelegy Ellipta: EPAR Risk-management plan summary. 2019. Accessed 08 May 2025 https:\/\/www.ema.europa.eu\/en\/medicines\/human\/EPAR\/trelegy-ellipta."},{"key":"3421_CR8","unstructured":"Pharmaceutical and Medical Devices Agency. Trelegy ellipta drug risk management plan. 2020. Accessed 08 May 2025 https:\/\/www.pmda.go.jp\/RMP\/www\/340278\/ab15ef60-42b6-402a-b47f-cc756cef75a4\/340278_22908A1G1022_009RMP.pdf."},{"key":"3421_CR9","doi-asserted-by":"publisher","first-page":"69","DOI":"10.1016\/S2213-2600(20)30389-1","volume":"9","author":"LA Lee","year":"2021","unstructured":"Lee LA, Bailes Z, Barnes N, et al. Efficacy and safety of once-daily single-inhaler triple therapy (FF\/UMEC\/VI) versus FF\/VI in patients with inadequately controlled asthma (CAPTAIN): a double-blind, randomised, phase 3A trial. Lancet Respir Med. 2021;9:69\u201384.","journal-title":"Lancet Respir Med"},{"key":"3421_CR10","doi-asserted-by":"publisher","first-page":"438","DOI":"10.1164\/rccm.201703-0449OC","volume":"196","author":"DA Lipson","year":"2017","unstructured":"Lipson DA, Barnacle H, Birk R, et al. Fulfil trial: once-daily triple therapy for patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med. 2017;196:438\u201346.","journal-title":"Am J Respir Crit Care Med"},{"key":"3421_CR11","doi-asserted-by":"publisher","first-page":"1671","DOI":"10.1056\/NEJMoa1713901","volume":"378","author":"DA Lipson","year":"2018","unstructured":"Lipson DA, Barnhart F, Brealey N, et al. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med. 2018;378:1671\u201380.","journal-title":"N Engl J Med"},{"key":"3421_CR12","doi-asserted-by":"publisher","first-page":"1925","DOI":"10.2147\/COPD.S302864","volume":"16","author":"NA Hanania","year":"2021","unstructured":"Hanania NA, Scott C, Tedi S, et al. Effect of age on efficacy and safety of fluticasone Furoate\/Vilanterol (FF\/VI), Umeclidinium (UMEC), and UMEC + FF\/VI in patients with chronic obstructive pulmonary disease: analyses of five randomized clinical trials. Int J Chron Obstruct Pulmon Dis. 2021;16:1925\u201338.","journal-title":"Int J Chron Obstruct Pulmon Dis"},{"key":"3421_CR13","doi-asserted-by":"publisher","first-page":"657","DOI":"10.1016\/j.jfda.2018.12.006","volume":"27","author":"MT Wang","year":"2019","unstructured":"Wang MT, Lai JH, Tsai CL, Liou JT. Risk of adverse cardiovascular events with use of inhaled long-acting bronchodilators in management of chronic obstructive pulmonary disease. J Food Drug Anal. 2019;27:657\u201370.","journal-title":"J Food Drug Anal"},{"key":"3421_CR14","doi-asserted-by":"publisher","first-page":"229","DOI":"10.1001\/jamainternmed.2017.7720","volume":"178","author":"MT Wang","year":"2018","unstructured":"Wang MT, Liou JT, Lin CW, et al. Association of cardiovascular risk with inhaled long-acting bronchodilators in patients with chronic obstructive pulmonary disease: a nested case-control study. JAMA Intern Med. 2018;178:229\u201338.","journal-title":"JAMA Intern Med"},{"key":"3421_CR15","doi-asserted-by":"publisher","first-page":"799","DOI":"10.1016\/j.chest.2022.11.027","volume":"163","author":"CF Weng","year":"2023","unstructured":"Weng CF, Wu CC, Wu MH, Lin FJ. Comparison of clinical outcomes among different fixed-dose combinations of long-acting muscarinic antagonists and long-acting \u03b2(2)-agonists in patients with COPD. Chest. 2023;163:799\u2013814.","journal-title":"Chest"},{"key":"3421_CR16","doi-asserted-by":"publisher","first-page":"2309","DOI":"10.1378\/chest.125.6.2309","volume":"125","author":"SR Salpeter","year":"2004","unstructured":"Salpeter SR, Ormiston TM, Salpeter EE. Cardiovascular effects of beta-agonists in patients with asthma and COPD: a meta-analysis. Chest. 2004;125:2309\u201321.","journal-title":"Chest"},{"key":"3421_CR17","doi-asserted-by":"publisher","first-page":"3629","DOI":"10.1016\/j.jaip.2023.07.041","volume":"11","author":"GW Canonica","year":"2023","unstructured":"Canonica GW, Blasi F, Carpagnano GE, et al. Severe asthma network Italy definition of clinical remission in severe asthma: a delphi consensus. J Allergy Clin Immunol Pract. 2023;11:3629\u201337.","journal-title":"J Allergy Clin Immunol Pract"},{"key":"3421_CR18","doi-asserted-by":"publisher","first-page":"869","DOI":"10.1164\/rccm.202311-2192OC","volume":"210","author":"L Perez-de-Llano","year":"2024","unstructured":"Perez-de-Llano L, Scelo G, Tran TN, et al. Exploring definitions and predictors of severe asthma clinical remission after biologic treatment in adults. Am J Respir Crit Care Med. 2024;210:869\u201380.","journal-title":"Am J Respir Crit Care Med"},{"key":"3421_CR19","unstructured":"Hozawa S, Crawford J, Hibi R, Ito R, Moore A, Noorduyn SG. Asthma clinical remission with single-inhaler FF\/UMEC\/VI in Japanese patients: post hoc analysis of a long-term phase III open-label study. The 65th Annual Meeting of the Japanese Respiratory Society; 2025 11\u201313 April 2025; Tokyo, Japan."},{"key":"3421_CR20","first-page":"PA1198","volume":"64","author":"J Oppenheimer","year":"2024","unstructured":"Oppenheimer J, Lugogo N, Crawford J, et al. Assessment of the components of clinical remission with moderate\u2013severe asthma after 24\u201352 weeks of treatment: captain post hoc analysis. Eur Respir J. 2024;64:PA1198.","journal-title":"Eur Respir J"},{"key":"3421_CR21","first-page":"PA1199","volume":"64","author":"J Oppenheimer","year":"2024","unstructured":"Oppenheimer J, Pavord I, Crawford J, et al. Impact of varying lung function threshold on clinical remission in asthma with FF\/UMEC\/VI: CAPTAIN post hoc analysis. Eur Respir J. 2024;64:PA1199.","journal-title":"Eur Respir J"},{"key":"3421_CR22","unstructured":"Hozawa S, Crawford J, Hibi R, Ito R, Moore A, Noorduyn SG. Asthma clinical remission outcomes with single-inhaler triple therapy FF\/UMEC\/VI: post hoc analysis of\u00a0CAPTAIN, including Japan subgroup\u00a0analysis. The 65th Annual Meeting of the Japanese Respiratory Society; 2025 11\u201313 April 2025; Tokyo, Japan."},{"key":"3421_CR23","first-page":"39","volume":"45","author":"H Maruoka","year":"2024","unstructured":"Maruoka H, Ito R, Mukai I, et al. Evaluation of the safety and clinical outcomes of FF\/UMEC\/VI therapy in patients with asthma in Japan. Ther Res. 2024;45:39\u201357.","journal-title":"Ther Res"},{"key":"3421_CR24","unstructured":"International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). Medical dictionary for regulatory activities. Accessed 3 Sep 2025 https:\/\/www.meddra.org\/."},{"key":"3421_CR25","doi-asserted-by":"publisher","first-page":"59","DOI":"10.1016\/j.jaci.2003.09.008","volume":"113","author":"RA Nathan","year":"2004","unstructured":"Nathan RA, Sorkness CA, Kosinski M, et al. Development of the asthma control test: a survey for assessing asthma control. J Allergy Clin Immunol. 2004;113:59\u201365.","journal-title":"J Allergy Clin Immunol"},{"key":"3421_CR26","doi-asserted-by":"publisher","first-page":"1624","DOI":"10.1183\/09031936.96.09081624","volume":"9","author":"M Fujimura","year":"1996","unstructured":"Fujimura M, Kasahara K, Kamio Y, Naruse M, Hashimoto T, Matsuda T. Female gender as a determinant of cough threshold to inhaled capsaicin. Eur Respir J. 1996;9:1624\u20136.","journal-title":"Eur Respir J"},{"key":"3421_CR27","doi-asserted-by":"publisher","first-page":"70","DOI":"10.4081\/gc.2020.9137","volume":"6","author":"S Cavallero","year":"2020","unstructured":"Cavallero S, Dominguez LJ, Vernuccio L, Barbagallo M. Presbyphagia and dysphagia in old age. Geriatr Care. 2020;6:70\u20136.","journal-title":"Geriatr Care"},{"key":"3421_CR28","doi-asserted-by":"publisher","first-page":"2614","DOI":"10.3390\/biomedicines10102614","volume":"10","author":"M Kreslova","year":"2022","unstructured":"Kreslova M, Kirchnerova O, Rajdl D, et al. Bronchial asthma as a cardiovascular risk factor: a prospective observational study. Biomedicines. 2022;10:2614.","journal-title":"Biomedicines"},{"key":"3421_CR29","doi-asserted-by":"publisher","first-page":"1338","DOI":"10.1016\/j.chest.2020.11.053","volume":"159","author":"ME Pollevick","year":"2021","unstructured":"Pollevick ME, Xu KY, Mhango G, et al. The relationship between asthma and cardiovascular disease: an examination of the Framingham Offspring study. Chest. 2021;159:1338\u201345.","journal-title":"Chest"},{"key":"3421_CR30","doi-asserted-by":"publisher","DOI":"10.1016\/j.eclinm.2023.102230","volume":"64","author":"F Tian","year":"2023","unstructured":"Tian F, Chen L, Qian ZM, et al. Ranking age-specific modifiable risk factors for cardiovascular disease and mortality: evidence from a population-based longitudinal study. EClinicalMedicine. 2023;64:102230.","journal-title":"EClinicalMedicine"},{"key":"3421_CR31","doi-asserted-by":"publisher","first-page":"1273","DOI":"10.1056\/NEJMoa2206916","volume":"389","author":"C Magnussen","year":"2023","unstructured":"Global Cardiovascular Risk C, Magnussen C, Ojeda FM, et al. Global effect of modifiable risk factors on cardiovascular disease and mortality. N Engl J Med. 2023;389:1273\u201385.","journal-title":"N Engl J Med"},{"key":"3421_CR32","unstructured":"Global Initiative for Chronic Obstructive Lung Disease. Global strategy for prevention, diagnosis and management of COPD: 2025 Report. Accessed 3 Sep 2025 https:\/\/goldcopd.org\/2025-gold-report\/."},{"key":"3421_CR33","doi-asserted-by":"publisher","first-page":"1309","DOI":"10.2147\/JAA.S424055","volume":"16","author":"M Bogart","year":"2023","unstructured":"Bogart M, Germain G, Lalibert\u00e9 F, et al. Real-world study of single-inhaler triple therapy with fluticasone furoate\/umeclidinium\/vilanterol on asthma control in the US. J Asthma Allergy. 2023;16:1309\u201322.","journal-title":"J Asthma Allergy"},{"key":"3421_CR34","doi-asserted-by":"publisher","first-page":"1061","DOI":"10.1007\/s12325-024-03083-6","volume":"42","author":"AP Baptist","year":"2025","unstructured":"Baptist AP, Germain G, Klimek J, et al. Medicare advantage population in the United States: outcomes of patients with asthma treated with ICS\/LABA before and after initiation with Fluticasone Furoate\/Umeclidinium\/Vilanterol (FF\/UMEC\/VI). Adv Ther. 2025;42:1061\u201374.","journal-title":"Adv Ther"},{"key":"3421_CR35","doi-asserted-by":"publisher","DOI":"10.1093\/ageing\/afab282","volume":"51","author":"KH Pitkala","year":"2022","unstructured":"Pitkala KH, Strandberg TE. Clinical trials in older people. Age Ageing. 2022;51:afab282.","journal-title":"Age Ageing"},{"key":"3421_CR36","doi-asserted-by":"publisher","first-page":"1763","DOI":"10.1007\/s12325-018-0805-y","volume":"35","author":"L Blonde","year":"2018","unstructured":"Blonde L, Khunti K, Harris SB, Meizinger C, Skolnik NS. Interpretation and impact of real-world clinical data for the practicing clinician. Adv Ther. 2018;35:1763\u201374.","journal-title":"Adv Ther"},{"key":"3421_CR37","doi-asserted-by":"publisher","first-page":"1131949","DOI":"10.3389\/fphys.2023.1131949","volume":"14","author":"A Umeda","year":"2023","unstructured":"Umeda A, Shimada H, Yamane T, et al. Real-world effects of once-daily inhaled steroid (fluticasone furoate) combined with long-acting beta-2 agonist (vilanterol) and long-acting muscarinic antagonist (umeclidinium) on lung function tests of asthma patients in Japan. Front Physiol. 2023;14:1131949.","journal-title":"Front Physiol"},{"key":"3421_CR38","doi-asserted-by":"publisher","first-page":"757","DOI":"10.1016\/j.jaci.2019.12.006","volume":"145","author":"A Menzies-Gow","year":"2020","unstructured":"Menzies-Gow A, Bafadhel M, Busse WW, et al. An expert consensus framework for asthma remission as a treatment goal. J Allergy Clin Immunol. 2020;145:757\u201365.","journal-title":"J Allergy Clin Immunol"},{"key":"3421_CR39","doi-asserted-by":"publisher","DOI":"10.1016\/j.jacig.2025.100431","volume":"4","author":"M Ishizuka","year":"2025","unstructured":"Ishizuka M, Sugimoto N, Kobayashi K, et al. Clinical remission of mild-to-moderate asthma: rates, contributing factors, and stability. J Allergy Clin Immunol Glob. 2025;4:100431.","journal-title":"J Allergy Clin Immunol Glob"},{"key":"3421_CR40","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2023.11.851","volume":"153","author":"N Lugogo","year":"2024","unstructured":"Lugogo N, Oppenheimer J, Crawford J, et al. Is asthma clinical remission achievable by inhaled therapy? A post-hoc analysis of single inhaler triple therapy with FF\/UMEC\/VI in the CAPTAIN trial. J Allergy Clin Immunol. 2024;153:AB266.","journal-title":"J Allergy Clin Immunol"}],"container-title":["Advances in Therapy"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-025-03421-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s12325-025-03421-2","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s12325-025-03421-2.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,1,30]],"date-time":"2026-01-30T09:32:12Z","timestamp":1769765532000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s12325-025-03421-2"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,11,28]]},"references-count":40,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2026,1]]}},"alternative-id":["3421"],"URL":"https:\/\/doi.org\/10.1007\/s12325-025-03421-2","relation":{},"ISSN":["0741-238X","1865-8652"],"issn-type":[{"value":"0741-238X","type":"print"},{"value":"1865-8652","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,11,28]]},"assertion":[{"value":"16 July 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 October 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"28 November 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Kazuhisa Asai has received speaker\/consultancy fees from AstraZeneca, Boehringer Ingelheim, GSK, Novartis, and Sanofi. Yoriko Morioka, Risako Ito, Masaki Komatsubara, and Hiroki Maruoka are employees of, and\/or hold financial equities in, GSK.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"This study was reviewed and approved by the Ethics Review Board of Kitamachi Clinic central ethics committee (approval number GSK08027) and conducted in accordance with\u00a0the declaration of Helsinki and the Japanese Good Post Marketing Study Practice ordinance. All patients provided informed, written consent.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethical Approval"}}]}}