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These post-hoc analyses of the KRONOS study in patients with COPD and without an asthma diagnosis, examine the effects of fixed-dose triple therapy with budesonide\/glycopyrronium\/formoterol fumarate dihydrate (BGF) versus dual therapies on lung function and exacerbations based on blood EOS count \u2013 focusing on blood EOS count 100 to &lt;\u2009300 cells\/mm<jats:sup>3<\/jats:sup> \u2013 as a function of exacerbation history and COPD severity.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>In KRONOS, patients were randomized to receive treatments that included BGF 320\/14.4\/10 \u00b5g, glycopyrronium\/formoterol fumarate dihydrate (GFF) 14.4\/10 \u00b5g, or budesonide\/formoterol fumarate dihydrate (BFF) 320\/10 \u00b5g via metered dose inhaler (two inhalations twice-daily for 24 weeks). These post-hoc analyses assessed changes from baseline in morning pre-dose trough forced expiratory volume in 1\u00a0s (FEV<jats:sub>1<\/jats:sub>) over 12\u201324 weeks and moderate or severe COPD exacerbations rates over 24 weeks. The KRONOS study was not prospectively powered for these subgroup analyses.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Among patients with blood EOS count 100 to &lt;\u2009300 cells\/mm<jats:sup>3<\/jats:sup>, least squares mean treatment differences for lung function improvement favored BGF over BFF in patients without an exacerbation history in the past year and in patients with moderate and severe COPD, with observed differences ranging from 62\u00a0ml to 73\u00a0ml across populations. In this same blood EOS population, moderate or severe exacerbation rates were reduced for BGF relative to GFF by 56% in patients without an exacerbation history in the past year, by 47% in patients with moderate COPD, and by 50% in patients with severe COPD.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>These post-hoc analyses of patients with moderate-to-very severe COPD from the KRONOS study seem to indicate clinicians may want to consider a step-up to triple therapy in patients with persistent\/worsening symptoms with blood EOS count\u2009&gt;\u2009100 cells\/mm<jats:sup>3<\/jats:sup>, even if disease severity is moderate and there is no recent history of exacerbations.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>ClinicalTrials.gov registry number NCT02497001 (registration date, 13 July 2015).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12931-024-02918-8","type":"journal-article","created":{"date-parts":[[2024,8,5]],"date-time":"2024-08-05T12:03:58Z","timestamp":1722859438000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Benefits of budesonide\/glycopyrronium\/formoterol fumarate dihydrate on lung function and exacerbations of COPD: a post-hoc analysis of the KRONOS study by blood eosinophil level and exacerbation history"],"prefix":"10.1186","volume":"25","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7452-9191","authenticated-orcid":false,"given":"Shigeo","family":"Muro","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Tomotaka","family":"Kawayama","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Hisatoshi","family":"Sugiura","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Munehiro","family":"Seki","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Duncan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin","family":"Bowen","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan","family":"Marshall","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ayman","family":"Megally","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-0435-858X","authenticated-orcid":false,"given":"Mehul","family":"Patel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2024,8,5]]},"reference":[{"key":"2918_CR1","doi-asserted-by":"publisher","first-page":"2095","DOI":"10.1016\/S0140-6736(12)61728-0","volume":"380","author":"R Lozano","year":"2012","unstructured":"Lozano R, Naghavi M, Foreman K, Lim S, Shibuya K, Aboyans V, Abraham J, Adair T, Aggarwal R, Ahn SY, et al. 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The protocol and informed consent form were approved by appropriate institutional review boards or independent ethics committees prior to the start of the study (a full listing of appropriate institutional review boards or independent ethics committees has been published []). All patients provided written informed consent before screening.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"SM has received lecture fees from AstraZeneca, GlaxoSmithKline, Nippon Boehringer Ingelheim, and Novartis Pharma. TK has received grants from Helios co. Ltd. and lecture fees from AstraZeneca, Boehringer Ingelheim, GlaxoSmithKline, Kyorin, Novartis, Sanofi, and Teijin healthcare. HS has received lecture fees from AstraZeneca, GlaxoSmithKline, Nippon Boehringer Ingelheim, Novartis Pharma, and Sanofi. MS is an employee of AstraZeneca K.K. Kita-ku and owns stock and\/or stock options in the company. EAD is a former employee of AstraZeneca and owns stock and\/or stock options in the company. KB, JM, AM, and MP are employees of AstraZeneca and own stock and\/or stock options in the company.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"297"}}