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The primary endpoint was trough forced expiratory volume in 1\u2009s (FEV<jats:sub>1<\/jats:sub>) at Week 24. The study was also powered for the secondary endpoint of Transition Dyspnoea Index at Week 24. Other efficacy assessments included spirometry, symptoms, heath status and short-term disease worsening measured by the composite endpoint of clinically important deterioration using three definitions.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Change from baseline in trough FEV<jats:sub>1<\/jats:sub> at Week 24 was 66\u2009mL (95% confidence interval [CI]: 43, 89) and 141\u2009mL (95% CI: 118, 164) greater with umeclidinium\/vilanterol versus umeclidinium and salmeterol, respectively (both <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001). Umeclidinium\/vilanterol demonstrated consistent improvements in Transition Dyspnoea Index versus both monotherapies at Week 24 (vs umeclidinium: 0.37 [95% CI: 0.06, 0.68], <jats:italic>p<\/jats:italic>\u2009=\u20090.018; vs salmeterol: 0.45 [95% CI: 0.15, 0.76], <jats:italic>p<\/jats:italic>\u2009=\u20090.004) and all other symptom measures at all time points. Regardless of the clinically important deterioration definition considered, umeclidinium\/vilanterol significantly reduced the risk of a first clinically important deterioration compared with umeclidinium (by 16\u201325% [<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01]) and salmeterol (by 26\u201341% [<jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001]). Safety profiles were similar between treatments.<\/jats:p>\n              <\/jats:sec>\n              <jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>Umeclidinium\/vilanterol consistently provides early and sustained improvements in lung function and symptoms and reduces the risk of deterioration\/treatment failure versus umeclidinium or salmeterol in symptomatic patients with low exacerbation risk not receiving inhaled corticosteroids. These findings suggest a potential for early use of dual bronchodilators to help optimise therapy in this patient group.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12931-019-1193-9","type":"journal-article","created":{"date-parts":[[2019,10,30]],"date-time":"2019-10-30T20:44:07Z","timestamp":1572468247000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":114,"title":["Efficacy of umeclidinium\/vilanterol versus umeclidinium and salmeterol monotherapies in symptomatic patients with COPD not receiving inhaled corticosteroids: the EMAX randomised trial"],"prefix":"10.1186","volume":"20","author":[{"given":"Fran\u00e7ois","family":"Maltais","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leif","family":"Bjermer","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Edward M.","family":"Kerwin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul W.","family":"Jones","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael L.","family":"Watkins","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Lee","family":"Tombs","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian P.","family":"Naya","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Isabelle H.","family":"Boucot","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David A.","family":"Lipson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Chris","family":"Compton","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mitra","family":"Vahdati-Bolouri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Claus F.","family":"Vogelmeier","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2019,10,30]]},"reference":[{"key":"1193_CR1","unstructured":"Global Initiative for Chronic Obstructive Lung Disease (GOLD). 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All patients provided written informed consent via a form signed at either the Pre-screening or Screening visit.","order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"IHB, DAL, CC, MV-B, and PWJ are employees of GSK and hold stocks and shares in GSK. IPN and MLW were employees of GSK at the time of the study. LT is a contingent worker on assignment at GSK. FM has received research grants for participating in multicentre trials for AstraZeneca, Boehringer Ingelheim, GSK, Sanofi, and Novartis, and has received unrestricted research grants and personal fees from Boehringer Ingelheim, Grifols, and Novartis. LB has received honoraria for giving a lecture or attending an advisory board for Airsonett, ALK-Abello, AstraZeneca, Boehringer Ingelheim, Chiesi, GSK, Meda, Novartis and Teva. EMK has served on advisory boards, speaker panels or received travel reimbursement from for Amphastar, AstraZeneca, Boehringer Ingelheim, GSK, Mylan, Novartis, Pearl, Sunovion, Teva, and Theravance and has received consulting fees from Cipia and GSK. CFV has received grants from AstraZeneca, Boehringer Ingelheim, GSK, Grifols, Novartis, Bayer-Schering, MSD, and Pfizer, and has received personal fees from AstraZeneca, Boehringer Ingelheim, Chiesi, Cipla, CSL Behring, GSK, Grifols, Menarini, Mundipharma, Novartis, and Teva. ELLIPTA and DISKUS are owned by\/licensed to the GSK group of companies.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"238"}}