{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T13:56:25Z","timestamp":1760622985769},"reference-count":19,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2016,6,23]],"date-time":"2016-06-23T00:00:00Z","timestamp":1466640000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2016,6,23]],"date-time":"2016-06-23T00:00:00Z","timestamp":1466640000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["npj Prim Care Resp Med"],"abstract":"<jats:title>Abstract<\/jats:title><jats:p>Benefits of triple therapy with a long-acting muscarinic antagonist (LAMA), added to inhaled corticosteroid (ICS)\/long-acting \u03b2<jats:sub>2<\/jats:sub>-agonist (LABA), have been demonstrated. Limited data assessing the efficacy of the LAMA umeclidinium (UMEC) added to ICS\/LABA are available. The aim of this study is to evaluate the efficacy and safety of UMEC added to ICS\/LABAs in patients with moderate-to-very-severe COPD. This is a multicentre, randomised, double-blind, parallel-group study. Patients were symptomatic (modified Medical Research Council Dyspnoea Scale score \u2a7e2), despite receiving ICS\/LABA (fluticasone propionate\/salmeterol (FP\/SAL, branded) 500\/50\u2009mcg, budesonide\/formoterol (BD\/FOR, branded) 200\/6\u2009mcg or 400\/12\u2009mcg, or other ICS\/LABAs) \u2a7e30 days before the run-in (7\u00b12 days). Patients were randomised 1:1 to once-daily UMEC 62.5\u2009mcg or placebo (PBO), added to twice-daily open-label ICS\/LABA for 12 weeks. Primary end point was trough forced expiratory volume in 1\u2009s (FEV<jats:sub>1<\/jats:sub>) at Day 85; secondary end point was weighted mean (WM) 0\u20136\u2009h FEV<jats:sub>1<\/jats:sub> at Day 84; other end points included COPD Assessment Test (CAT) score and Transition Dyspnoea Index (TDI) score. Adverse events (AEs) were investigated. In the UMEC+ICS\/LABA and PBO+ICS\/LABA groups, 119 and 117 patients were randomised, respectively. Patients received FP\/SAL (40%), BD\/FOR (43%) and other ICS\/LABAs (17%). UMEC+ICS\/LABA resulted in significant improvements in trough FEV<jats:sub>1<\/jats:sub> (Day 85) and in WM 0\u20136\u2009h FEV<jats:sub>1<\/jats:sub> (Day 84) versus PBO+ICS\/LABA (difference: 123 and 148\u2009ml, respectively, both <jats:italic>P<\/jats:italic>&lt;0.001). Change from baseline for UMEC+ICS\/LABA versus PBO+ICS\/LABA was significantly different for CAT score at Day 84 (\u22121.31, <jats:italic>P<\/jats:italic>&lt;0.05), but not for TDI score (0.40, <jats:italic>P<\/jats:italic>=0.152). AE incidence was similar with UMEC+ICS\/LABA (38%) and PBO+ICS\/LABA (42%). UMEC+ICS\/LABA improved lung function and CAT score in patients with symptomatic COPD versus PBO+ICS\/LABA (ClinicalTrials.gov NCT02257372).<\/jats:p>","DOI":"10.1038\/npjpcrm.2016.31","type":"journal-article","created":{"date-parts":[[2016,6,23]],"date-time":"2016-06-23T10:49:51Z","timestamp":1466678991000},"update-policy":"http:\/\/dx.doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":16,"title":["The effect of umeclidinium added to inhaled corticosteroid\/long-acting \u03b22-agonist in patients with symptomatic COPD: a randomised, double-blind, parallel-group study"],"prefix":"10.1038","volume":"26","author":[{"given":"Ana R","family":"Sousa","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"John H","family":"Riley","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Alison","family":"Church","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Chang-Qing","family":"Zhu","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Yogesh S","family":"Punekar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"William A","family":"Fahy","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2016,6,23]]},"reference":[{"key":"BFnpjpcrm201631_CR1","unstructured":"GOLD. 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