{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,1,18]],"date-time":"2026-01-18T03:29:54Z","timestamp":1768706994848,"version":"3.49.0"},"reference-count":22,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T00:00:00Z","timestamp":1487894400000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2017,2,24]],"date-time":"2017-02-24T00:00:00Z","timestamp":1487894400000},"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>Bronchodilator therapy is the backbone of the management of chronic obstructive pulmonary disease. In some patients, inhaled corticosteroids can be prescribed in combination with bronchodilators. Through a subgroup analysis of pooled data from two large phase III clinical trials of bronchodilator therapy according to concomitant inhaled corticosteroid use (user vs. non-user), we sought to evaluate the clinical benefit of adding inhaled corticosteroids to dual bronchodilator therapy in chronic obstructive pulmonary disease. The primary focus of this analysis of pooled data from the phase III ACLIFORM and AUGMENT studies was to evaluate the efficacy of aclidinium\/formoterol on lung function stratified by inhaled corticosteroid use. We found that lung-function end points were significantly improved regardless of concomitant inhaled corticosteroid use among patients treated with the dual bronchodilator aclidinium\/formoterol 400\/12\u2009\u00b5g twice daily compared with placebo and both monotherapies. Together with the previously reported observations that aclidinium\/formoterol 400\/12\u2009\u00b5g reduces exacerbations vs. placebo in inhaled corticosteroid users and improves dyspnoea compared to monotherapy in inhaled corticosteroid non-users, these data suggest that both groups achieve lung function improvements, which translates to different clinical benefits depending on whether or not a patient is receiving concomitant inhaled corticosteroids.<\/jats:p>","DOI":"10.1038\/s41533-016-0009-3","type":"journal-article","created":{"date-parts":[[2017,2,20]],"date-time":"2017-02-20T14:50:04Z","timestamp":1487602204000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Use of concomitant inhaled corticosteroids: pooled data from two phase III studies of aclidinium plus formoterol in COPD"],"prefix":"10.1038","volume":"27","author":[{"given":"Anthony","family":"D\u2019Urzo","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Dave","family":"Singh","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Esther","family":"Garcia Gil","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"297","published-online":{"date-parts":[[2017,2,24]]},"reference":[{"key":"9_CR1","unstructured":"European Medicines Agency. Duaklir\u00ae Genuair\u2122 (aclidinium bromide \/ formoterol fumarate dihydrate), http:\/\/www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/003745\/human_med_001811.jsp&mid=WC0b01ac058001d124, Accessed 28 November 2016."},{"key":"9_CR2","unstructured":"Health Canada. Health Canada Regulatory Decision Summary: DUAKLIR GENUAIR, http:\/\/www.hc-sc.gc.ca\/dhp-mps\/prodpharma\/rds-sdr\/drug-med\/rds_sdr_duaklir_genuair_172711-eng.php, Accessed 28 November 2016."},{"key":"9_CR3","unstructured":"Australian Register of Therapeutic Goods. Public ARTG Summary BRIMICA GENUAIR 340\/12 aclidinium bromide and eformoterol fumarate dihydrate powder for inhalation dry powder inhaler, https:\/\/www.ebs.tga.gov.au\/servlet\/xmlmillr6?dbid=ebs\/PublicHTML\/pdfStore.nsf&docid=7D48BD935C36BFE5CA257E3800423B12&agid=(PrintDetailsPublic)&actionid=1, Accessed 28 November 2016."},{"key":"9_CR4","doi-asserted-by":"publisher","first-page":"123","DOI":"10.1186\/s12931-014-0123-0","volume":"15","author":"AD D\u2019Urzo","year":"2014","unstructured":"D\u2019Urzo, A. D. et al. Efficacy and safety of fixed-dose combinations of aclidinium bromide\/formoterol fumarate: the 24-week, randomized, placebo-controlled AUGMENT COPD study. Respir. Res. \n                           15, 123\u2013141 (2014).","journal-title":"Respir. Res."},{"key":"9_CR5","doi-asserted-by":"publisher","first-page":"178","DOI":"10.1186\/1471-2466-14-178","volume":"14","author":"D Singh","year":"2014","unstructured":"Singh, D. et al. Efficacy and safety of aclidinium bromide\/formoterol fumarate fixed-dose combinations compared with individual components and placebo in patients with COPD (ACLIFORM-COPD): a multicentre, randomised study. BMC Pulm. Med. \n                           14, 178\u2013189 (2014).","journal-title":"BMC Pulm. Med."},{"key":"9_CR6","doi-asserted-by":"publisher","first-page":"92","DOI":"10.1186\/s12931-015-0250-2","volume":"16","author":"ED Bateman","year":"2015","unstructured":"Bateman, E. D. et al. Aclidinium bromide and formoterol fumarate as a fixed-dose combination in COPD: pooled analysis of symptoms and exacerbations from two six-month, multicentre, randomised studies (ACLIFORM and AUGMENT). Respir. Res. \n                           16, 92 (2015).","journal-title":"Respir. Res."},{"key":"9_CR7","doi-asserted-by":"publisher","first-page":"1484","DOI":"10.1183\/09031936.00200212","volume":"42","author":"ED Bateman","year":"2013","unstructured":"Bateman, E. D. et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur. Respir. J. \n                           42, 1484\u20131494 (2013).","journal-title":"Eur. Respir. J."},{"key":"9_CR8","doi-asserted-by":"publisher","first-page":"969","DOI":"10.1183\/09031936.00136014","volume":"45","author":"R Buhl","year":"2015","unstructured":"Buhl, R. et al. Tiotropium and olodaterol fixed-dose combination versus mono-components in COPD (GOLD 2-4). Eur. Respir. J. \n                           45, 969\u2013979 (2015).","journal-title":"Eur. Respir. J."},{"key":"9_CR9","doi-asserted-by":"publisher","first-page":"1538","DOI":"10.1016\/j.rmed.2013.06.001","volume":"107","author":"JF Donohue","year":"2013","unstructured":"Donohue, J. F. et al. Efficacy and safety of once-daily umeclidinium\/vilanterol 62.5\/25 mcg in COPD. Respir. Med. \n                           107, 1538\u20131546 (2013).","journal-title":"Respir. Med."},{"key":"9_CR10","unstructured":"Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease, http:\/\/goldcopd.org\/gold-reports\/, Accessed 28 November 2016."},{"key":"9_CR11","doi-asserted-by":"publisher","first-page":"73","DOI":"10.1186\/s12931-016-0387-7","volume":"17","author":"D Singh","year":"2016","unstructured":"Singh, D. et al. Effects of tiotropium + olodaterol versus tiotropium or placebo by COPD disease severity and previous treatment history in the OTEMTO\u00ae studies. Respir. Res. \n                           17, 73 (2016).","journal-title":"Respir. Res."},{"key":"9_CR12","doi-asserted-by":"publisher","first-page":"519","DOI":"10.1136\/thoraxjnl-2014-206670","volume":"70","author":"PA Frith","year":"2015","unstructured":"Frith, P. A. et al. Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol\/fluticasone in patients with COPD: the GLISTEN study, a randomised controlled trial. Thorax \n                           70, 519\u2013527 (2015).","journal-title":"Thorax"},{"key":"9_CR13","doi-asserted-by":"publisher","first-page":"592","DOI":"10.1136\/thx.2007.087213","volume":"63","author":"D Singh","year":"2008","unstructured":"Singh, D., Brooks, J., Hagan, G., Cahn, A. & O\u2019Connor, B. J. Superiority of \u201ctriple\u201d therapy with salmeterol\/fluticasone propionate and tiotropium bromide versus individual components in moderate to severe COPD. Thorax \n                           63, 592\u2013598 (2008).","journal-title":"Thorax"},{"key":"9_CR14","doi-asserted-by":"publisher","first-page":"963","DOI":"10.1016\/S0140-6736(16)31354-X","volume":"388","author":"D Singh","year":"2016","unstructured":"Singh, D. et al. 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