{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,8,30]],"date-time":"2025-08-30T17:18:06Z","timestamp":1756574286254},"reference-count":19,"publisher":"Wiley","issue":"8","license":[{"start":{"date-parts":[[2015,9,15]],"date-time":"2015-09-15T00:00:00Z","timestamp":1442275200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/4.0\/"}],"funder":[{"name":"Daewoong pharmaceutical Co., Ltd., Seoul, Republic of Korea"},{"name":"Daewoong Pharmaceutical Co., Ltd., Seoul, Republic of Korea"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Respirology"],"published-print":{"date-parts":[[2015,11]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Background and objective<\/jats:title><jats:p>Aclidinium bromide (\u2018aclidinium\u2019) is a novel, inhaled long\u2010acting muscarinic antagonist. Therapeutic effects of aclidinium on chronic obstructive pulmonary disease (<jats:styled-content style=\"fixed-case\">COPD<\/jats:styled-content>) have been demonstrated in <jats:styled-content style=\"fixed-case\">C<\/jats:styled-content>aucasian populations in several clinical trials. This was a randomized, double\u2010blind, multi\u2010centre phase\u20103 clinical trial to evaluate the efficacy and safety of aclidinium in a <jats:styled-content style=\"fixed-case\">K<\/jats:styled-content>orean population.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>A total of 263 <jats:styled-content style=\"fixed-case\">K<\/jats:styled-content>orean patients with moderate\u2010to\u2010severe <jats:styled-content style=\"fixed-case\">COPD<\/jats:styled-content> were randomized to receive aclidinium (400\u2009\u03bcg, bd) (Genuai) or placebo via a dry\u2010powder inhaler. The primary end point was change in trough forced expiratory volume in one second (<jats:styled-content style=\"fixed-case\">FEV<\/jats:styled-content><jats:sub>1<\/jats:sub>) at 12 weeks. Other lung function measurements, <jats:styled-content style=\"fixed-case\">COPD<\/jats:styled-content> exacerbation, health status (<jats:styled-content style=\"fixed-case\">S<\/jats:styled-content>t <jats:styled-content style=\"fixed-case\">G<\/jats:styled-content>eorge's <jats:styled-content style=\"fixed-case\">R<\/jats:styled-content>espiratory <jats:styled-content style=\"fixed-case\">Q<\/jats:styled-content>uestionnaire (<jats:styled-content style=\"fixed-case\">SGRQ<\/jats:styled-content>), dyspnoea (<jats:styled-content style=\"fixed-case\">T<\/jats:styled-content>ransition <jats:styled-content style=\"fixed-case\">D<\/jats:styled-content>yspnea <jats:styled-content style=\"fixed-case\">I<\/jats:styled-content>ndex (<jats:styled-content style=\"fixed-case\">TDI<\/jats:styled-content>) and safety were assessed throughout the study period.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>A significant improvement in trough <jats:styled-content style=\"fixed-case\">FEV<\/jats:styled-content><jats:sub>1<\/jats:sub> from baseline was shown with aclidinium compared with the placebo (0.126\u2009<jats:styled-content style=\"fixed-case\">L<\/jats:styled-content>, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001). Significant improvements were also demonstrated in peak <jats:styled-content style=\"fixed-case\">FEV<\/jats:styled-content><jats:sub>1<\/jats:sub> (0.190\u2009<jats:styled-content style=\"fixed-case\">L<\/jats:styled-content>, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.0001), <jats:styled-content style=\"fixed-case\">SGRQ<\/jats:styled-content> and <jats:styled-content style=\"fixed-case\">TDI<\/jats:styled-content>. Furthermore, aclidinium significantly reduced the prevalence of exacerbations (aclidinium, 5.4%; placebo, 15.6%, <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05), and the duration of exacerbations was shorter compared with placebo (rate ratio: 0.27; <jats:italic>P<\/jats:italic>\u2009&lt;\u20090.05). Aclidinium (400\u2009\u03bcg) was well tolerated and the prevalence of adverse events was comparable with the placebo.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Inhaled aclidinium (400\u2009\u03bcg) was shown to be safe and efficacious in <jats:styled-content style=\"fixed-case\">K<\/jats:styled-content>orean patients with moderate\u2010to\u2010severe <jats:styled-content style=\"fixed-case\">COPD<\/jats:styled-content>.<\/jats:p><jats:p><jats:bold>Clinical trial registration:<\/jats:bold> NCT01636401 at Clinicaltrials.gov<\/jats:p><\/jats:sec>","DOI":"10.1111\/resp.12641","type":"journal-article","created":{"date-parts":[[2015,9,15]],"date-time":"2015-09-15T10:38:07Z","timestamp":1442313487000},"page":"1222-1228","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy and safety of aclidinium bromide in patients with <scp>COPD<\/scp>: A phase 3 randomized clinical trial in a <scp>K<\/scp>orean population"],"prefix":"10.1111","volume":"20","author":[{"given":"Sang Haak","family":"Lee","sequence":"first","affiliation":[{"name":"Department of Internal Medicine St. Paul's Hospital The Catholic University of Korea College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jongmin","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine St. Paul's Hospital The Catholic University of Korea College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Kwang Ha","family":"Yoo","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Konkuk University College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Soo\u2010Taek","family":"Uh","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Soonchunhyang University College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Myung Jae","family":"Park","sequence":"additional","affiliation":[{"name":"Department of Respiratory and Critical Care Medicine Kyung Hee University College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Sang Yeub","family":"Lee","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Korea University College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jae Yeol","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Chung\u2010Ang University College of Medicine  Seoul Korea"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Deog Kyeom","family":"Kim","sequence":"additional","affiliation":[{"name":"Department of Internal Medicine Seoul Metropolitan Governmental Seoul National University Boramae Medical Center  Seoul 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