{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2025,10,16]],"date-time":"2025-10-16T13:54:10Z","timestamp":1760622850738},"reference-count":22,"publisher":"Wiley","issue":"2","license":[{"start":{"date-parts":[[2012,1,24]],"date-time":"2012-01-24T00:00:00Z","timestamp":1327363200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["Respirology"],"published-print":{"date-parts":[[2012,2]]},"abstract":"<jats:title>ABSTRACT<\/jats:title><jats:p><jats:bold>Background and objective:\u2003<\/jats:bold> The efficacy and safety of indacaterol, a novel inhaled once daily ultra long\u2010acting \u03b2<jats:sub>2<\/jats:sub>\u2010agonist was evaluated in COPD patients in six Asian countries\/areas. This study was primarily designed to obtain the regulatory approval of indacaterol in Japan.<\/jats:p><jats:p><jats:bold>Methods:\u2003<\/jats:bold> Moderate\u2010to\u2010severe COPD patients were randomized to indacaterol 150\u2003\u00b5g, indacaterol 300\u2003\u00b5g or placebo once daily. Efficacy variables: trough FEV<jats:sub>1<\/jats:sub> (average of 23\u2003h 10\u2003min and 23\u2003h 45\u2003min post\u2010dose values), health status (St. George's Respiratory Questionnaire) and transition dyspnoea index at week 12. Safety\/tolerability was evaluated.<\/jats:p><jats:p><jats:bold>Results:\u2003<\/jats:bold> A total of 347 patients were randomized (96.5% male, mean (SD) age 66.7 (8.38) years, post\u2010bronchodilator FEV<jats:sub>1<\/jats:sub>% predicted: 53.7 (12.50)); 88.8% completed. The least squares means (LSM) trough FEV<jats:sub>1<\/jats:sub> at week 12 for indacaterol 150\u2003\u00b5g, indacaterol 300\u2003\u00b5g and placebo were 1.34\u2003L, 1.37\u2003L and 1.17\u2003L, respectively, with differences versus placebo exceeding the prespecified minimal clinically important difference of 0.12\u2003L (0.17\u2003L and 0.20\u2003L for indacaterol 150\u2003\u00b5g and 300\u2003\u00b5g, respectively, both <jats:italic>P<\/jats:italic>\u2003&lt;\u20030.001). The week 12 LSM transition dyspnoea index score was statistically superior for both indacaterol doses versus placebo (differences of 1.30 and 1.26, <jats:italic>P<\/jats:italic>\u2003&lt;\u20030.001; both exceeding the minimal clinically important difference of 1). At week 12, both indacaterol doses provided statistically significant (<jats:italic>P<\/jats:italic>\u2003\u2264\u20030.005) and clinically meaningful (\u22654 units) improvements in LSM St. George's Respiratory Questionnaire total score versus placebo (differences: \u22124.8 and \u22125.7 units). Adverse events for indacaterol (49.1%, both doses) were lower than placebo (59.0%) and were mostly mild\/moderate in severity; no deaths were reported.<\/jats:p><jats:p><jats:bold>Conclusions:\u2003<\/jats:bold> Indacaterol provided clinically significant bronchodilation and improvements in dyspnoea and health status in Asian COPD patients.<\/jats:p>","DOI":"10.1111\/j.1440-1843.2011.02107.x","type":"journal-article","created":{"date-parts":[[2011,11,28]],"date-time":"2011-11-28T21:45:40Z","timestamp":1322516740000},"page":"379-389","source":"Crossref","is-referenced-by-count":31,"title":["Efficacy and safety of indacaterol 150 and 300\u2003\u00b5g in chronic obstructive pulmonary disease patients from six Asian areas including Japan: A 12\u2010week, placebo\u2010controlled study"],"prefix":"10.1111","volume":"17","author":[{"given":"MASAHARU","family":"KINOSHITA","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"SANG HAAK","family":"LEE","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"LIANG\u2010WEN","family":"HANG","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"MASAKAZU","family":"ICHINOSE","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"MOTOI","family":"HOSOE","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"NAOKO","family":"OKINO","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"NIYATI","family":"PRASAD","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"BENJAMIN","family":"KRAMER","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"YOSHINOSUKE","family":"FUKUCHI","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"name":"FOR THE INDACATEROL ASIAN COPD STUDY INVESTIGATORS","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2012,1,24]]},"reference":[{"key":"e_1_2_6_2_2","doi-asserted-by":"publisher","DOI":"10.1046\/j.1440-1843.2003.00460.x"},{"key":"e_1_2_6_3_2","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1843.2004.00637.x"},{"key":"e_1_2_6_4_2","unstructured":"Global Initiative for Chronic Obstructive Lung Disease (GOLD).Global strategy for the diagnosis management and prevention of chronic obstructive pulmonary disease. 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