{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,15]],"date-time":"2026-09-15T01:32:30Z","timestamp":1789435950299,"version":"build-2803163510"},"reference-count":22,"publisher":"European Respiratory Society (ERS)","issue":"1","funder":[{"DOI":"10.13039\/100008349","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100008349","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2016,9,4]]},"published-print":{"date-parts":[[2017,1]]},"abstract":"<jats:p>We present results from the first phase III trial of once-daily tiotropium add-on to inhaled corticosteroids (ICS) plus one or more controller therapies in adolescents with severe symptomatic asthma.<\/jats:p><jats:p>In this double-blind, parallel-group trial (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT01277523\">NCT01277523<\/jats:ext-link>), 392 patients aged 12\u201317\u2005years were randomised to receive once-daily tiotropium 5\u2005\u00b5g or 2.5\u2005\u00b5g, or placebo, as an add-on to ICS plus other controller therapies over 12\u2005weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1\u2005s (FEV<jats:sub>1<\/jats:sub>) within 3\u2005h post-dosing (FEV<jats:sub>1(0\u20133h)<\/jats:sub>) and trough FEV<jats:sub>1<\/jats:sub>, respectively, after 12\u2005weeks of treatment.<\/jats:p><jats:p>Tiotropium 5\u2005\u00b5g provided numerical improvements in peak FEV<jats:sub>1(0\u20133h)<\/jats:sub>response, compared with placebo (90\u2005mL; p=0.104), and significant improvements were observed with tiotropium 2.5\u2005\u00b5g (111\u2005mL; p=0.046). Numerical improvements in trough FEV<jats:sub>1<\/jats:sub>response and asthma control were observed with both tiotropium doses, compared with placebo. The safety and tolerability of tiotropium were comparable with those of placebo.<\/jats:p><jats:p>Once-daily tiotropium Respimat add-on to ICS plus one or more controller therapies in adolescents with severe symptomatic asthma was well tolerated. The primary end-point of efficacy was not met, although positive trends for improvements in lung function and asthma control were observed.<\/jats:p>","DOI":"10.1183\/13993003.01100-2016","type":"journal-article","created":{"date-parts":[[2016,11,4]],"date-time":"2016-11-04T01:10:50Z","timestamp":1478221850000},"page":"1601100","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":91,"title":["A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma"],"prefix":"10.1183","volume":"49","author":[{"given":"Eckard","family":"Hamelmann","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jonathan A.","family":"Bernstein","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mark","family":"Vandewalker","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Petra","family":"Moroni-Zentgraf","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Daniela","family":"Verri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anna","family":"Unseld","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Michael","family":"Engel","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Attilio L.","family":"Boner","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2016,11,3]]},"reference":[{"key":"2024102100150672000_49.1.1601100.1","unstructured":"Asthma UK. 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