%0 Journal Article %A Eckard Hamelmann %A Jonathan A. Bernstein %A Mark Vandewalker %A Petra Moroni-Zentgraf %A Daniela Verri %A Anna Unseld %A Michael Engel %A Attilio L. Boner %T A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma %D 2017 %R 10.1183/13993003.01100-2016 %J European Respiratory Journal %P 1601100 %V 49 %N 1 %X 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.In this double-blind, parallel-group trial (NCT01277523), 392 patients aged 12–17 years were randomised to receive once-daily tiotropium 5 µg or 2.5 µg, or placebo, as an add-on to ICS plus other controller therapies over 12 weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1 s (FEV1) within 3 h post-dosing (FEV1(0–3h)) and trough FEV1, respectively, after 12 weeks of treatment.Tiotropium 5 µg provided numerical improvements in peak FEV1(0–3h) response, compared with placebo (90 mL; p=0.104), and significant improvements were observed with tiotropium 2.5 µg (111 mL; p=0.046). Numerical improvements in trough FEV1 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.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.Tiotropium add-on therapy provided numerical improvements in outcomes in adolescents with asthma http://ow.ly/eL8g304a9XV %U https://erj.ersjournals.com/content/erj/49/1/1601100.full.pdf