PT - JOURNAL ARTICLE AU - Eckard Hamelmann AU - Jonathan A. Bernstein AU - Mark Vandewalker AU - Petra Moroni-Zentgraf AU - Daniela Verri AU - Anna Unseld AU - Michael Engel AU - Attilio L. Boner TI - A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma AID - 10.1183/13993003.01100-2016 DP - 2017 Jan 01 TA - European Respiratory Journal PG - 1601100 VI - 49 IP - 1 4099 - http://erj.ersjournals.com/content/49/1/1601100.short 4100 - http://erj.ersjournals.com/content/49/1/1601100.full SO - Eur Respir J2017 Jan 01; 49 AB - 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