Tiotropium in asthmatic adolescents symptomatic despite inhaled corticosteroids: A randomised dose-ranging study

Summary Introduction Tiotropium, a once-daily long-acting anticholinergic agent, has been shown to be an efficacious and safe add-on treatment for adults with symptomatic asthma, despite treatment with inhaled corticosteroids (ICS). A large proportion of asthmatic adolescents have symptomatic disease despite a wide range of therapeutic options. We investigated the efficacy and safety of three doses of tiotropium, administered in the evening (via Respimat® SoftMist™ inhaler), versus placebo in asthmatic adolescents symptomatic despite ICS treatment. Methods This randomised, double-blind, placebo-controlled, incomplete crossover study evaluated once-daily tiotropium 5 μg, 2.5 μg and 1.25 μg versus placebo in three 4-week treatment periods. Primary efficacy end point was change in peak forced expiratory volume in 1 s within 3 h post-dose from baseline (peak FEV1(0–3h) ). Results From 139 enrolled patients, 105 were randomised to receive one of four treatment sequences. Peak FEV1(0–3h) response for tiotropium 5 μg was significantly greater versus placebo ( p = 0.0043). Trough FEV1 responses were significantly greater for tiotropium 5 μg ( p