A randomised controlled trial of tiotropium in adolescents with severe symptomatic asthma

[摘要] 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 12xe2x80x9317xe2x80x85years were randomised to receive once-daily tiotropium 5xe2x80x85xc2xb5g or 2.5xe2x80x85xc2xb5g; or placebo; as an add-on to ICS plus other controller therapies over 12xe2x80x85weeks. The primary and key secondary end-points were change from baseline (response) in peak forced expiratory volume in 1xe2x80x85s (FEV1) within 3xe2x80x85h post-dosing (FEV1(0xe2x80x933h)) and trough FEV1; respectively; after 12xe2x80x85weeks of treatment.Tiotropium 5xe2x80x85xc2xb5g provided numerical improvements in peak FEV1(0xe2x80x933h) response; compared with placebo (90xe2x80x85mL; p=0.104); and significant improvements were observed with tiotropium 2.5xe2x80x85xc2xb5g (111xe2x80x85mL; 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.

[学科分类] 呼吸医学