TY - JOUR T1 - Tiotropium add-on therapy is safe and reduces seasonal worsening in paediatric asthma patients JF - European Respiratory Journal JO - Eur Respir J DO - 10.1183/13993003.01824-2018 VL - 53 IS - 6 SP - 1801824 AU - Christian Vogelberg AU - Stanley J. Szefler AU - Elianne J.L.E. Vrijlandt AU - Attilio L. Boner AU - Michael Engel AU - Georges El Azzi AU - Sebastian Dan Vulcu AU - Petra M. Moroni-Zentgraf AU - Olaf Eickmeier AU - Eckard H. Hamelmann Y1 - 2019/06/01 UR - http://erj.ersjournals.com/content/53/6/1801824.abstract N2 - There remains an unmet need for effective, well-tolerated therapeutic options in paediatric patients with not fully controlled asthma, for whom safety is of paramount importance.Data were pooled from five randomised, double-blind, placebo-controlled studies evaluating tiotropium 5 or 2.5 µg versus placebo add-on therapy in patients with symptomatic asthma aged 1–17 years. Analysis included adverse events (AEs) and serious AEs (SAEs) reported throughout and for 30 days following treatment.Of 1691 patients treated, 1119 received tiotropium. Reporting of AEs was low and comparable across all groups: tiotropium 5 µg (51%), tiotropium 2.5 µg (51%) and placebo (54%). Reporting of drug-related AEs, those leading to discontinuation and SAEs was also low and balanced between treatment groups, irrespective of age, disease severity or sex. The number of AEs related to asthma symptoms and exacerbations was lower with tiotropium (5 µg) than with placebo, particularly during the seasonal peaks of these AEs.This comprehensive analysis of a large safety database allowed subgroup analyses that are often impractical with individual trials and provides further support for the safety of once-daily tiotropium Respimat add-on therapy in paediatric patients with symptomatic asthma.Once-daily tiotropium Respimat add-on therapy is safe in paediatric patients and reduces adverse events related to asthma exacerbations and symptoms, especially during seasonal peaks http://ow.ly/ujHw30of3xk ER -