P172 Safety profile of tiotropium add-on therapy in paediatric patients by gender

Introduction Tiotropium Respimat® has a safety profile comparable with placebo when given as add-on therapy to at least inhaled corticosteroids (ICS) in paediatric patients with symptomatic asthma. We aimed to determine whether the safety and tolerability of tiotropium add-on in paediatric patients is independent of gender. Methods Data were pooled from all parallel-group, randomised, double-blinded, placebo-controlled studies of ≥12 weeks’ duration in 1–17 year-olds (n=1691) with symptomatic asthma treated with tiotropium 5 µg or 2.5 µg or placebo (as two puffs once daily) as add-on to ICS ±other controllers. This analysis includes adverse events (AEs) and serious AEs (SAEs) recorded throughout treatment, and for 30 days after. Results Baseline characteristics and exposure to study medication were comparable between treatment groups within each trial. Of 1691 patients treated, 1119 received tiotropium. Overall, the proportion of patients reporting AEs was comparable for tiotropium 5 µg, 2.5 µg and placebo (table 1). This was true for both genders, although slightly fewer female than male patients in the tiotropium 5 µg group reported AEs. Reporting of drug-related AEs, AEs leading to discontinuation and SAEs was low and balanced between treatment groups, irrespective of gender. Conclusion The safety and tolerability profile of once-daily tiotropium as add-on to ICS ±additional controllers is comparable with placebo among paediatric patients with symptomatic asthma, irrespective of gender. Please refer to page A267 for declarations of interest related to this abstract.