Efficacy and safety of tiotropium in school‐age children with moderate‐to‐severe symptomatic asthma: A systematic review

Abstract Background Recently published data support the benefits and safety of the once‐daily ( OD ) long‐acting anticholinergic tiotropium bromide bronchodilator for the treatment of uncontrolled moderate‐to‐severe asthma in adults and adolescents. However, its role for the treatment of school‐age asthmatics has not yet been clearly defined. The aim of this systematic review was to assess the efficacy and safety of tiotropium Respimat ® in children aged 6‐11 years with moderate‐to‐severe symptomatic asthma. Methods Randomized, placebo‐controlled trials were included. Primary outcomes were peak forced expiratory volume in 1 s measured within 3 h post‐dosing) [ FEV 1 (0‐3 h) ] and trough FEV 1 measured at the end of the dosing interval. Results Three studies (more than 900 patients) were selected. Tiotropium was associated with significant improvements in FEV 1 peak (mean change from baseline) by 102 mL ( P <.0001) and trough by 82 mL ( P <.0001) compared with placebo. Tiotropium 5 μg dose presented a trend (statistically non‐significant) toward a greater bronchodilation in comparison with 2.5 μg dose. Tiotropium significantly increased the rate of the Asthma Control Questionnaire ( ACQ ‐7) responders compared with placebo (82.2% vs 75.4%, number needed to treat for benefit [NNTB]=15) and significantly decreased the number of patients with at least one exacerbation in comparison with placebo (29.1% vs. 39.8%, with a NNTB of 10). There were no significant differences in rescue medication use, withdrawals, and adverse events. Conclusions OD tiotropium Respimat ® is efficacious and well tolerated as an add‐on to inhaled corticosteroids plus one or more controller medications in school‐age symptomatic asthmatics.