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

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) [FEV1 (0-3 h) ] and trough FEV1 measured at the end of the dosing interval. RESULTS: Three studies (more than 900 patients) were selected. Tiotropium was associated with significant improvements in FEV1 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.