Once-daily tiotropium Respimat® add-on therapy improves PEF in participants aged 6-17 years with symptomatic asthma

Abstract

Background: PEF is a sensitive measure of bronchoconstriction and asthma control. Phase II studies in adolescents and children with symptomatic asthma showed improvements in PEF with once-daily (QD) tiotropium Respimat ® (tioR). Aim: To assess changes in PEF with QD tioR add-on therapy in participants aged 6-17 years with moderate or severe symptomatic asthma. Methods: Three Phase III, randomised, double-blind, placebo-controlled, parallel-group trials of tioR 5 µg (2 puffs, 2.5 µg) or tioR 2.5 µg (2 puffs, 1.25 µg) in participants aged 6-11 years with severe symptomatic asthma (VivaTinA [n=401]; NCT01634152) and participants aged 12-17 years with moderate (RubaTinA [n=398]; NCT01257230) or severe (PensieTinA [n=392]; NCT01277523) symptomatic asthma. Weekly morning and evening pre-dose PEF response (adjusted mean difference from baseline) measured at home (RubaTinA, PensieTinA), and pre-dose PEF response measured in clinic (VivaTinA). Results: 1191 participants were randomised across all trials; baseline demographics and disease characteristics were balanced between treatment groups. TioR 5 µg and 2.5 µg showed significant improvements in PEF vs placebo, with a numerically greater difference with tioR 5 µg (Table). Conclusion: Tiotropium Respimat ® add-on therapy is an effective bronchodilator, producing significant improvements in PEF in participants aged 6-17 years with moderate or severe asthma.