Published: 7 February 2015
Abstract (provisional)
Background
A considerable number of children with asthma remain symptomatic despite treatment with inhaled corticosteroids, resulting in significant morbidity, reduced quality of life, increased healthcare costs and lost school days. The aim of our study was to assess the efficacy, safety and tolerability of once-daily tiotropium Respimat 5µg, 2.5µg and 1.25µg add-on to medium-dose inhaled corticosteroids, with or without a leukotriene modifier, in children aged 6-11 years with symptomatic asthma.
Methods
In this Phase II, double-blind, placebo-controlled, incomplete-crossover, dose-ranging study, patients were randomised to receive three of the four treatments evaluated: once-daily tiotropium Respimat 5µg, 2.5µg or 1.25µg or placebo Respimat, in the evening during the 12-week (three x 4-week) treatment period.
Results
In total, 76, 74, 75 and 76 patients aged 6?11 years received tiotropium Respimat 5ug, 2.5ug, 1.25ug and placebo Respimat, respectively. For the primary end point (peak forced expiratory volume in 1 second measured within 3 hours post-dosing), the adjusted mean responses with tiotropium Respimat 5ug (272umL), 2.5ug (290 mL) and 1.25ug (261mL) were significantly greater than with placebo Respimat (185 mL; p=0.0002, p - 0.0001 and p=0.0011, respectively). The safety and tolerability of all doses of tiotropium Respimat were comparable with those of placebo Respimat, with no serious adverse events and no events leading to discontinuation.
Conclusions
Tiotropium Respimat add-on to medium-dose inhaled corticosteroids, with or without a leukotriene modifier, was efficacious in paediatric patients with symptomatic asthma and had comparable safety and tolerability with placebo Respimat.Trial registrationClinicalTrials.gov identifier NCT01383499
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