A Randomised Dose-ranging Study of Tiotropium Respimat® in Children With Symptomatic Asthma Despite Inhaled Corticosteroids

Christian Vogelberg; Petra Moroni-Zentgraf; Migle Leonaviciute-Klimantaviciene; Ralf Sigmund; Eckard Hamelmann; Michael Engel; Stanley Szefler

Disclosures

Respiratory Research. 2015;16(20) 

In This Article

Background

Asthma is a leading cause of childhood morbidity.[1] In the USA alone, around 7 million children and adolescents suffer from asthma,[2] and in the UK, one in every seven children aged 2–15 years has asthma symptoms requiring regular treatment.[3] As in adults, a considerable proportion of asthma in children is inadequately controlled by inhaled corticosteroid (ICS) guideline therapy, which represents a significant healthcare concern.[4] In addition to the negative impact on patients' quality of life, this considerably increases their risk of future exacerbations, with associated increased requirement for healthcare utilisation and costs.[5–7] Data for the USA show that in 2011, 56% of children with asthma suffered an attack,[2] with almost 20% visiting an emergency department.[8]

While the goals of treatment for children with asthma[9,10] are broadly the same as for adults (to improve control, reduce exacerbations, reduce rescue medication usage, reduce hospitalisations and allow maximum possible participation in normal daily activities), treatment can be complicated by issues that are specific to, or more pronounced in, this age group. Adherence to asthma medication is notably poor in children and adolescents,[11] and compliance with twice-daily ICS treatment regimens may be sub-optimal, particularly during asymptomatic periods. In addition, the detection and appropriate management of children with poor asthma control is hampered by the fact that both the affected children and their parents tend to underestimate their asthma severity.[5,6,11–14]

Given the prevalence of uncontrolled asthma in children and its health, educational and financial impact, there is clearly a need to further improve asthma control and prevent exacerbations in this population; the long-acting anticholinergic bronchodilator tiotropium represents a potential add-on therapy for such patients.[15,16] Tiotropium has demonstrated efficacy in the treatment of asthma in adults[17–21] and adolescents.[22] Here we report data from the first assessment of tiotropium treatment in children aged 6–11 years with symptomatic asthma. This study evaluated the efficacy, safety and tolerability of three doses of tiotropium in children with symptomatic asthma despite maintenance treatment with ICS.

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