New data from the Phase III VivaTinA-asthma® study show that when used as an add-on to maintenance asthma therapy (inhaled corticosteroid, ICS, or ICS plus another maintenance therapy), tiotropium improves peak lung function (FEV1) in young children aged 6-11 years with symptomatic asthma, compared to placebo (p<0.001).2 These results were presented today at the ATS 2016 International Conference, San Francisco.2,3,4
The primary endpoint of the VivaTinA-asthma® study was FEV1 change from baseline within three hours after treatment (FEV1(0-3h)). The study results demonstrate that tiotropium significantly improves peak (p<0.001) and trough (p=0.012) FEV1 responses in patients taking tiotropium as an add-on therapy versus placebo.2 The safety and tolerability of tiotropium in asthma has been shown to be balanced as compared to placebo.3
The VivaTinA-asthma® study is the first Phase III study of tiotropium in children and is part of a large-scale UniTinA-asthma® clinical trial programme.*
"We need new and effective treatment options to offer young people with asthma who, despite their other maintenance therapies, continue to experience symptoms. There are concerns regarding the safety of medicines in children and very few asthma treatments have been well-studied in younger patient populations," said Professor Klaus Dugi, Managing Director and Medical Director, BI UK and Ireland. "These important results are therefore very welcome as they show that this add-on therapy can also benefit children and adolescents with symptomatic asthma without having to increase their steroid dose."
Also presented at ATS, were new data from five Phase II and Phase III studies from the UniTinA-asthma® clinical trial programme, investigating tiotropium as an add on to maintenance therapy (ICS or ICS plus another maintenance therapy). The analyses show that adding tiotropium to children and adolescents' existing maintenance treatment improves lung function (FEV1) and airflow in the small airways of the lungs (FEF25-75), versus placebo (p<0.001).4 The safety and tolerability of tiotropium in asthma has been shown to be balanced as compared to placebo.3
Tiotropium is indicated as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of inhaled corticosteroids (≥800 μg budesonide/day or equivalent) and long-acting β2 agonists and who experienced one or more severe exacerbations in the previous year.1
Spiriva® Respimat® is an inhaled long-acting, anticholinergic bronchodilator. It works by opening narrowed airways and helps to keep them open for at least 24 hours.5,6,7