Tiotropium found to improve lung function of children with asthma
Posted: 18 May 2016 | | No comments yet
New data has revealed tiotropium improves lung function in children who continue to experience asthma symptoms despite taking other maintenance therapies.
New data has revealed tiotropium improves lung function in children who continue to experience asthma symptoms despite taking other maintenance therapies.1,2,3
New data from the Phase III VivaTinA-asthma® study has found tiotropium, when used as an add-on to maintenance asthma therapy (inhaled corticosteroid, ICS, or ICS plus another maintenance therapy), 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, Boehringer Ingelheim 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.”
Tiotropium improves airflow in the small airways of the lungs three hours after treatment
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 hours5,6,7
* UniTinA-asthma® clinical trial programme includes 18 clinical studies in more than 150 sites globally, across 6,000 adult and children patients.
1 Spiriva® Respimat® Summary of Product Characteristics. Available from: https://www.boehringer-ingelheim.com/products/prescription_medicines/respiratory/copd/spiriva/public/images/Spiriva-Respimat-UK-SPC-Sept-2014.pdf. Last accessed: May 2016.
2 Szelfer S, Harper III T, Laki I, et al. Once-daily tiotropium Respimat® Add-on Therapy Improves Lung Function in Children with Severe Symptomatic Asthma. ATS 2016 International Conference.
3 Szelfer S, Rupp N, Boner A, et al. Safety and Tolerability of Once-daily tiotropium Respimat® Add-on Therapy in Children with Severe Symptomatic Asthma. ATS 2016 International Conference.
4 Goldstein S, Szelfer S, Vogelberg C, et al. Once-daily tiotropium Respimat® Add-on Therapy Improves FEF25–75% in Children and Adolescent Patients with Persistent Symptomatic Asthma. ATS 2016 International Conference.
5 Casaburi R, et al. A long-term evaluation of once-daily inhaled tiotropium in chronic obstructive pulmonary disease. Eur Respir J 2002; 19: 217-224.
6 Celli B, et al. Improvement in resting inspiratory capacity and hyperinflation with tiotropium in COPD patients with increased static lung volumes. Chest 2003; 124: 1743-1748
7 Casaburi R, et al. Improvement in exercise tolerance with the combination of tiotropium and pulmonary rehabilitation in patients with COPD. Chest 2005; 127: 809-817