LONDON & INGELHEIM, Germany–(BUSINESS WIRE)– Boehringer Ingelheim announced today new study results from the Phase III CanoTinA-asthma ® trial that showed adding tiotropium Respimat ® to maintenance asthma therapy significantly improved lung function, as measured by FEV 1(0-3h), in children aged 6-11, compared to placebo (p<0.0001). 1 These findings were presented today at the European Respiratory Society (ERS) International Congress 2016 in London.
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The trial investigated tiotropium Respimat ® as an add-on therapy for children who were already taking an inhaled corticosteroid (ICS), or an ICS combined with other maintenance therapy. 1,2 In this study, the safety and tolerability of tiotropium Respimat ® were shown to be comparable to placebo. 1,2
“Asthma is the most common chronic childhood disease, but many children still continue to experience asthma symptoms despite taking other maintenance therapies,” said Professor Christian Vogelberg, University Hospital Dresden, Germany.
A new pooled analysis from four studies, VivaTinA-asthma ®, RubaTinA-asthma ®, PensieTinA-asthma ® and CanoTinA-asthma ® also presented at ERS, showed adding tiotropium Respimat ® to maintenance therapy for children aged 6-17 years has a comparable safety profile to placebo. 3 In addition, this analysis showed tiotropium Respimat ® significantly improved peak expiratory flow (PEF), a common measure of asthma control. 6
“These new results showed significant lung function improvements for children with asthma and importantly confirm that the safety profile of tiotropium Respimat ® in children aged six years and above is comparable to placebo,” said Professor Vogelberg.
In the important subgroup of children aged 1-5, a new post-hoc analysis presented from the NinoTinA-asthma ® trial showed the safety profile of adding tiotropium Respimat ® to maintenance therapy is consistent with that found in older children and adults. 5
The CanoTinA-asthma ®, NinoTinA-asthma ®, VivaTinA-asthma ®, RubaTinA-asthma ® and PensieTinA-asthma ® trials are part of the 18 clinical studies from the Phase II and Phase III UniTinA-asthma ® clinical development program, which included more than 150 sites globally with over 6,000 patients, including over 1,800 children and adolescents aged 1-17 years.
“At Boehringer Ingelheim, we have a strong commitment to scientific research with the goal of improving the care of people living with serious respiratory diseases such as asthma,” said Dr William Mezzanotte, Vice President and Head of Respiratory Medicine at Boehringer Ingelheim. “Data from these studies build on the body of evidence that we have learned about tiotropium Respimat ® as an add-on therapy for asthma.”
SPIRIVA ® (tiotropium) Respimat ® 5µg is indicated in Europe as an add-on maintenance bronchodilator treatment in adult patients with asthma who are currently treated with the maintenance combination of ICS (≥800µg budesonide/day or equivalent) and long-acting β 2 agonists (LABA) and who experienced one or more severe exacerbations in the previous year. 7
Tiotropium is an inhaled long-acting, muscarinic antagonist. It works by opening airways and helps to keep them open for at least 24 hours.
SPIRIVA ® Respimat ® is currently NOT APPROVED for use in children and adolescents under 18 years of age in the EU, or in children under 12 years in the US. SPIRIVA ® Respimat ®has been approved for use in asthma in over 50 countries, including the EU, US and Japan. The indication varies by country. Please refer to the local product information.
For ‘Notes to Editors’ and ‘References’ please visit: http://www.boehringer-ingelheim.com/press-release/tiotropium-respimat-improved-lung-function-in-children-with-asthma
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