New results from the phase 3 CanoTinA-asthma trial have shown that adding tiotropium Respimat to maintenance asthma therapy in children 6 to 11 years old significantly improved lung function, measured by forced expiratory volume in one second up to three hours after dosing, compared with placebo (P
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. In this study, the safety and tolerability of tiotropium Respimat were shown to be comparable to placebo.
“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 of University Children’s Hospital Dresden, Germany. “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 1 year and above is comparable to placebo.”
Also presented at ERS, a new pooled analysis from four studies—VivaTinA-asthma, RubaTinA-asthma, PensieTinA-asthma, and CanoTinA-asthma—showed adding tiotropium Respimat to maintenance therapy for children 6 to 17 years old has a comparable safety profile to placebo. In addition, this analysis showed tiotropium Respimat improved peak expiratory flow (PEF), a common measure of asthma control, in participants in this age group.
A further analysis presented from the NinoTinA-asthma trial showed the safety profile of adding tiotropium Respimat to maintenance therapy among children ages 1 to 5 years is consistent with that found in older children and adults.
The CanoTinA-asthma (NCT01634139), NinoTinA-asthma (NCT01634113), VivaTinA-asthma (NCT01634152), RubaTinA-asthma (NCT01257230), and PensieTinA-asthma (NCT01277523) trials are part of the 18 clinical studies from the phase 2 and phase 3 UniTinA-asthma clinical development program, which included more than 150 sites globally with more than 6,000 patients, including more than 1,800 children and adolescents 1 to 17 years of age.
In the U.S., Spiriva Respimat (tiotropium bromide) inhalation spray (1.25 mcg/puff, two puffs, once daily) is approved for the long-term maintenance treatment of asthma in people 12 years of age and older. It is not a treatment for sudden asthma symptoms.
Tiotropium is an inhaled long-acting, anticholinergic bronchodilator. It works by opening airways and helps to keep them open for at least 24 hours.
Source: Boehringer Ingelheim; September 6, 2016.