Boehringer Ingelheim has presented new data evaluating tiotropium in asthma, including the first study assessing the efficacy and safety of the drug in adolescent patients with the disease.
These data were unveiled during an oral session at the European Respiratory Society (ERS) International Congress 2014 in Munich, Germany. Although tiotropium is being studied to determine its safety in treating asthma, it is not currently approved for this indication.
The first presentation of Phase III results from the RubaTinA-asthma study demonstrated tiotropium's potential benefit among adolescents with moderate persistent asthma. The data presented at ERS show tiotropium 5 mcg delivered via the Respimat inhaler significantly improved lung function, as measured by forced expiratory volume in one second response, in adolescent patients with asthma who remain symptomatic.
"Asthma is a leading cause of chronic illness among young people in the US," said Mark Vandewalker, MD, director, Clinical Research of the Ozarks, Columbia, Missouri.
"The results of this Phase III trial provide important insight into the potential role of investigational tiotropium in treating adolescent patients who require additional asthma control despite treatment with usual maintenance therapy."
In the Phase III RubaTinA-asthma study, adolescent asthma patients (12-17 years) were randomised to receive once-daily tiotropium 5 mcg, tiotropium 2.5 mcg or placebo as add-on to inhaled corticosteroids (ICS) maintenance therapy over 48 weeks.
Tiotropium 5 mcg delivered via the Respimat inhaler demonstrated statistically significant improvement across lung function measurements, as compared to placebo, at 24 and 48 weeks.