Date: 2014-09-08
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the European Respiratory Society (ERS) International Congress 2014 in Munich, Germany
Company: Boehringer Ingelheim (Germany)
Product: tiotropium
Action mechanism:
Disease: asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country:
Trial
details: In the Phase III RubaTinA-asthma® study, adolescent asthma patients (12-17 years) were randomized 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. The primary endpoint was peak FEV1—a measure of the amount of air exhaled in one second—within three hours of dosing (FEV1(0-3h) response), evaluated at Week 24. Additional endpoints included other breathing measurement tests, evaluations of symptom control and assessments of adverse events (AEs)
Latest
news: * On September 8, 2014, Boehringer Ingelheim presented new data from the company\'s Phase III trial program (UniTinA-asthma®) evaluating tiotropium in asthma, including the first study assessing the efficacy and safety of tiotropium in adolescent patients with symptomatic asthma. These data were unveiled during an oral session at the European Respiratory Society (ERS) International Congress 2014 in Munich, Germany. The first presentation of Phase III results from the RubaTinA-asthma® (NCT01257230) 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 statistically significantly improved lung function, as measured by forced expiratory volume in one second (FEV1) response, in adolescent patients with asthma who remain symptomatic. 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. Overall, AEs were reported in 62.7 percent of those treated with tiotropium 5 mcg, 63.2 percent of those treated with tiotropium 2.5 mcg and 59.4 percent of those in the placebo group. The most common individual AEs were asthma, nasopharyngitis, viral respiratory tract infection and headache.
