Boehringer Ingelheim announced results from its Phase 3 UniTinA-asthma trial program evaluating tiotropium in adults, adolescents, and pediatric patients with different severities of asthma who remain symptomatic on maintenance treatment with at least inhaled corticosteroid (ICS). The program includes over 4,000 patients.
In the RubaTinA-asthma study, adolescent asthma patients (12–17 years) were randomized to receive once-daily tiotropium 5mcg, tiotropium 2.5mcg, or placebo as add-on to ICS maintenance therapy over 48 weeks. The primary endpoint was peak FEV1 within three hours of dosing (FEV1(0-3h) response), evaluated at Week 24.
Results from the RubaTinA-asthma study demonstrated that tiotropium 5mcg delivered via the Respimat inhaler statistically significantly improved lung function in adolescents with asthma who remain symptomatic. Tiotropium 5mcg delivered via the Respimat inhaler demonstrated statistically significant improvement across lung function measurements, as compared to placebo, at 24 (mean peak: P=0.0005) and 48 weeks (mean peak: P=0.0085).
Boehringer Ingelheim also announced results from a secondary analysis of six Phase 3 studies from the UniTinA-asthma clinical trial program involving adults with symptomatic asthma. In the six studies, once-daily tiotropium was given as add-on treatment to patients with varying severities of asthma who remained symptomatic despite maintenance therapy of ICS or ICS/long-acting beta agonist (LABA). The Asthma Control Questionnaire (ACQ-7) score of patients in previous Phase 3 studies of tiotropium in asthma was reviewed to measure asthma control. Patients were considered responders if there was an improvement in responder rate of at least 0.5 for the ACQ.
An analysis of the data demonstrates that the addition of once-daily tiotropium delivered via the Respimat inhaler to maintenance asthma therapy is associated with an improvement in asthma control responder rate, as measured by the ACQ-7, among adult patients with mild, moderate, and severe symptomatic asthma.
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