New data from Boehringer's Phase III trial program evaluates efficacy of tiotropium in asthma patients

Boehringer Ingelheim today 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. Tiotropium is being studied to determine its efficacy and safety in treating asthma patients and is not currently approved for this indication.

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.

"Asthma is a leading cause of chronic illness among young people in the U.S.," 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 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 (FEV_1(0-3h) response), evaluated at Week 24. Additional endpoints included other breathing measurement tests, evaluations of symptom control and assessments of adverse events (AEs).

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.

"Finding new therapies for the growing number of people living with and affected by asthma is an important priority for Boehringer Ingelheim," said Tunde Otulana, MD, senior vice president, Clinical Development and Medical Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "We are encouraged by these latest data from the UniTinA-asthma^® program and they are an important addition to the growing data supporting the potential use of tiotropium in treating asthma patients across ages and severities. These data indicate tiotropium's potential benefit in asthma may be extended to adolescents who continue to need additional treatment options for their asthma."

Additional Data Presented at ERS 2014
During the same oral session today, Boehringer Ingelheim presented data from a secondary analysis of six Phase III 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).

To measure asthma control, investigators looked at the Asthma Control Questionnaire (ACQ-7) score of patients in previous Phase III studies of tiotropium in asthma. The definition of responder used in this trial was characterized as patients with an improvement in responder rate of at least 0.5 for the ACQ.

Data from the analysis demonstrate 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.

Additionally at ERS 2014, a pooled study evaluating the safety of tiotropium compared to placebo in five Phase III and one Phase II trial was presented. In the six trials, adults with asthma received tiotropium delivered via the Respimat^® inhaler as add-on to at least ICS maintenance therapy.

The most common individual AEs were asthma, peak expiratory flow (PEF) rate decrease and nasopharyngitis.