Boehringer's Spiriva Respimat meets in asthma trial

Boehringer Ingelheim GmbH (Ingelheim, Germany) said once-daily Spiriva Respimat tiotropium as add-on therapy met the primary endpoint in the Phase III GraziaTinA-asthma trial of improving peak forced expiratory volume in one second (FEV1) within the first three hours of dosing at week 12 vs. placebo. Specifically, placebo-adjusted differences in peak FEV1 were 159 mL in patients receiving 2.5 ug once-daily Spiriva Respimat (p<0.0001) and 128 mL in the 5 ug once-daily arm (p=0.0005). The double-blind, international trial enrolled 464 patients with mild persistent asthma who remained symptomatic while receiving low-dose inhaled corticosteroid (ICS) treatment. Data were presented at the American Academy of Allergy, Asthma & Immunology meeting in San Diego.

The GraziaTinA-asthma trial is part of the Phase III UniTinA-asthma program, which is evaluating Spiriva Respimat in over 4,000 patients with different asthma severities who remain symptomatic on ICS. Last year, Boehringer submitted an MAA to EMA to expand the label of Spiriva Respimat to include treatment of asthma in adults. ...