Boehringer Ingelheim presented today the first data from the Phase III UniTinA-asthma™ program. In two studies, presented at the 2012 European Respiratory Society (ERS) Congress in Vienna, Austria, tiotropium delivered once daily via the Respimat® inhaler significantly improved lung function and reduced asthma exacerbations in patients who remained symptomatic on current treatment with at least high dose inhaled corticosteroids (ICS) and long-acting beta agonists (LABA). This data was simultaneously published online in the New England Journal of Medicine.
The two PrimoTinA-asthma(TM)
studies were replicate double-blind parallel-group trials including asthma
patients with post-bronchodilator FEV1 <80% predicted and asthma control
questionnaire score >/= 1.5 while on at least high dose ICS/LABA. A total of
912 patients were randomized to receive tiotropium 5 microgram or placebo in
addition to usual care for 48 weeks.
The pre-specified co-primary lung function endpoints included peak and trough FEV1 at 24 weeks. Adding tiotropium provided significant lung function improvements at 24 weeks (mean change from baseline tiotropium vs placebo (plus or minus standard error): peak FEV1 trial 1: 86 (plus or minus 34) mL>P<0.001); trough FEV1 trial 1: 88 (plus or minus 34) mL>P<0.001)), which were sustained over 48 weeks.