Positive data from Phase III trial of Spiriva (Boehringer) in Asthma patients

Initial data from the Phase III UniTinA-asthma program reveals that Spiriva (tiotropium bromide), from Boehringer, delivered 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). The two studies were replicate double-blind parallel-group trials including Asthma patients with post-bronchodilator FEV1 less than 80% predicted and asthma control questionnaire score at or above 1.5 while on at least high dose ICS/LABA. A total of 912 patients were treated for 48 weeks.

Adding Spiriva provided significant lung function improvements at 24 weeks (mean change from baseline tiotropium vs placebo: peak FEV1 trial 1: 86 (plus or minus 34) mL, trial 2: 154 (plus or minus 32) mL greater; trough FEV1 trial 1: 88 (plus or minus 34) mL, trial 2: 111 (plus or minus 30) mL greater. Results were sustained over 48 weeks. In the pre-specified combined analysis of the two trials, the addition of Spiriva was associated with a 21% risk reduction in time to first severe exacerbation at 48 weeks. The addition of Spiriva also reduced the risk of any asthma exacerbation by 31%.

The results were presented at the 2012 European Respiratory Society (ERS) Congress and published in the New England Journal of Medicine. See: >"Tiotropium in Asthma Poorly Controlled with Standard Combination Therapy" Huib A.M. Kerstjens et al. NEJM September 3, 2012 (10.1056/NEJMoa1208606)