Analysis of two Phase III studies shows Spiriva (Boehringer) provides benefits for Asthma patients

New data from two UniTinA-asthma studies of Spiriva (tiotropium bromide), from Boehringer, shows that the drug improved lung function and Asthma control in patients with poorly controlled Asthma, irrespective of their allergic status. The two studies were replicate double-blind parallel-group trials involving a total of 912 patients, who were randomized to receive tiotropium 5 mcg or placebo in addition to usual care for 48 weeks. Peak FEV1 improved with tiotropium in Trial 1 irrespective of allergic status for IgE and eosinophilia and in Trial 2 for IgE, eosinophilia and CJ.

Predose FEV1 improved with tiotropium compared with placebo, irrespective of allergic status, across all criteria in Trial 1 and Trial 2. Pooled prespecified data analyses revealed that time to first severe asthma exacerbation and to first Asthma worsening were increased with tiotropium compared with placebo. Adverse events were balanced between the allergic and non-allergic subgroups. The most frequently reported treatment-emergent AEs in both Phase III studies included asthma, peak expiratory flow rate decrease and nasopharyngitis. Data was presented at at the American Academy of Allergy, Asthma & Immunology Annual Meeting.