Spiriva Respimat tiotropium: Phase II data

A double-blind, crossover, international Phase II trial in 105 patients aged 12-17 with symptomatic, moderate persistent asthma who were receiving inhaled corticosteroids (ICS) with or without long-acting beta agonists (LABA) or leukotriene receptor antagonists showed that once-daily 5 µg Spiriva Respimat significantly improved lung function from baseline to week 4 as measured by peak FEV1 from 0-3 hours post-dose, the primary endpoint, vs. placebo (0.602 vs. 0.489 L, p=0.004). Once-daily 5 µg Spiriva Respimat also significantly improved trough FEV1 vs. placebo (0.442 vs. 0.292 L, p<0.001). Once-daily 1.25 µg Spiriva Respimat led to a peak FEV1 from 0-3 hours of 0.566 L and once-daily 2.5 µg Spiriva Respimat led to a peak FEV1 from 0-3 hours of 0.546 L. All doses of Spiriva Respimat were well tolerated. Boehringer said the once-daily 5 µg dose of Spiriva Respimat was chosen for further studies in this patient population. Data were presented at the American Thoracic Society meeting in San Francisco. ...