Spiriva Respimat tiotropium: Phase III data

The company initiated the TIOSPIR trial to compare Spiriva Respimat to Spiriva HandiHaler to further evaluate a non-significant numerical imbalance of mortality identified in an analysis of 5 clinical trials with Spiriva Respimat. In 2011, researchers at Johns Hopkins University and colleagues reported data from a meta-analysis of 6,522 COPD patients from the 5 clinical trials showing that Spiriva Respimat was associated with a 52% increased risk of all-cause mortality compared to placebo (p=0.02). The researchers said the increased risk of death may be caused by the Respimat Soft Mist Inhaler delivering higher concentrations of tiotropium than it should (see BioCentury, June 20, 2011). ...