One of largest chronic obstructive pulmonary disease (COPD) trials conducted to date confirms comparable safety and efficacy profile of Spiriva (tiotropium) Respimat 5 mcg and Spiriva HandiHaler 18mcg from family-owned German drug major Boehringer Ingelheim.
The TIOSPIR trial included more than 17,000 COPD patients and was one of the largest international COPD trials. The trial population was representative of typical, real-world COPD patients, including patients with the full range of COPD severities, comprehensive use of concomitant COPD medications, and patients with stable cardiac disorders. The trial was designed to provide evidence of the relative safety and efficacy profile of Spiriva Respimat 5 mcg compared with Spiriva HandiHaler 18mcg.
The results showed no difference between the two in risk of death, risk of first exacerbation, on-treatment all-cause mortality, and incidents of cardiovascular adverse events. In particular, in patients with a history of cardiac arrhythmia, there was no difference in mortality.
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