International Congress Barcelona 2013

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Lunchtime Session "Tiotropium soft mist inhaler and mortality in COPD: results of the TIOSPIR clinical trial"

Hot topics
Chairs: I. Horvath (Budapest, Hungary), M. Decramer (Leuven, Belgium)
Aims: Based on meta-analysis of registration trials not powered to detect a safety signal but which did suggest a reduction in COPD exacerbations with the soft mist formulation. Database review has also cast doubt about the safety of the soft mist formulation but only a large prospective randomised trial such as this one can provide a clear answer of whether these concerns are well founded. This is an event driven study and the necessary 1266 deaths to permit analysis will have accrued by April of this year. Allowing time for data cleaning and review we will be in a position to present this study for the first time at the ERS. There is interest in publishing these data from a major medical Journal subject to the usual peer-review processes.

The way forward: how to link real-life situations and clinical trial results O. Yusuf (Islamabad, Pakistan)