The Tiotropium Safety and Performance in Respimat(R) Trial (TIOSPIR(R)), a large scale, randomized, controlled, parallel-group trial-design and rationale

Background: Tiotropium bromide is an effective therapy for COPD patients. Comparing across programs tiotropium Respimat(R) Soft MistTM inhaler was at least as efficacious as tiotropium HandiHaler(R), however, concerns have been raised about tiotropium's safety when given via Respimat(R). Methods: The TIOSPIR(R) trial (NCT01126437) compares the safety and efficacy of tiotropium Respimat(R) 5 mug once daily (marketed) and 2.5 mug once daily (investigational) with tiotropium HandiHaler(R) 18 mu once daily (marketed). The hypotheses to be tested are 1). that tiotropium Respimat(R) 5 mug once daily and Respimat(R) 2.5 mug once daily are non-inferior to HandiHaler(R) in terms of all-cause mortality, and 2). that tiotropium Respimat(R) 5 mug once daily is superior to HandiHaler(R) in terms of time to first exacerbation. A spirometry substudy evaluates the bronchodilator efficacy. The trial is a randomized, double-blind, double dummy, event-driven, parallel group study. Participants can use any background treatment for COPD except inhaled anticholinergic agents. The study encompasses a wide range of COPD patients, e.g. patients with stable cardiac diseases including arrhythmia can be included. Clinical sites are international and include both primary care as well as specialists. Results: To date, over 17,000 participants have been randomized from over 1200 sites in 50 countries with an anticipated treatment duration of 2--3 years. Conclusion: TIOSPIR(R) will provide precise estimates of the relative safety and efficacy of the Respimat(R) and HandiHaler(R) formulations of tiotropium, assess potential dose-dependence of important outcomes and provide information on the clinical epidemiology of COPD in a large international patient cohort.



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