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document
The Tiotropium Safety and Performance in Respimat Trial ( TIOSPIR ) , 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 Soft Mist inhaler was at least as efficacious as tiotropium HandiHaler , however , concerns have been raised about tiotropium 's safety when given via Respimat . METHODS The TIOSPIR trial ( NCT01126437 ) compares the safety and efficacy of tiotropium Respimat 5 μg once daily ( marketed ) and 2.5 μg once daily ( investigational ) with tiotropium HandiHaler 18 μ once daily ( marketed ) . The hypotheses to be tested are 1 ) . that tiotropium Respimat 5 μg once daily and Respimat 2.5 μg once daily are non-inferior to HandiHaler in terms of all-cause mortality , and 2 ) . that tiotropium Respimat 5 μg once daily is superior to HandiHaler 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 will provide precise estimates of the relative safety and efficacy of the Respimat and HandiHaler 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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Intervention_Pharmacological
Tiotropium
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Intervention_Pharmacological
Tiotropium bromide
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Intervention_Pharmacological
tiotropium Respimat Soft Mist inhaler
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Intervention_Pharmacological
tiotropium HandiHaler
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Intervention_Pharmacological
tiotropium 's
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Outcome_Other
Safety
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Outcome_Other
Performance
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Outcome_Other
safety
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Outcome_Other
efficacy