Abstract | BACKGROUND: 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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Authors | Robert A Wise, Antonio Anzueto, Peter Calverley, Ronald Dahl, Daniel Dusser, Gordon Pledger, Michael Koenen-Bergmann, Elizabeth Joseph, Daniel Cotton, Bernd Disse |
Journal | Respiratory research
(Respir Res)
Vol. 14
Pg. 40
(Apr 02 2013)
ISSN: 1465-993X [Electronic] England |
PMID | 23547660
(Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
- Bronchodilator Agents
- Scopolamine Derivatives
- Tiotropium Bromide
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Topics |
- Administration, Inhalation
- Bronchodilator Agents
(administration & dosage)
- Female
- Humans
- Internationality
- Male
- Metered Dose Inhalers
(statistics & numerical data)
- Prevalence
- Pulmonary Disease, Chronic Obstructive
(drug therapy, epidemiology)
- Risk Factors
- Scopolamine Derivatives
(administration & dosage)
- Tiotropium Bromide
- Treatment Outcome
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