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

Robert A Wise1*, Antonio Anzueto2, Peter Calverley3, Ronald Dahl4, Daniel Dusser5, Gordon Pledger6, Michael Koenen-Bergmann7, Elizabeth Joseph8, Daniel Cotton8 and Bernd Disse7

Author Affiliations

1 Johns Hopkins Asthma & Allergy Center, 5501 Hopkins Bayview Circle, Baltimore, MD, 21224, USA

2 Pulmonary Critical Care Center, San Antonio, TX, USA

3 School of Clinical Science, University Hospital Aintree, Liverpool, UK

4 Department of Respiratory Diseases, Aarhus University Hospital, Aarhus University, Aarhus, Denmark

5 Service de Pneumologie Hopital Cochin, Paris, France

6 Hamilton, TX, USA

7 Boehringer Ingelheim Pharma GmBH & Co, Ingelheim, Germany

8 Boehringer Ingelheim Pharmaceuticals Inc, Ridgefield, CT, USA

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Respiratory Research 2013, 14:40  doi:10.1186/1465-9921-14-40

Published: 2 April 2013

Abstract

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.

Keywords:
Tiotropium; COPD; Respimat® Soft Mist™ Inhaler; HandiHaler®