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

Robert A Wise, Antonio Anzueto, Peter Calverley, Ronald Dahl, Daniel Dusser, Gordon Pledger, Michael Koenen-Bergmann, Elizabeth Joseph, Daniel Cotton, Bernd Disse

Research output: Contribution to journalArticle

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.

Original languageEnglish (US)
Article number40
JournalRespiratory Research
Volume14
Issue number1
DOIs
StatePublished - Apr 2 2013

Fingerprint

Safety
Chronic Obstructive Pulmonary Disease
Tiotropium Bromide
Nebulizers and Vaporizers
Bronchodilator Agents
Spirometry
Cholinergic Antagonists
Cardiac Arrhythmias
Heart Diseases
Primary Health Care
Epidemiology
Therapeutics
Mortality

Keywords

  • COPD
  • HandiHaler®
  • Respimat® Soft Mist™ Inhaler
  • Tiotropium

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

Cite this

The Tiotropium Safety and Performance in Respimat® Trial (TIOSPIR®), a large scale, randomized, controlled, parallel-group trial-design and rationale. / Wise, Robert A; Anzueto, Antonio; Calverley, Peter; Dahl, Ronald; Dusser, Daniel; Pledger, Gordon; Koenen-Bergmann, Michael; Joseph, Elizabeth; Cotton, Daniel; Disse, Bernd.

In: Respiratory Research, Vol. 14, No. 1, 40, 02.04.2013.

Research output: Contribution to journalArticle

Wise, Robert A ; Anzueto, Antonio ; Calverley, Peter ; Dahl, Ronald ; Dusser, Daniel ; Pledger, Gordon ; Koenen-Bergmann, Michael ; Joseph, Elizabeth ; Cotton, Daniel ; Disse, Bernd. / The Tiotropium Safety and Performance in Respimat® Trial (TIOSPIR®), a large scale, randomized, controlled, parallel-group trial-design and rationale. In: Respiratory Research. 2013 ; Vol. 14, No. 1.
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