11 Sep COPD: Comparing Tiotropium Delivery Devices
MedicalResearch.com: What are the main findings of the study?
Dr. Wise: The TIOSPIR trial was a landmark study, one of the largest ever conducted for chronic obstructive pulmonary disease (COPD). It was designed to test the comparative safety and effectiveness of two delivery devices of tiotropium, a long-acting bronchodilator. One formulation is the Respimat multi-dose soft mist inhaler and the other formulation is the single dose HandiHaler dry powder inhaler.
After following more than 17000 patients for an average of 2.3 years, TIOSPIR showed that there was no difference in either the safety in terms of mortality or adverse cardiovascular events between the two devices. Moreover, both devices showed similar effectiveness in terms of time to first COPD exacerbation.
A lung function substudy in 1370 patients showed that the 5 microgram dose of Respimat was equivalent to the HandiHaler as a bronchodilator, but the 2.5 microgram dose was not quite as effective.
MedicalResearch.com: Were any of the findings unexpected?
Dr. Wise: Although the tiotropium HandiHaler had been associated with lower mortality rates in a large, long-term studies, preliminary analysis of smaller short-term studies with the newer Respimat device had raised concerns whether the Respimat device was associated with higher mortality. This large trial comparing the two devices in terms of mortality allayed these concerns and found that the Respimat did not have increased risk compared to the traditional HandiHaler. These findings support the findings that the 5 microgram Respimat has similar bronchodilating efficacy and systemic absorption as the 18 microgram HandiHaler.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Wise: These findings should give clinicians and patients reassurance that they have the option of taking tiotropium safely by either HandiHaler or Respimat in countries where both devices are available. The tiotropium Respimat is currently available in 70 countries, but is not approved for use in the United States at the present time.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Dr. Wise: This study demonstrates that very large trials with adequate duration of follow-up are necessary to determine with adequate precision whether newer drugs are safe and effective compared to standard formulations.
Tiotropium Respimat Inhaler and the Risk of Death in COPD
Robert A. Wise, M.D., Antonio Anzueto, M.D., Daniel Cotton, M.S., Ronald Dahl, M.D., Theresa Devins, Dr.Ph., Bernd Disse, M.D., Daniel Dusser, M.D., Elizabeth Joseph, M.P.H., Sabine Kattenbeck, Ph.D., Michael Koenen-Bergmann, M.D., Gordon Pledger, Ph.D., and Peter Calverley, D.Sc. for the TIOSPIR Investigators
NEJM September 8, 2013DOI: 10.1056/NEJMoa1303342