Exacerbation risk reduction

SPIOLTO® RESPIMAT® contains tiotropium, the active ingredient in SPIRIVA®.1,2 In clinical trials SPIRIVA® demonstrated a statistically significant reduction in risk of a COPD exacerbation compared to placebo.3-5 No study has yet reported compelling evidence on whether LAMA/LABA is superior to SPIRIVA® in reducing the risk of moderate-to-severe COPD exacerbations.*1-9

COPD exacerbations were included as an additional endpoint in the pivotal 52-week trials with SPIOLTO® RESPIMAT®. While the studies were not specifically designed to evaluate the effect of the treatments on COPD exacerbations, there was a trend that SPIOLTO® RESPIMAT® better reduced the risk of exacerbations than SPIRIVA®.1,9

*Previous LAMA/LABA vs tiotropium studies were not designed to investigate the risk of moderate to severe exacerbations as a primary endpoint and available data from these studies are inconsistent.


  1. SPIOLTO® RESPIMAT® Summary of Product Characteristics February 2017.
  2. SPIRIVA® RESPIMAT® Summary of Product Characteristics January 2017.
  3. Tashkin DP, et al. N Engl J Med 2008;359:1543-1554.
  4. Bateman ED, et al. Respir Med 2010;104:1460-1472.
  5. Halpin DMG, et al. Respir Med 2016;114:1-8.
  6. Buhl R, et al. Eur Respir J 2015;45:969-979.
  7. Wedzicha JA, et al. Lancet Respir Med 2013;1(3):199-209.
  8. Decramer M, et al. Lancert Respir Med 2014;2(6):427-486.
  9. Novartis Clinical Trial Report. CQVA149A2304. Available at: www.novctrd.com/ctrdWebApp/clinicaltrialrepository/displayFile.do?trialResult=9283 [Accessed August 2017].