| Design | Double-blind, double-dummy, parallel-group RCT |
|---|---|
| Treatment | Tiotropium 18 microg once daily |
| Control | Salmeterol 50 microg twice daily |
| Population | 7376 patients with moderate-to-very-severe COPD and an exacerbation in the preceding year |
| Follow-up | 1 year |
| Primary endpoint | Time to first moderate or severe exacerbation |
| Result | Time to first exacerbation 187 days with tiotropium versus 145 days with salmeterol (HR 0.83, 95% CI 0.77 to 0.90, p<0.001). Moderate or severe exacerbations 0.64 versus 0.72 per year (rate ratio 0.89, p=0.002); severe exacerbations 0.09 versus 0.13 per year (rate ratio 0.73, p<0.001). Serious adverse events were similar. |
| Secondary endpoints | Time to first severe exacerbation, annual exacerbation rates |
These results show that, in patients with moderate-to-very-severe COPD, tiotropium is more effective than salmeterol in preventing exacerbations.
The trial authors, in the published abstract
Settled the LAMA-versus-LABA question for exacerbation-prone patients and put the LAMA first in most treatment algorithms. The comparison has since moved on to dual bronchodilation versus inhaled steroid combinations (FLAME).
Vogelmeier C, Hederer B, Glaab T, et al. Tiotropium versus salmeterol for the prevention of exacerbations of COPD. N Engl J Med 2011 Mar 24;364(12):1093-1103.