COPD · LABA/LAMA versus LABA/ICS
Effect of Indacaterol Glycopyrronium vs Fluticasone Salmeterol on COPD Exacerbations
| Design | Double-blind, double-dummy, non-inferiority then superiority RCT |
|---|---|
| Treatment | Indacaterol 110 microg / glycopyrronium 50 microg once daily |
| Control | Salmeterol 50 microg / fluticasone 500 microg twice daily |
| Population | 3362 patients with COPD and at least one exacerbation in the previous year |
| Follow-up | 52 weeks |
| Primary endpoint | Annual rate of all COPD exacerbations |
| Result | All exacerbations 3.59 versus 4.03 per year (rate ratio 0.89, 95% CI 0.83 to 0.96, p=0.003) — non-inferior and then superior. Time to first exacerbation 71 versus 51 days (HR 0.84, p<0.001). Moderate or severe exacerbations 0.98 versus 1.19 per year (rate ratio 0.83, 95% CI 0.75 to 0.91, p<0.001). |
| Secondary endpoints | Time to first exacerbation, moderate or severe exacerbation rate, pneumonia |
Indacaterol-glycopyrronium was more effective than salmeterol-fluticasone in preventing COPD exacerbations in patients with a history of exacerbation during the previous year.
The trial authors, in the published abstract
The strongest argument for reaching for LABA/LAMA before an inhaled steroid. Its force is limited by an eosinophil ceiling at enrolment, which excluded exactly the patients most likely to benefit from a steroid — the group IMPACT and ETHOS went on to treat with triple therapy.
Wedzicha JA, Banerji D, Chapman KR, et al. Indacaterol-Glycopyrronium versus Salmeterol-Fluticasone for COPD. N Engl J Med 2016 Jun 9;374(23):2222-34.