Title: FLAME Trial Summary: Indacaterol-Glycopyrronium (LABA+LAMA) versus Salmeterol-Fluticasone (LABA+ICS) for COPD

Design: Randomized, double-blind, double-dummy, noninferiority trial

Objective: To compare LABA + LAMA with LABA + ICS for reducing COPD exacerbations in patients with COPD and mMRC dyspnea grade ?2 symptoms


Year of publication: 2016

Inclusion Criteria: patients (?40 years) who are current or former smokers Stable COPD per GOLD 2011 criteria on a stable medication

Comparison groups: Indacaterol+glycopyrronium (LABA + LAMA) n=1680 vs Salmeterol+fluticasone (LABA + ICS) n=1682

Primary Outcome:

  • Treatment continued for 52 weeks 4.09
  • Annual rate of COPD exacerbations RR 0.88; 95% CI 0.82-0.94; P<0.001

Secondary Outcome:

  • Annual rate of moderate or severe exacerbations RR 0.83; 95% CI 0.75-0.91; P<0.001

Conclusion: Indacaterol+glycopyrronium (LABA+LAMA) is associate d with a ~ 11% reduction in the rate of annual COPD exacerbations when compared to salmeterol+fluticasone (LABA+ICS)

Source: Wedzicha JA, et al. NEJM. 2016. 374(23):2222-2234.| Visualmed.org