Indacaterol/glycopyrronium (IND/GLY) reduces exacerbation and improves lung function versus salmeterol/fluticasone (SFC) in patients with and without prior ICS use: The FLAME study

Introduction Current GOLD strategy recommends use of LABA/ICS and/or LAMA as first-choice treatment in COPD patients with high exacerbation risk (GOLD 2016). FLAME is the first study to compare the effect of IND/GLY (LABA/LAMA) vs SFC (LABA/ICS) in COPD patients with risk of exacerbations (≥1 moderate-severe COPD exacerbation in the previous year). Here, we present data on exacerbation and lung function in patients with and without prior ICS use from the FLAME study. Methods FLAME is a 52-week, multicentre, double-blind study. Patients with a post bronchodilator forced expiratory volume in one second (FEV 1 ) predicted ≥25– Results Of the 3362 patients randomised, 1893 (56.3%) were on prior ICS therapy. IND/GLY compared with SFC significantly (p 1 and pre-dose FVC, both in patients with/without baseline ICS use (Table). Conclusion The FLAME study demonstrated significant reductions in rate of all and moderate or severe exacerbations and significant improvement in lung function irrespective of baseline ICS use in patients with moderate-to-very severe COPD.