Once-daily QVA149 demonstrates superior outcomes in COPD patients previously treated with fixed-dose long-acting β ₂ -agonist/inhaled corticosteroid (LABA/ICS): The ILLUMINATE study

Introduction The ILLUMINATE study evaluated the superiority of the once-daily QVA149 110/50µg, a dual bronchodilator combining the LABA indacaterol and the LAMA glycopyrronium, compared to twice-daily LABA/ICS, salmeterol/fluticasone 50/500µg (SFC), in terms of efficacy, safety and tolerability in patients (pts) with moderate-to-severe COPD. This analysis reports the efficacy and safety of QVA149 vs. SFC in the sub-group population using fixed-dose LABA/ICS prior to study enrollment. Methods 122 pts on LABA/ICS prior to study entry were randomized to QVA149 (n=54) and SFC (n=68). FEV 1 area under the curve for 0-12h (AUC 0-12h ), pre-dose trough FEV 1 , rescue medication use, exacerbations and safety were assessed after 26wks. Results QVA149 significantly improved FEV 1 AUC 0-12h , pre-dose trough FEV 1 and reduced rescue medication use in COPD pts regardless of previous LABA/ICS use at study entry (Table). Number of exacerbations (QVA149: 23; SFC: 41) and pts with incidence of adverse events (QVA149: 50%; SFC: 55.9%) was numerically lower with QVA149. Treatment difference, QVA149 vs. SFC Parameter Pts with LABA/ICS prior to baseline (n=122) Overall pt population (N=522) Wk 12 Wk 26 Wk 12 Wk 26 FEV 1 AUC 0-12h , mL 180(34)* 160(38)* 120(16)* 140(19)* Pre-dose trough FEV 1 , mL 140(35)* 150(40)* 90(17)* 100(19)* Rescue medication use, puffs/day -0.56(0.34) -0.71(0.34) # -0.28(0.16) -0.39(0.17) # *p<0.001; # p<0.05 Conclusion In the subpopulation previously treated with LABA/ICS, QVA149 demonstrated significant improvements in lung function and rescue therapy use compared to SFC. These results were consistent with the overall study population.