P194 Once-Daily QVA149 Provides Superior Bronchodilation and Improves Lung Function Versus Twice-Daily Fluticasone/Salmeterol in COPD Patients: The ILLUMINATE Study

Abstract

Introduction QVA149 is a novel inhaled once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium, in development for the maintenance treatment of COPD. This study evaluated the superiority of QVA149 once daily in terms of efficacy over fluticasone/salmeterol twice daily in patients with COPD. Methods In this 26 week, multicentre, double-blind, double-dummy, parallel-group study patients aged ≥40 years with moderate-to-severe COPD (post-bronchodilator FEV1/FVC <0.7 and FEV1 ≥40% to <80% predicted), no history of exacerbations in the previous year and smoking history ≥10 pack-years, were randomised (1:1) to receive QVA149 110/50μg (via the Breezhaler® device) or fluticasone/salmeterol 500/50μg (via the Accuhaler® device). The primary efficacy end point was standardised FEV1 area under the curve (FEV1 AUC0-12h) at Week 26. The pre-dose trough FEV1 on Week 12 and 26 and peak FEV1 on Day 1, Week 12 and Week 26 were also measured. Results A total of 523 patients (35.1% on inhaled corticosteroids use) were randomised [QVA149, n=259; fluticasone/salmeterol, n=264; male (70.9%); mean age: 63.3 years; mean post-bronchodilator FEV1: 60.2% predicted], 82.6% completed. FEV1 AUC0-12h was found clinically meaningful and statistically significant in favour of QVA149 compared to fluticasone/salmeterol on Day 1, Week 12 and Week 26 (Least squares mean [LSM] treatment difference=70mL, 120mL, 140mL, respectively; all p<0.001). Pre-dose trough FEV1 was significantly (p<0.001) higher for QVA149 compared with fluticasone/salmeterol at Week 12 and 26 (LSM treatment difference=90mL and 100mL, respectively; p<0.001). The LSM treatment difference for peak FEV1 was also statistically significant for QVA149 compared with fluticasone/salmeterol on Day 1 (70mL), Week 12 (150mL) and Week 26 (150mL), all p<0.001. Conclusion QVA149 once daily provided superior bronchodilation at all time-points compared to fluticasone/salmeterol twice daily and showed clinically meaningful improvements in lung function for a sustained period of 26 weeks. In moderate-to-severe COPD patients without a history of exacerbations in the previous year, LABA/LAMA dual bronchodilation with once-daily QVA149 proves a superior alternative to twice-daily fluticasone/salmeterol. (Table presented).