SESSION TITLE: COPD QVA149 Posters
SESSION TYPE: Poster Presentations
PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM
PURPOSE: Combined use of long-acting bronchodilators with different mechanism of action optimizes bronchodilation and may reduce the risk of exacerbations. QVA149 is a novel dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol and long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237) for the maintenance treatment of COPD. Here, we report findings from the SPARK and ILLUMINATE studies of the IGNITE program, with a focus on the rate and prevention of exacerbations.
METHODS: Both SPARK and ILLUMINATE were multicenter, double-blind, randomized studies with treatment durations of 64 and 26 weeks, respectively. Patients (aged ≥40years) with severe-to-very severe COPD and a history of exacerbations were randomized to once-daily QVA149 (110/50μg), glycopyrronium (50μg), or open-label tiotropium 18μg (1:1:1) in the SPARK study. In the ILLUMINATE study, patients (aged ≥40years) with moderate-to-severe COPD with no history of exacerbations were randomized to once-daily QVA149 110/50μg or twice-daily salmeterol/fluticasone combination (SFC) 50/500μg (1:1).
RESULTS: SPARK and ILLUMINATE randomized 2224 (75% completed) and 523 (83% completed) patients, respectively. In the SPARK study, QVA149 significantly reduced the rate of all (mild, moderate and severe) exacerbations by 15% versus glycopyrronium (Rate Ratio [RR] 0.85; 95% confidence interval [CI] 0.77-0.94; p=0.001) and 14% versus tiotropium (RR 0.86; 95% CI 0.78-0.94; p=0.002). In the ILLUMINATE study, QVA149 reduced the rate of all exacerbations by 31% versus SFC (RR 0.69; 95% CI 0.44-1.07; p=0.098). Furthermore, QVA149 reduced the risk of time to first exacerbation by 35% versus SFC (hazard ratio 0.65; 95% CI 0.44-0.96; p=0.03) in the ILLUMINATE study.
CONCLUSIONS: QVA149 reduced the rate of exacerbations compared with glycopyrronium and tiotropium, and delayed the time to first exacerbation compared with salmeterol/fluticasone combination.
CLINICAL IMPLICATIONS: The results suggest the potential of QVA149 for reducing exacerbations compared to current standard of care (LAMA or LABA/inhaled corticosteroids), irrespective of patients having a history of exacerbations.
DISCLOSURE: Donald Banerji: Employee: Novartis Employee Mark Fedele: Employee: Novartis Employee Hungta Chen: Employee: Novartis Employee
Clinical trial results of QVA149, combination of approved products indacaterol and glycopyrronium, will be presented, QVA149 is in the late stage phase 3 trials prior to approval.