Comparison of COPD Exacerbations With Once-Daily QVA149 Versus Twice-Daily Salmeterol/Fluticasone Combination: The ILLUMINATE Study

Abstract

Introduction Exacerbations are the most frequent cause of hospitalisation and death among patients with COPD. Combinations of long-acting bronchodilators maximise bronchodilation and may reduce the risk of exacerbations. QVA149, a once-daily dual bronchodilator containing the long-acting (beta)2 agonist (LABA) indacaterol and long-acting muscarinic antagonist (LAMA) glycopyrronium, improves lung function, breathlessness and rescue medication use compared with twice-daily salmeterol/fluticasone combination (SFC), in patients with moderate-to-severe COPD.1 Methods In this 26-week, multicenter, double-blind study, patients (greater-than or equal to) 40 years with COPD (forced expiratory volume in 1 second [FEV1] (greater-than or equal to)40% to <80% predicted and no history of exacerbations in the previous year) were randomised (1:1) to QVA149 110/50 (mu)g or SFC 50/500 (mu)g. In this post hoc analysis, we report the rate of mild, moderate or severe COPD exacerbations during 26 weeks of treatment with QVA149 or SFC. Results Of 522 patients randomised [QVA149 (n = 258), SFC (n = 264); mean age: 63.3 years; mean post-bronchodilator FEV1: 60.2% predicted], 82.6% completed. Rate ratio of QVA149 versus SFC [RR] of moderate or severe exacerbations was 0.80 (95% confidence interval [CI]: 0.41-1.56) and for all COPD exacerbations (mild, moderate, and severe), RR was 0.69 (95% CI: 0.44-1.07) (neither statistically significant). Conclusion Risk of exacerbations with once-daily QVA149 was numerically, but not statistically significantly, lower than twice-daily SFC in patients with moderate-to-severe COPD and no previous history of exacerbations. The LABA/LAMA combination QVA149 has the potential to be an alternative to LABA/ICS in preventing COPD exacerbations.