Introduction QVA149 is a novel, inhaled, once-daily, fixed-dose combination of the long-acting β₂-agonist (LABA) indacaterol and the long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237) in development for the maintenance treatment of chronic obstructive pulmonary disease (COPD). The SHINE study compared the effects of QVA149 110/50 µg, indacaterol 150 µg, glycopyrronium 50 µg, tiotropium 18 µg and placebo in patients with COPD.¹ Here, we present the data on improvements in lung function (forced expiratory volume in 1 second area under the curve [FEV₁ AUC_{5 min-4 h}] and trough FEV₁), transition dyspnoea index (TDI) and St George’s Respiratory Questionnaire (SGRQ - total score) by prior medication use and COPD disease severity subgroups.

Methods In this 26-week, multicentre, double-blind, parallel-group, placebo- and active-controlled (open-label tiotropium) study, patients aged ≥40 years with moderate-to-severe COPD (post-bronchodilator FEV₁/forced vital capacity (FVC) <0.7 and FEV₁ ≥30% to <80% predicted) and a smoking history of ≥10 pack-years were randomised to receive once-daily QVA149, indacaterol, glycopyrronium, tiotropium or placebo (2:2:2:2:1).

Results Of the 2144 patients (mean age 63.9 years; mean FEV₁ post-bronchodilator 55.2% predicted) who were randomised (QVA149 [n = 475], indacaterol [n = 477], glycopyrronium [n = 475], tiotropium [n = 483] and placebo [n = 234]), 89.1% completed the study. QVA149 showed significant improvements in lung function, dyspnoea and health status compared with placebo in patient subgroups based on prior medication use and COPD disease severity (Table 1). Additionally, FEV₁ AUC_{5 min-4 h}was significantly improved for QVA149 versus placebo (p < 0.001) regardless of the prior medication use and disease severity.

Conclusion With once-daily QVA149, significant improvements were seen in both moderate and severe COPD patients and independent of medications used before recruitment and randomisation into the SHINE study.

Reference

1. Bateman et al. Dual bronchodilation with QVA149 versus single bronchodilator therapy: the SHINE study. Eur Respir J. 2013 May 30. [Epub ahead of print].