COPD exacerbations are linked to a rapid decline in lung function and increased mortality. QVA149 ( Ultibro Breezhaler ) is a once-daily dual bronchodilator with a fixed-dose combination of long-acting beta2-agonist ( Indacaterol ) and long-acting muscarinic antagonist ( Glycopyrronium ), for the treatment of COPD.
Researchers have reported the findings in a subgroup of patients from the SHINE study who had a history of at least one exacerbation and inhaled corticosteroid ( ICS ) use at baseline.
SHINE was a multicenter, double-blind, parallel-group, randomized, placebo and active-controlled trial. Patients with moderate-to-severe COPD and greater than or equal to 10 years of smoking history were randomized ( 2:2:2:2:1 ) to receive QVA149 110/50 mcg, Indacaterol 150 mcg, Glycopyrronium 50 mcg ( all administered via the Breezhaler device ), open-label Tiotropium 18 mcg ( administered via the HandiHaler device ) or placebo ( administered via the Breezhaler device ) for 26 weeks.
This post-hoc analysis has evaluated the effect of QVA149 on trough forced expiratory volume in 1 second ( FEV1 ) and forced vital capacity ( FVC ) in comparison with Indacaterol, Glycopyrronium, Tiotropium and placebo using a linear mixed model in patients with at least one exacerbation and ICS use at baseline.
In total, 2135 patients were included in the full analysis set, 542 patients had a history of exacerbations and baseline ICS use, of which 465 were included in this subgroup analysis ( QVA149=110, Indacaterol=105, Glycopyrronium=111, Tiotropium=102 and placebo=37 ).
At week 26, QVA149 significantly improved trough FEV1 compared with Indacaterol, Glycopyrronium, Tiotropium, and placebo ( treatment differences ranging from 0.08 to 0.23 L; p less than 0.01 ).
Trough FVC at week 26 was significantly improved with QVA149 compared with Indacaterol, Tiotropium, and placebo ( treatment differences ranging from 0.12 to 0.28 L; p less than 0.01 ) and was numerically higher than Glycopyrronium ( treatment difference: 0.06 L; p=0.1969 ).
In conclusion, in patients with a history of at least one exacerbation and baseline ICS use, QVA149 has shown improved lung function that was significantly greater than seen with Indacaterol, Glycopyrronium, Tiotropium or placebo. ( Xagena )
Source: American Thoracic Society ( ATS ) Meeting, 2014