Novartis announced results from its Phase 3 EXPEDITION trial for indacaterol/glycopyrronium (QVA149) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD).

The EXPEDITION trial program consists of two efficacy studies (FLIGHT 1 & 2) and one safety study (FLIGHT 3). FLIGHT 1 and 2 were 12-week, multi-center, double-blind, parallel-group, placebo- and active-controlled studies that randomized patients (1:1:1:1) to QVA149 27.5/12.5mcg, indacaterol 27.5mcg, glycopyrronium 12.5mcg or placebo, all administered twice daily via the Breezhaler device. Each study was designed to demonstrate superiority of QVA149 vs. indacaterol and glycopyrronium in terms of the primary endpoint of FEV1 AUC0-12 for FEV1, at Week 12.

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The primary endpoints of the FLIGHT 1 and 2 studies were met, with QVA149 27.5/12.5mcg demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1AUC0-12) at week 12, compared to its individual components, indacaterol 27.5mcg and glycopyrronium 12.5mcg, and placebo, all dosed twice-daily.

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