Ultibro Breezhaler improvements in COPD trials

Novartis announced new analyses of data for once-daily Ultibro Breezhaler (investigational QVA 149 - indacaterol 85 mcg/glycopyrronium 43 mcg delivered dose, equivalent to 110 mcg/50 mcg metered dose per capsule), which showed significant improvements in lung function, shortness of breath and health-related quality of life for Chronic Obstructive Pulmonary Disease (COPD) patients versus all comparators.These data were part of 39 respiratory abstracts presented at the European Respiratory Society (ERS) Annual Congress in Barcelona, Spain.

First results from a pooled analysis of 4,891 COPD patients in the IGNITE clinical trial program (SHINE, ILLUMINATE and SPARK studies) showed that QVA 149 provided superior, rapid and sustained improvements in lung function, and significantly reduced shortness of breath, compared to placebo, once-daily indacaterol maleate 150 mcg, glycopyrronium 50 mcg, open-label (OL) tiotropium 18 mcg and twice-daily salmeterol/fluticasone fixed dose combination (FDC SFC) 50 mcg/500 mcg,. These improvements were maintained throughout the duration of the trials.

A new evaluation of patients with moderate-to-severe COPD from the BLAZE study showed that QVA 149 provided significant improvements in patient-reported shortness of breath compared to tiotropium 18 mcg. In analyses from the SPARK study, glycopyrronium 50 mcg (via Breezhaler) showed a safety profile in patients with severe-to-very severe COPD that was similar to OL tiotropium 18 mcg (via HandiHaler).