Novartis (NVS) said it presented new data from the Novartis chronic obstructive pulmonary disease or COPD portfolio at the American Thoracic Society or ATS International Conference May 17-22, 2013 in Philadelphia, PA, USA. In total, Novartis presented 34 respiratory abstracts, featuring latest findings from the IGNITE clinical trial program including BLAZE and SPARK studies, plus data from pooled GLOW1 and 2 studies.
The late-breaking BLAZE study included patient self-reported data that demonstrated improvements in shortness of breath with investigational once-daily QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) when compared to placebo and blinded tiotropium 18 mcg.
The company said the SPARK study showed that QVA149 significantly reduced the rate of all COPD exacerbations versus glycopyrronium 50 mcg and open-label (OL) tiotropium 18 mcg.
All treatments in the BLAZE and SPARK studies had an acceptable safety profile with no meaningful differences between the treatment groups in the incidence of adverse or serious adverse events, the company said.
In a pooled analysis of GLOW1 and GLOW2 data, once-daily glycopyrronium 50 mcg (Seebri Breezhaler) demonstrated significant improvements in lung function during first 4 hours following morning administration (measured by FEV1 AUC0-4h) versus placebo and OL tiotropium 18 mcg, at Day 1, 12 weeks and 26 weeks. Once-daily glycopyrronium 50 mcg also demonstrated sustained improvements in lung function (measured by trough FEV1) versus placebo over the long term.
Glycopyrronium 50 mcg was well-tolerated with a similar incidence of adverse events to placebo and OL tiotropium 18 mcg.
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