Novartis International AG ( NVS ) said the 64-week SPARK study results demonstrated that investigational once-daily dual bronchodilator QVA149 was more effective at reducing all chronic obstructive pulmonary disease or COPD exacerbations, compared with glycopyrronium 50 mcg and open-label or OL tiotropium 18 mcg a treatment with established efficacy in preventing exacerbations.
According to the company, this is the first trial to assess the effect on exacerbations of dual bronchodilation with a fixed-dose combination of a long-acting beta-agonist or LABA and a long-acting muscarinic antagonist or LAMA, versus single LAMA therapies.
SPARK was a 64-week, multi-center, double-blind, parallel-group, active controlled trial with the primary objective to show superiority of QVA149 versus glycopyrronium 50 mcg for the rate of moderate to severe COPD exacerbations in 2,224 patients with severe to very severe COPD; whereas the key secondary objective was to show superiority of QVA149 versus OL tiotropium 18 mcg relating to the rate of moderate or severe COPD exacerbations in the treatment period.
The study met its primary endpoint showing that QVA149 significantly reduced the rate of moderate or severe COPD exacerbations by 12% versus glycopyrronium. Moreover, SPARK showed that the dual bronchodilator effect of QVA149 led to substantially improved lung function.
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