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Sosei Group Corporation QVA149 Phase III Study Meets Primary Endpoint in Reducing Exacerbations in COPD Patients and Filings in EU and Japan by End of Year
Date:8/29/2012

pared to open-label (OL) tiotropium 18 mcg[1].

A further analysis of the data demonstrated that QVA149 was statistically significantly more effective in reducing the overall rate of all exacerbations (mild, moderate and severe) compared to glycopyrronium 50 mcg (p=0.001) and OL tiotropium 18 mcg (p=0.002)[1]. The adverse event (AE) profile of QVA149 was similar to both glycopyrronium 50 mcg and OL tiotropium 18 mcg[1].

The management of COPD exacerbations is important to both patients and physicians, as exacerbations can impose a significant burden of morbidity, mortality, reduced quality of life and healthcare costs[6,7]. Frequent exacerbations are linked to an accelerated decline in lung function[8,9] and patients are also known to have a poorer quality of life[10]. Admissions to hospital due to exacerbations are increasing[11] and patients with more severe underlying disease account for around 70% of the direct medical costs of COPD[12].

SPARK was a 64-week, multi-center, randomized, double-blind, parallel-group, active controlled study designed to evaluate the effect of QVA149 (indacaterol maleate 110 mcg / glycopyrronium 50 mcg) QD versus glycopyrronium 50 mcg and QD OL tiotropium 18 mcg on moderate-to-severe COPD exacerbations in 2,224 patients with severe to very severe COPD[1].

QVA149 is an investigational inhaled, once-daily, fixed-dose combination of the long-acting beta2-adrenergicagonist (LABA) indacaterol maleate, and the investigational long-acting muscarinic antagonist (LAMA) glycopyrronium bromide, being investigated for the treatment of COPD in the Phase III IGNITE clinical trial program. IGNITE is one of the largest in
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