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Sosei Group Corporation: Data at ERS Shows Efficacy of Once-daily COPD Portfolio Versus Comparators, Further Establishes Dual-bronchodilator QVA149
Date:9/2/2012

mes versus comparators[1,2,6]

SHINE met its primary endpoint by demonstrating that once-daily QVA149 110/50 mcg improved lung function as measured by trough FEV1 compared to once-daily indacaterol maleate 150 mcg (+70mL above indacaterol alone; p<0.001) and once-daily glycopyrronium 50 mcg (+90mL above glycopyrronium alone; p<0.001)[1]. QVA149 110/50 mcg is an investigational inhaled dry-powder fixed-dose combination medication that provides the equivalent amount of indacaterol as Onbrez (indacaterol maleate) 150 mcg along with glycopyrronium 50 mcg[7].  QVA149 was also more effective at improving lung function compared to OL tiotropium 18 mcg (+80mL above tiotropium; p<0.001) and placebo (+200mL; p<0.001)[1]. Mean peak FEV1 at Week 26 was also significantly higher with QVA149 compared to placebo (+330mL, p<0.001), indacaterol 150 mcg (+120mL; p<0.001), glycopyrronium 50 mcg (+130mL; p<0.001) and OL tiotropium 18 mcg (+130mL; p<0.001)[1]. Mean FEV1 area under the curve (AUC) for 0-24hr at Week 26 was significantly higher with QVA149 compared to placebo (+320mL, p<0.001), indacaterol 150 mcg (+110mL; p<0.001), glycopyrronium 50 mcg (+110mL; p<0.001) and OL tiotropium 18 mcg (+110mL; p<0.001)[1].

The results also showed that QVA149 improved breathlessness measured by the transition dyspnea index or TDI (p<0.001 versus placebo; p<0.05 versus OL tiotropium 18 mcg), increased health-related quality of life (HRQoL) measured by the St George's Respiratory Questionnaire or SGRQ (p<0.01 versus placebo; p<0.05 versus OL tiotropium 18 mcg) and reduced rescue medication use (p<0.001 versus both placebo and OL tiotropium 18 mcg)[1]. QVA149 was superio
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