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Sep 17, 2012
 |  BC Week In Review  |  Clinical News  |  Clinical Results

Indacaterol/glycopyrronium bromide: Additional Phase III data

Additional data from the double-blind, international Phase III SHINE trial in 2,144 patients with moderate to severe COPD showed that once-daily QVA149 produced a 70 mL mean improvement in trough FEV1 at week 26 compared to once-daily indacaterol and a 90 mL mean improvement compared to NVA237. Earlier this year, the partners said QVA149 met the primary endpoint of change in trough FEV1 compared to indacaterol or NVA237 (p<0.001) (see BioCentury, April 9). On secondary endpoints, QVA149 produced a 200 mL reduction in trough FEV1 vs. placebo and an 80 mL reduction vs. open-label 18 µg tiotropium (p<0.001). Additionally, QVA149 significantly reduced peak FEV1 from 0-4 hours at 26 weeks by 120 mL vs. indacaterol; 130 mL vs. NVA237; 130 mL vs. tiotropium; and 330 mL vs. placebo...

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