BioCentury
ARTICLE | Clinical News

Indacaterol/glycopyrronium bromide: Additional Phase III data

September 17, 2012 7:00 AM UTC

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 (p<0.001 for all). QVA149 also significantly reduced Transition Dyspnea Index (TDI) focal score by 1.09 points vs. placebo (p<0.001) and by 0.51 points vs. tiotropium (p<0.05). QVA149 non-significantly reduced TDI focal score by 0.26 points vs. indacaterol and by 0.21 points vs. NVA237.

Additionally, QVA149 significantly improved St. George's Respiratory Questionnaire total score compared to placebo (3.01-point reduction, p<0.01) and tiotropium (2.13-point reduction, p<0.05), but did not significantly improve the score vs. indacaterol (1.09-point reduction) or NVA237 (1.18-point reduction). QVA149 significantly reduced the rate of rescue medication use compared to placebo (0.96, p<0.001), tiotropium (0.54, p<0.001), indacaterol (0.3, p<0.05) and NVA237 (0.66, p<0.001). Data were presented at the European Respiratory Society meeting in Vienna. ...