Placebo | Difference versus placebo | ||||||
QVA149 110/50 μg | Indacaterol 150 μg | Glycopyrronium 50 μg | Tiotropium 18 μg | ||||
Trough FEV1 L | |||||||
End of day 1 | 1.27±0.010 | 0.19 (0.17–0.21)***,¶,+,§ | 0.11 (0.09–0.14)*** | 0.11 (0.09–0.13)*** | 0.12 (0.09–0.14)*** | ||
Week 12# | 1.24±0.014 | 0.23 (0.19–0.26)***,¶,+,§ | 0.15 (0.12–0.18)***,ƒ | 0.12 (0.09–0.15)*** | 0.13 (0.10–0.17)*** | ||
Week 26# | 1.25±0.015 | 0.20 (0.17–0.24)***,¶,+,§ | 0.13 (0.10–0.16)*** | 0.12 (0.08–0.15)*** | 0.13 (0.09–0.16)*** | ||
FEV1 AUC0–4 | |||||||
Day 1 | 1.30±0.008 | 0.22 (0.20–0.24)***,¶,+,§ | 0.16 (0.14–0.18)***,¶,## | 0.19 (0.17–0.20)***,¶,§ | 0.14 (0.12–0.16)*** | ||
Week 26 | 1.23±0.015 | 0.34 (0.30–0.37)***,¶,+,§ | 0.23 (0.19–0.26)***,¶¶ | 0.20 (0.16–0.23)*** | 0.20 (0.17–0.24)*** | ||
Peak FEV1 | |||||||
Day 1 | 1.38±0.009 | 0.21 (0.19–0.23)***,¶,+,§ | 0.15 (0.13–0.17)*** | 0.18 (0.16–0.20)***,¶,§ | 0.13 (0.11–0.15)*** | ||
Week 26 | 1.31±0.016 | 0.33 (0.29–0.36)***,¶,+,§ | 0.21 (0.18–0.25)*** | 0.20 (0.16–0.23)*** | 0.20 (0.16–0.23)*** | ||
FEV1 AUC0–12 | |||||||
Day 1 | 1.24±0.023 | 0.26 (0.21–0.31)***,¶,+,§ | 0.16 (0.11–0.21)*** | 0.18 (0.13–0.23)***,++ | 0.13 (0.08–0.18)*** | ||
Week 26 | 1.18±0.036 | 0.33 (0.25–0.42)***,¶,+,§ | 0.20 (0.12–0.29)*** | 0.21 (0.12–0.29)*** | 0.21 (0.13–0.29)*** | ||
FEV1 AUC12–24 at week 26 | 1.11±0.038 | 0.30 (0.21–0.38)***,§§,ƒƒ,### | 0.20 (0.11–0.28)*** | 0.20 (0.12–0.28)*** | 0.21 (0.13–0.29)*** | ||
FEV1 AUC0–24 at week 26 | 1.15±0.036 | 0.32 (0.24–0.40)***,¶,+,§ | 0.20 (0.12–0.28)*** | 0.20 (0.12–0.28)*** | 0.21 (0.13–0.29)*** | ||
FEV1 2 h post-dose week 26 | 1.19±0.039 | 0.40 (0.31–0.49)***,¶,+,§ | 0.23 (0.14–0.32)*** | 0.25 (0.16–0.34)*** | 0.24 (0.15–0.33)*** |
Data are presented as least squares mean±se or least squares mean (95% CI). One-sided adjusted p-values are presented for comparisons in the statistical gatekeeping procedure and two-sided p-values are presented for all other comparisons. FEV1: forced expiratory volume in 1 s; AUC0–4, 0–12, 12–24, 0–24: area under the curve from 0 to 4 h, 0 to 12 h, 12–24 h and 0–24 h, respectively. #: imputed with last observation carried forward. ***: p<0.001 versus placebo. Other symbols denote where significant treatment differences (not shown) occur: ¶: p<0.001 versus indacaterol; +: p<0.001 versus glycopyrronium; §: p<0.001 versus tiotropium; ƒ: p = 0.013 versus glycopyrronium and tiotropium; ##: p = 0.010 versus tiotropium; ¶¶: p = 0.043 versus glycopyrronium; ++: p = 0.026 versus tiotropium; §§: p = 0.004 versus indacaterol; ƒƒ: p = 0.004 versus glycopyrronium; ###: p = 0.009 versus tiotropium.