Table 1.
Wixela Inhub | Advair Diskus | Placebo | |
---|---|---|---|
Day 1 change from baseline in FEV1 AUC(0–12) | |||
n | 497 | 494 | 94 |
LS mean (95% CI) | 3.973 (3.639–4.308) | 3.541 (3.228–3.854) | 0.840 (0.248–1.432) |
Difference from placeboa | |||
LS mean (95% CI) | 3.133 (2.472–3.795)c | 2.701 (2.047–3.3556)c | |
Equivalence test | |||
LS mean ratio (90% CI) | 1.120 (1.016–1.237) | ||
Day 29 change from baseline in trough FEV1 | |||
n | 498 | 497 | 99 |
LS mean (95% CI) | 0.291 (0.259–0.323) | 0.273 (0.241–0.305) | 0.057 (–0.012–0.127) |
Difference from placeboc | |||
LS mean (95% CI) | 0.234 (0.159–0.309)b | 0.215 (0.140–0.291)b | |
Equivalence test | |||
LS mean (90% CI) | 1.069 (0.938–1.220) |
ANCOVA analysis of covariance, AUC(0–12) area under the effect curve over 12 h post-dose, CI confidence interval, FEV1 forced expiratory volume in 1 s, LS least squares
aBased on ANCOVA
bP < 0.0001
cDifference of LS means (Inhub minus placebo; Diskus minus placebo) from the ANCOVA model