Table 3 Statistical analysis of change from baseline in trough FEV 1 (L) at Week 24 by randomisation strata and ICS dose during run-in (intent-to-treat population)
Trough FEV1(Week 24) | FF 100 μg | FF 200 μg |
|---|---|---|
(N = 108) | (N = 111) | |
Predicted FEV 1 at baseline | ||
≥ 40% to ≤ 65% | ||
n | 45 | 48 |
LS mean at baseline | 1.561 | 1.699 |
LS mean at Week 24 | 2.368 | 2.422 |
LS mean change from baseline (SE) | 0.305 (0.074) | 0.359 (0.073) |
Treatment difference vs. | NA | 0.055 |
FF 100 μg (95% CI) | (-0.122, 0.232) | |
> 65% to ≤ 90% | ||
n | 61 | 61 |
LS mean at baseline | 2.387 | 2.372 |
LS mean at Week 24 | 2.197 | 2.290 |
LS mean change from baseline (SE) | 0.134 (0.062) | 0.227 (0.062) |
Treatment difference vs. | NA | 0.093 |
FF 100 μg (95% CI) | (-0.061, 0.247) | |
Run-in ICS use | ||
Mid-dose | ||
n | 79 | 89 |
LS mean at baseline | 2.039 | 2.085 |
LS mean at Week 24 | 2.278 | 2.340 |
LS mean change from baseline (SE) | 0.222 (0.051) | 0.284 (0.047) |
Treatment difference vs. | NA | 0.063 |
FF 100 μg (95% CI) | (-0.070, 0.195) | |
High-dose | ||
n | 27 | 19 |
LS mean at baseline | 2.041 | 1.987 |
LS mean at Week 24 | 2.228 | 2.360 |
LS mean change from baseline (SE) | 0.172 (0.092) | 0.304 (0.110) |
Treatment difference vs. | NA | 0.132 |
FF 100 μg (95% CI) | (-0.124, 0.388) | |