Table 3.
Evening pre-dose FEV1 on Day 28 of treatment and improvement from period baseline for each treatment regimen (all placebo treatments were pooled for these analyses)
| Placebo | FF 200 μg OD | FF 100 μg BD | FP 200 μg OD | FP 100 μg BD | |
|---|---|---|---|---|---|
| Number of patients | 187 | 140 | 142 | 42 | 43 |
| LS mean, ml (SE) | 2605 (43.4) |
2714 (44.4) |
2703 (44.3) |
2693 (53.5) |
2737 (53.3) |
| LS mean change from period baseline, ml (SE) | 112 (18.6) |
221 (20.9) |
210 (20.7) |
199 (36.5) |
244 (36.1) |
|
LS mean difference (active-placebo), ml (95% CI) |
NA | 108 (64-153); p < 0.001 |
98 (54-142); p < 0.001 |
87 (14-161); p = 0.020 |
132 (59-205); p < 0.001 |
|
LS mean difference (FF 200 μg OD-FF 100 μg BD), ml (95% CI) |
NA | 11 (-35-56); p = 0.641 |
NA | NA | NA |
Absolute values and all differences are LS means, with 95% CI for non-inferiority and p values for superiority analysis for all comparisons between treatments. Data shown are for the ITT population.
BD = twice daily; CI = confidence interval; FF = fluticasone furoate;
FP = fluticasone propionate; LS = least square, NA = not applicable; OD = once daily; SE = standard error