Table 2.
Efficacy outcomes by therapy arm
| Parameter | Placebo | FF 100 μg | VI 25 μg | FF/VI 100/25 μg |
|---|---|---|---|---|
| FEV1: change from pre-dose day 1 to pre-allergen challenge day 21 | ||||
| Adjusted mean, l (95% CI) | −0.061 (−0.147, 0.024) | 0.116 (0.030, 0.202) | 0.183 (0.095, 0.272) | 0.230 (0.145, 0.315) |
| FEV1: change from pre-dose day 1 to pre-methacholine challenge day 22 | ||||
| Adjusted mean, l (95% CI) | −0.203 (−0.298, −0.107) | 0.030 (−0.066, 0.127) | 0.023 (−0.073, 0.119) | 0.203 (0.109, 0.296) |
| EAR (0–2 h post-challenge): change from saline on day 21 | ||||
| Adjusted mean min FEV1, l (95% CI) | −1.091 (−1.344, −0.837) | −0.826 (−1.070, −0.581) | −0.955 (−1.209, −0.702) | −0.614 (−0.858, −0.370) |
| Adjusted mean wm FEV1, l (95% CI) | −0.560 (−0.745, −0.374) | −0.386 (−0.565, −0.207) | −0.533 (−0.718, −0.348) | −0.297 (−0.476, −0.118) |
| Adjusted mean FEV1,% (95% CI) | −28.05 (−35.60, −20.51) | −22.33 (−28.82, −15.85) | −23.10 (−30.27, −15.93) | −16.10 (−22.22, −9.99) |
| LAR (4–10 h post-challenge): change from saline on day 21 | ||||
| Adjusted mean min FEV1, l (95% CI) | −0.731 (−0.878, −0.584) | −0.188 (−0.315, −0.061) | −0.536 (−0.676, −0.396) | −0.216 (−0.343, −0.088) |
| Adjusted mean wm FEV1, l (95% CI) | −0.466 (−0.589, −0.343) | 0.018 (−0.089, 0.125) | −0.298 (−0.415, −0.181) | 0.018 (−0.089, 0.124) |
| Adjusted mean FEV1,% (95% CI) | −21.08 (−26.72, −15.44) | −5.02 (−8.34, −1.69) | −14.30 (−18.81, −9.78) | −5.83 (−9.30, −2.37) |
| Methacholine challenge: day 22 | ||||
| Geometric mean PC20 concentration, mg/ml (95% CI) | 0.191 (0.110, 0.331) | 0.585 (0.342, 1.000) | 0.228 (0.133, 0.393) | 1.028 (0.610, 1.732) |
EAR, early asthmatic response; FEV1, forced expiratory volume in 1 s; FF, fluticasone furoate; LAR, late asthmatic response; VI, vilanterol; wm, weighted mean.