FP/SAL 250/50 μg (N = 314) | SAL 50 μg (N = 325) | LS Mean Diff. (SE) | 95% CI | |||
---|---|---|---|---|---|---|
ITT population | ||||||
Baseline | FEV1 | n | 313 | 325 | ||
Mean (SE) | 1.08 (0.027) | 1.14 (0.026) | ||||
Endpoint | FEV1 | n | 281 | 271 | ||
Mean (SE) | 1.22 (0.034) | 1.18 (0.031) | ||||
Change from baseline | n | 280 | 271 | 0.10 (0.028) | (0.04, 0.16) | |
Mean (SE) | 0.14 (0.021) | 0.04 (0.019) | ||||
Baseline post-bronchodilator % predicted FEV1≥ 30% and no prior ICS use | ||||||
Baseline | FEV1 | n | 60 | 66 | ||
Mean (SE) | 1.28 (0.057) | 1.26 (0.054) | ||||
Endpoint | FEV1 | n | 57 | 59 | ||
Mean (SE) | 1.52 (0.083) | 1.39 (0.072) | ||||
Change from baseline | n | 57 | 59 | 0.13 (0.083) | (−0.04, 0.29) | |
Mean (SE) | 0.25 (0.064) | 0.13 (0.051) | ||||
Baseline post-bronchodilator % predicted FEV1≥ 30% and prior ICS use | ||||||
Baseline | FEV1 | n | 180 | 193 | ||
Mean (SE) | 1.20 (0.033) | 1.26 (0.031) | ||||
Endpoint | FEV1 | n | 162 | 159 | ||
Mean (SE) | 1.30 (0.039) | 1.28 (0.036) | ||||
Change from baseline | n | 162 | 159 | 0.10 (0.036) | (0.03, 0.17) | |
Mean (SE) | 0.12 (0.027) | 0.01 (0.025) | ||||
Baseline post-bronchodilator % predicted FEV1≥ 30% and concurrent tiotropium use | ||||||
Baseline | FEV1 | n | 88 | 95 | ||
Mean (SE) | 1.17 (0.044) | 1.19 (0.041) | ||||
Endpoint | FEV1 | n | 79 | 71 | ||
Mean (SE) | 1.24 (0.055) | 1.21 (0.052) | ||||
Change from baseline | n | 79 | 71 | 0.02 (0.053) | (−0.09, 0.12) | |
Mean (SE) | 0.07 (0.037) | 0.06 (0.041) | ||||
Baseline post-bronchodilator % predicted FEV1≥ 30% and no concurrent tiotropium use | ||||||
Baseline | FEV1 | n | 152 | 164 | ||
Mean (SE) | 1.25 (0.037) | 1.31 (0.034) | ||||
Endpoint | FEV1 | n | 140 | 147 | ||
Mean (SE) | 1.43 (0.047) | 1.36 (0.042) | ||||
Change from baseline | n | 140 | 147 | 0.16 (0.044) | (0.07, 0.25) | |
Mean (SE) | 0.21 (0.035) | 0.03 (0.027) | ||||
Baseline post-bronchodilator % predicted FEV1< 30% | ||||||
Baseline | FEV1 | n | 72 | 65 | ||
Mean (SE) | 0.64 (0.032) | 0.63 (0.022) | ||||
Endpoint | FEV1 | n | 60 | 53 | ||
Mean (SE) | 0.72 (0.046) | 0.65 (0.025) | ||||
Change from baseline | n | 60 | 53 | 0.06 (0.037) | (−0.01, 0.14) | |
Mean (SE) | 0.08 (0.023) | 0.01 (0.028) |