FP/SAL 250/50 μg (N = 314) | SAL 50 μg (N = 325) | Ratio FP/SAL:SAL (95% CI) | PValue | |
---|---|---|---|---|
Severe exacerbations, ITT population; n (%) | ||||
Patients having exacerbation | 43 (14) | 39 (12) | ||
Number of exacerbations | 50 | 51 | ||
Mean annualized exacerbation rate | 0.44 | 0.48 | 0.92 (0.58, 1.45) | .710 |
Moderate/severe exacerbations, ITT population; n (%) | ||||
Patients having exacerbation | 102 (32) | 115 (35) | ||
Number of exacerbations | 156 | 182 | ||
Mean annualized exacerbation rate | 1.49 | 1.81 | 0.82 (0.64, 1.06) | .136 |
Moderate/severe exacerbations, patient subgroups; n (%) | ||||
Baseline post-bronchodilator % predicted FEV1≥ 30% and prior ICS use | ||||
n | 180 | 193 | ||
Patients having exacerbation | 49 (27) | 66 (34) | ||
Number of exacerbations | 74 | 106 | ||
Mean annualized exacerbation rate | 1.54 | 2.28 | 0.68 (0.47, 0.97) | NA |
Baseline post-bronchodilator % predicted FEV1≥ 30% and no prior ICS use | ||||
n | 60 | 66 | ||
Patients having exacerbation | 21 (35) | 24 (36) | ||
Number of exacerbations | 38 | 34 | ||
Mean annualized exacerbation rate | 1.07 | 0.91 | 1.18 (0.69, 2.00) | NA |
Baseline post-bronchodilator % predicted FEV1≥ 30% and concurrent tiotropium use | ||||
n | 88 | 95 | ||
Patients having exacerbation | 28 (32) | 32 (34) | ||
Exacerbations | 40 | 56 | ||
Mean annualized exacerbation rate | 1.00 | 1.48 | 0.67 (0.41, 1.11) | NA |
Baseline post-bronchodilator % predicted FEV1≥ 30% and no concurrent tiotropium use | ||||
n | 152 | 164 | ||
Patients having exacerbation | 42 (28) | 58 (35) | ||
Number of exacerbations | 72 | 84 | ||
Mean annualized exacerbation rate | 1.88 | 2.22 | 0.85 (0.58, 1.24) | NA |
Baseline post-bronchodilator % predicted FEV1< 30% | ||||
n | 72 | 65 | ||
Patients using concurrent tiotropium | 33 (46) | 30 (46) | ||
Patients having exacerbation | 31 (43) | 25 (38) | ||
Number of exacerbations | 43 | 42 | ||
Mean annualized exacerbation rate | 2.78 | 2.84 | 0.98 (0.61, 1.57) | NA |