Table 1 Patient demographics and baseline characteristics (ITT Population)
FP/SAL 250/50 μg (N = 314) | SAL 50 μg (N = 325) | Total (N = 639) | |
|---|---|---|---|
Age, years | 63.1 (9.15) | 62.7 (9.30) | 62.9 (9.22) |
Female sex, n (%) | 140 (45) | 151 (46) | 291 (46) |
White race, n (%) | 284 (90) | 300 (92) | 584 (91) |
Duration of COPD, years | 7.0 (5.7) | 6.6 (5.2) | 6.8 (5.4) |
COPD type | |||
Chronic bronchitis (%) | 114 (36) | 129 (40) | 243 (38) |
Emphysema (%) | 121 (39) | 119 (37) | 240 (38) |
Both (%) | 79 (25) | 77 (24) | 156 (24) |
Smoking pack-years | 52.0 (30.0) | 56.3 (33.4) | 54.2 (31.8) |
Body mass index, kg/m2 | 28.0 (6.85) | 28.3 (6.95) | 28.2 (6.90) |
Baseline pre-bronchodilator FEV1, L | 1.08 (0.476) | 1.14 (0.467) | 1.11 (0.472) |
Baseline % predicted FEV1 | 38.5 (14.82) | 41.2 (16.85) | 39.9 (15.93) |
FEV1% reversibility | 15.1 (23.79) | 12.1 (16.69) | 13.6 (20.52) |
Reversibility | |||
Non-reversible (%) | 232 (74) | 245 (76) | 477 (75) |
Reversible (%) | 80 (26) | 79 (24) | 159 (25) |