Table 1 Demographics and baseline disease characteristics (ITT population)a
Placebo (n = 164) | MEDI8968 (n = 160) | Total (N = 324) | ||
|---|---|---|---|---|
Age, years, mean (SD) | 63.0 (6.8) | 62.8 (6.7) | 62.9 (6.8) | |
Male, n (%) | 110 (67.1) | 110 (68.8) | 220 (67.9) | |
BMI, kg/m2, mean (SD) | 25.8 (5.1) | 25.7 (4.9) | 25.7 (5.0) | |
Baseline GOLD 2001 status, n (%) | II | 44 (26.8) | 44 (27.5) | 88 (27.2) |
III | 90 (54.9) | 79 (49.4) | 169 (52.2) | |
IV | 30 (18.3) | 37 (23.1) | 67 (20.7) | |
FEV1, L, mean (SD) | Pre-bronchodilator | 1.1 (0.4) | 1.2 (0.5) | 1.16 (0.5) |
Post-bronchodilator | 1.2 (0.4) | 1.3 (0.5) | 1.24 (0.5) | |
FEV1 predicted, %, mean (SD) | Pre-bronchodilator | 38.6 (12.7) | 39.7 (14.1) | 39.1 (13.4) |
Post-bronchodilator | 42.1 (13.3) | 41.9 (14.4) | 42.0 (13.8) | |
SGRQ-C, mean (SD) | Total | 58.9 (18.0) | 61.2 (17.6) | 60.0 (17.8) |
Symptom | 72.4 (18.8) | 74.4 (18.0) | 73.4 (18.4) | |
CRP, mg/dL, n (%) | <0.347 | 84 (51.2) | 84 (52.5) | 168 (51.9) |
≥0.347 | 80 (48.8) | 76 (47.5) | 156 (48.1) | |
Fibrinogen, n (%) | < median | 82 (51.6) | 73 (46.2) | 155 (48.9) |
≥ median | 77 (48.4) | 85 (53.8) | 162 (51.1) | |