Table 1.
Baseline demographics and disease characteristics
| CHF6001 | Budesonide 800 μg (N = 187) | Placebo (N = 193) | Overall (N = 1130) | ||||
|---|---|---|---|---|---|---|---|
| 400 μg BID (N = 190) | 800 μg BID (N = 179) | 1200 μgBID (N = 188) | 1600 μg BID (N = 193) | ||||
| Age (years) | 64.0 (8.5) | 65.2 (7.9) | 65.2 (8.6) | 62.9 (8.4) | 64.7 (7.8) | 64.5 (8.0) | 64.4 (8.2) |
| Sex, male | 133 (70.0) | 129 (72.1) | 131 (69.7) | 135 (69.9) | 132 (70.6) | 133 (68.9) | 793 (70.2) |
| Race | |||||||
| Asian | 0 | 0 | 0 | 0 | 1 (0.5) | 0 | 1 (0.1) |
| White | 190 (100) | 179 (100) | 188 (100) | 193 (100) | 186 (99.5) | 193 (100) | 1129 (99.9) |
| BMI (kg/m2) | 26.20 (4.04) | 26.36 (3.64) | 26.19 (4.03) | 26.10 (3.98) | 26.04 (3.82) | 26.05 (3.73) | 26.16 (3.87) |
| Time since COPD diagnosis (years) | 8.9 (6.1) | 8.6 (5.9) | 9.0 (5.8) | 8.3 (5.3) | 9.4 (6.4) | 8.7 (5.3) | 8.8 (5. 8) |
| Main COPD phenotypea | |||||||
| Chronic bronchitis only | 101 (53.2) | 93 (52.0) | 107 (56.9) | 113 (58.5) | 106 (56.7) | 108 (56.0) | 628 (55.6) |
| Emphysema only | 39 (20.5) | 41 (22.9) | 34 (18.1) | 36 (18.7) | 36 (19.3) | 42 (21.8) | 228 (20.2) |
| Mixed | 50 (26.3) | 45 (25.1) | 47 (25.0) | 44 (22.8) | 45 (24.1) | 43 (22.3) | 274 (24.2) |
| Exacerbations in previous year | 1.2 (0.4) | 1.1 (0.4) | 1.1 (0.3) | 1.1 (0.4) | 1.1 (0.4) | 1.1 (0.4) | 1.1 (0.4) |
| 1 | 160 (84.2) | 157 (87.7) | 164 (87.2) | 173 (89.6) | 161 (86.1) | 174 (90.2) | 989 (87.5) |
| 2 | 30 (15.8) | 19 (10.6) | 24 (12.8) | 16 (8.3) | 24 (12.8) | 17 (8.8) | 130 (11.5) |
| > 2 | 0 | 3 (1.7) | 0 | 4 (2.1) | 2 (1.1) | 2 (1.0) | 11 (1.0) |
| Smoking history | |||||||
| Pack-years | 33.4 (15.4) | 36.1 (15.1) | 36.4 (17.5) | 35.2 (15.1) | 36.1 (15.0) | 36.1 (14.3) | 35.5 (15.4) |
| Ex-smoker | 91 (47.9) | 85 (47.5) | 97 (51.6) | 77 (39.9) | 82 (43.9) | 100 (51.8) | 532 (47.1) |
| Current smoker | 99 (52.1) | 94 (52.5) | 91 (48.4) | 116 (60.1) | 105 (56.1) | 93 (48.2) | 598 (52.9) |
| FEV1 (% predicted)b | 48.7 (10.4) | 48.6 (11.2) | 47.1 (10.3) | 47.9 (10.3) | 48.0 (10.6) | 48.1 (11.0) | 48.1 (10.6) |
| FEV1/FVC ratiob | 0.454 (0.114) | 0.445 (0.109) | 0.452 (0.110) | 0.445 (0.098) | 0.431 (0.100) | 0.439 (0.095) | 0.444 (0.104) |
| CAT total score | 20.7 (5.1) | 20.6 (5.5) | 21.0 (4.9) | 20.4 (5.0) | 20.4 (5.1) | 20.2 (5.0) | 20.5 (5.1) |
| mMRC score | 2.4 (0.5) | 2.4 (0.5) | 2.4 (0.5) | 2.3 (0.5) | 2.3 (0.5) | 2.3 (0.5) | 2.3 (0.5) |
Data are mean (SD) or number (%). aAs assessed by the investigator. bPost-bronchodilator. BID twice daily, BMI body mass index, COPD chronic obstructive pulmonary disease, FEV1 forced expiratory volume in 1 s, FVC forced vital capacity, CAT COPD Assessment Test, mMRC modified Medical Research Council dyspnoea scale