Table 1 Patient demographics and baseline characteristics for the pooled ACLIFORM and AUGMENT studies
FDC 400/12 μg (n = 720) | Aclidinium 400 μg (n = 720) | Formoterol 12 μg (n = 715) | Placebo (n = 525) | |
|---|---|---|---|---|
Age, years | 63.4 ± 8.5 | 63.7 ± 8.5 | 63.5 ± 8.2 | 63.7 ± 8.6 |
Gender, male, n (%) | 429 (59.6) | 442 (61.4) | 423 (59.2) | 313 (59.6) |
Current smoker, n (%) | 354 (49.2) | 351 (48.8) | 350 (49.0) | 263 (50.1) |
FEV1, L | 1.4 ± 0.5 | 1.4 ± 0.5 | 1.4 ± 0.5 | 1.4 ± 0.6 |
Post-bronchodilator FEV1, % predicted | 53.9 ± 13.2 | 53.3 ± 13.1 | 54.2 ± 13.1 | 53.5 ± 13.4 |
Number of exacerbations in previous 12 months | 0.5 (0.9) | 0.5 (0.8) | 0.4 (0.8) | 0.3 (0.7) |
Prior COPD medicationa, n (%) | ||||
Any COPD medication | 576 (80.0) | 591 (82.1) | 574 (80.3) | 411 (78.3) |
LABA + ICS | 210 (29.2) | 234 (32.5) | 222 (31.0) | 172 (32.8) |
LAMA | 209 (29.0) | 190 (26.4) | 181 (25.3) | 141 (26.9) |
ICS | 114 (15.8) | 106 (14.7) | 96 (13.4) | 62 (11.8) |
LABA | 85 (11.8) | 81 (11.3) | 92 (12.9) | 42 (8.0) |
BDI focal score | 6.4 ± 2.1 | 6.5 ± 2.1 | 6.4 ± 2.2 | 6.5 ± 2.2 |
E-RS total scoreb | 12.9 ± 6.8 | 12.5 ± 6.4 | 12.3 ± 6.6 | 12.2 ± 6.3 |
Overall night-time COPD symptom severity scorec | 1.1 ± 0.7 | 1.1 ± 0.7 | 1.1 ± 0.7 | 1.1 ± 0.7 |
Overall early-morning COPD symptom severity scorec | 1.3 ± 0.7 | 1.3 ± 0.7 | 1.2 ± 0.7 | 1.2 ± 0.6 |
GOLD group, n (%) | ||||
A | 62 (8.8) | 51 (7.3) | 74 (10.6) | 48 (9.4) |
B | 320 (45.5) | 322 (46.0) | 327 (46.7) | 224 (43.7) |
C | 16 (2.3) | 27 (3.9) | 16 (2.3) | 17 (3.3) |
D | 305 (43.4) | 300 (42.9) | 283 (40.4) | 224 (43.7) |