Table 1.
Patient demographics and baseline characteristics (pooled safety population)
| Aclidinium/formoterol 400/12 µg (n=720) | Aclidinium 400 µg (n=722) | Formoterol 12 µg (n=716) | Placebo (n=526) | Total (n=2,684) | |
|---|---|---|---|---|---|
|
| |||||
| Age, mean years (SD) | 63.4 (8.5) | 63.7 (8.5) | 63.5 (8.2) | 63.7 (8.5) | 63.6 (8.4) |
| ≥65 years, n (%) | 327 (45.4) | 346 (47.9) | 337 (47.1) | 250 (47.5) | 1,260 (46.9) |
| Male, n (%) | 429 (59.6) | 444 (61.5) | 424 (59.2) | 313 (59.5) | 1,610 (60.0) |
| Caucasian, n (%) | 672 (93.3) | 677 (93.8) | 673 (94.0) | 500 (95.1) | 2,522 (94.0) |
| Current smoker, n (%) | 354 (49.2) | 353 (48.9) | 350 (48.9) | 263 (50.0) | 1,320 (49.2) |
| Mean cigarette consumption, pack-years (SD) | 46.6 (25.1) | 44.9 (23.7) | 45.8 (22.3) | 49.1 (26.5) | 46.4 (24.3) |
| Severity of airflow obstruction, n (%) | |||||
| Stage II (moderate)a | 418 (58.1) | 410 (57.1) | 434 (60.8) | 293 (55.9) | 1,555 (58.1) |
| Stage III (severe)b | 298 (41.4) | 304 (42.3) | 275 (38.5) | 227 (43.3) | 1,104 (41.3) |
| Baseline FEV1, L (SD) | 1.387 (0.524) | 1.376 (0.519) | 1.397 (0.510) | 1.382 (0.550) | 1.386 (0.524) |
| Percent predicted FEV1 at baseline (SD) | 48.7 (14.6) | 47.9 (13.9) | 48.9 (14.3) | 47.4 (14.1) | 48.3 (14.2) |
| BDI focal score (SD) | 6.4 (2.1) | 6.5 (2.1) | 6.4 (2.2) | 6.5 (2.2) | 6.4 (2.2) |
| Number of exacerbations in previous 12 months, mean (SD) | 0.5 (0.9) | 0.5 (0.8) | 0.4 (0.8) | 0.3 (0.7) | 0.4 (0.8) |
| 0, n (%) | 503 (69.9) | 505 (69.9) | 509 (71.1) | 396 (75.3) | 1,913 (71.3) |
| ≥1, n (%) | 217 (30.1) | 217 (30.1) | 207 (28.9) | 130 (24.7) | 771 (28.7) |