| Placebo | FDC | FDC | Aclidinium | Formoterol | Total |
---|---|---|---|---|---|---|
400/12 μg | 400/6 μg | 400 μg | 12 μg | |||
Patients, n | 194 | 385 | 381 | 385 | 384 | 1729 |
Age, years | 64.2 ± 8.0 | 62.7 ± 8.1 | 62.9 ± 7.7 | 63.1 ± 8.2 | 63.4 ± 7.8 | 63.2 ± 8.0 |
Males, n (%) | 138 (71.1) | 261 (67.8) | 259 (68.0) | 256 (66.5) | 255 (66.4) | 1169 (67.6) |
Caucasians, n (%) | 183 (94.3) | 367 (95.3) | 366 (96.1) | 363 (94.3) | 362 (94.3) | 1641 (94.9) |
Current smoker, n (%) | 94 (48.5) | 181 (47.0) | 182 (47.8) | 182 (47.3) | 179 (46.6) | 818 (47.3) |
Severity of airflow obstruction, n (%), based on GOLD 2010 criteriaa | Â | Â | Â | Â | Â | |
  Moderate | 116 (60.1) | 229 (59.5) | 230 (60.4) | 226 (58.9) | 237 (61.9) | 1038 (60.1) |
  Severe | 77 (39.9) | 156 (40.5) | 151 (39.6) | 157 (40.9) | 144 (37.6) | 685 (39.7) |
Baseline FEV1, L | 1.42 ± 0.54 | 1.42 ± 0.49 | 1.41 ± 0.48 | 1.40 ± 0.51 | 1.40 ± 0.48 | 1.41 ± 0.50 |
Post-bronchodilator FEV1, % predicted | 55.0 ± 13.4 | 54.6 ± 13.1 | 54.1 ± 13.0 | 53.6 ± 13.0 | 54.5 ± 13.2 | 54.3 ± 13.1 |
Patients meeting bronchial reversibility criteria, n (%)b | 66 (34.0) | 134 (34.8) | 127 (33.3) | 125 (32.6) | 114 (29.8) | 566 (32.8) |
Prior COPD medication, n (%) | Â | Â | Â | Â | Â | |
  Any COPD-related medication | 167 (86.1) | 330 (85.7) | 331 (86.9) | 337 (87.5) | 329 (85.7) | 1494 (86.4) |
  LABA + ICSc | 63 (32.5) | 118 (30.6) | 128 (33.6) | 121 (31.4) | 119 (31.0) | 549 (31.8) |
  LAMA | 60 (30.9) | 118 (30.6) | 122 (32.0) | 107 (27.8) | 110 (28.6) | 517 (29.9) |
  LABA | 38 (19.6) | 79 (20.5) | 69 (18.1) | 78 (20.3) | 80 (20.8) | 344 (19.9) |
  ICS | 39 (20.1) | 85 (22.1) | 72 (18.9) | 79 (20.5) | 68 (17.7) | 343 (19.8) |
BDI focal score | 6.6 ± 2.0 | 6.6 ± 2.1 | 6.6 ± 2.0 | 6.5 ± 2.0 | 6.5 ± 2.1 | 6.5 ± 2.1 |
SGRQ total score | 45.8 ± 17.6 | 46.1 ± 17.9 | 46.7 ± 17.6 | 46.8 ± 16.8 | 45.2 ± 18.2 | 46.2 ± 17.6 |