Table 1.
Patients Demographics and Baseline Characteristics
| Demographic/characteristic |
FF/UMEC/VI N=4151 |
FF/VI N=4134 |
UMEC/VI N=2070 |
Overall N=10 355 |
|---|---|---|---|---|
| Age, y, mean (SD) | 65.3 (8.2) | 65.3 (8.3) | 65.2 (8.3) | 65.3 (8.3) |
| Sex, male, n (%) | 2766 (67) | 2748 (66) | 1356 (66) | 6870 (66) |
| Body mass index, mean (SD), kg/m2 | 26.6 (6.2) | 26.7 (6.1) | 26.6 (5.9) | 26.6 (6.1) |
| Race, n (%) | ||||
| American Indian or Alaskan Native | 87 (2) | 86 (2) | 45 (2) | 218 (2) |
| Asian | 668 (16) | 676 (16) | 335 (16) | 1679 (16) |
| Black | 122 (3) | 99 (2) | 43 (2) | 264 (3) |
| Native Hawaiian or other Pacific Islander | 2 (<1) | 3 (<1) | 2 (<1) | 7 (<1) |
| White | 3231 (78) | 3224 (78) | 1628 (79) | 8083 (78) |
| Multiple | 41 (<1) | 45 (1) | 17 (<1) | 103 (<1) |
| Smoking status, n (%) | ||||
| Current smoker | 1436 (35) | 1423 (34) | 728 (35) | 3587 (35) |
| Former smoker | 2715 (65) | 2711 (66) | 1342 (65) | 6768 (65) |
| Chronic obstructive pulmonary disease exacerbations in previous year, n (%) | ||||
| <2 moderate and no severe | 1198 (29) | 1242 (30) | 616 (30) | 3056 (30) |
| ≥2 moderate or ≥1 severe | 2953 (71) | 2892 (70) | 1454 (70) | 7299 (70) |
| Postbronchodilator forced expiratory volume in 1 second % predicted, mean (SD) | 45.7 (15.0) | 45.5 (14.8) | 45.4 (14.7) | 45.5 (14.8) |
| Cardiovascular risk factors at screening*, n (%) | ||||
| 0 | 1365 (33) | 1322 (32) | 656 (32) | 3343 (32) |
| 1 | 1147 (28) | 1158 (28) | 580 (28) | 2885 (28) |
| ≥2 | 1639 (39) | 1654 (40) | 834 (40) | 4127 (40) |
FF indicates fluticasone furoate; UMEC, umeclidinium; and VI, vilanterol.
*
As captured in the electronic case report form.