Table 1.
Baseline Characteristics of the ITT Population
| Characteristics | FF/UMEC/VI (N=911) | BUD/FOR (N=899) | Total (N=1810) |
|---|---|---|---|
| Age, years, mean (SD) | 64.2 (8.6) | 63.7 (8.7) | 63.9 (8.6) |
| Female, n (%) | 233 (26) | 236 (26) | 469 (26) |
| BMI, kg/m2, mean (SD)a,b | 26.9 (5.2) | 27.0 (5.1) | 26.9 (5.1) |
| Current smokers, n (%)b | 400 (44) | 394 (44) | 794 (44) |
| Smoking history, pack-years, mean (SD) | 39.5 (21.9) | 39.2 (22.2) | 39.4 (22.0) |
| Moderate/severe exacerbations in past year, n (%) | |||
| 0 | 313 (34) | 317 (35) | 630 (35) |
| 1 | 252 (28) | 253 (28) | 505 (28) |
| ≥2 | 346 (38) | 329 (37) | 675 (37) |
| Severe exacerbations in past year, n (%) | |||
| 0 | 726 (80) | 699 (78) | 1425 (79) |
| 1 | 167 (18) | 177 (20) | 344 (19) |
| ≥2 | 18 (2) | 23 (3) | 41 (2) |
| Post-bronchodilator FEV1, % predicted, mean (SD)a | 45.5 (13.0) | 45.1 (13.6) | 45.3 (13.3) |
| SGRQ total score, mean (SD)c | 51.8 (16.3) | 50.8 (16.7) | N/A |
| Eosinophils, 109/L, mean (SD)b,d | 0.213 (0.191) | 0.213 (0.280) | N/A |
Notes: aFF/UMEC/VI n=908, BUD/FOR n=897, total n=1805. bAt screening. cFF/UMEC/VI n=904, BUD/FOR n=893. dFF/UMEC/VI n=887, BUD/FOR n=873, total n=1804.
Abbreviations: BUD, budesonide; FEV1, forced expiratory volume in 1 second; FF, fluticasone furoate; FOR, formoterol; N/A, not available; SD, standard deviation; SGRQ, St George’s respiratory questionnaire; UMEC, umeclidinium; VI, vilanterol.