Table 1.
Patient baseline demographics and screening lung function (intent-to-treat population)
| FF/VI 100/25 µg OD (N=201) |
FF/VI 200/25 µg OD (N=202) |
FP 500 µg BD (N=100) |
|
|---|---|---|---|
| Age, years | |||
| Mean (SD) | 39.7 (15.85) | 38.5 (15.64) | 38.6 (15.97) |
| Sex, female | |||
| n (%) | 130 (65) | 124 (61) | 62 (62) |
| Race, n (%) | |||
| White | 135 (67) | 134 (66) | 68 (68) |
| Asian | 50 (25) | 51 (25) | 26 (26) |
| African American/African heritage | 15 (7) | 17 (8) | 6 (6) |
| Other* | 1 (<1) | 0 | 0 |
| Exacerbation history: number in previous 12 months, n (%) | |||
| 0 | 139 (69) | 140 (69) | 74 (74) |
| 1 | 43 (21) | 41 (20) | 21 (21) |
| ≥2 | 19 (9) | 21(10) | 5 (5) |
| Screening lung function† | |||
| Pre-bronchodilator FEV1 (l) mean (SD) | 2.305 (0.6613) | 2.290 (0.6545) | 2.353 (0.6719) |
| % predicted FEV1 (%), mean (SD) | 74.2 (13.48) | 74.1 (14.13) | 75.2 (12.46) |
*African American/African Heritage and White.
†Total of 74 (37%) of patients allocated to FF/VI 100/25 µg OD, 78 (39%) of patients allocated to FF/VI 200/25 µg OD and 38 (38%) of patients allocated to FP had historical documentation of FEV1 reversibility.
BD, twice daily; FEV1, forced expiratory volume in 1 s; FF, fluticasone furoate; FP, fluticasone propionate; OD, once daily; SD, standard deviation; VI, vilanterol.