Table 1.
Patient demographics and lung function at screening/baseline (intent-to-treat population)
| Placebo OD PM (N = 111) | FF 50 mcg OD PM (N = 111) | |
|---|---|---|
| Age, mean (SD) | 33.8 (13.90) | 36.7 (16.16) |
| Age range, years | 12–68 | 12–77 |
| Female, n (%) | 70 (63) | 63 (57) |
| Race, n (%) | ||
| American Indian or Alaska Native | 59 (53) | 45 (41) |
| White | 29 (26) | 42 (38) |
| American Indian or Alaska Native and White | 21 (19) | 24 (22) |
| Other | 2 (2) | 0 |
| Screening characteristics, mean (SD) | ||
| Pre-bronchodilator FEV1 (L) | 2.527 (0.6940) | 2.452 (0.6843) |
| Percent predicted FEV1, % | 77.33 (12.884) | 74.71 (9.493) |
| Post-bronchodilator FEV1 (L) | 3.139 (0.8784) | 3.047 (0.8443) |
| Percent reversibility FEV1, % | 24.32 (10.368) | 24.77 (9.906) |
| Baseline characteristics, mean (SD) | ||
| Pre-bronchodilator FEV1* (L) | 2.712 (0.8305) | 2.669 (0.8172) |
| Percent predicted FEV1*, % | 82.30 (14.115) | 80.85 (12.277) |
| Rescue-free 24-h periods, % | 7.5 (21.04) | 10.2 (21.49) |
| Symptom-free 24-h periods, % | 3.2 (12.73) | 5.0 (14.53) |
| PM PEF (L/min) | 356.8 (120.53) | 359.0 (121.14) |
| AM PEF (L/min) | 350.3 (115.89) | 349.2 (117.21) |
*Assessed in 110 patients from each treatment arm; FEV1 = forced expiratory volume in one second; FF = fluticasone furoate; OD = once daily; PEF = peak expiratory flow PM = evening; SD = standard deviation.