Table 1.
Baseline characteristics (ITT population)
| Demographic Characteristics | Placebo (n = 101) |
FF dose | ||||
|---|---|---|---|---|---|---|
| 200 mcg OD/AM (n = 105) |
200 mcg OD/PM (n = 103) |
400 mcg OD/AM (n = 111) |
400 mcg OD/PM (n = 113) |
200 mcg BD (n = 113) |
||
| Female gender, n (%) | 62 (61) | 62 (59) | 74 (72) | 73 (66) | 70 (62) | 78 (69) |
| Age (years), mean | 44.4 | 45.0 | 43.7 | 46.9 | 45.0 | 45.6 |
| Race, n (%)† | ||||||
| White | 60 (60) | 68 (65) | 67 (66) | 74 (67) | 75 (68) | 76 (67) |
| Asian | 16 (16) | 14 (13) | 15 (15) | 16 (15) | 15 (14) | 17 (15) |
| Other | 24 (24) | 22 (22) | 20 (20) | 20 (18) | 21 (19) | 20 (18) |
| Asthma history, n (%) | ||||||
| < 1 year | 3 (3) | 1 (< 1) | 3 (3) | 2 (2)* | 3 (3) | 3 (3)* |
| ≥ 1 to < 5 years | 16 (16) | 12 (11) | 19 (18) | 14 (13) | 19 (17) | 17 (15) |
| ≥ 5 to < 10 years | 24 (24) | 26 (25) | 26 (25) | 30 (27) | 24 (21) | 35 (31) |
| ≥ 10 years | 58 (57) | 66 (63) | 55 (53) | 65 (59) | 67 (59) | 58 (51) |
| Lung function, mean | ||||||
| Pre-bronchodilator FEV1, litres | 1.966 | 1.969 | 1.986 | 1.931 | 1.995 | 1.976 |
| % predicted FEV1, (%) | 66.37 | 66.52 | 68.24 | 67.23 | 67.69 | 68.14 |
| % reversibility FEV1, (%) | 30.16 | 29.25 | 29.29 | 27.94 | 30.90 | 26.32 |
*1 patient < 6 months
†Data on race unavailable for 6 patients
AM = morning dosing; BD = twice daily; FEV1 = forced expiratory volume in one second; OD = once daily; PM = evening dosing