Table 1.
Baseline Demographic and Clinical Characteristics (Safety Set)
| Characteristic | T (n = 512) | R (n = 512) | Placebo (n = 103) | Total (n = 1127) |
|---|---|---|---|---|
| Age, mean (range), years | 42.6 (18–84) | 42.5 (18–81) | 43.5 (18–77) | 42.6 (18–84) |
| Males, n (%) | 206 (40.2) | 203 (39.6) | 39 (37.9) | 448 (39.8) |
| Race, n (%) | ||||
| White | 378 (73.8) | 372 (72.7) | 73 (70.9) | 823 (73.0) |
| Black/African American | 92 (18.0) | 98 (19.1) | 22 (21.4) | 212 (18.8) |
| Other | 42 (8.2) | 42 (8.2) | 8 (7.8) | 92 (8.2) |
| BMI, mean (SD), kg/m2 | 29.4 (6.0) | 29.1 (5.9) | 29.4 (5.9) | 29.3 (5.9) |
| Duration of asthma, mean (range), years | 26.9 (0.3–79.8) | 27.1 (0.8–70.7) | 28.3 (0.6–65.8) | 27.1 (0.3–79.8) |
| Prior asthma medication, n (%) | ||||
| ICS or ICS/LABA | 275 (53.7) | 272 (53.1) | 60 (58.3) | 607 (53.9) |
| ICS | 86 (16.8) | 97 (18.9) | 20 (19.4) | 203 (18.0) |
| ICS/LABA | 189 (36.9) | 175 (34.2) | 40 (38.8) | 404 (35.8) |
| Prebronchodilator spirometry | ||||
| n | 512 | 511 | 103 | 1126 |
| FEV1, mean (SD), L | 2.33 (0.61) | 2.32 (0.61) | 2.28 (0.59) | 2.32 (0.61) |
| FVC, mean (SD), L | 3.46 (1.00) | 3.41 (0.95) | 3.42 (0.94) | 3.43 (0.97) |
| FEV1/FVC, mean (SD), % | 68.60 (9.05) | 69.97 (9.30) | 67.88 (9.39) | 68.70 (9.19) |
| FEV1, mean (SD), % predicted | 69.92 (8.64) | 70.05 (8.83) | 69.48 (9.03) | 69.94 (8.76) |
| FEV1 reversibility | ||||
| n | 511 | 511 | 103 | 1125 |
| Improvement, mean (SD), % | 23.23 (15.37) | 24.43 (16.80) | 23.97 (16.88) | 23.84 (16.17) |
| Reversibility, mean (SD), L | 0.53 (0.29) | 0.55 (0.32) | 0.53 (0.30) | 0.54 (0.30) |
BMI, body mass index; FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; ICS, inhaled corticosteroids; LABA, long-acting β-agonist; R, reference product (Advair Diskus); SD, standard deviation; T, test product (Wixela Inhub).