Table 1.
Demographics and Baseline Characteristics (ITT Population)
| Study 1 | Study 2 | |||||
|---|---|---|---|---|---|---|
| MEDI-528 | ||||||
| Parameter | Placebo (n = 9) |
0.3 mg/kg (n = 9) |
1 mg/kg (n = 9) |
3 mg/kg (n = 9) |
Placebo (n = 4) |
MEDI-528 50 mg (n = 7) |
| Mean age, years (range) | 38.6 (22-63) | 38.2 (18-61) | 33.2 (19-57) | 28.9 (19-55) | 31.8 (19-47) | 32.1 (19-39) |
| Female, n (%) | 8 (88.9) | 8 (88.9) | 5 (55.6) | 5 (55.6) | 2 (50) | 6 (85.7) |
| Race/Ethnicity, n (%) | ||||||
| White/non-Hispanic | 8 (88.9) | 6 (66.7) | 9 (100) | 5 (55.6) | 3 (75.0) | 6 (85.7) |
| White/Hispanic | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (14.3) |
| Black | 0 (0.0) | 2 (22.2) | 0 (0.0) | 3 (33.3) | 1 (25.0) | 0 (0.0) |
| Asian | 0 (0.0) | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) |
| Multiracial | 1 (11.1) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
| Mean weight, kg (range) | 68.5 (52.0-93.9) | 78.9 (58.2-99.7) | 72.3 (43.0-99.1) | 72.7 (57.6-97.7) | 77.3 (57.7-93.2) | 73.4 (52.7-97.3) |
| Mean (SD) FEV1 (L)* | 2.8 (0.58) | 2.8 (0.93) | 3.2 (0.73) | 3.4 (0.43) | 3.3 (1.25) | 2.8 (0.56) |
| Ever smoked, n (%) | 7 (77.8) | 1 (11.1) | 1 (11.1) | 0 (0.0) | 1 (25.0) | 2 (28.6) |
| Exacerbations in past year, no. (%) | ||||||
| None | 4 (44.4) | 6 (66.7) | 6 (66.7) | 4 (44.4) | 2 (50.0) | 3 (42.9) |
| 1-2 | 5 (55.6) | 3 (33.3) | 2 (22.2) | 5 (55.6) | 2 (50.0) | 4 (57.1) |
| 3-5 | 0 (0.0) | 0 (0.0) | 1 (11.1) | 0 (0.0) | 0 (0.0) | 0 (0.0) |
*Measurements from evaluable subjects (those who received ≥7 or ≥4 doses of the study drug in study 1 and study 2, respectively); ITT = intent to treat (all randomized subjects); SD = standard deviation; FEV1 = forced expiratory volume in 1 second.