Table 1 Demographic and baseline asthma characteristics (ITT Population)
Variable | MEDI-528 | P valuea | ||||
|---|---|---|---|---|---|---|
Placebo | 30 mg | 100 mg | 300 mg | Combined | ||
(n = 82) | (n = 81) | (n = 83) | (n = 81) | (n = 245) | ||
Age, years, mean (SD) | 43.6 (11.6) | 41.8 (11.1) | 45.1 (11.6) | 41.5 (12.3) | 42.8 (11.7) | 0.16 |
Male, n (%) | 29 (35.4) | 26 (32.1) | 21 (25.3) | 26 (32.1) | 73 (29.8) | 0.56 |
Race, n (%) | 0.62 | |||||
White | 42 (51.2) | 34 (42.0) | 33 (39.8) | 40 (49.4) | 107 (43.7) | |
Asian | 18 (22.0) | 17 (21.0) | 25 (30.1) | 18 (22.2) | 60 (24.5) | |
American Indian or Alaskan Native | 5 (6.1) | 8 (9.9) | 8 (9.6) | 4 (4.9) | 20 (8.2) | |
Black or African American | 2 (2.4) | 3 (3.7) | 4 (4.8) | 5 (6.2) | 12 (4.9) | |
Mixed race | 1 (1.2) | 0 (0.0) | 0 (0.0) | 2 (2.5) | 2 (0.8) | |
Other | 14 (17.1) | 19 (23.5) | 13 (15.7) | 12 (14.8) | 44 (18.0) | |
BMI, kg/m2, mean (SD) | 27.6 (4.3) | 27.1 (4.4) | 26.9 (4.3) | 27.2 (4.4) | 27.1 (4.3) | 0.79 |
FEV1 (L) | 2.21 (0.74) | 2.22 (0.71) | 2.05 (0.62) | 2.27 (0.66)b | 2.18 (0.67)c | 0.19 |
FEV1, % predicted | 70.7 (15.9) | 71.8 (17.6) | 70.6 (16.6) | 72.2 (15.9)b | 71.5 (16.7)c | 0.90 |
FVC, % predicted | 83.9 (14.6) | 86.1 (16.7) | 84.8 (14.3) | 84.7 (14.8) | 85.2 (15.2) | 0.83 |
FEV1/FVC | 68.0 (10.4) | 67.6 (10.8) | 67.0 (11.3) | 69.4 (10.8)b | 68.0 (11.0)c | 0.57 |
FEV1 reversibility, %, mean (SD) | 25.2 (13.8)b | 23.9 (10.2)d | 25.6 (15.3)d | 21.8 (11.1)e | 23.8 (12.5)f | 0.25 |
Atopic asthma, n (%) | 70 (85.4) | 69 (85.2) | 69 (83.1) | 68 (84.0) | 206 (84.1) | 0.98 |
Number of exacerbations requiring oral steroids in past year, n (%)g | 0.33 | |||||
0 | 2 (2.4) | 5 (6.2) | 1 (1.2) | 4 (4.9) | 10 (4.1) | |
1 | 45 (54.9) | 47 (58.0) | 42 (51.2) | 39 (48.1) | 128 (52.5) | |
2 | 16 (19.5) | 12 (14.8) | 16 (19.5) | 12 (14.8) | 40 (16.4) | |
3 | 5 (6.1) | 5 (6.2) | 10 (12.2) | 15 (18.5) | 30 (12.3) | |
4+ | 14 (17.1) | 12 (14.8) | 13 (15.7) | 11 (13.6) | 36 (14.7) | |
ICS use, n (%) | 0.81 | |||||
Medium dose | 43 (52.4) | 38 (46.9) | 38 (45.8) | 41 (50.6) | 117 (47.8) | |
High dose | 39 (47.6) | 43 (53.1) | 45 (54.2) | 40 (49.4) | 128 (52.2) | |
Rescue medication use, puffs per day, mean (SD) | 4.3 (4.0) | 4.9 (5.6) | 4.5 (4.5) | 5.9 (7.3) | 5.1 (5.9) | 0.25 |
Mean ACQ-6 score, mean (SD) | 2.8 (0.7) | 2.7 (0.9) | 2.8 (0.7) | 2.9 (0.9) | 2.8 (0.8) | 0.62 |
Overall AQLQ(S) score, mean (SD) | 3.6 (0.8)d | 3.8 (1.1)h | 3.8 (0.9)i | 3.8 (0.9)h | 3.8 (0.9)j | 0.60 |
Eosinophil count ≥ 0.3 × 10 3/μL, n (%) | 44 (53.7) | 38 (47.5)b | 43 (51.8) | 39 (48.1) | 120 (49.2)c | 0.84 |
Eosinophil count (103/μL) | 0.47 | |||||
Mean | 0.40 | 0.34b | 0.40 | 0.35 | 0.36c | |
Median | 0.31 | 0.28b | 0.37 | 0.29 | 0.29c | |
Basophil count (103/μL) | 0.05 | |||||
Mean | 0.03 | 0.03b | 0.03 | 0.03 | 0.03c | |
Median | 0.03 | 0.03b | 0.02 | 0.03 | 0.02c | |