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 | |
Abbreviations: ACQ-6 Asthma Control Questionnaire, AQLQ Asthma Quality of Life Questionnaire, BMI Body mass index, FEV1 Forced expiratory volume in 1 second, FVC Forced vital capacity, ICS Inhaled corticosteroids, ITT Intent-to-treat.
aP value for differences among groups (placebo and MEDI-528 groups) by analysis of variance for continuous variables and the chi-square test for categorical variables.
bn = 80; cn = 244; dn=79; en=78; fn=236; gOne value is missing in the MEDI-528 100 mg group; hn = 76; in = 81; jn = 233.