Table 5.
Exploratory Analyses in Studies 1 and 2 (Evaluable Population)
| Study 1 | Study 2 | |||||
|---|---|---|---|---|---|---|
| MEDI-528 | ||||||
| Parameter | Placebo | 0.3 mg/kg | 1 mg/kg | 3 mg/kg | Placebo | MEDI-528 50 mg |
| Pulmonary function | ||||||
| FEV1, L | ||||||
| Baseline | 2.8 ± 0.58 (n = 9) |
2.8 ± 0.93 (n = 9) |
3.2 ± 0.73 (n = 9) |
3.4 ± 0.43 (n = 9) |
3.3 ± 1.25 (n = 2) |
2.8 ± 0.56 (n = 7) |
| End of study | 2.9 ± 0.48 (n = 8) |
2.6 ± 1.02 (n = 9) |
3.3 ± 0.67 (n = 8) |
3.6 ± 0.56 (n = 8) |
3.0 ± 1.30 (n = 2) |
2.9 ± 0.42 (n = 5) |
| FEV1, % predicted | ||||||
| Baseline | 89.3 ± 10.49 (n = 9) |
85.8 ± 7.95 (n = 9) |
86.0 ± 12.07 (n = 9) |
93.3 ± 12.40 (n = 9) |
||
| End of study | 91.4 ± 8.87 (n = 8) |
79.2 ± 11.04 (n = 9) |
90.3 ± 9.64 (n = 8) |
99.6 ± 13.14 (n = 8) |
||
| Asthma symptom score, overall | ||||||
| Baseline | 1.11 ± 0.83 (n = 6) |
1.87 ± 1.70 (n = 7) |
1.37 ± 1.59 (n = 6) |
0.00 ± N/A (n = 1) |
1.92 ± 1.53 (n = 2) |
0.93 ± 0.82 (n = 6) |
| Treatment | 0.74 ± 0.55 (n = 7) |
0.91 ± 0.63 (n = 6) |
1.10 ± 1.49 (n = 6) |
0.13 ± 0.18 (n = 2) |
0.91 ± 0.07 (n = 2) |
0.41 ± 0.66 (n = 6) |
| Rescue short-acting β2-agonist use (no. of puffs/day), overall during study | 0.63 ± 0.60 (n = 9) |
0.65 ± 0.51 (n = 8) |
0.66 ± 0.80 (n = 8) |
0.02 ± 0.04 (n = 5) |
0.22 ± 0.02 (n = 2) |
0.28 ± 0.32 (n = 7) |
| AQLQ score, overall | ||||||
| Baseline | 5.56 ± 1.11 (n = 9) |
5.20 ± 0.79 (n = 9) |
5.73 ± 0.70 (n = 9) |
5.97 ± 0.78 (n = 9) |
5.73 ± 0.11 (n = 2) |
5.75 ± 0.65 (n = 7) |
| Day 28 | 5.64 ± 0.82 (n = 9) |
5.68 ± 0.66 (n = 9) |
5.95 ± 0.87 (n = 9) |
6.07 ± 0.60 (n = 9) |
6.22 ± 0.09 (n = 2) |
5.94 ± 0.57 (n = 7) |
Values are mean ± SD.
AQLQ = Asthma Quality of Life Questionnaire; FEV1 = forced expiratory volume in 1 second.