Table III. Individual and Mean Results for Spirometry and Adenosine Challenge (n =15 patients who completed both placebo and omalizumab treatment periods).
Placebo | Omalizumab | |||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|
FEV1 (Liters) | PC20 | FEV1 (Liters) | PC20 | |||||||||
Subject | Before | End | % Change | Before | End | Fold Change* | Before | End | % Change | Before | End | Fold Change* |
Order = OMA/Placebo | ||||||||||||
1 | 1.85 | 1.96 | 6 | 146.4 | 19.93 | 0.1 | 1.90 | 1.72 | -9 | 10.3 | 182.34 | 17.8 |
4 | 3.68 | 3.96 | 8 | 60.8 | 72.09 | 1.2 | 4.02 | 3.98 | -1 | 39.8 | 30.46 | 0.8 |
9 | 2.08 | 2.65 | 27 | 17.1 | 20.36 | 1.2 | 2.47 | 2.43 | -2 | 12.2 | 35.74 | 2.9 |
14†† | 2.21 | 2.42 | 10 | 16.6 | 15.89 | 1.0 | 2.01 | 1.99 | -1 | 13.8 | 117.28 | 8.5 |
16 | 3.44 | 3.64 | 6 | 31.2 | 29.34 | 0.9 | 2.69 | 2.87 | 7 | 9.22 | 4.81 | 0.5 |
21 | 2.48 | 2.69 | 8 | 4.40 | 16.24 | 3.7 | 2.61 | 2.50 | -4 | 9.67 | 4.93 | 0.5 |
36 | 4.42 | 4.31 | -2 | 85.8 | 22.53 | 0.3 | 4.20 | 4.58 | 9 | 19.2 | 65.06 | 3.4 |
Order = Placebo/OMA | ||||||||||||
3 | 2.63 | 2.89 | 10 | 19.7 | 54.23 | 2.8 | 2.70 | 2.73 | 1 | 65.2 | >200 | 3.1 |
6†† | 4.13 | 4.26 | 3 | 12.3 | 7.80 | 0.6 | 3.59 | 4.82 | 34 | 3.10 | 15.51 | 5.0 |
10†† | 2.55 | 2.81 | 10 | 10.9 | 5.23 | 0.5 | 2.39 | 3.22 | 35 | 2.45 | 5.93 | 2.4 |
13†† | 3.14 | 3.25 | 4 | 9.30 | 52.78 | 5.7 | 2.88 | 3.14 | 9 | 5.17 | 141.30 | 27.3 |
27†† | 2.81 | 2.60 | -7 | 5.50 | 2.64 | 0.5 | 2.27 | 2.40 | 6 | 1.05 | 4.45 | 4.2 |
30 | 3.23 | 3.19 | -1 | 40.8 | 158.09 | 3.9 | 3.23 | 3.35 | 4 | 27.8 | >200 | 7.2 |
34 | 2.44 | 2.26 | -7 | 15.4 | 2.91 | 0.2 | 2.54 | 2.47 | -3 | 20.2 | 90.51 | 4.5 |
38†† | 1.80 | 2.02 | 12 | 13.9 | 14.81 | 1.1 | 1.96 | 2.16 | 10 | 17.6 | 11.86 | 0.7 |
Mean | 2.86 | 2.99 | 6 | 2.76 | 2.96 | 6 | ||||||
SD | 0.80 | 0.76 | 9 | 0.71 | 0.91 | 13 | ||||||
Geometric Mean | 20.1 | 18.5 | 0.9 | 10.8 | 33.9 | 3.1† | ||||||
95% CI | 11.7,34.6 | 9.8,35.1 | 0.5,1.7 | 5.9,19.7 | 15.0,76.8 | 1.6,6.2 |
Fold change = PC20 end/PC20 beginning of period. The log of these values was used in the statistical analysis.
Significantly greater than placebo (p = 0.022).
Received prednisone during placebo. Subject #10 required two courses.