| Placebo | Etanercept | ||||||||
| Mean | Mean | ||||||||
| n | Before | After | Diff (95%CI) | n | Before | After | Diff (95%C) | p Value | |
| Clinical outcomes | |||||||||
| AQLQ | |||||||||
| Score (0–7) | 20 | 3.57 | 4.26 | 0.68 (0.14, 1.23) | 19 | 3.74 | 4.76 | 1.03 (0.64, 1.396) | 0.084 |
| ACQ | |||||||||
| Score (0–7) | 20 | 3.08 | 2.56 | −0.52 (−0.97, −0.07) | 19 | 3.35 | 2.24 | −1.11 (−1.56, −0.75) | 0.037 |
| Lung function | |||||||||
| Actual FEV1 (l) | 20 | 2.01 | 1.89 | −0.11 (−0.34, 0.12) | 19 | 1.85 | 1.88 | 0.03 (−0.12, 0.19) | 0.282 |
| % Predicted FEV1 | 20 | 64.20 | 61.30 | −2.75 (−9.75, 4.25) | 19 | 60.31 | 61.57 | 1.01 (−4.56, 6.57) | 0.387 |
| Expiratory ratio (FEV1/FVC) | 20 | 0.63 | 0.67 | 0.04 (0.01, 0.07) | 19 | 0.61 | 0.67 | 0.06 (0.02, 0.11) | 0.232 |
| FEV25–75 | 20 | 1.15 | 1.10 | −0.05 (−0.28, 0.17) | 19 | 1.03 | 1.12 | 0.09 (−0.14, 0.33) | 0.240 |
| PEF | |||||||||
| Morning PEF (l/min) | 20 | 302.1 | 312.2 | 10.10 (−6.49, 26.69) | 19 | 283.3 | 310.75 | 27.31 (−1.38, 56.01) | 0.332 |
| Evening PEF (l/min) | 20 | 314.29 | 320.50 | 6.79 (−8.56, 22.14) | 19 | 300.01 | 317.01 | 17.00 (−8.18, 42.17) | 0.467 |
| Diurnal variation in PEF | 20 | 10.41 | 9.90 | −0.51 (−5.17, 6.20) | 19 | 10.69 | 4.13 | −6.56 (−12.69, −0.43) | 0.095 |
| Average PEF (l/min) | 20 | 308.0 | 316.5 | 8.45 (−5.94, 22.84) | 19 | 291.7 | 313.9 | 22.15 (−3.83, 48.15) | 0.276 |
| PC20 | |||||||||
| Geometric mean (mg methacholine/ml) | 13 | 0.54 | 0.56 | 0.06† (−1.22†, 1.34) | 11 | 1.06 | 2.03 | 0.94† (−0.77†, 2.65) | 0.366*† |
| Serum | |||||||||
| Cells, inflammatory markers | |||||||||
| Eosinophils (×109/l) | 19 | 0.530 | 0.401 | −0.131 (−0.267, 0.004) | 18 | 0.400 | 0.472 | 0.050 (−0.154, 0.254) | 0.125 |
| Neutrophils (×109/l) | 19 | 5.270 | 5.459 | 0.189 (−0.741, 1.120) | 18 | 4.896 | 5.724 | 0.828 (−0.139, 1.794) | 0.323 |
| Albumin (gm/l) | 17 | 38.36 | 37.89 | −0.470 (−1.434, 0.493) | 16 | 39.29 | 40.29 | 1.000 (0.128, 1.871) | 0.022 |
| CRP (mg/l) | 15 | 5.245 | 4.959 | −0.286 (−1.706, 1.134) | 14 | 3.859 | 2.697 | −1.162 (−2.003, −0.321) | 0.029 |
| TNFα (pg/ml) | 18 | 2.490 | 2.006 | −0.485 (−1.084, 0.114) | 18 | 2.943 | 57.41 | 54.47 (50.33, 58.60) | <0.001 |
| Total IgE (IU/ml) | 17 | 357.1 | 331.13 | −26.04 (−80.21, 28.13) | 16 | 629.1 | 621.43 | −7.73 (−135.2, 119.7) | 0.778* |
| Sputum | |||||||||
| Mean | Mean | ||||||||
| n | Before | After | Diff (IQR) | n | Before | After | Diff (IQR) | p Value | |
| Cells | |||||||||
| Eosinophils (%) | 8 | 10 | 11 | −5.1 (−13.2, 3.8) | 8 | 4.1 | 11 | 8.0 (2.4, 15.7) | 0.098* |
| Neutrophils (%) | 8 | 37 | 25 | −13 (−26.8, 5.8) | 8 | 33 | 30 | 2.1 (−1.5, 20.7) | 0.204* |
| Macrophages (%) | 8 | 44 | 52 | 11 (−3.3, 19.5) | 8 | 48 | 30 | −8.9 (−26.5, −0.8) | 0.017* |
| Cytokines | |||||||||
| IL6 (pg/ml) | 8 | 43.10 | 33.90 | 21.90 (−2.03, 66.88) | 8 | 37.70 | 25.75 | −7.25 (−33.45, −3.88) | 0.216* |
| IL8 (pg/ml) | 8 | 1696.2 | 2318.5 | 1496.3 (−10.45, 1799.33) | 8 | 2500.5 | 2891.9 | 0.00 (−889.93, 892.80) | 0.098* |
| IL1β (pg/ml) | 8 | 0.00 | 0.00 | 0.00 (−3.60, 0.00) | 8 | 55.80 | 0.00 | −55.80 (−131.90, 24.45) | 0.308* |
The table refers to the differences in change in outcome between the mean of visit 0 and mean of visits 11 and 12 for all outcomes except AQLQ, PC20, FEV25–75, and sputum and serum samples, which refer to the change between visit 0 and 12.
n is the number of patients or paired serum and sputum samples available for analysis for clinical or laboratory outcomes, respectively.
*Non-parametric Mann–Whitney U tests used; all others are Student’s t tests.
†The doubling dilution is the difference in the log PC20 before and after treatment divided by log 2.
ACQ, Asthma Control Questionnaire; AQLQ, Asthma Quality of Life Questionnaire; CRP, C reactive protein; FEV1, forced expiratory volume in 1 s; FVC, forced vital capacity; ICS, inhaled corticosteroid; IL, interleukin; OCS, oral corticosteroid; PEF, peak expiratory flow; TNFα, tumour necrosis factor α.