Characteristics and outcomes | Baseline | Time A | Time B |
Age years | |||
Omalizumab | 47 (22–66) | ||
Placebo | 53.50 (25–59) | ||
Male/female n | |||
Omalizumab | 5/3 | ||
Placebo | 3/5 | ||
Weight kg | |||
Omalizumab | 84 (55–133) | ||
Placebo | 87.50 (61–112) | ||
Height cm | |||
Omalizumab | 172 (155–178) | ||
Placebo | 166 (152–177) | ||
Never-smokers n (of 8 total) | |||
Omalizumab | 3 | ||
Placebo | 4 | ||
Serum total IgE IU·mL−1 | |||
Omalizumab | 75 (8–264) | ||
Placebo | 49 (2–284) | ||
FEV1 L | |||
Omalizumab | 2.44 (1.81–3.43) | 0.225 (−0.32–1.24) | 0.26 (0.03–0.67)# |
Placebo | 2.34 (1.16–3.66) | 0.005 (−0.30–0.45) | −0.06 (−0.63–0.39) |
FEV1% predicted | |||
Omalizumab | 75 (50–98) | 6 (−13–36) | 11 (1–19)¶ |
Placebo | 80 (47–114) | −4 (−11–14) | −2 (−23–15) |
ACQ score | |||
Omalizumab | 2.28 (1.43–3.43) | −0.50 (−1.85–0.72) | −0.71 (−1.14–0.14) |
Placebo | 2.42 (0.71–3.28) | −0.35 (−1.00–0.57) | −0.28 (−1.71–1.14) |
Mini-AQLQ score | |||
Omalizumab | 4.33 (2.53–5.27) | 0.18 (−1.00–2.26) | 0.46 (−0.40–2.06) |
Placebo | 4.60 (3.73–5.80) | 0.37 (−1.34–1.87) | 0.67 (−1.60–2.30) |
ICS BDP equivalent μg·day−1 | |||
Omalizumab | 2000 (800–4000) | No change from baseline | Reduced to 200 μg BDP equivalent per day |
Placebo | 1800 (500–2000) | No change from baseline | Reduced to 200 μg BDP equivalent per day |
Data are presented as median (range). FEV1: forced expiratory volume in 1 s; ACQ: Juniper Asthma Control Questionnaire; mini-AQLQ: Juniper mini-Asthma Quality of Life Questionnaire; ICS: inhaled corticosteroids; BDP: beclometasone dipropionate. #: p=0.04, ¶: p=0.015 compared with baseline (Mann-Whitney U-test).