Characteristics of study patients at baseline, presented as mean (SD) unless otherwise stated
| Patients randomly allocated to treatment (n=312) | Patients in primary efficacy analysis (n=282) | |||
| Active (n=207) | Placebo (n=105) | Active (n=189) | Placebo (n=93) | |
| Age (years) | 24.2 (16.1) | 24.2 (15.6) | 24.7 (16.1) | 24.9 (16.0) |
| Age <12, n (%) | 51 (25%) | 26 (25%) | 46 (24%) | 22 (24%) |
| Male sex, n (%) | 117 (57%) | 50 (48%) | 107 (57%) | 44 (47%) |
| Country: | ||||
| Sweden, n (%) | 99 (48%) | 51 (49%) | 91 (48%) | 47 (51%) |
| Denmark, n (%) | 33 (16%) | 22 (21%) | 32 (17%) | 22 (24%) |
| UK, n (%) | 34 (16%) | 19 (18%) | 30 (16%) | 13 (14%) |
| Germany, n (%) | 23 (11%) | 11 (11%) | 23 (12%) | 10 (11%) |
| Norway, n (%) | 7 (3%) | 0 (0%) | 7 (4%) | 0 (0%) |
| Finland, n (%) | 6 (3%) | 1 (1%) | 6 (3%) | 1 (1%) |
| BMI (kg/m2) of adults (>18) | 25.8 (4.4) | 25.8 (5.2) | 25.8 (4.5) | 25.7 (5.4) |
| Duration of asthma (years) | 14.6 (12.8) | 12.1 (10.5) | 14.8 (12.9) | 11.7 (10.6) |
| AQLQ* | 4.20 (0.96) | 4.27 (0.96) | 4.21 (0.92) | 4.25 (0.97) |
| FEV1 (% predicted) | 89.6 (17.7) | 91.8 (16.9) | 89.9 (17.6) | 91.2 (15.3) |
| PEF (% predicted) | 92.7 (18.8) | 92.5 (22.0) | 93.3 (18.6) | 92.5 (21.3) |
| FEF50 (% predicted) | 71.3 (27.9) | 71.2 (30.4) | 71.4 (28.1) | 72.4 (29.7) |
| FENO (ppb) | 37.3 (38.0) | 34.0 (34.1) | 38.5 (38.6) | 34.5 (33.3) |
| Eosinophil count (%) | 0.45 (0.62) | 0.45 (0.56) | 0.45 (0.62) | 0.45 (0.56) |
| ACT score | 15.7 (3.9) | 16.1 (3.5) | 15.8 (3.7) | 15.9 (3.5) |
| Inhaled corticosteroid dose† | 586 (445) | 610 (372) | 576 (368) | 616 (376) |
| House dust mite sensitised, n (%)‡ | 133 (66%) | 70 (695) | 127 (67%) | 64 (69%) |
| IgE Der. pteronyssinus, median (IQR) | 3.9 (0.3, 32.7) | 4.1 (0.3, 37.3) | 3.9 (0.3, 32.7) | 4.1 (0.3, 37.3) |
| IgE Der. farinae, median (IQR) | 4.0 (0.3, 31.1) | 3.9 (0.3, 29.8) | 4.0 (0.3, 31.1) | 3.9 (0.3, 29.8) |
| Cat sensitised, n (%)‡ | 139 (69%) | 73 (72%) | 127 (67%) | 66 (71%) |
| IgE cat, median (IQR) | 2.0 (0.3, 10.6) | 1.0 (0.3, 5.1) | 2.0 (0.3, 10.6) | 1.0 (0.3, 5.1) |
| Dog sensitised, n (%)‡ | 118 (59%) | 61 (60%) | 109 (58%) | 56 (60%) |
| IgE dog, median (IQR) | 1.1 (0.3, 5.4) | 0.8 (0.3, 3.8) | 1.1 (0.3, 5.4) | 0.8 (0.3, 3.8) |
| Seasonal allergen sensitised, n (%)§ | 87 (43%) | 43 (42%) | 85 (45%) | 38 (41%) |
| Total IgE, median (IQR) | 281 (109, 662) | 257 (120, 506) | 281 (109, 662) | 257 (120, 506) |
| Rhinitis, n (%) | 191 (95%) | 98 (96%) | 180 (95%) | 88 (95%) |
| Eczema, n (%) | 49 (24%) | 18 (17%) | 45 (24%) | 17 (18%) |
| Food allergy, n (%) | 28 (14%) | 8 (8%) | 23 (12%) | 7 (8%) |
All IgE levels are in kU/litre.
↵* AQLQ=mini-AQLQ for those aged ≥12 years, PAQLQ for those <12 years.
↵† Inhaled corticosteroid dose is beclomethasone dipropionate equivalent daily dose.
↵‡ Sensitised=specific IgE level ≥0.70 KU/litre or positive skin prick test (weal diameter to allergen ≥ weal diameter of positive control) to the relevant allergen, taken within 2 years of study enrolment (1 year if ≤12 years).
↵§ Seasonal allergen=grass pollen, birch pollen, mugwort or mould.
ACT, Asthma Control Test; AQLQ, Asthma Quality of Life Questionnaire; BMI, body mass index; Der. farinae, Dermatophagoides farina; Der. pteronyssinus, Dermatophagoides pteronyssinus; FEF50, forced expiratory flow at 50% of vital capacity; FENO, fractional exhaled nitric oxide; FEV1, forced expiratory volume in 1 s; PAQLQ, Paediatric Asthma Quality of Life Questionnaire; PEF, peak expiratory flow.