All patients | All placebo patients | Placebo patients with ≥1 exacerbations | Placebo patients with 0 exacerbations | |
Patients | 5701 | 2016 | 850 | 1166 |
Age years | 49.5±14.0 | 49.6±14.3 | 50.1±13.7 | 49.2±14.8 |
Female | 3756 (66) | 1331 (66) | 583 (69) | 748 (64) |
Ex-smoker | 1085 (19) | 378 (19) | 183 (22) | 195 (17) |
BMI kg·m−2 | 28.6±6.3 | 28.6±6.4 | 28.9±6.9 | 28.4±6.0 |
≥3 exacerbations in past 12 months | 1642 (29) | 586 (29) | 324 (38) | 262 (22) |
≥1 exacerbations resulting in hospitalisation or ED visit in past 12 months | 1877 (33) | 673 (34) | 330 (40) | 343 (30) |
Age at asthma diagnosis years | 29.9±18.7 | 29.8±19.1 | 30.2±18.4 | 29.5±19.5 |
Asthma diagnosed as an adult | 3962 (69) | 1398 (69) | 611 (72) | 787 (68) |
Pre-bronchodilator FEV1 % pred | 60.5±14.9 | 60.7±15.0 | 58.4±15.7 | 62.4±14.2 |
Reversibility % | 22.9±26.3 | 23.3±28.7 | 23.8±34.4 | 22.9±23.7 |
Blood eosinophil count cells·μL−1# | 260 (0‒7510) | 250 (0‒5330) | 280 (0‒3000) | 240 (0‒5330) |
FENO ppb¶ | 21.5 (0‒312.5) | 21.2 (0‒276.3) | 22.7 (3.9‒193.8) | 20.0 (0‒276.3) |
Total serum IgE kU·L−1+ | 170.1 (0.3‒46 983.8) | 171.3 (1.0‒24 749.4) | 182.7 (2.0‒17 317.0) | 167.1 (1.0–24 749.4) |
ACQ-6 score | 2.6±0.9 | 2.6±0.9 | 2.7±0.9 | 2.6±0.9 |
Diagnosis of allergic rhinitis§ | 1297 (38) | 494 (39) | 218 (47) | 276 (35) |
Nasal polyposis | 746 (13) | 260 (13) | 139 (16) | 121 (10) |
Atopic-positive per Phadiatop/FEIAƒ | 3347 (61) | 1194 (62) | 507 (63) | 687 (62) |
Background high-dosage ICS | 3205 (56) | 1110 (55) | 471 (55) | 639 (55) |
Maintenance OCS use | 420 (7) | 140 (7) | 90 (11) | 50 (4) |
History of omalizumab## | 130 (3) | 49 (3) | 39 (6) | 10 (1) |
Data are presented as n, mean±sd, n (%) or median (range). BMI: body mass index; ED: emergency department; FEV1: forced expiratory volume in 1 s; FENO: exhaled nitric oxide fraction; ACQ-6: Asthma Control Questionnaire-6; FEIA: fluorescence enzyme immunoassay; ICS: inhaled corticosteroid; OCS: oral corticosteroid. #: data available for 5621 patients overall and for 1993 patients in the placebo group; ¶: data available for 3014 patients overall and for 1111 patients in the placebo group; +: data available for 5528 patients overall and for 1957 patients in the placebo group; §: data available for 3453 patients overall and for 1255 patients in the placebo group; ƒ: data available for 5482 patients overall and for 1926 patients in the placebo group; ##: data available for 4188 patients overall and for 1536 patients in the placebo group.