TABLE 1

Demographics and baseline clinical characteristics

All patientsAll placebo patientsPlacebo patients with ≥1 exacerbationsPlacebo patients with 0 exacerbations
Patients570120168501166
Age years49.5±14.049.6±14.350.1±13.749.2±14.8
Female3756 (66)1331 (66)583 (69)748 (64)
Ex-smoker1085 (19)378 (19)183 (22)195 (17)
BMI kg·m−228.6±6.328.6±6.428.9±6.928.4±6.0
≥3 exacerbations in past 12 months1642 (29)586 (29)324 (38)262 (22)
≥1 exacerbations resulting in hospitalisation or ED visit in past 12 months1877 (33)673 (34)330 (40)343 (30)
Age at asthma diagnosis years29.9±18.729.8±19.130.2±18.429.5±19.5
Asthma diagnosed as an adult3962 (69)1398 (69)611 (72)787 (68)
Pre-bronchodilator FEV1 % pred60.5±14.960.7±15.058.4±15.762.4±14.2
Reversibility %22.9±26.323.3±28.723.8±34.422.9±23.7
Blood eosinophil count cells·μL−1#260 (0‒7510)250 (0‒5330)280 (0‒3000)240 (0‒5330)
FENO ppb21.5 (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 score2.6±0.92.6±0.92.7±0.92.6±0.9
Diagnosis of allergic rhinitis§1297 (38)494 (39)218 (47)276 (35)
Nasal polyposis746 (13)260 (13)139 (16)121 (10)
Atopic-positive per Phadiatop/FEIAƒ3347 (61)1194 (62)507 (63)687 (62)
Background high-dosage ICS3205 (56)1110 (55)471 (55)639 (55)
Maintenance OCS use420 (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.