Tralokinumab | Placebo | Total | |
Patients | 70 | 70 | 140 |
Age years | 54.0±11.05 | 55.4±10.26 | 54.7±10.65 |
Female | 48 (68.6) | 39 (55.7) | 87 (62.1) |
BMI kg·m−2 | 28.1±5.07 | 30.8±6.84 | 29.4±6.15 |
Race | |||
Caucasian | 66 (94.3) | 63 (90.0) | 129 (92.1) |
Other | 4 (5.7) | 7 (10.0) | 11 (7.8) |
Smoking history | |||
Never-smokers | 57 (81.4) | 50 (71.4) | 107 (76.4) |
Ex-smokers¶ | 13 (18.6) | 20 (28.6) | 33 (23.6) |
Pack-years+ | 4.5±2.37 | 4.7±3.10 | 4.6±2.79 |
Time since asthma diagnosis§ years | 21.5 (3–52) | 25.5 (1.6–55.0) | 24.0 (1.6–55.0) |
Exacerbations in the past 1 year | |||
0 | 9 (12.9) | 11 (15.7) | 20 (14.3) |
1 | 19 (27.1) | 24 (34.3) | 43 (30.7) |
2 | 21 (30.0) | 17 (24.3) | 38 (27.1) |
≥3 | 21 (30.0) | 18 (25.7) | 39 (27.8) |
Asthma medications at baseline | |||
ICSƒ | 69 (98.6) | 70 (100) | 139 (99.3) |
LABA | 70 (100) | 70 (100) | 140 (100) |
OCS dose at trial entry mg | 14.14±6.03 | 13.50±5.18 | 13.82±5.61 |
Optimised total daily OCS dose## mg | 13.21±6.17 | 12.82±4.96 | 13.02±5.58 |
Prebronchodilator FEV1 | |||
Volume L | 1.69±0.59 | 1.65±0.68 | 1.67±0.63 |
% predicted | 56.67±15.58 | 54.74±17.67 | 55.71±16.63 |
Prebronchodilator FVC L | 2.87±0.84 | 2.81±0.98 | 2.84±0.91 |
Percentage reversibility of FEV1¶¶ | 17.22±14.04 | 18.19±19.24 | 17.71±16.79 |
Total asthma symptom score | 2.3±1.14 | 2.3±1.25 | Not done |
ACQ-6 score | 2.4±1.12 | 2.5±1.26 | Not done |
AQLQ score | 4.4±1.15 | 4.4±1.29 | Not done |
FeNO ppb | 28.3 (6.4–175.2) | 23.9 (4.2–134.9) | 27.55 (4.1–175.2) |
FeNO distribution | |||
High ≥37 ppb | 23 (32.9) | 21 (30.0) | 44 (31.4) |
Mid ≥30 and <37 ppb | 11 (15.7) | 11 (15.7) | 22 (15.7) |
Low <30 ppb | 36 (51.4) | 36 (51.4) | 72 (51.4) |
No baseline assessment | 0 | 2 (2.9) | 2 (1.4) |
Data are presented as n, mean±sd, n (%) or median (range). BMI: body mass index; ICS: inhaled corticosteroids; LABA: long-acting β2-agonists; OCS: oral corticosteroids; FEV1: forced expiratory volume in 1 s; FVC: forced vital capacity; ACQ-6: Asthma Control Questionnaire-6; AQLQ: Asthma Quality of Life Questionnaire (standardised for patients aged ≥12 years); FeNO: fractional exhaled nitric oxide. #: the full analysis set consisted of all patients who were randomised and received any dose of either tralokinumab or placebo, irrespective of their protocol adherence and continued participation in the trial. ¶: stopped smoking ≥3 months before enrolment. +: for patients who had stopped smoking (former smokers). §: calculated as (date of asthma diagnosis/date when asthma symptoms started – date of randomisation) + 1. ƒ: one patient in the tralokinumab group was not receiving ICS at trial entry, and one patient in the tralokinumab group was receiving a lower ICS daily dose than the required limit. These infractions were considered as important protocol deviations. More patients in the placebo group were using asthma medications other than ICS/LABA. ##: for patients entering the optional OCS dose optimisation on visit 2. ¶¶: this was the first post-bronchodilation measurement taken after four, six or eight inhalations of a short-acting β2-agonist. The percentage reversibility of the FEV1 was calculated with FEV1 values obtained before and after bronchodilation at baseline: reversibility (%) = ((post-bronchodilation FEV1 – prebronchodilation FEV1)/prebronchodilation FEV1) × 100.