Data source
This is an observational, cross-sectional study designed by the Allergy
Department of Castellon’s University General Hospital, Spain. Subjects
recruited were pediatric patients with severe asthma in treatment with
MAB, pertaining to the Pediatric Allergy Department in our hospital.
Inclusion criteria: patients with severe asthma, in treatment with MAB
(omalizumab, mepolizumab, benralizumab, reslizumab or dupilumab), for 6
months or more and with a positive complementary study for asthma
diagnosis (spirometry with positive bronchial dilatation, or positive
methacholine test). Exclusion criteria: patients who had recently
started biological treatment (˂ 6 months), or patients who did not
compliment treatment correctly. Analysis dates went from 1º March to 31º
July 2020.
To answer the objectives proposed, a questionnaire was developed with a
total of 19 questions (Table 1) divided in 3 blocks. Block one:
(questions 1 to 4) patients were asked about their lifestyle before the
pandemic. Block two: (questions 5 to 9) referred to COVID-19 symptoms
and possible exposition to the disease. Block Three: (questions 10 to
19) analyzed patients’ behavior, asthma control and treatment during the
pandemic.
When analyzing their daily activity before the pandemic (question 1), an
active level of activity was defined as going out 7 days a week (school,
sport activities, social meetings, shopping, etc.); a normal level 5
days a week, a moderate level less than 5 days a week, and a low level
of activity less than 2 days a week. When referring to therapeutic
adherence to base treatment (question 10), Test of Adherence to Inhalers
(TAI – 10 items) [6] was used. A result of 50 meant good adherence,
between 46-49 meant intermedia adherence, and 45 or below, meant bad
adherence. Subsequently, to analyze patients’ asthma control (question
15), the Asthma control test (ACT) [7] was used. A result of 20 or
more meant good asthma control, meanwhile, 19 or less, meant poor asthma
control. Questionnaires were filled out with a face-to-face interview
with prior authorization from their parents. Approval from the ethics
committee was obtained.
Clinical data was also collected for each patient (Table 2), using the
hospital‘s clinical network. Clinical values were chosen based on risk
and protective factors described for coronavirus disease. [8,9] Data
registered included, sex, age, type of asthma, inhaled corticosteroid
doses, and comorbidities. Significant clinical values for asthma
syndrome were recorded: FEV1, association of nasal polyps, Samter’s
Triad, Allergic bronchopulmonary Aspergillosis (ABPA), and the need of
medical attention or hospitalization in the last year, due to
uncontrolled asthma.
Finally, in order to study COVID-19 prevalence in our patients,
serological tests were performed at the hospital’s laboratory, to all
patients, by using total SARS-Cov-2 antibody test by
immunochromatography (Wondfo®, Guangzhou Wondfo Biotech Co., Ltd. P.R.
China), being its sensitivity (86.43%) and its specificity (99.57%).