Data source
This is an observational, cross-sectional study designed by the Allergy
Department of Castellon’s University General Hospital, Spain. Subjects
recruited were patients with severe asthma in treatment with MAB,
pertaining to the Departments of Allergy and/or Pneumology in our
hospital (108 patients). A list of all patients was obtained by using
the data base available in each department. Inclusion criteria: patients
with severe asthma, in treatment with any of the MAB, approved for
severe asthma treatment (omalizumab, mepolizumab, benralizumab or
reslizumab), during 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 had discontinued treatment by self-decision. The time span of
analysis dates from 1º March to 30º May 2020, corresponding to the
months with most incidence of the disease in Spain.
In order to answer the principal objective, a questionnaire was
developed with a total of 19 questions (Table 1) divided in 3 blocks.
Block one corresponds to questions 1 to 4, where patients were asked
about COVID-19 symptoms, COVID-19 RT-PCR and serological tests results.
Block two: questions 5 to 11 made reference to asthma control and
treatment during the pandemic. Block Three: questions 12 to 19 analyzed
possible exposition to the disease, and their lifestyle before the
pandemic.
When referring to therapeutic adherence to base treatment (questions 5
and 10), Test of Adherence to Inhalers (TAI – 10 items) [10] was
used. A result of 50 meant good adherence, between 46-49 meant
intermedia adherence, and 45 or below, meant bad adherence.
Subsequently, in order to analyze patients’ asthma control, the Asthma
control test (ACT) [11] was used. A result of 20 or more meant good
asthma control, meanwhile, 19 or less, meant poor asthma control. When
analyzing their daily activity before the pandemic (question 15), an
active level of activity, was defined as, going out 7 days a week (for
work, 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. Questionnaires were
completed either face-to-face or by telephone. Before filling in the
questionnaire, oral consent was requested to each patient. Approval from
the ethics committee was obtained.
Clinical data values analyzed for each patient (Table 2), were collected
using the hospital‘s clinical network. Clinical values were chosen based
on risk and protective factors described for coronavirus disease [12,
13]. Data registered included, sex, age, type of asthma, inhaled
corticosteroid doses, oral corticosteroid treatment, 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. Once each
variable was collected and analyzed, serological tests were performed at
the hospital’s laboratory, to patients who have had suggestive COVID-19
symptoms, by using total SARS-Cov-2 antibody test by
immunochromatography (Wondfo®, Guangzhou Wondfo Biotech Co., Ltd. P.R.
China). During the months of June and July, blood tests were carried out
to patients, the day they came for their biological treatment
administration.