An observational study in Asthma in Children, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 3 Years to 16 Years. Per ClinicalTrials.gov, last updated 2026-05-14.
Sponsored by University Hospital, Lille · Observational
The SARS-CoV2 pandemic, which emerged in the first quarter of 2020, has led to an unprecedented health crisis in our modern healthcare systems and has resulted in strong national public health measures. The impact of the pandemic and its indirect environmental consequences on pediatric asthma is currently being assessed. In particular, the study of its role on the risk of exacerbations and modification of control is one of the priority research objectives defined by European societies.
The primary aim is to study the impact of the pandemic on asthma control in children aged 3-16 years with a medical diagnosis of asthma, compared to data from other observational cohorts conducted in the same region prior to the pandemic.
A sub-population of children 3-16 years will be assessed at exacerbation and at a follow-up visit, 2-4 months later, with clinical data, biological and microbiological samples.
Children aged 3-16 years with a medical diagnosis of asthma, will be assessed for asthma control, exacerbation rate.
Data will be compared to data from other observational cohorts conducted in the same region prior to the pandemic.
A sub-population of children 3-16 years will be assessed at exacerbation and at a follow-up visit, 2-4 months later, with clinical data, biological and microbiological samples.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 577 is above the median of 260 across 3,135 observational studies indexed under COVID-19.
Browse COVID-19 studies →University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.
Counted across the registry records on this site, refreshed daily.
children and adolescents diagnosed with asthma.
Criteria for the sub-population assessed at "exacerbation" and second visit:
Exclusion Criteria:
population included in the VIRASTHMA COVID G4 study
population included in the previous studies "VIRASTHMA", "CHAMPIASTHMA" (IRDCB No.: 2019-A03310-57), "COBRAPED" (NCT02114034), "VIRASTHMA 2" (IRDCB No.: 2014 A01687 40, NCT: 03960359), "INCOVPED" (pediatric emergencies, NCT04336761).
Controlled asthma
Composite criteria defined by a cACT (4-11 years) or ACT (12-16 years) score ≥ 20 and according to GINA criteria.
Time frame: at inclusion
Characteristics of asthma
Composite criteria : allergic phenotype, severity assessed by GINA treatment level, number of exacerbations in the past year, lung function
Time frame: At inclusion and follow-up visit at 2-4 months for the sub-population included at exacerbation
history of SARS-Cov2 infection in the past year
history of SARS-Cov2 infection based on patient report
Time frame: At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
number of infectious episodes in the past year
number of infectious episodes based on patient report
Time frame: At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Observance
Assessed by four-items Morisky-Green questionnaire : 1/ Do you ever forget to take your medication; 2/ Are you careless sometimes about taking your medication 3/ When you feel better, do you sometimes stop taking your medication 4/ Sometimes, if you feel worse when you take your medication, do you stop taking it. An answer "no" to any of the 4 questions is considered as "not well-observed medication".
Time frame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
QoL (Quality of life) in children aged 7-17 years
Assessed by PAQLQ : PAEDIATRIC ASTHMA QUALITY OF LIFE QUESTIONNAIRE. The PAQLQ has 23 questions in 3 domains (symptoms, activity limitation and emotional function). The activity domain contains 3 'patient-specific' questions. Children are asked to think about how they have been during the previous week and to respond to each of the 32 questions on a 7-point scale (7 = not bothered at all - 1 = extremely bothered). The overall PAQLQ score is the mean of all 23 responses and the individual domain scores are the means of the items in those domains. The highest the score is, the better QoL is.
Time frame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Outdoor levels of pollutants and pollens
Composite criteria : monthly average measurements of CO, O3, NO, NO2, SO2, PM2.5, PM10 and pollen counts
Time frame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Respiratory virus infection (SARS-CoV2 and other)
Results of viral PCR
Time frame: at exacerbation and at follow-up visit at 2-4 months for the sub-population included at exacerbation
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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University Hospital, Lille