Consequences of COVID 19 Pandemic on Childhood Asthma

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Consequences of SARS-CoV2 Pandemic on Childhood Asthma Control and Exacerbations: French Multicenter Cross-sectional VIRASTHMA COVID G4 Study

Conditions
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Asthma in Children

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children and adolescents aged 3 to 16 years old With a medical diagnosis of asthma as per-guidelines, who had been followed-up for at least 6 months, Assessed in one of the pediatric departments participating in the study, After written consent of at least one of the 2 parents and/or representative of the parental authority, and of the child if he is older than 8 years old. Criteria for the sub-population assessed at exacerbation and second visit: Children and adolescents aged 3 to 16 years With a medical diagnosis of asthma as per-guidelines, who had been followed-up for at least 6 months, Hospitalized for a severe asthma exacerbation (requiring hospitalization and general corticosteroid therapy) at Lille University Hospital After written consent of both parents and/or representative of the parental authority, and of the child if he is over 8 years old Exclusion Criteria: History of chronic respiratory disease other than asthma, Inability of parents to receive informed information, inability to participate in the entire study, refusal to sign the consent form

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br>population included in the VIRASTHMA COVID G4 study | |
| Group 2<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Controlled asthma | Composite criteria defined by a cACT (4-11 years) or ACT (12-16 years) score ≥ 20 and according to GINA criteria. | at inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characteristics of asthma | Composite criteria : allergic phenotype, severity assessed by GINA treatment level, number of exacerbations in the past year, lung function | 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 | 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 | 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. | 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. | 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 | 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 | at exacerbation and at follow-up visit at 2-4 months for the sub-population included at exacerbation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma control, COVID-19 pandemic, Respiratory infection, Environmental pollution