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NCT Number: NCT04821908

Consequences of COVID 19 Pandemic on Childhood Asthma

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.

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Key information

Conditions

Asthma in Children COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Lille

Lille, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Controlled asthma

    Time frame: at inclusion

    Composite criteria defined by a cACT (4-11 years) or ACT (12-16 years) score ≥ 20 and according to GINA criteria.

Secondary outcomes

  1. Characteristics of asthma

    Time frame: At inclusion and follow-up visit at 2-4 months for the sub-population included at exacerbation

    Composite criteria : allergic phenotype, severity assessed by GINA treatment level, number of exacerbations in the past year, lung function

  2. history of SARS-Cov2 infection in the past year

    Time frame: At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation

    history of SARS-Cov2 infection based on patient report

  3. number of infectious episodes in the past year

    Time frame: At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation

    number of infectious episodes based on patient report

  4. Observance

    Time frame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation

    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".

  5. QoL (Quality of life) in children aged 7-17 years

    Time frame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation

    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.

  6. Outdoor levels of pollutants and pollens

    Time frame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation

    Composite criteria : monthly average measurements of CO, O3, NO, NO2, SO2, PM2.5, PM10 and pollen counts

  7. Respiratory virus infection (SARS-CoV2 and other)

    Time frame: at exacerbation and at follow-up visit at 2-4 months for the sub-population included at exacerbation

    Results of viral PCR

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: VIRASTHCOVID

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Mar 30, 2021
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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