Clinical trial NCT04821908: Consequences of COVID 19 Pandemic on Childhood Asthma
Official title: Consequences of SARS-CoV2 Pandemic on Childhood Asthma Control and Exacerbations: French Multicenter Cross-sectional VIRASTHMA COVID G4 Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma in Children
Keywords: Asthma control
COVID-19 pandemic
Respiratory infection
Environmental pollution
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-03-30
Enrollment: 577
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: children and adolescents diagnosed with asthma.

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Controlled asthma
timeFrame: at inclusion
Secondary outcomes:
measure: Characteristics of asthma
timeFrame: At inclusion and follow-up visit at 2-4 months for the sub-population included at exacerbation
measure: history of SARS-Cov2 infection in the past year
timeFrame: At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
measure: number of infectious episodes in the past year
timeFrame: At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
measure: Observance
timeFrame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
measure: QoL (Quality of life) in children aged 7-17 years
timeFrame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
measure: Outdoor levels of pollutants and pollens
timeFrame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
measure: Respiratory virus infection (SARS-CoV2 and other)
timeFrame: at exacerbation and at follow-up visit at 2-4 months for the sub-population included at exacerbation
Other outcomes:
Locations:
city: Lille
country: France
facility: CHU Lille
Study officials:
affiliation: University Hospital, Lille
name: Stéphanie Lejeune, MD
role: PRINCIPAL_INVESTIGATOR
References: