NCT04821908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
577

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 30, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

September 14, 2021

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

May 14, 2026

Status Verified

March 1, 2025

Enrollment Period

3.5 years

First QC Date

March 29, 2021

Last Update Submit

May 11, 2026

Conditions

Asthma in Children

Keywords

Asthma controlCOVID-19 pandemicRespiratory infectionEnvironmental pollution

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Characteristics of asthma

    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

    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

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

  • Observance

    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

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

  • +2 more secondary outcomes

Study Arms (2)

Group 1

population included in the VIRASTHMA COVID G4 study

Group 2

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).

Eligibility Criteria

Age3 Years - 16 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

children and adolescents diagnosed with asthma.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Lille

Lille, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

plasma nasal swab

MeSH Terms

Conditions

COVID-19Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Stéphanie Lejeune, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 29, 2021

First Posted

March 30, 2021

Study Start

September 14, 2021

Primary Completion

March 31, 2025

Study Completion

March 31, 2025

Last Updated

May 14, 2026

Record last verified: 2025-03

Locations

FR(1)