VIRASTHCOVID: Consequences of COVID 19 Pandemic on Childhood Asthma

Sponsor
University Hospital, Lille (Other)
Overall Status
Recruiting
CT.gov ID
NCT04821908
Collaborator
(none)
577
1
45.5
12.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    577 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    Consequences of SARS-CoV2 Pandemic on Childhood Asthma Control and Exacerbations: French Multicenter Cross-sectional VIRASTHMA COVID G4 Study
    Actual Study Start Date :
    Sep 14, 2021
    Anticipated Primary Completion Date :
    Jul 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    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).

    Outcome Measures

    Primary Outcome Measures

    1. Controlled asthma [at inclusion]

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

    Secondary Outcome Measures

    1. Characteristics of asthma [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 [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 [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 [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 [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 [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) [at exacerbation and at follow-up visit at 2-4 months for the sub-population included at exacerbation]

      Results of viral PCR

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CHU Lille Lille France

    Sponsors and Collaborators

    • University Hospital, Lille

    Investigators

    • Principal Investigator: Stéphanie Lejeune, MD, University Hospital, Lille

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Lille
    ClinicalTrials.gov Identifier:
    NCT04821908
    Other Study ID Numbers:
    • 2020_85
    • 2020-A03365-34
    First Posted:
    Mar 30, 2021
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Lille
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022