Asthma in ChildrenVIRASTHCOVIDNCT04821908
Consequences of COVID 19 Pandemic on Childhood Asthma
An observational study of Asthma in Children, run by University Hospital, Lille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 16 years
- Conditions the study is for
- Asthma in Children
- How many people
- 577 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2021to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 16 years
- All sexes
- No healthy volunteers
- Child
Study population: children and adolescents diagnosed with asthma.
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Consequences of SARS-CoV2 Pandemic on Childhood Asthma Control and Exacerbations: French Multicenter Cross-sectional VIRASTHMA COVID G4 Study
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.
Read the 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.
- Conditions
- Asthma in Children
- Keywords
- Asthma control, COVID-19 pandemic, Respiratory infection, Environmental pollution
- Medical subject headings
- COVID-19, Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Controlled asthma
Composite criteria defined by a cACT (4-11 years) or ACT (12-16 years) score ≥ 20 and according to GINA criteria.
Measured: at inclusion
Secondary outcomes (7)
Characteristics of asthma
Composite criteria : allergic phenotype, severity assessed by GINA treatment level, number of exacerbations in the past year, lung function
Measured: 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
Measured: 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
Measured: 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".
Measured: 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.
Measured: 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
Measured: 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
Measured: at exacerbation and at follow-up visit at 2-4 months for the sub-population included at exacerbation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2021
- Study start14 Sep 2021
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 577 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stéphanie Lejeune, MD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04821908
- Sponsor's protocol ID
- 2020_85
- Other IDs
- 2020-A03365-34
- Acronym
- VIRASTHCOVID
- Status last verified
- Mar 2025
- First submitted
- 29 Mar 2021
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Consequences of SARS-CoV2 Pandemic on Childhood Asthma Control and Exacerbations: French Multicenter Cross-sectional VIRASTHMA COVID G4 Study
- ClinicalTrials.gov ID
- NCT04821908
- Acronym / sponsor ID
- VIRASTHCOVID / 2020_85
- Conditions
- Asthma in Children
- Keywords
- Asthma control, COVID-19 pandemic, Respiratory infection, Environmental pollution
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 577 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 14 Sep 2021 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 30 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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). |
Who may qualify
- Ages
- 3 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- children and adolescents diagnosed with asthma.
Key inclusion criteria (9 listed)
- 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.
- Children and adolescents aged 3 to 16 years
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Characteristics of asthma
Time frame: 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
Time frame: 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
Time frame: At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Observance
Time frame: 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
Time frame: At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
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
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 and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stéphanie Lejeune, MD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Controlled asthma (time frame: at inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.