Consequences of COVID 19 Pandemic on Childhood Asthma

Asthma in Children Clinical Trial

— VIRASTHCOVID  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04821908
• Other study ID #: 2020_85
• Secondary ID: 2020-A03365-34
• Status: Recruiting
• Start date: September 14, 2021
• Est. completion date: July 2025

Study information

• Verified date: December 2023
• Source: University Hospital, Lille
• Contact: Stéphanie Lejeune, MD
• Phone: 0320445962
• Email: stephanie.lejeune[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 577
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Locations

Country	Name	City	State
France	CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Characteristics of asthma	Composite criteria : allergic phenotype, severity assessed by GINA treatment level, number of exacerbations in the past year, lung function	At inclusion and follow-up visit at 2-4 months for the sub-population included at exacerbation
Secondary	history of SARS-Cov2 infection in the past year	history of SARS-Cov2 infection based on patient report	At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Secondary	number of infectious episodes in the past year	number of infectious episodes based on patient report	At inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Secondary	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".	At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Secondary	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.	At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Secondary	Outdoor levels of pollutants and pollens	Composite criteria : monthly average measurements of CO, O3, NO, NO2, SO2, PM2.5, PM10 and pollen counts	At Inclusion and Follow-up visit at 2-4 months for the sub-population included at exacerbation
Secondary	Respiratory virus infection (SARS-CoV2 and other)	Results of viral PCR	at exacerbation and at follow-up visit at 2-4 months for the sub-population included at exacerbation