Clinical trial NCT04918394: Mold Exposure and Impact on Asthma Control in French Asthmatic Children
Official title: Assessment of Mold Exposure in Asthmatic Children Follow-up in Nord and Pas-De-Calais Departments, France, and Impact on Asthma Control
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma in Children
Keywords: Asthma
Children
Mold
Moisture
Asthma Control
Lead sponsor: University Hospital, Lille
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 451
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children follow-up by a specialized asthma pediatrician in secondary (general hospital) and tertiary care (Lille university hospital) centers.

Brief summary: Observational, multicenter, study conducted in 12 hospitals in the Nord and Pas-De-Calais departments. The aim of this study is to describe the relationship between reported exposure to molds and asthma control in a pediatric population.

Each patient followed by a specialized asthma pediatrician in one of the study center will be proposed to participate in the study.

Children aged 1 to \< 18 years, with asthma diagnosis, based on the assessment of a specialized physician after a follow-up of at least 6 months Inclusion, non-inclusion and exclusion criteria will be verified by the investigators. The questionnaires will be completed during the consultation, collected by the physician in charge of the consultation and sent to the principal investigator for data entry.

Inclusion will take place over a period of 12 consecutive months from the date of obtaining regulatory approval.


Eligibility criteria: Inclusion Criteria:

* Children aged 1 to \< 18 years, with asthma diagnosis, based on the assessment of a specialized physician after a follow-up of at least 6 months, Follow-up in one of the study center in Nord and Pas de Calais departments (Lille, Lens, Tourcoing, Valenciennes, Arras, Roubaix, Seclin, Armentières, Calais, Boulogne/mer, Dunkerque, GHICL-Saint Vincent) over an inclusion period of 12 months

Exclusion Criteria:

* Children living ≤ 50% of the weekly time in their primary home (e.g., shared custody)
* Children whose living arrangement characteristics are difficult to analyze (e.g., child accompanied by grandparents or by the parent without primary custody)
* Children whose residence has recently changed, making it impossible to assess the impact of the living arrangement over the past year
* Children living outside of the Nord and Pas-de-Calais departments
* Children whose parents are unable to complete the questionnaire

Primary outcomes:
measure: Asthma control according to GINA guidelines
timeFrame: At the time of inclusion
Secondary outcomes:
measure: Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20
timeFrame: At the time of inclusion
measure: Asthma control according to pACT score in children aged 1 to 11 years old: Controlled if ACT ≥ 20
timeFrame: At the time of inclusion
measure: Asthma treatment step according to GINA guidelines: Step 1 to step 4 in children aged < 6 years Step 1 to step 5 in children aged ≥ 6 years
timeFrame: At the time of inclusion
measure: Inhaled corticosteroid doses in µg/day of fluticasone
timeFrame: At the time of inclusion
measure: Acute asthma events in the past 12 months
timeFrame: At the time of inclusion
measure: Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents)
timeFrame: At the time of inclusion
measure: Exposure to indoor allergens: declarative exposure to animal danders
timeFrame: At the time of inclusion
measure: Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)
timeFrame: At the time of inclusion
Other outcomes:
Locations:
city: Armentières
country: France
facility: Ch Armentieres
city: Boulogne Sur Mer
country: France
facility: Ch Boulogne-Sur-Me
city: Calais
country: France
facility: Ch Calais
city: Dunkerque
country: France
facility: CH Dunkerque
city: Lens
country: France
facility: Centre Hospitalier de Lens
city: Lille
country: France
facility: Hop Jeanne de Flandre Chu Lille
city: Lille
country: France
facility: Centre Hospitalier St Vincent
city: Roubaix
country: France
facility: Centre hospitalier de Roubaix
city: Seclin
country: France
facility: Centre Hospitalier de Seclin
city: Valenciennes
country: France
facility: Centre Hospitalier,
Study officials:
affiliation: University Hospital, Lille
name: Antoine DESCHILDRE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: