Mold Exposure and Impact on Asthma Control in French Asthmatic Children

Study Overview
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Brief Summary
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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.

Official Title
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Assessment of Mold Exposure in Asthmatic Children Follow-up in Nord and Pas-De-Calais Departments, France, and Impact on Asthma Control

Conditions
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Asthma in Children

Intervention / Treatment
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* Other: Questionnaire of Mold / moisture exposure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Asthma patients unexposed to mold / moisture<br>No mold / moisture exposure is defined by a negative response to all of the 5 following questions, asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home. | Other: Questionnaire of Mold / moisture exposure<br>* Mold / moisture exposure is assessed by the 5 following questions, whose positive response has been associated with the actual presence of mold in the household (according to data from the literature data), asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home: Presence of visible mold Impression of dampness Apparent dampness Existence of recent water damage in the last year Presence of a moldy odor<br>|
| Asthma patients exposed to mold / moisture<br>Mold / moisture exposure is defined by a positive response to at least one of the 5 following questions, asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home. | Other: Questionnaire of Mold / moisture exposure<br>* Mold / moisture exposure is assessed by the 5 following questions, whose positive response has been associated with the actual presence of mold in the household (according to data from the literature data), asked in the form of a parent-completed declarative questionnaire regarding the child's primary living home: Presence of visible mold Impression of dampness Apparent dampness Existence of recent water damage in the last year Presence of a moldy odor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control according to GINA guidelines | The Global Initiative for Asthma (GINA)guidelines: Well controlled Partly controlled Uncontrolled | At the time of inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20 | Asthma Control Test: Each question is assigned a score between 1 and 5 (the score for the first answer proposal is 1, the second is 2, and so on). The score of the 5 questions is added up to a total score that can vary between 5 and 25. The higher the total score, the better the asthma is controlled. | At the time of inclusion | 
| Asthma control according to pACT score in children aged 1 to 11 years old: Controlled if ACT ≥ 20 |  | At the time of inclusion | 
| 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 |  | At the time of inclusion | 
| Inhaled corticosteroid doses in µg/day of fluticasone |  | At the time of inclusion | 
| Acute asthma events in the past 12 months | Acute asthma events: emergency room visits, hospitalization, general corticosteroid course | At the time of inclusion | 
| Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents) |  | At the time of inclusion | 
| Exposure to indoor allergens: declarative exposure to animal danders |  | At the time of inclusion | 
| Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress) |  | At the time of inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Children, Mold, Moisture, Asthma Control