Mold Exposure and Impact on Asthma Control in French Asthmatic Children (CHAMPIASTHMA)
Assessment of Mold Exposure in Asthmatic Children Follow-up in Nord and Pas-De-Calais Departments, France, and Impact on Asthma Control
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
-
Armentières, Francia
- Ch Armentieres
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Boulogne Sur Mer, Francia, 62321
- Ch Boulogne-Sur-Me
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Calais, Francia
- Ch Calais
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Dunkerque, Francia, 59385
- Ch Dunkerque
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Lens, Francia
- Centre Hospitalier de LENS
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Lille, Francia, 59037
- Hop Jeanne de Flandre Chu Lille
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Lille, Francia
- Centre Hospitalier St Vincent
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Roubaix, Francia
- Centre Hospitalier de Roubaix
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Seclin, Francia
- Centre Hospitalier de Seclin
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Valenciennes, Francia
- Centre Hospitalier,
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Asthma patients unexposed to mold / moisture
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.
|
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:
|
|
Asthma patients exposed to mold / moisture
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.
|
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:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Asthma control according to GINA guidelines
Periodo de tiempo: At the time of inclusion
|
The Global Initiative for Asthma (GINA)guidelines: Well controlled Partly controlled Uncontrolled |
At the time of inclusion
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20
Periodo de tiempo: At the time of inclusion
|
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
Periodo de tiempo: At the time of inclusion
|
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
Periodo de tiempo: At the time of inclusion
|
At the time of inclusion
|
|
|
Inhaled corticosteroid doses in µg/day of fluticasone
Periodo de tiempo: At the time of inclusion
|
At the time of inclusion
|
|
|
Acute asthma events in the past 12 months
Periodo de tiempo: At the time of inclusion
|
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)
Periodo de tiempo: At the time of inclusion
|
At the time of inclusion
|
|
|
Exposure to indoor allergens: declarative exposure to animal danders
Periodo de tiempo: At the time of inclusion
|
At the time of inclusion
|
|
|
Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)
Periodo de tiempo: At the time of inclusion
|
At the time of inclusion
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Antoine DESCHILDRE, MD,PhD, University Hospital, Lille
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2019_49
- 2019-A03310-57 (Otro identificador: ID-RCB number,ANSM)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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