Mold Exposure and Impact on Asthma Control in French Asthmatic Children

Asthma in Children Clinical Trial

— CHAMPIASTHMA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04918394
• Other study ID #: 2019_49
• Secondary ID: 2019-A03310-57
• Status: Completed
• Start date: June 10, 2020
• Est. completion date: August 20, 2021

Study information

• Verified date: March 2022
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 451
• Est. completion date: August 20, 2021
• Est. primary completion date: August 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Other:
• Questionnaire of Mold / moisture exposure
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

Locations

Country	Name	City	State
France	Ch Armentieres	Armentières
France	Ch Boulogne-Sur-Me	Boulogne Sur Mer
France	Ch Calais	Calais
France	CH Dunkerque	Dunkerque
France	Centre Hospitalier de Lens	Lens
France	Centre Hospitalier St Vincent	Lille
France	Hop Jeanne de Flandre Chu Lille	Lille
France	Centre hospitalier de Roubaix	Roubaix
France	Centre Hospitalier de Seclin	Seclin
France	Centre Hospitalier,	Valenciennes

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma control according to GINA guidelines	The Global Initiative for Asthma (GINA)guidelines: Well controlled Partly controlled Uncontrolled	At the time of inclusion
Secondary	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
Secondary	Asthma control according to pACT score in children aged 1 to 11 years old: Controlled if ACT = 20		At the time of inclusion
Secondary	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
Secondary	Inhaled corticosteroid doses in µg/day of fluticasone		At the time of inclusion
Secondary	Acute asthma events in the past 12 months	Acute asthma events: emergency room visits, hospitalization, general corticosteroid course	At the time of inclusion
Secondary	Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents)		At the time of inclusion
Secondary	Exposure to indoor allergens: declarative exposure to animal danders		At the time of inclusion
Secondary	Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)		At the time of inclusion