Mold Exposure and Impact on Asthma Control in French Asthmatic Children

NCT ID: NCT04918394

Last Updated: 2022-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

451 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-06-10

Study Completion Date

2021-08-20

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.

Detailed Description

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Conditions

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Asthma in Children

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Questionnaire of Mold / moisture exposure

Intervention Type OTHER

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

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.

Questionnaire of Mold / moisture exposure

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antoine DESCHILDRE, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Ch Armentieres

Armentières, , France

Site Status

Ch Boulogne-Sur-Me

Boulogne-sur-Mer, , France

Site Status

Ch Calais

Calais, , France

Site Status

CH Dunkerque

Dunkirk, , France

Site Status

Centre Hospitalier de Lens

Lens, , France

Site Status

Hop Jeanne de Flandre Chu Lille

Lille, , France

Site Status

Centre Hospitalier St Vincent

Lille, , France

Site Status

Centre hospitalier de Roubaix

Roubaix, , France

Site Status

Centre Hospitalier de Seclin

Seclin, , France

Site Status

Centre Hospitalier,

Valenciennes, , France

Site Status

Countries

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France

References

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Sauvere M, Lejeune S, Chagnon F, Drumez E, Cisterne C, Mordacq C, Thumerelle C, Scalbert M, Le Mee A, Amani M, El Mourad S, Enchery S, Pouessel G, Roussel J, Dartus M, Behal H, Deschildre A. Home exposure to moisture and mold is associated with poorer asthma control in children: CHAMPIASTHMA study. J Allergy Clin Immunol Glob. 2025 Jan 17;4(2):100415. doi: 10.1016/j.jacig.2025.100415. eCollection 2025 May.

Reference Type DERIVED
PMID: 40130077 (View on PubMed)

Other Identifiers

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2019-A03310-57

Identifier Type: OTHER

Identifier Source: secondary_id

2019_49

Identifier Type: -

Identifier Source: org_study_id

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