Mold Exposure and Impact on Asthma Control in French Asthmatic Children (CHAMPIASTHMA)

April 17, 2026 updated by: University Hospital, Lille

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

451

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Armentières, France
        • Ch Armentieres
      • Boulogne-sur-Mer, France, 62321
        • Ch Boulogne-Sur-Me
      • Calais, France
        • CH Calais
      • Dunkirk, France, 59385
        • Ch Dunkerque
      • Lens, France
        • Centre Hospitalier de LENS
      • Lille, France, 59037
        • Hop Jeanne de Flandre Chu Lille
      • Lille, France
        • Centre Hospitalier St Vincent
      • Roubaix, France
        • Centre Hospitalier de Roubaix
      • Seclin, France
        • Centre Hospitalier de Seclin
      • Valenciennes, France
        • Centre Hospitalier,

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
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
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.
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Asthma control according to GINA guidelines
Time Frame: At the time of inclusion

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
Time Frame: 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
Time Frame: 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
Time Frame: At the time of inclusion
At the time of inclusion
Inhaled corticosteroid doses in µg/day of fluticasone
Time Frame: At the time of inclusion
At the time of inclusion
Acute asthma events in the past 12 months
Time Frame: 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)
Time Frame: At the time of inclusion
At the time of inclusion
Exposure to indoor allergens: declarative exposure to animal danders
Time Frame: At the time of inclusion
At the time of inclusion
Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)
Time Frame: At the time of inclusion
At the time of inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Antoine DESCHILDRE, MD,PhD, University Hospital, Lille

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2020

Primary Completion (Actual)

August 20, 2021

Study Completion (Actual)

August 20, 2021

Study Registration Dates

First Submitted

June 2, 2021

First Submitted That Met QC Criteria

June 2, 2021

First Posted (Actual)

June 8, 2021

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019_49
  • 2019-A03310-57 (Other Identifier: ID-RCB number,ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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