NCT04918394

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
451

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2020

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 10, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 8, 2021

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2021

Completed
Last Updated

April 22, 2026

Status Verified

March 1, 2022

Enrollment Period

1.2 years

First QC Date

June 2, 2021

Last Update Submit

April 17, 2026

Conditions

Keywords

AsthmaChildrenMoldMoistureAsthma Control

Outcome Measures

Primary Outcomes (1)

  • Asthma control according to GINA guidelines

    The Global Initiative for Asthma (GINA)guidelines: Well controlled Partly controlled Uncontrolled

    At the time of inclusion

Secondary Outcomes (8)

  • Asthma control according to Asthma Control Test (ACT) score in children aged 12 years and older: Controlled if ACT ≥ 20

    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

    At the time of inclusion

  • +3 more secondary outcomes

Study Arms (2)

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

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

Interventions

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 / moistureAsthma patients unexposed to mold / moisture

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children follow-up by a specialized asthma pediatrician in secondary (general hospital) and tertiary care (Lille university hospital) centers.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Ch Armentieres

Armentières, France

Location

Ch Boulogne-Sur-Me

Boulogne-sur-Mer, 62321, France

Location

Ch Calais

Calais, France

Location

CH Dunkerque

Dunkirk, 59385, France

Location

Centre Hospitalier de Lens

Lens, France

Location

Hop Jeanne de Flandre Chu Lille

Lille, 59037, France

Location

Centre Hospitalier St Vincent

Lille, France

Location

Centre hospitalier de Roubaix

Roubaix, France

Location

Centre Hospitalier de Seclin

Seclin, France

Location

Centre Hospitalier,

Valenciennes, France

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Antoine DESCHILDRE, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 8, 2021

Study Start

June 10, 2020

Primary Completion

August 20, 2021

Study Completion

August 20, 2021

Last Updated

April 22, 2026

Record last verified: 2022-03

Locations