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Completed

NCT Number: NCT04918394

Mold Exposure and Impact on Asthma Control in French Asthmatic Children

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.

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Key information

Conditions

Asthma in Children Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ch Armentieres, Armentières, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire of Mold / moisture exposure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. Inhaled corticosteroid doses in µg/day of fluticasone

    Time frame: At the time of inclusion

  5. 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

  6. Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents)

    Time frame: At the time of inclusion

  7. Exposure to indoor allergens: declarative exposure to animal danders

    Time frame: At the time of inclusion

  8. Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)

    Time frame: At the time of inclusion

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: CHAMPIASTHMA

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 8, 2021
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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