Asthma in ChildrenCHAMPIASTHMANCT04918394
Mold Exposure and Impact on Asthma Control in French Asthmatic Children
An observational study of Asthma in Children, run by University Hospital, Lille at 10 sites in France.
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. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Questionnaire of Mold / moisture exposure
- How many people
- 451 participants
- Where
- 10 sitesFrance
- Study dates
- 10 Jun 2020to 20 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Children follow-up by a specialized asthma pediatrician in secondary (general hospital) and tertiary care (Lille university hospital) centers.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
France10 sites
Ch Armentieres
Armentières
Ch Boulogne-Sur-Me
Boulogne-sur-Mer, 62321
Ch Calais
Calais
CH Dunkerque
Dunkirk, 59385
Centre Hospitalier de Lens
Lens
Hop Jeanne de Flandre Chu Lille
Lille, 59037
Centre Hospitalier St Vincent
Lille
Centre hospitalier de Roubaix
Roubaix
Centre Hospitalier de Seclin
Seclin
Centre Hospitalier,
Valenciennes
About this study
Official title: 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.
Read more
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.
- Conditions
- Asthma in Children
- Being tested
- Questionnaire of Mold / moisture exposure
- Keywords
- Asthma, Children, Mold, Moisture, Asthma Control
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire of Mold / moisture exposureOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Questionnaire of Mold / moisture exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control according to GINA guidelines
The Global Initiative for Asthma (GINA)guidelines:
Well controlled Partly controlled Uncontrolled
Measured: 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
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.
Measured: At the time of inclusion
Asthma control according to pACT score in children aged 1 to 11 years old: Controlled if ACT ≥ 20
Measured: 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
Measured: At the time of inclusion
Inhaled corticosteroid doses in µg/day of fluticasone
Measured: At the time of inclusion
Acute asthma events in the past 12 months
Acute asthma events: emergency room visits, hospitalization, general corticosteroid course
Measured: At the time of inclusion
Exposure to other indoor pollutants: cigarette smoke (declarative smoking by at least one of the parents)
Measured: At the time of inclusion
Exposure to indoor allergens: declarative exposure to animal danders
Measured: At the time of inclusion
Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)
Measured: At the time of inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start10 Jun 2020
- Primary completion20 Aug 2021
- Study completion20 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 451 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine DESCHILDRE, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918394
- Sponsor's protocol ID
- 2019_49
- Other IDs
- 2019-A03310-57
- Acronym
- CHAMPIASTHMA
- Status last verified
- Mar 2022
- First submitted
- 2 Jun 2021
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 40130077
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Mold Exposure in Asthmatic Children Follow-up in Nord and Pas-De-Calais Departments, France, and Impact on Asthma Control
- ClinicalTrials.gov ID
- NCT04918394
- Acronym / sponsor ID
- CHAMPIASTHMA / 2019_49
- Conditions
- Asthma in Children
- Keywords
- Asthma, Children, Mold, Moisture, Asthma Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 451 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 10 Jun 2020 (actual)
- Primary completion
- 20 Aug 2021 (actual)
- Study completion
- 20 Aug 2021 (actual)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma patients unexposed to mold / moisture | – | Other: Questionnaire of Mold / moisture exposureNo 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. |
| Asthma patients exposed to mold / moisture | – | Other: Questionnaire of Mold / moisture exposureMold / 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. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Children follow-up by a specialized asthma pediatrician in secondary (general hospital) and tertiary care (Lille university hospital) centers.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire of Mold / moisture exposureMold / 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 | Other | Asthma patients exposed to mold / moisture, Asthma patients unexposed to mold / moisture |
Primary outcome
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
8 secondary outcomes
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 according to pACT score in children aged 1 to 11 years old: Controlled if ACT ≥ 20
Time frame: 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
Inhaled corticosteroid doses in µg/day of fluticasone
Time frame: At the time of inclusion
Acute asthma events in the past 12 months
Time frame: 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
Exposure to indoor allergens: declarative exposure to animal danders
Time frame: At the time of inclusion
Exposure to indoor allergens: declarative exposure to house dust mite (carpet, mattress)
Time frame: At the time of inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Results publication: PubMed 40130077Sauvere 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antoine DESCHILDRE, MD,PhD principal investigator
University Hospital, Lille
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by University Hospital, Lille at 10 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control according to GINA guidelines (time frame: At the time of inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04918394, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.