Category 3 Study (Non-interventional Research)EvalPCENCT04927689
Evaluation of an Environmental Counsellor's Home Stay in Children Treated for Asthma or Allergic Rhinitis Via a Standardized Medical Questionnaire Randomized Controlled Superiority Trial in Parallel Arms, Multicentric (EvalPCE)
An observational study of Category 3 Study (Non-interventional Research), run by University Hospital, Angers at 3 sites in France.
Trial summary
Assessment of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Category 3 Study (Non-interventional Research)
- How many people
- 100 participants
- Where
- 3 sitesFrance
- Study dates
- 20 Oct 2021to 15 Jan 2026
- How long will I take part?
- 18 Months
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patient under 18 years of age with asthma or allergic rhinitis for whom a home visit by an environmental consultant is prescribed
Who may be able to join
- Patient under 18 years of age
- With asthma or allergic rhinitis
- For whom a home visit by an environmental consultant is prescribed
Who cannot join
- Parental refusal to participate in the study
- Poor understanding of the French language not allowing to fill in the questionnaire
- Asthmatic child under 7 years old or child with allergic rhinitis under 6 years old (questionnaires not validated below these ages)
- Patient concerned by a current request for relocation
Trial locations and contacts
3 sites in 1 country.
France3 sites
CHU Angers
Angers
Chd Vendee
La Roche-sur-Yon, 85000
Chu Nantes
Nantes, 44800
About this study
Assessment of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires.
Read the detailed description
Asthma and allergic rhinitis are chronic diseases whose control is multifactorial (drug treatment, therapeutic education of the family and the child, consideration of a possible allergen...). When this control is not optimal, it leads to significant school absenteeism, pediatric emergency room visits and hospitalizations. Environmental conditions at home play a role in asthma exacerbations and poor control of allergic rhinitis in children. Mites, animal allergens, passive smoking, molds, cockroaches, household products, etc., are the main causes. The visit of a home environment advisor, who intervenes on medical prescription, makes it possible to evaluate the source of allergens and pollutants in the home and then to propose changes to the home. This position was created in France in 2009 by the Ministry of the Environment and is funded by the Agence Régional de Santé (ARS - Regional Health Agency). The few studies carried out to assess the effectiveness of a home visit by an environmental advisor on exacerbations of these diseases are contradictory: some show an improvement in the quality of life of asthmatic children after a home visit (via the average reduction in the number of days with symptoms/year) as well as a reduction in asthma-related morbidity thanks to a reduction in exposure to indoor allergens. Others have shown that it does not reduce the number of emergency room visits for asthma exacerbations. Furthermore, it would appear that targeted allergen avoidance measures do not reduce drug treatment in asthmatics who are already on optimal pharmacological treatment.
To our knowledge, there are no studies in France that use standardized medical questionnaires to assess disease control and quality of life before and after the visit of a home environmental consultant. For example, in Angers and Nantes, evaluation questionnaires are carried out with patients at 6 months and 1 year after a home visit, but the answers are not standardized and sometimes very subjective.
- Keywords
- Asthma, Allergic rhinitis, Environmental consultant
- Medical subject headings
- Asthma, Rhinitis, Allergic
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life of asthmatic children and children with allergic rhinitis
Assessment of the quality of life of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires.
Measured: 6 months
Secondary outcomes (1)
Disease control, health care utilization and change in drug therapy
Assessment of disease control, health care utilization and change in drug therapy of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2021
- Study start20 Oct 2021
- Primary completion15 Jan 2025
- Study completion15 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Category 3 Study (Non-interventional Research)Studies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- 100 participants (actual)
- Target duration
- 18 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- CARBALLIDO, Study director, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927689
- Sponsor's protocol ID
- 49RC21_0186
- Acronym
- EvalPCE
- Status last verified
- Feb 2026
- First submitted
- 9 Jun 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of an Environmental Counsellor's Home Stay in Children Treated for Asthma or Allergic Rhinitis Via a Standardized Medical Questionnaire Randomized Controlled Superiority Trial in Parallel Arms, Multicentric (EvalPCE)
- ClinicalTrials.gov ID
- NCT04927689
- Acronym / sponsor ID
- EvalPCE / 49RC21_0186
- Keywords
- Asthma, Allergic rhinitis, Environmental consultant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2026 (actual)
- First posted
- 16 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.
Assessment of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires.
Detailed description
Asthma and allergic rhinitis are chronic diseases whose control is multifactorial (drug treatment, therapeutic education of the family and the child, consideration of a possible allergen...). When this control is not optimal, it leads to significant school absenteeism, pediatric emergency room visits and hospitalizations. Environmental conditions at home play a role in asthma exacerbations and poor control of allergic rhinitis in children. Mites, animal allergens, passive smoking, molds, cockroaches, household products, etc., are the main causes. The visit of a home environment advisor, who intervenes on medical prescription, makes it possible to evaluate the source of allergens and pollutants in the home and then to propose changes to the home. This position was created in France in 2009 by the Ministry of the Environment and is funded by the Agence Régional de Santé (ARS - Regional Health Agency). The few studies carried out to assess the effectiveness of a home visit by an environmental advisor on exacerbations of these diseases are contradictory: some show an improvement in the quality of life of asthmatic children after a home visit (via the average reduction in the number of days with symptoms/year) as well as a reduction in asthma-related morbidity thanks to a reduction in exposure to indoor allergens. Others have shown that it does not reduce the number of emergency room visits for asthma exacerbations. Furthermore, it would appear that targeted allergen avoidance measures do not reduce drug treatment in asthmatics who are already on optimal pharmacological treatment.
To our knowledge, there are no studies in France that use standardized medical questionnaires to assess disease control and quality of life before and after the visit of a home environmental consultant. For example, in Angers and Nantes, evaluation questionnaires are carried out with patients at 6 months and 1 year after a home visit, but the answers are not standardized and sometimes very subjective.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 18 Months
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patient under 18 years of age with asthma or allergic rhinitis for whom a home visit by an environmental consultant is prescribed
Key inclusion criteria (3 listed)
- Patient under 18 years of age
- With asthma or allergic rhinitis
- For whom a home visit by an environmental consultant is prescribed
Key exclusion criteria (4 listed)
- Parental refusal to participate in the study
- Poor understanding of the French language not allowing to fill in the questionnaire
- Asthmatic child under 7 years old or child with allergic rhinitis under 6 years old (questionnaires not validated below these ages)
- Patient concerned by a current request for relocation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Quality of life of asthmatic children and children with allergic rhinitis
Time frame: 6 months
Assessment of the quality of life of asthmatic children and children with allergic rhinitis at day 0 and 6 months after a home visit by an environmental consultant via standardized medical questionnaires.
1 secondary outcome
Disease control, health care utilization and change in drug therapy
Time frame: 6 months
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 9 Mar 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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.
CARBALLIDO study director
University Hospital, Angers
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Category 3 Study (Non-interventional Research), run by University Hospital, Angers at 3 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 3 inclusion and 4 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 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Quality of life of asthmatic children and children with allergic rhinitis (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2026.