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Study of Indoor Air Pollutants and Their Impact in Children's Health and Wellbeing

ConditionAllergy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-12
SponsorUniversity Hospital, Montpellier

About this trial

The goal of this study is to identify and assess in real time the impact of the combined action of various types of air and dust pollutants within a classroom on children's health and quality of life, particularly regarding atopic/allergic diseases in children, and on potential exposure to pollutants at home.

Participants will answer questionnaires regarding their health and medications, undergo allergy tests, perform non-invasive lung function tests and check blood oxygen levels.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Child included in the SynAir-G observational study

Child and caregiver(s) willing to follow the study procedures

Written informed consent from the child's parents/guardians

For case group: Diagnosis of asthma/allergic rhinitis/eczema/food allergy (based on SYNAIR-G baseline questionnaire), active during the past year.

Disqualifiers

Refuse to participate in the project / to give informed consent.

Do not want to follow the protocol procedures.

Do not read or/and write in French.

Plan a long stay outside the region that does not allow them to follow the visit plan.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Standardized questionnaires

    Other intervention

    Baseline questionnaires for cases and follow-up questionnaires for cases and controls will be completed to collect data on sociodemographic characteristics, health outcomes, potential risk factors, lifestyle, and living environment.

  • Lung function tests

    Other intervention

    All participants, including cases and controls, will undergo comprehensive spirometry testing, pulse oximetry assessment, and fractional exhaled nitric oxide (FeNO) measurement.

  • Prick tests

    Diagnostic test

    Cases and controls will undergo skin prick testing for common allergens, including house dust mites, cat, dog, Alternaria, cypress, birch, plane tree (Platanus), grass, latex, olive tree, ragweed, and mugwort,...

  • Biological samples

    Other intervention

    Subjects and their parents/guardians will be given the option to provide blood, urine, and nasopharyngeal samples.

  • Portable sensors

    Device

    Up to 10 subjects ( with their parents/guardians consent) will be given the option to use CANARIN devices, to monitor at the individual level exposures to air pollutants (PM and VOC) and other environmental factors (temperature, humidity, pressure) in and outside school.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Case groupOther 5 interventions
Group B: Control groupOther 5 interventions

Trial outcomes

Primary outcomes

1

Statistically significant differences in spirometric parameter, Peak Flow, between case and control groups

Assessment of peak expiratory flow (Peak Flow, defined as the maximum flow achieved during a forced expiration, measured in L/min) between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study

Time frame
10 Months
2

Statistically significant differences in FeNO measurements between case and control groups

Evaluation of statistically significant differences in fractional exhaled nitric oxide (FeNO, the concentration of nitric oxide in exhaled breath, measured in parts per billion \[ppb\]) between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study

Time frame
10 Months
3

Evaluation of statistically significant differences in spirometric parameter, FEV, between case and control groups

Assessment of Forced expiratory volume in 1 second (FEV₁, defined as the volume exhaled during the first second of a forced expiration, measured in L) comparing case and control groups with respect to air and dust contaminants, as assessed in the SynAirG observational study

Time frame
10 months
4

Evaluation of statistically significant differences in spirometric parameter, FVC, between case and control groups

Assessment of forced vital capacity (FVC, defined as the total volume forcibly exhaled after full inspiration, measured in L), comparing case and control groups with respect to air and dust contaminants within the SynAirG observational study

Time frame
10 months

Secondary outcomes

1

Disease control in asthma and allergies in relation to air and dust contaminants

Evaluation of statistically significant differences in disease control (for asthma and allergic rhinitis and other allergies) between cases, in relation to air and dust contaminants as assessed in the SynAirG observational study

Time frame
10 Months
2

Statistically significant differences in biological biomarkers between case and control groups

Evaluation of statistically significant differences in biological biomarkers (blood, urine, nasopharyngeal samples) between cases and controls, in relation to air and dust contaminants as assessed in the SynAirG observational study

Time frame
10 Months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospital, Montpellier

Lead sponsor

Source ClinicalTrials.gov
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