NCT07402200

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

First Submitted

Initial submission to the registry

January 19, 2026

Completed
16 days until next milestone

Study Start

First participant enrolled

February 4, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 11, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Completed
Last Updated

February 11, 2026

Status Verified

February 1, 2026

Enrollment Period

4 months

First QC Date

January 19, 2026

Last Update Submit

February 6, 2026

Conditions

Allergy

Keywords

Air pollutionasthmaallergy

Outcome Measures

Primary Outcomes (7)

  • 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

    10 Months

  • 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

    10 Months

  • 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

    10 months

  • 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

    10 months

  • Statistically significant differences in the spirometric parameter, FEV₁/FVC ratio, between case and control groups

    Assessment of the FEV₁/FVC ratio (the proportion of FVC exhaled in the first second, measured in %), between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study

    10 months

  • Statistically significant differences in spirometric parameter, FEF, between case and control groups

    Assessment of forced expiratory flow at 25%, 50%, and 75% of FVC (FEF₂₅, FEF₅₀, and FEF₇₅, instantaneous expiratory flow rates at the corresponding lung volumes, measured in L/s), between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study

    10 months

  • Evaluation of statistically significant differences in spirometric parameter, mean forced expiratory flow, between case and control groups

    Assessment of mean forced expiratory flow between 25% and 75% of FVC (FEF₂₅-₇₅, the average expiratory flow over the middle portion of forced expiration, measured in L/s), between cases and controls in relation to air and dust contaminants, as assessed in the SynAirG observational study

    10 months

Secondary Outcomes (2)

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

    10 Months

  • Statistically significant differences in biological biomarkers between case and control groups

    10 Months

Study Arms (2)

Case group

OTHER

Subjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases)

Other: Standardized questionnairesOther: Lung function testsDiagnostic Test: Prick testsOther: Biological samplesDevice: Portable sensors

Control group

OTHER

Subjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls)

Other: Standardized questionnairesOther: Lung function testsDiagnostic Test: Prick testsOther: Biological samplesDevice: Portable sensors

Interventions

Standardized questionnairesOTHER

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.

Case groupControl group
Lung function testsOTHER

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

Case groupControl group
Prick testsDIAGNOSTIC_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,...

Case groupControl group
Biological samplesOTHER

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

Case groupControl group
Portable sensorsDEVICE

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.

Case groupControl group

Eligibility Criteria

Age8 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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, at least one positive answer (yes) to any of the following questions and for control group, negative answers to all the following questions based on the baseline questionnaire administered in the SynAir-G observational study, as shown below.:
  • a. General health i. Does your child have any health problems (if yes to asthma, allergic rhinitis /rhino-conjunctivitis, atopic dermatitis)? b. Asthma i. Has your child ever had wheezing or whistling in the chest in the past 12 months? ii. In the past 12 months, has your child's chest sounded wheezy during or after exercise? iii. In the past 12 months, has your child had a dry cough at night, apart from a cough associated with a cold or chest infection? c. Rhinitis i. In the past 12 months has your child had a problem with sneezing, or a runny, or blocked nose when she/he DID NOT have a cold or the flu? d. Eczema (both answers yes) i. Has your child had this itchy rash at any time in the past 12 months? If so, has this itchy rash at any time affected any of the following places: the folds of the elbows, behind the knees, in front of the ankles, under the buttocks, or around the neck, ears or eyes? e. Food allergy i. Has your child had diagnosed food allergy during last 12 months?
  • For case group: Diagnosis of asthma/allergic rhinitis/eczema/food allergy (based on SYNAIR-G baseline questionnaire), active during the past year.
  • For control group: absence of diagnosis of asthma/allergic rhinitis/eczema/food allergy (based on SYNAIR-G baseline questionnaire)

You may not qualify if:

  • Child or child's parents/guardians who:
  • 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.
  • The child is not affiliated to the French social security service

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Montpellier

Montpellier, France

RECRUITING

MeSH Terms

Conditions

HypersensitivityAsthma

Interventions

Respiratory Physiological Phenomena

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, Immediate

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2026

First Posted

February 11, 2026

Study Start

February 4, 2026

Primary Completion

June 1, 2026

Study Completion

June 1, 2026

Last Updated

February 11, 2026

Record last verified: 2026-02

Locations

FR(1)