AllergySynAir-G2NCT07402200
Study of Indoor Air Pollutants and Their Impact in Children's Health and Wellbeing
A study testing Standardized questionnaires, Lung function tests and Prick tests in people with Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 12 years
- Conditions the study is for
- Allergy
- What is being tested?
- Standardized questionnaires, Lung function tests and Prick tests
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2026to Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.:
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Montpellier
Montpellier
Dr CAIMMI, MD, +33467336107, dp-caimmi@chu-montpellier.fr
About this study
Official title: Disrupting Noxious Synergies of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing, Using Advanced Intelligent Multisensing and Green Interventions: an Interventional Study in a Sub-group of Schoolchildren
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.
Read the detailed description
The number and types of indoor air pollutants in schools is rising, however little is known about the impact of their potentially synergistic interactions, upon schoolchildren health. Among children, highly susceptible individuals to air pollution include allergy and asthma sufferers, and a low socioeconomic background, however no specific guidance is available.
The design of the study provides a unique setting to prospectively assess the synergistic effect of pollutants at school and outdoor on several health aspects in a large and diverse cohort. Most importantly, the continuous nature of information provided by sentinel devices will provide an individualized baseline of specific indicators that will be monitored during the follow up period, to identify personalized health alterations, instead of comparing to generalized standards. Health outcome data, including respiratory health, immune fitness and both mental and non-mental perspectives, focusing on asthmatic/allergic children, will contribute to pollution sensing in an iterative way
- Conditions
- Allergy
- Being tested
- Standardized questionnaires, Lung function tests, Prick tests, Biological samples, Portable sensors
- Keywords
- Air pollution, asthma, allergy
- Medical subject headings
- Hypersensitivity, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
Lung function testsOther
All participants, including cases and controls, will undergo comprehensive spirometry testing, pulse oximetry assessment, and fractional exhaled nitric oxide (FeNO) measurement.
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,...
Biological samplesOther
Subjects and their parents/guardians will be given the option to provide blood, urine, and nasopharyngeal samples.
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.
| Study group | Role | What they receive |
|---|---|---|
| Case group | Other | Subjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases) Receives: Other: Standardized questionnaires; Other: Lung function tests; Diagnostic Test: Prick tests; Other: Biological samples; Device: Portable sensors |
| Control group | Other | Subjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls) Receives: Other: Standardized questionnaires; Other: Lung function tests; Diagnostic Test: Prick tests; Other: Biological samples; Device: Portable sensors |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 10 months
Secondary outcomes (2)
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
Measured: 10 Months
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
Measured: 10 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study start4 Feb 2026
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AllergyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07402200
- Sponsor's protocol ID
- RECHMPL23_0262
- Other IDs
- 2024-A00254-43
- Acronym
- SynAir-G2
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disrupting Noxious Synergies of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing, Using Advanced Intelligent Multisensing and Green Interventions: an Interventional Study in a Sub-group of Schoolchildren
- ClinicalTrials.gov ID
- NCT07402200
- Acronym / sponsor ID
- SynAir-G2 / RECHMPL23_0262
- Conditions
- Allergy
- Keywords
- Air pollution, asthma, allergy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 4 Feb 2026 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Feb 2026 (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.
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.
Detailed description
The number and types of indoor air pollutants in schools is rising, however little is known about the impact of their potentially synergistic interactions, upon schoolchildren health. Among children, highly susceptible individuals to air pollution include allergy and asthma sufferers, and a low socioeconomic background, however no specific guidance is available.
The design of the study provides a unique setting to prospectively assess the synergistic effect of pollutants at school and outdoor on several health aspects in a large and diverse cohort. Most importantly, the continuous nature of information provided by sentinel devices will provide an individualized baseline of specific indicators that will be monitored during the follow up period, to identify personalized health alterations, instead of comparing to generalized standards. Health outcome data, including respiratory health, immune fitness and both mental and non-mental perspectives, focusing on asthmatic/allergic children, will contribute to pollution sensing in an iterative way
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group | Other | Other: Standardized questionnaires, Other: Lung function tests, Diagnostic Test: Prick tests, Other: Biological samples, Device: Portable sensorsSubjects who have previously declared to suffer from asthma and/or allergic rhinitis and/or other allergic diseases (cases) |
| Control group | Other | Other: Standardized questionnaires, Other: Lung function tests, Diagnostic Test: Prick tests, Other: Biological samples, Device: Portable sensorsSubjects who have previously declared not presenting any allergic/respiratory symptoms (healthy controls) |
Who may qualify
- Ages
- 8 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.:
- For case group: Diagnosis of asthma/allergic rhinitis/eczema/food allergy (based on SYNAIR-G baseline questionnaire), active during the past year.
Key exclusion criteria (6 listed)
- Child or child's parents/guardians who:
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 |
|---|---|---|
| Standardized questionnairesBaseline 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. | Other | Case group, Control group |
| Lung function testsAll participants, including cases and controls, will undergo comprehensive spirometry testing, pulse oximetry assessment, and fractional exhaled nitric oxide (FeNO) measurement. | Other | Case group, Control group |
| Prick testsCases 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,... | Diagnostic test | Case group, Control group |
| Biological samplesSubjects and their parents/guardians will be given the option to provide blood, urine, and nasopharyngeal samples. | Other | Case group, Control group |
| Portable sensorsUp 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. | Device | Case group, Control group |
Primary outcome
Statistically significant differences in spirometric parameter, Peak Flow, between case and control groups
Time frame: 10 Months
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
Statistically significant differences in FeNO measurements between case and control groups
Time frame: 10 Months
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
Evaluation of statistically significant differences in spirometric parameter, FEV, between case and control groups
Time frame: 10 months
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
Evaluation of statistically significant differences in spirometric parameter, FVC, between case and control groups
Time frame: 10 months
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
Statistically significant differences in the spirometric parameter, FEV₁/FVC ratio, between case and control groups
Time frame: 10 months
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
Statistically significant differences in spirometric parameter, FEF, between case and control groups
Time frame: 10 months
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
Evaluation of statistically significant differences in spirometric parameter, mean forced expiratory flow, between case and control groups
Time frame: 10 months
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
2 secondary outcomes
Disease control in asthma and allergies in relation to air and dust contaminants
Time frame: 10 Months
Statistically significant differences in biological biomarkers between case and control groups
Time frame: 10 Months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standardized questionnaires, Lung function tests and Prick tests in people with Allergy, run by University Hospital, Montpellier at 1 site 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Statistically significant differences in spirometric parameter, Peak Flow, between case and control groups (time frame: 10 Months). The study lists 7 primary outcomes in all. 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 11 Feb 2026.