Asthma in ChildrenSynAIR-GNCT05997784
Study of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing
An observational study of Asthma in Children and Allergy, run by University Hospital, Montpellier at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Asthma in Children, Allergy
- What is being tested?
- Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO)), Filling of standardized questionnaires and Using an App on a device
- Type of treatment
- Pill or oral medicine
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 30 Jan 2025to 1 Sep 2028
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: A maximum of 500 schoolchildren at CM1 level (French education system), equally distributed between males and females, will derive from a maximum of eight primary schools and 2-3 classes of CM1 in each school, when available. Therefore, two-three classrooms per schools, in no more than 8 schools, each year, over 2 consecutive school years will be monitored, and children will be followed-up during 10 months. The selection of schools will be based on socioeconomic and air pollution criteria (differences between different regions of the participating centres) and whenever possible on annual reports on air quality (if available) from the respectively Directorate of Climate Change and Atmospheric Quality of the Ministry of Environment.
Who may be able to join
- Child attending CM1 level at the beginning of the school year
- Child in a classroom selected for the project
- Child and caregiver(s) willing to follow the study procedures.
Who cannot join
- Child or child's parents/guardian's who:
- Refuse to participate to the project / to give informed consent
- Do not want to use the application to fill the questionnaire and 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 locations and contacts
1 site in 1 country.
About this study
Official title: Disrupting Noxious Synergies of Indoor Air Pollutants and Their Impact in Childhood Health and Wellbeing, Using Advanced Intelligent Multisensing
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 Syn-Air-G project will develop a comprehensive and responsive multipollutant monitoring system (in accessible and actionable formats) by constructing and deploying novel but validated and improved sensors of chemical and biological (allergens, microbes) pollutants) and advancing environmentally friendly interventions (including air purifiers). Health: A comprehensive multidisciplinary and exposome approach of health effects of multi-pollution in small children.
Read the detailed description
Exposure to indoor air pollutants is evidently a critical issue for human health. For the paediatric population, good indoor air quality in the school's environment is an important contributor to the overall and respiratory health, attendance, and academic performance , while poor air quality is associated to a high risk for adverse health outcomes, especially in the vulnerable asthmatic population . Viruses, microbes, allergens, and chemical pollutants exhibit a complex interaction with the human immune system, depending upon several factors such as the age, predisposition (e.g., atopy) and identity of the agent . Pollen exposure increases the risk of viral infections, such as those attributed to rhinoviruses (RVs) and SARS-Cov2 , while viruses and allergens have been shown to interact with pollutants such as ozone (O3) and fine particles (PM2.5), increasing their morbidity effects. Viral infections, especially RVs, impair anti-bacterial innate immune responses , thus affecting the overall microbiome homeostasis.
There are suggestions of potential synergies between different environmental factors, including gas and particulate chemical pollutants, allergens, and viral/microbial species, particularly in the sensitive younger ages, however, such synergies have not been addressed in a real-life epidemiological, systematic, longitudinal study.
The list of indoor air pollutants associated with significant burden on health disorders and increasing social and economic costs, is long and expanding, as current knowledge evolves, on this particular subject. The detrimental effects of air pollution on several health aspects have recently been reviewed. Additionally, a joint statement by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) integrated the latest scientific evidence showing that air pollution affects almost all systems of the human body, including the respiratory, cardiovascular, central nervous, and endocrine systems Studies based on google trend models have shown significant impact of pollutants on respiratory symptoms, especially during increased pollen season in sensitized individuals . Children, one of the most susceptible subgroups in the population, spend a large proportion of their time indoors such as in the school environments, thus, raising the interest in characterizing the health relevant air pollutants in this microenvironment. Studies of air quality composition in classrooms, has shown that several pollutants' levels exceed the recommended air quality standards . The detrimental health effects of exposure to school-derived pollution have been shown for certain pollutants , while a disproportionate effect has been documented in asthmatics, more so in those born prematurely. Schools also act as accumulators of airborne threats, such as viruses or allergens, which are of particular importance to a large but quite vulnerable proportion of the paediatric population: those will allergies and asthma . Allergens are well known elicitors of respiratory symptoms in sensitized individuals, although the allergen effect is person-specific and non-linear , while associations between aeroallergen exposure in schools and increased asthma morbidity has been documented . Although there is evidence suggesting potential synergies between several different factors, health effects of pollutants are more frequently assessed individually, while results on studies assessing multiple pollutants provide divergent results . The cumulative and/or synergistic exposure between chemical and biological (allergens, microbes) pollutants and how these may affect respiratory symptoms, immune, and mental health and DNA damage is barely known. Moreover, school-based environmental interventions on health outcomes studies, are small and not adequately powered.
The SynAir-Child study, within the context of the EU SynAir-G project, is an epidemiological real-life observational study, aiming to assess if there's a possible association and synergy between indoor air pollutant variability and general, respiratory, immune, and mental health outcomes in school children, based on different socioeconomic backgrounds and on different settings, in different Countries.
Previous studies, such as the European SINPHONIE study, the CAMP study on the association Between Allergen Exposure in Inner-City Schools and Asthma Morbidity Among Students, assessed in real-life settings the composition of school air quality and the impact of certain environmental elements on different health outcomes. Although the indication and aim of the studies is similar, the design of the SynAir-Child study provides a unique setting to prospectively assess the synergistic effects of pollutants at school and outdoor on several health aspects in a large and diverse cohort. In addition, outcomes that constitute an adverse health effect of air pollution on humans' health, as stated in the joint ERS/ATS policy statement, will be evaluated and included in the study. Most importantly, the continuous nature of information provided by sentinel devices set in the schools, 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. It is estimated that the use of a personalized physiological profile can more accurately detect subtle changes in an individual's health markers, leading to a greater likelihood of early detection, in relation to the cumulative environmental exposures. Health outcome data, including respiratory health, immune fitness and both mental and non-mental perspectives will contribute to pollution sensing in an iterative way.
- Conditions
- Asthma in Children, Allergy
- Being tested
- Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO)), Filling of standardized questionnaires, Using an App on a device, Urine sample, Sensors and devices will be used to assess air pollutants in classrooms during the survey
- Keywords
- Air pollution, Asthma, Allergy, Epidemiology, Public health, App, Remote sensors
- Medical subject headings
- Hypersensitivity, Asthma, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO))Other
Performing lung function tests and FeNO following European Respiratory Society (ERS) standardized guidelines, through the MIR portable spirometer and the NIOX Vero®, respectively.
Spirometry is performed using a portable spirometer. All manoeuvres are performed according to the American Thoracic Society and European Respiratory Society (ATS/ERS) standards.
FeNO test is a quick and non-invasive test that is easy for children to do. To take the test, the child have to blow into a handheld device (NIOX Vero®). More in detail, children are asked to inhale ambient air through a nitrogen oxide scrubber to total lung capacity, and then exhale for 10 seconds. The test results are available right away.
Filling of standardized questionnairesOther
(Baseline, Follow-up, Quality of life and Final) allowing to collect data on sociodemographic characteristics, health outcomes, potential risk factors, lifestyle and living environment.
Health outcomes will consider general health (general status, infections, allergies), respiratory health (asthma symptoms, diagnosis, control, triggers, medications, etc.), perception of health and well-being.
Using an App on a deviceOther
Children will have to answer a daily questionnaire on cell phone, tablet, computer...), with the help of parents/caregivers.
To encourage children to answer the questions, the questionnaires will be incorporated into a game that will also teach them about environmental challenges and pollutants in Europe.
There will be a general health questionnaire with 3 questions assessed on a Likert scale.
The application will also include 2 questions on respiratory health, with Yes/No answers. If the answer is Yes to one of the questions, the intensity of symptoms will be assessed on a visual analog scale from 0 to 100 (0 almost no symptoms and 100 the most intense symptoms imaginable).
Urine sampleOther
On a voluntary basis, a urine sample will be collected, as well.
Sensors and devices will be used to assess air pollutants in classrooms during the surveyOther
- Particulate matter (PM) will be assessed with a counter as a well as a remote sensor (Canarin) .
- Volatile Organic Compound (VOCs) with a passive sampler (Radiello).
- Virus and bacteria will be collected with a pump.
The devices will be attached to the classroom wall.
In addition, dust pollution will be assessed by collecting dust with a vacuum cleaner in order to assess phthalates (Dimethyl phthalate, diethyl phthalates, Di(2-ethylhexyl) phthalate).
What is being measured
The primary outcome is the main question the study is designed to answer.
Indoor classroom air concentrations of Pollutants and dust
Classrooms concentrations (mean with standard deviation SD) of Viruses, Microbe, Allergens, Chemical Air Pollutants (particulate mater PM , NO2, VOCs, phthalates) (ppm part per million) in air and dust.
Measured: For 10 Months
Prevalence for respiratory disease
Health outcomes measures by the prevalence (%) for allergic and respiratory health reported physician-based diagnosis of asthma and/or allergies.
Questionnaires about respiratory health disease based on validated International Study of Asthma and Allergies in Childhood (ISAAC) and PreDicta respiratory
- Asthma Control Test (ACT) composed of 7 items with a Score 20 to 25 means a well-controlled asthma, Score 15 - 19: partially controlled asthma and a Score < 15 means an uncontrolled asthma
- Asthma control questionnaire (ACQ) composed of 7 items and Scores range between 0 (totally controlled asthma) and 6 (severely uncontrolled).)
- Visual Analogic Scale (VAS) Questionnaire on the App (a score of 0 no symptoms and 100 the most respiratory symptoms)
Measured: For 10 Months
Association between asthma and indoor air contaminants
Significant association of indoor air quality contaminants and their interactions with health outcomes in schoolchildren: odds-ratio and 95% confidence interval between active asthma and indoor air total Volatile Organic Compound (VOCs) and dust phthalates.
Measured: For 10 Months
Secondary outcomes (5)
prevalence of children presenting airways obstruction
In children, the severity of airway obstruction can be graded according to Forced expiratory volume in one second (FEV1) measured by spirometry, percentage predicted measured by spirometry: FEV1 <100% to 80% indicates mild obstruction in children; FEV1 <80% to 50% indicates moderate obstruction; FEV1 <50% to 30% indicates severe airway obstruction; and FEV1 <30% indicates very severe obstruction.
Measured: Between baseline and 10 Months
Prevalence of children with an abnormal FeNO
Percentages of children with an abnormal FeNO. In clinical practice, a normal FeNO test in children is any number less than 20 parts per billion (ppb) in patients without lung inflammation.
The FeNO will be measured with a handheld device (NIOX Vero®).
Measured: Between baseline and 10 Months
Quality of life and wellbeing
General health outcomes will be measured with the use of a subset of questions from the Child Health Questionnaire (CHD) with 13 items, height (centimeter) and weight (kilogram) Quality of life will be measured with the validated Pediatric Quality of Life (PedsQL) questionnaire composed of 23 items and score on a reverse scale of 100 points. ("Never") = 100 = better quality of life, ("Almost Never") = 75("Sometimes") = 50("Often") = 25 ("Almost Always") = 0 = worst quality of life.
Measured: At 10 months
diagnosis of any disease and respiratory diseases
General health confirmed by questionnaire and physicians based diagnosis VAS Questionnaire on the app Through Quality of life and wellbeing questionnaires based on validated International Study of Asthma and Allergies in Childhood (ISAAC), PreDicta respiratory, ACT, ACQ
Measured: At 10 months
Environmental source of pollutants
Children and their caregivers will answer standardized questionnaires on sources and exposures of pollutant. (qualitative questionnaire, no scoring)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start30 Jan 2025
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- 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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Tbilisi State Medical University, University of Manchester, University of Oulu
- Responsible party
- Sponsor
- Investigators
- Davide CAIMMI, CAIMMI, Study director, CHU de Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05997784
- Sponsor's protocol ID
- RECHMPL23_0206
- Acronym
- SynAIR-G
- Status last verified
- Jul 2025
- First submitted
- 23 Jun 2023
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. 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
- ClinicalTrials.gov ID
- NCT05997784
- Acronym / sponsor ID
- SynAIR-G / RECHMPL23_0206
- Conditions
- Asthma in Children, Allergy
- Keywords
- Air pollution, Asthma, Allergy, Epidemiology, Public health, App, Remote sensors
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- National and Kapodistrian University of Athens, Tbilisi State Medical University, University of Manchester, University of Oulu
- Study start
- 30 Jan 2025 (actual)
- Primary completion
- 1 Sep 2027 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 18 Aug 2023 (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 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 Syn-Air-G project will develop a comprehensive and responsive multipollutant monitoring system (in accessible and actionable formats) by constructing and deploying novel but validated and improved sensors of chemical and biological (allergens, microbes) pollutants) and advancing environmentally friendly interventions (including air purifiers). Health: A comprehensive multidisciplinary and exposome approach of health effects of multi-pollution in small children.
Detailed description
Exposure to indoor air pollutants is evidently a critical issue for human health. For the paediatric population, good indoor air quality in the school's environment is an important contributor to the overall and respiratory health, attendance, and academic performance , while poor air quality is associated to a high risk for adverse health outcomes, especially in the vulnerable asthmatic population . Viruses, microbes, allergens, and chemical pollutants exhibit a complex interaction with the human immune system, depending upon several factors such as the age, predisposition (e.g., atopy) and identity of the agent . Pollen exposure increases the risk of viral infections, such as those attributed to rhinoviruses (RVs) and SARS-Cov2 , while viruses and allergens have been shown to interact with pollutants such as ozone (O3) and fine particles (PM2.5), increasing their morbidity effects. Viral infections, especially RVs, impair anti-bacterial innate immune responses , thus affecting the overall microbiome homeostasis.
There are suggestions of potential synergies between different environmental factors, including gas and particulate chemical pollutants, allergens, and viral/microbial species, particularly in the sensitive younger ages, however, such synergies have not been addressed in a real-life epidemiological, systematic, longitudinal study.
The list of indoor air pollutants associated with significant burden on health disorders and increasing social and economic costs, is long and expanding, as current knowledge evolves, on this particular subject. The detrimental effects of air pollution on several health aspects have recently been reviewed. Additionally, a joint statement by the American Thoracic Society (ATS) and the European Respiratory Society (ERS) integrated the latest scientific evidence showing that air pollution affects almost all systems of the human body, including the respiratory, cardiovascular, central nervous, and endocrine systems Studies based on google trend models have shown significant impact of pollutants on respiratory symptoms, especially during increased pollen season in sensitized individuals . Children, one of the most susceptible subgroups in the population, spend a large proportion of their time indoors such as in the school environments, thus, raising the interest in characterizing the health relevant air pollutants in this microenvironment. Studies of air quality composition in classrooms, has shown that several pollutants' levels exceed the recommended air quality standards . The detrimental health effects of exposure to school-derived pollution have been shown for certain pollutants , while a disproportionate effect has been documented in asthmatics, more so in those born prematurely. Schools also act as accumulators of airborne threats, such as viruses or allergens, which are of particular importance to a large but quite vulnerable proportion of the paediatric population: those will allergies and asthma . Allergens are well known elicitors of respiratory symptoms in sensitized individuals, although the allergen effect is person-specific and non-linear , while associations between aeroallergen exposure in schools and increased asthma morbidity has been documented . Although there is evidence suggesting potential synergies between several different factors, health effects of pollutants are more frequently assessed individually, while results on studies assessing multiple pollutants provide divergent results . The cumulative and/or synergistic exposure between chemical and biological (allergens, microbes) pollutants and how these may affect respiratory symptoms, immune, and mental health and DNA damage is barely known. Moreover, school-based environmental interventions on health outcomes studies, are small and not adequately powered.
The SynAir-Child study, within the context of the EU SynAir-G project, is an epidemiological real-life observational study, aiming to assess if there's a possible association and synergy between indoor air pollutant variability and general, respiratory, immune, and mental health outcomes in school children, based on different socioeconomic backgrounds and on different settings, in different Countries.
Previous studies, such as the European SINPHONIE study, the CAMP study on the association Between Allergen Exposure in Inner-City Schools and Asthma Morbidity Among Students, assessed in real-life settings the composition of school air quality and the impact of certain environmental elements on different health outcomes. Although the indication and aim of the studies is similar, the design of the SynAir-Child study provides a unique setting to prospectively assess the synergistic effects of pollutants at school and outdoor on several health aspects in a large and diverse cohort. In addition, outcomes that constitute an adverse health effect of air pollution on humans' health, as stated in the joint ERS/ATS policy statement, will be evaluated and included in the study. Most importantly, the continuous nature of information provided by sentinel devices set in the schools, 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. It is estimated that the use of a personalized physiological profile can more accurately detect subtle changes in an individual's health markers, leading to a greater likelihood of early detection, in relation to the cumulative environmental exposures. Health outcome data, including respiratory health, immune fitness and both mental and non-mental perspectives will contribute to pollution sensing in an iterative way.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A maximum of 500 schoolchildren at CM1 level (French education system), equally distributed between males and females, will derive from a maximum of eight primary schools and 2-3 classes of CM1 in each school, when available. Therefore, two-three classrooms per schools, in no more than 8 schools, each year, over 2 consecutive school years will be monitored, and children will be followed-up during 10 months. The selection of schools will be based on socioeconomic and air pollution criteria (differences between different regions of the participating centres) and whenever possible on annual reports on air quality (if available) from the respectively Directorate of Climate Change and Atmospheric Quality of the Ministry of Environment.
Key inclusion criteria (3 listed)
- Child attending CM1 level at the beginning of the school year
- Child in a classroom selected for the project
- Child and caregiver(s) willing to follow the study procedures.
Key exclusion criteria (5 listed)
- Refuse to participate to the project / to give informed consent
- Do not want to use the application to fill the questionnaire and 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
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 |
|---|---|---|
| Performing lung function tests (spirometry and fraction of exhaled nitric oxide (FeNO))Performing lung function tests and FeNO following European Respiratory Society (ERS) standardized guidelines, through the MIR portable spirometer and the NIOX Vero®, respectively. Spirometry is performed using a portable spirometer. All manoeuvres are performed according to the American Thoracic Society and European Respiratory Society (ATS/ERS) standards. FeNO test is a quick and non-invasive test that is easy for children to do. To take the test, the child have to blow into a handheld device (NIOX Vero®). More in detail, children are asked to inhale ambient air through a nitrogen oxide scrubber to total lung capacity, and then exhale for 10 seconds. The test results are available right away. | Other | – |
| Filling of standardized questionnaires(Baseline, Follow-up, Quality of life and Final) allowing to collect data on sociodemographic characteristics, health outcomes, potential risk factors, lifestyle and living environment. Health outcomes will consider general health (general status, infections, allergies), respiratory health (asthma symptoms, diagnosis, control, triggers, medications, etc.), perception of health and well-being. | Other | – |
| Using an App on a deviceChildren will have to answer a daily questionnaire on cell phone, tablet, computer...), with the help of parents/caregivers. To encourage children to answer the questions, the questionnaires will be incorporated into a game that will also teach them about environmental challenges and pollutants in Europe. There will be a general health questionnaire with 3 questions assessed on a Likert scale. The application will also include 2 questions on respiratory health, with Yes/No answers. If the answer is Yes to one of the questions, the intensity of symptoms will be assessed on a visual analog scale from 0 to 100 (0 almost no symptoms and 100 the most intense symptoms imaginable). | Other | – |
| Urine sampleOn a voluntary basis, a urine sample will be collected, as well. | Other | – |
| Sensors and devices will be used to assess air pollutants in classrooms during the survey* Particulate matter (PM) will be assessed with a counter as a well as a remote sensor (Canarin) . * Volatile Organic Compound (VOCs) with a passive sampler (Radiello). * Virus and bacteria will be collected with a pump. The devices will be attached to the classroom wall. In addition, dust pollution will be assessed by collecting dust with a vacuum cleaner in order to assess phthalates (Dimethyl phthalate, diethyl phthalates, Di(2-ethylhexyl) phthalate). | Other | – |
Primary outcome
Indoor classroom air concentrations of Pollutants and dust
Time frame: For 10 Months
Classrooms concentrations (mean with standard deviation SD) of Viruses, Microbe, Allergens, Chemical Air Pollutants (particulate mater PM , NO2, VOCs, phthalates) (ppm part per million) in air and dust.
Prevalence for respiratory disease
Time frame: For 10 Months
Health outcomes measures by the prevalence (%) for allergic and respiratory health reported physician-based diagnosis of asthma and/or allergies. Questionnaires about respiratory health disease based on validated International Study of Asthma and Allergies in Childhood (ISAAC) and PreDicta respiratory * Asthma Control Test (ACT) composed of 7 items with a Score 20 to 25 means a well-controlled asthma, Score 15 - 19: partially controlled asthma and a Score < 15 means an uncontrolled asthma * Asthma control questionnaire (ACQ) composed of 7 items and Scores range between 0 (totally controlled asthma) and 6 (severely uncontrolled).) * Visual Analogic Scale (VAS) Questionnaire on the App (a score of 0 no symptoms and 100 the most respiratory symptoms)
Association between asthma and indoor air contaminants
Time frame: For 10 Months
Significant association of indoor air quality contaminants and their interactions with health outcomes in schoolchildren: odds-ratio and 95% confidence interval between active asthma and indoor air total Volatile Organic Compound (VOCs) and dust phthalates.
5 secondary outcomes
prevalence of children presenting airways obstruction
Time frame: Between baseline and 10 Months
Prevalence of children with an abnormal FeNO
Time frame: Between baseline and 10 Months
Quality of life and wellbeing
Time frame: At 10 months
diagnosis of any disease and respiratory diseases
Time frame: At 10 months
Environmental source of pollutants
Time frame: Baseline
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 15 Dec 2025.
- Individual participant dataSharing planned: Undecided
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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.
Davide CAIMMI, CAIMMI study director
CHU de Montpellier
1 site 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 and 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 3 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: under way, not looking for participants, as of the sponsor's last update on 15 Dec 2025. 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?
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?
Indoor classroom air concentrations of Pollutants and dust (time frame: For 10 Months). The study lists 3 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 15 Dec 2025.