AsthmaEXAPNCT05525169
Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma
An observational study of Asthma, run by Nantes University Hospital at 1 site in France.
Trial summary
The project is to measure exposure to outdoor and indoor air pollutants in asthma patients in order to show a possible association between variation in pollutant exposure and the occurrence of exacerbations in these patients Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Asthma
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2022to 15 Nov 2026
- How long will I take part?
- 1 Year
- 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 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will consist of adult men and women recruited from the active file of asthma patients followed at the Nantes University Hospital, the Saint Nazaire Hospital, the Châteaubriant Nozay Pouancé Hospital and the Erdre et Loire Hospital. Regardless of the type of asthma, patients will be potentially included if they have a minimum of 4 exacerbations during the year preceding inclusion in the EXAP project>. Participation in other non-interventional research is allowed during the study unless this research increases the number of exacerbations.
Who may be able to join
- Patient over 18 years of age,
- Patient with a confirmed diagnosis of asthma for at least 12 months as defined by the investigator,
- Patient with at least 4 asthma exacerbations in the last year
- Patient sleeping at least 6 nights per week in the same home
Who cannot join
- Patient who is an active smoker or living with an active smoker,
- Patient with a diagnosis of COPD, ABPA or associated pulmonary fibrosis,
- Patient with an asthma exacerbation within 15 days prior to the inclusion visit,
- Patient with known occupational exposure,
- Patient living in a dwelling that does not allow the installation of sensors (inability to connect the sensor to the power supply, no location for the outdoor sensor...)
- Patient who plans to move in the next 6 months,
Show all 10Show fewer
- Patient with a life expectancy of less than 6 months,
- Patient who has someone living in their household also included in EXAP,
- Patient who lives in an apartment and does not have a balcony or space for the outdoor sensor,
- Pregnant or breastfeeding women,
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Megguy Bernard contact
France1 site, 1 recruiting
- Recruiting
CHU de Nantes
Nantes, 44093
François-Xavier Blanc, PU-PH, 02 40 16 53 33, xavier.blanc@chu-nantes.fr
Megguy Bernard, megguy.bernard@chu-nantes.fr
About this study
The project is to measure exposure to outdoor and indoor air pollutants in asthma patients in order to show a possible association between variation in pollutant exposure and the occurrence of exacerbations in these patients
Read the detailed description
Asthma is a chronic airway disease affecting between 6% and 7% of the French adult population. Asthma is responsible for nearly 1000 deaths each year in France. Air pollution (indoor and outdoor) is responsible for 7 million deaths each year according to the World Health Organization (WHO) assessment published in 2018, including 65,000 in France. Studies monitoring exposure to indoor air pollutants are few in number in asthmatic patients. Very little research has been devoted to continuous monitoring of indoor air quality in homes. Our hypothesis is that variation in exposure to indoor air pollutants, in relation to outdoor air, would have an impact on the occurrence of exacerbations in asthmatic patients.
- Conditions
- Asthma
- Keywords
- Asthma, exacerbations, outdoor and indoor air pollutants
- Medical subject headings
- Asthma
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma exacerbations
The primary criterion is the association between the occurrence of exacerbations and the concentrations of the following pollutants or other environmental factors measured daily in the patients' homes by air pollution sensor inside and outside the home.
- the concentration of indoor pollutants: PM1 (µg/m3), PM2.5 (µg/m3), PM10 (µg/m3), volatile organic compounds (VOC) (µg/m3) , CO2 (ppm),
- the concentration of outdoor pollutants (µg/m3): PM1, PM2.5, PM10,
- The ratios (indoor/outdoor air) of PM1, PM2.5 and PM10 in the home,
- Temperature(°C) and relative humidity (RH) (%) in indoor and outdoor air,
- Exceedances of regulatory (provided by the Environmental Code) or recommended (determined by the sensor supplier) pollutant thresholds.
Measured: 36 months
Secondary outcomes (1)
Daily Peak flow (l/ min)
The secondary criterion is the the temporal association between the daily Peak flow and the concentrations of the same pollutants or other environmental factors listed in the primary criterion.
Subgroup analyses : groups of patients will be created according to the characteristics of their habitat (heating mode, ventilation, rural or urban area...).
Both primary and secondary outcomes will be studied in these subgroups.
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start15 Nov 2022
- Primary completion15 Nov 2026 (estimated)
- Study completion15 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François-Xavier Blanc, PU-PH, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525169
- Sponsor's protocol ID
- RC22_0115
- Acronym
- EXAP
- Status last verified
- Apr 2026
- First submitted
- 7 Jul 2022
- Last updated
- 17 Apr 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma
- ClinicalTrials.gov ID
- NCT05525169
- Acronym / sponsor ID
- EXAP / RC22_0115
- Conditions
- Asthma
- Keywords
- Asthma, exacerbations, outdoor and indoor air pollutants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 15 Nov 2026 (estimated)
- Study completion
- 15 Nov 2026 (estimated)
- First posted
- 1 Sep 2022 (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 project is to measure exposure to outdoor and indoor air pollutants in asthma patients in order to show a possible association between variation in pollutant exposure and the occurrence of exacerbations in these patients
Detailed description
Asthma is a chronic airway disease affecting between 6% and 7% of the French adult population. Asthma is responsible for nearly 1000 deaths each year in France. Air pollution (indoor and outdoor) is responsible for 7 million deaths each year according to the World Health Organization (WHO) assessment published in 2018, including 65,000 in France. Studies monitoring exposure to indoor air pollutants are few in number in asthmatic patients. Very little research has been devoted to continuous monitoring of indoor air quality in homes. Our hypothesis is that variation in exposure to indoor air pollutants, in relation to outdoor air, would have an impact on the occurrence of exacerbations in asthmatic patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will consist of adult men and women recruited from the active file of asthma patients followed at the Nantes University Hospital, the Saint Nazaire Hospital, the Châteaubriant Nozay Pouancé Hospital and the Erdre et Loire Hospital. Regardless of the type of asthma, patients will be potentially included if they have a minimum of 4 exacerbations during the year preceding inclusion in the EXAP project>. Participation in other non-interventional research is allowed during the study unless this research increases the number of exacerbations.
Key inclusion criteria (4 listed)
- Patient over 18 years of age,
- Patient with a confirmed diagnosis of asthma for at least 12 months as defined by the investigator,
- Patient with at least 4 asthma exacerbations in the last year
- Patient sleeping at least 6 nights per week in the same home
Key exclusion criteria (10 listed)
- Patient who is an active smoker or living with an active smoker,
- Patient with a diagnosis of COPD, ABPA or associated pulmonary fibrosis,
- Patient with an asthma exacerbation within 15 days prior to the inclusion visit,
- Patient with known occupational exposure,
- Patient living in a dwelling that does not allow the installation of sensors (inability to connect the sensor to the power supply, no location for the outdoor sensor...)
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
Asthma exacerbations
Time frame: 36 months
The primary criterion is the association between the occurrence of exacerbations and the concentrations of the following pollutants or other environmental factors measured daily in the patients' homes by air pollution sensor inside and outside the home. * the concentration of indoor pollutants: PM1 (µg/m3), PM2.5 (µg/m3), PM10 (µg/m3), volatile organic compounds (VOC) (µg/m3) , CO2 (ppm), * the concentration of outdoor pollutants (µg/m3): PM1, PM2.5, PM10, * The ratios (indoor/outdoor air) of PM1, PM2.5 and PM10 in the home, * Temperature(°C) and relative humidity (RH) (%) in indoor and outdoor air, * Exceedances of regulatory (provided by the Environmental Code) or recommended (determined by the sensor supplier) pollutant thresholds.
1 secondary outcome
Daily Peak flow (l/ min)
Time frame: 36 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 17 Apr 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.
Megguy Bernard contact
François-Xavier Blanc, PU-PH principal investigator
Nantes University Hospital
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, run by Nantes University Hospital 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 4 inclusion and 10 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 17 Apr 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?
Contact François-Xavier Blanc, PU-PH (02 40 16 53 33, xavier.blanc@chu-nantes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma exacerbations (time frame: 36 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 17 Apr 2026.