Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma
EXAP
1 other identifier
observational
30
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Nov 2022
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 7, 2022
CompletedFirst Posted
Study publicly available on registry
September 1, 2022
CompletedStudy Start
First participant enrolled
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 15, 2026
April 17, 2026
April 1, 2026
4 years
July 7, 2022
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
36 months
Secondary Outcomes (1)
Daily Peak flow (l/ min)
36 months
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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 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,
- 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,
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU de Nantes
Nantes, 44093, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
François-Xavier Blanc, PU-PH
Nantes University Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Target Duration
- 1 Year
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 7, 2022
First Posted
September 1, 2022
Study Start
November 15, 2022
Primary Completion (Estimated)
November 15, 2026
Study Completion (Estimated)
November 15, 2026
Last Updated
April 17, 2026
Record last verified: 2026-04