Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma

Asthma Clinical Trial

— EXAP  

Official title:

Study of the Impact of Exposure to Outdoor and Indoor Pollutants in Patients With Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525169
• Other study ID #: RC22_0115
• Status: Recruiting
• Start date: November 15, 2022
• Est. completion date: September 15, 2025

Study information

• Verified date: November 2022
• Source: Nantes University Hospital
• Contact: François-Xavier Blanc, PU-PH
• Phone: 02 40 16 53 33
• Email: xavier.blanc[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: September 15, 2025
• Est. primary completion date: September 15, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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,

• 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,

Related Conditions & MeSH terms

• Asthma

Locations

Country	Name	City	State
France	CHU de Nantes	Nantes

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	36 months