NCT05525169

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

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
6mo left

Started Nov 2022

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Nov 2022Nov 2026

First Submitted

Initial submission to the registry

July 7, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

November 15, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2026

Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

July 7, 2022

Last Update Submit

April 14, 2026

Conditions

Keywords

Asthmaexacerbationsoutdoor and indoor air pollutants

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

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

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

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • François-Xavier Blanc, PU-PH

    Nantes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

François-Xavier Blanc, PU-PH

CONTACT

Megguy Bernard

CONTACT

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

Locations