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Domestic Environmental Exposure and Progression of ILD: An Exploratory Case-Control Study

Domestic Environmental Exposure and Progression of Fibrosing Interstitial Lung Diseases: An Exploratory Case-Control Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07457502
Acronym
EXPODOM-PID
Enrollment
100
Registered
2026-03-09
Start date
2023-04-26
Completion date
2026-10-26
Last updated
2026-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Assess CMEI Recommendations' Impact on Respiratory Health, Assess PID Diagnosis Revision After CMEI Audit, ILD Progression and Exposure to Indoor Environnemental Risk, ILD Progression and Exposure to Outdoor Polluants

Keywords

Interstitial Lung Disease, Air polution, fibrosing, Environmental health, Indoor exposure

Brief summary

The project titled "Domestic Environmental Exposure and Progression of Progressive or Stable Fibrosing Interstitial Lung Diseases: An Exploratory Case-Control Study" is a Category 3 study involving 60 patients with progressive or stable fibrosing interstitial lung diseases (ILDs). These patients are matched based on the same ILD subtype and their use or non-use of antifibrotic medication. The study aims to thoroughly describe the domestic environment of these patients and investigate the associations between the progression of pulmonary fibrosis and: i) The presence of pollutants and risk factors in the home, including concentrations of nitrogen dioxide, volatile organic compounds, aldehydes, fine particles, mold, dust mite allergens, building defects, and lifestyle habits that increase pollutant exposure. ii) The ambient air quality at the patients' addresses. Occupational exposures will also be considered in the analysis. This project is designed to enhance our understanding of how an unfavorable domestic environment impacts the progression of pulmonary fibrosis and to evaluate the effects of the CMEI (Comprehensive Environmental and Indoor Audit) on patients' ability to manage identified risk factors within their homes, their respiratory health, and their medical diagnosis. The CMEI audit is a preventive measure that could serve as a significant intervention to alter patient behavior, reduce exposure, and improve health outcomes. This project is sponsored by the Environmental Health Laboratories Department, in collaboration with Unit 1018 of the Research Center in Epidemiology and Population Health (CESP), and two investigative centers: Tenon Hospital and Paris Saint-Joseph Hospital.

Interventions

OTHEREnvironmental audit of patient housing

During the home audit of the patient, the Environmental Health Medical Advisor searchs for potential sources of indoor pollution and other housing risk factors (building defects and occupant habits that negatively impact respiratory health). An environmental questionnaire is administered to the patient to gather information about the home environment (ventilation, presence of plants, presence of pets, pests, etc.) and the patient's lifestyle (ventilation habits, use of air fresheners and cleaning products, smoking, etc.). The home audit is conducted according to the principles of the NF X43-406 standard. During the home audit, direct measurements (TVOC index, particles, ambient parameters, cold surfaces) and standardized environmental samples (NO2, VOCs, aldehydes, mold, allergens) will be collected, followed by analysis in the SPSE. The outdoor polluants data concentration are recovred from the ambiant monitoring network at the patient's address by modeling.

Sponsors

Ville de Paris
Lead SponsorOTHER_GOV
Institut National de la Santé Et de la Recherche Médicale, France
CollaboratorOTHER_GOV
Tenon Hospital, Paris
CollaboratorOTHER
Fondation Hôpital Saint-Joseph
CollaboratorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patient aged over 18 years * Patient affected by one of the following interstitial lung diseases (ILDs): Idiopathic Pulmonary Fibrosis (IPF), Nonspecific Interstitial Pneumonia (NSIP), Pneumoconioses, ILDs associated with autoimmune features, Pleuroparenchymal Fibroelastosis (PPFE), Chronic Hypersensitivity Pneumonitis (CHP) whose etiology is not primarily related to the domestic environment, Stage 4 fibrosing sarcoidosis, unclassifiable ILDs. * ILD patient with progressive fibrosis over the past 12 months (case group) * ILD patient with non-progressive fibrosis over the past 12 months (control group) * Patients without reduction in the treatment of interstitial lung disease in the 12 months prior to inclusion, patients without treatment can be included * Matching "1 progressive fibrosis" / "2 non-progressive fibrosis": * Same ILD diagnosis * Use of antifibrotic treatment for both paired patients or absence of antifibrotic treatment for both paired patients * Both patients should preferably be matched within 3 months to limit significant contrasts in lifestyle and housing use related to the season * Patient who has received information about the protocol and does not object to participating * Patient affiliated with or beneficiary of a social security scheme or universal health coverage

Exclusion criteria

* Patient who has already received advice from a CMEI (Environmental and Occupational Medicine Consultation Center) in the past 12 months * Patient who has recently moved into their home (less than 1 year) * Patient living less than 6 months per year in the home to be investigated * Patient followed in psychiatry for a severe condition * Patient who does not speak French and is not accompanied by a person who shares their home and speaks French to act as a translator * Patient refusing to consent to participate in the research * Patient not living in Île-de-France * Patient with non-chronic Hypersensitivity Pneumonitis related to the domestic environment * Patient with sarcoidosis (except stage 4 fibrosing sarcoidosis) * Adult patient under legal protection and unable to give consent

Design outcomes

Primary

MeasureTime frameDescription
ILD development linked to exposure to indoor risk factors6 monthsThe aim of this study is to thoroughly characterize the domestic environment and ambient air quality near patients' homes, and to evaluate their roles in the progression of pulmonary fibrosis in patients with fibrosing ILD. We will compare exposure levels to major indoor pollutants, other housing risk factors identified by Environmental Health Risk Assessment (CMEI) (e.g., defective ventilation, building defects, lifestyle factors, overcrowding), and outdoor air pollutants near the homes between the case and control groups.

Secondary

MeasureTime frameDescription
Determine the revision of the ILD diagnosis following the CMEI audit6 monthsThe number of patients reclassified as having domistic Hypersensitivity pneumonitis will be determined after the EHRA audit, which will have objectively identified the presence of sources of exposure to domestic pollutants responsible for Hypersensitivity pneumonitis.
Assess the impact of EHRA recommendations on patients' respiratory health 6 months after the audit6 monthsThis will be done through a questionnaire on compliance with the given recommendations (since no environmental samples will be taken 6 months after the audit) and by analyzing the patients' ability to address the risk factors identified in their homes for the whole cohort.

Countries

France

Contacts

CONTACTValerie BEX, 1
valerie.bex@paris.fr+33144978771
CONTACTOualid ALIOUI
oualid.alioui@paris.fr+33144978767
PRINCIPAL_INVESTIGATORJean-Marc NACCACHE, 1

Groupe Hospitalier Paris Saint Josèphe

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026