Domestic Environmental Exposure and Progression of ILD: An Exploratory Case-Control Study (EXPODOM-PID)

March 2, 2026 updated by: Valerie BEX, Ville de Paris

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
    • Paris
      • Paris, Paris, France, 75014
        • Recruiting
        • Hopital Paris Saint Joseph
        • Contact:
        • Sub-Investigator:
          • Sadek MORTADA
      • Paris, Paris, France, 75020
        • Recruiting
        • Hôpital de Tenon
        • Contact:
        • Sub-Investigator:
          • Ingrid BERGER

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The recruited patients will be divided into two groups:

  • The "case" group will consist of patients with a fibrosing interstitial lung disease (ILD) who meet one of the criteria for fibrotic progression during the 6 months prior to inclusion.
  • The "control" group will be composed of patients with a fibrosing ILD who do not meet any of the criteria for fibrotic progression during the 6 months prior to inclusion.

The proposed criteria for progression, which will be used in our project, are:

Relative decrease in FVC ≥ 10%, Relative decrease in FVC ≥ 5% and a decrease in DLCO ≥ 15%, Relative decrease in FVC ≥ 5% and worsening of fibrotic signs on a scan, Relative decrease in FVC ≥ 5% and worsening of symptoms, Worsening of symptoms and fibrotic signs on a scan.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Case
Patients with progressive ILD criteria
Other: Environmental 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.
Control
Patients with non-progressive ILD criteria
Other: Environmental 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ILD development linked to exposure to indoor risk factors
Time Frame: 6 months
The 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.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine the revision of the ILD diagnosis following the CMEI audit
Time Frame: 6 months
The 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.
6 months
Assess the impact of EHRA recommendations on patients' respiratory health 6 months after the audit
Time Frame: 6 months
This 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ville de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France
Tenon Hospital, Paris
Fondation Hôpital Saint-Joseph

Investigators

  • Principal Investigator: Jean-Marc NACCACHE, 1, Groupe Hospitalier Paris Saint Josèphe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 26, 2023

Primary Completion (Estimated)

October 26, 2026

Study Completion (Estimated)

October 26, 2026

Study Registration Dates

First Submitted

March 2, 2026

First Submitted That Met QC Criteria

March 2, 2026

First Posted (Actual)

March 9, 2026

Study Record Updates

Last Update Posted (Actual)

March 9, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-A03572-37

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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