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NCT Number: NCT07457502

Domestic Environmental Exposure and Progression of ILD: 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Paris Saint Joseph, Paris, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Environmental audit of patient housing

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Oualid ALIOUI

CONTACT

[email protected]

+33144978767

Valerie BEX, 1

CONTACT

[email protected]

+33144978771

Sponsors and collaborators

Lead sponsor

Ville de Paris

Other Gov

Collaborators

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

Registry information

Official study title

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

Acronym: EXPODOM-PID

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 9, 2026
Registry last updated
Mar 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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