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Assess PID Diagnosis Revision After CMEI AuditEXPODOM-PIDNCT07457502

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

An observational study of Assess PID Diagnosis Revision After CMEI Audit and Assess CMEI Recommendations' Impact on Respiratory Health, run by Ville de Paris at 2 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Environmental audit of patient housing
How many people
100 participants
Where
2 sitesFrance
Study dates
26 Apr 2023to 26 Oct 2026
How long will I take part?
6 Months
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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":
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  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

France2 sites, 2 recruiting
  • Hôpital Paris Saint Joseph

    Paris, Paris, 75014

    Jean-Marc NACCACHE, : 01 44 12 75 82, jmnaccache@ghpsj.fr

    Sadek MORTADA

    Recruiting
  • Hôpital de Tenon

    Paris, Paris, 75020

    Jacques CADRANEL, jacques.cadranel@aphp.fr

    Ingrid BERGER

    Recruiting

Other trials in France

About this study

Official title: 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.

Being tested
Environmental audit of patient housing
Keywords
Interstitial Lung Disease, Air polution, fibrosing, Environmental health, Indoor exposure
Medical subject headings
Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Environmental audit of patient housingOther

    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.

Study groups in NCT07457502
Study groupRoleWhat they receive
CasePatients with progressive ILD criteria
Receives: Other: Environmental audit of patient housing
ControlPatients with non-progressive ILD criteria
Receives: Other: Environmental audit of patient housing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. ILD development linked to exposure to indoor risk factors

    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.

    Measured: 6 months

Secondary outcomes (2)
  1. Determine the revision of the ILD diagnosis following the CMEI audit

    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.

    Measured: 6 months

  2. Assess the impact of EHRA recommendations on patients' respiratory health 6 months after the audit

    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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2026
  2. Study start26 Apr 2023
  3. Primary completion26 Oct 2026 (estimated)
  4. Study completion26 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
100 participants (estimated)
Target duration
6 Months
IDs, dates and publications
ClinicalTrials.gov ID
NCT07457502
Sponsor's protocol ID
2021-A03572-37
Acronym
EXPODOM-PID
Status last verified
Sep 2025
First submitted
2 Mar 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Mouly D, Joulin E, Rosin C, Beaudeau P, Zeghnoun A, Olszewski-Ortar A, Munoz JF, Welte B, Joyeux M, Seux R, Montiel A, Rodriguez MJ. Variations in trihalomethane levels in three French water distribution systems and the development of a predictive model. Water Res. 2010 Oct;44(18):5168-79. doi: 10.1016/j.watres.2010.06.028. Epub 2010 Jun 19.

    PubMed 20663536
  • WHO Guidelines for Indoor Air Quality: Selected Pollutants. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138705/

    PubMed 23741784
  • Viegi G, Simoni M, Scognamiglio A, Baldacci S, Pistelli F, Carrozzi L, Annesi-Maesano I. Indoor air pollution and airway disease. Int J Tuberc Lung Dis. 2004 Dec;8(12):1401-15.

    PubMed 15636485
  • Tran VV, Park D, Lee YC. Indoor Air Pollution, Related Human Diseases, and Recent Trends in the Control and Improvement of Indoor Air Quality. Int J Environ Res Public Health. 2020 Apr 23;17(8):2927. doi: 10.3390/ijerph17082927.

    PubMed 32340311
  • Annesi-Maesano I, Hulin M, Lavaud F, Raherison C, Kopferschmitt C, de Blay F, Charpin DA, Denis C. Poor air quality in classrooms related to asthma and rhinitis in primary schoolchildren of the French 6 Cities Study. Thorax. 2012 Aug;67(8):682-8. doi: 10.1136/thoraxjnl-2011-200391. Epub 2012 Mar 21.

    PubMed 22436169
  • Raju S, Siddharthan T, McCormack MC. Indoor Air Pollution and Respiratory Health. Clin Chest Med. 2020 Dec;41(4):825-843. doi: 10.1016/j.ccm.2020.08.014.

    PubMed 33153698
  • Charpin D, Baden R, Bex V, Bladt S, Charpin-Kadouch C, Keimeul C, da Mata P, de Blay F, Kuske M, Le Moullec Y, Nicolas A, Ott M, Marc R, Speyer C, Vervloet D, Squinazi F. Environmental home inspection services in Western Europe. Environ Health Prev Med. 2011 Mar;16(2):73-9. doi: 10.1007/s12199-010-0171-0. Epub 2010 Aug 14.

    PubMed 21432221
  • Dalibert E, Dusseaux M, Bex V, Mathieu C, Barral S, Dubrou S. [Domestic exposure to moulds and mite allergens in Parisian patients]. Rev Mal Respir. 2018 Nov;35(9):907-918. doi: 10.1016/j.rmr.2018.01.012. Epub 2018 Aug 20. French.

    PubMed 30139719
  • Wijsenbeek M, Suzuki A, Maher TM. Interstitial lung diseases. Lancet. 2022 Sep 3;400(10354):769-786. doi: 10.1016/S0140-6736(22)01052-2. Epub 2022 Aug 11.

    PubMed 35964592
  • Sese L, Jeny F, Uzunhan Y, Khamis W, Freynet O, Valeyre D, Bernaudin JF, Annesi-Maesano I, Nunes H. [The effect of air pollution in diffuse interstitial lung disease]. Rev Mal Respir. 2020 May;37(5):389-398. doi: 10.1016/j.rmr.2020.02.015. Epub 2020 Apr 8. French.

    PubMed 32278507
  • Johannson KA, Vittinghoff E, Lee K, Balmes JR, Ji W, Kaplan GG, Kim DS, Collard HR. Acute exacerbation of idiopathic pulmonary fibrosis associated with air pollution exposure. Eur Respir J. 2014 Apr;43(4):1124-31. doi: 10.1183/09031936.00122213. Epub 2013 Oct 31.

    PubMed 24176998
  • Sese L, Nunes H, Cottin V, Sanyal S, Didier M, Carton Z, Israel-Biet D, Crestani B, Cadranel J, Wallaert B, Tazi A, Maitre B, Prevot G, Marchand-Adam S, Guillot-Dudoret S, Nardi A, Dury S, Giraud V, Gondouin A, Juvin K, Borie R, Wislez M, Valeyre D, Annesi-Maesano I. Role of atmospheric pollution on the natural history of idiopathic pulmonary fibrosis. Thorax. 2018 Feb;73(2):145-150. doi: 10.1136/thoraxjnl-2017-209967. Epub 2017 Aug 10.

    PubMed 28798214
  • de Blay F, Fourgaut G, Hedelin G, Vervloet D, Michel FB, Godard P, Charpin D, Pauli G; Scientific Committee of the MIEC study. Medical Indoor Environment Counselor (MIEC): role in compliance with advice on mite allergen avoidance and on mite allergen exposure. Allergy. 2003 Jan;58(1):27-33. doi: 10.1034/j.1398-9995.2003.23674.x.

    PubMed 12580803
  • Le Cann P, Paulus H, Glorennec P, Le Bot B, Frain S, Gangneux JP. Home Environmental Interventions for the Prevention or Control of Allergic and Respiratory Diseases: What Really Works. J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):66-79. doi: 10.1016/j.jaip.2016.07.011. Epub 2016 Sep 21.

    PubMed 27665387
  • Reddy AL, Gomez M, Dixon SL. An Evaluation of a State-Funded Healthy Homes Intervention on Asthma Outcomes in Adults and Children. J Public Health Manag Pract. 2017 Mar/Apr;23(2):219-228. doi: 10.1097/PHH.0000000000000530.

    PubMed 28121774

Questions about this trial

What is this clinical trial studying?

An observational study of Assess PID Diagnosis Revision After CMEI Audit and Assess CMEI Recommendations' Impact on Respiratory Health, run by Ville de Paris at 2 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Valerie BEX, 1 (+33144978771, valerie.bex@paris.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

ILD development linked to exposure to indoor risk factors (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07457502, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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