Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-30 @ 12:19 AM
Study NCT ID:
NCT07457502
Status:
RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Domestic Environmental Exposure and Progression of ILD: An Exploratory Case-Control Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}, 'targetDuration': '6 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-10-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-02', 'studyFirstSubmitDate': '2026-03-02', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ILD development linked to exposure to indoor risk factors', 'timeFrame': '6 months', 'description': "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."}], 'secondaryOutcomes': [{'measure': 'Determine the revision of the ILD diagnosis following the CMEI audit', 'timeFrame': '6 months', 'description': '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.'}, {'measure': "Assess the impact of EHRA recommendations on patients' respiratory health 6 months after the audit", 'timeFrame': '6 months', 'description': "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."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interstitial Lung Disease', 'Air polution', 'fibrosing', 'Environmental health', 'Indoor exposure'], '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']}, 'referencesModule': {'references': [{'pmid': '20663536', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '23741784', 'type': 'BACKGROUND', 'citation': 'WHO Guidelines for Indoor Air Quality: Selected Pollutants. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138705/'}, {'pmid': '15636485', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32340311', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '22436169', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '33153698', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '21432221', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '30139719', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '35964592', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '32278507', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '24176998', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28798214', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '12580803', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '27665387', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '28121774', 'type': 'BACKGROUND', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The recruited patients will be divided into two groups:\n\n* 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.\n* 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.\n\nThe proposed criteria for progression, which will be used in our project, are:\n\nRelative 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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient aged over 18 years\n* 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.\n* ILD patient with progressive fibrosis over the past 12 months (case group)\n* ILD patient with non-progressive fibrosis over the past 12 months (control group)\n* Patients without reduction in the treatment of interstitial lung disease in the 12 months prior to inclusion, patients without treatment can be included\n* Matching "1 progressive fibrosis" / "2 non-progressive fibrosis":\n* Same ILD diagnosis\n* Use of antifibrotic treatment for both paired patients or absence of antifibrotic treatment for both paired patients\n* Both patients should preferably be matched within 3 months to limit significant contrasts in lifestyle and housing use related to the season\n* Patient who has received information about the protocol and does not object to participating\n* Patient affiliated with or beneficiary of a social security scheme or universal health coverage\n\nExclusion Criteria:\n\n* Patient who has already received advice from a CMEI (Environmental and Occupational Medicine Consultation Center) in the past 12 months\n* Patient who has recently moved into their home (less than 1 year)\n* Patient living less than 6 months per year in the home to be investigated\n* Patient followed in psychiatry for a severe condition\n* 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\n* Patient refusing to consent to participate in the research\n* Patient not living in Île-de-France\n* Patient with non-chronic Hypersensitivity Pneumonitis related to the domestic environment\n* Patient with sarcoidosis (except stage 4 fibrosing sarcoidosis)\n* Adult patient under legal protection and unable to give consent'}, 'identificationModule': {'nctId': 'NCT07457502', 'acronym': 'EXPODOM-PID', 'briefTitle': 'Domestic Environmental Exposure and Progression of ILD: An Exploratory Case-Control Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ville de Paris'}, 'officialTitle': 'Domestic Environmental Exposure and Progression of Fibrosing Interstitial Lung Diseases: An Exploratory Case-Control Study', 'orgStudyIdInfo': {'id': '2021-A03572-37'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Case', 'description': 'Patients with progressive ILD criteria', 'interventionNames': ['Other: Environmental audit of patient housing']}, {'label': 'Control', 'description': 'Patients with non-progressive ILD criteria', 'interventionNames': ['Other: Environmental audit of patient housing']}], 'interventions': [{'name': 'Environmental audit of patient housing', 'type': 'OTHER', 'description': "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.", 'armGroupLabels': ['Case', 'Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75014', 'city': 'Paris', 'state': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Marc NACCACHE', 'role': 'CONTACT', 'email': 'jmnaccache@ghpsj.fr', 'phone': ': 01 44 12 75 82'}, {'name': 'Sadek MORTADA', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital Paris Saint Joseph', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75020', 'city': 'Paris', 'state': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jacques CADRANEL', 'role': 'CONTACT', 'email': 'jacques.cadranel@aphp.fr'}, {'name': 'Ingrid BERGER', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hôpital de Tenon', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'centralContacts': [{'name': 'Valerie BEX, 1', 'role': 'CONTACT', 'email': 'valerie.bex@paris.fr', 'phone': '+33144978771'}, {'name': 'Oualid ALIOUI', 'role': 'CONTACT', 'email': 'oualid.alioui@paris.fr', 'phone': '+33144978767'}], 'overallOfficials': [{'name': 'Jean-Marc NACCACHE, 1', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Groupe Hospitalier Paris Saint Josèphe'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ville de Paris', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Institut National de la Santé Et de la Recherche Médicale, France', 'class': 'OTHER_GOV'}, {'name': 'Tenon Hospital, Paris', 'class': 'OTHER'}, {'name': 'Fondation Hôpital Saint-Joseph', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Engineer', 'investigatorFullName': 'Valerie BEX', 'investigatorAffiliation': 'Ville de Paris'}}}}