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

Официальное название

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

Обзор

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.

Вмешательства

• Другое 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 cleanin

Первичные конечные точки

• ILD development linked to exposure to indoor risk factors [Срок оценки: 6 months]

Вторичные конечные точки (2)

• Determine the revision of the ILD diagnosis following the CMEI audit [Срок оценки: 6 months]
• Assess the impact of EHRA recommendations on patients' respiratory health 6 months after the audit [Срок оценки: 6 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Франция · 2 центра

• Hôpital Paris Saint Joseph — Paris
• Hôpital de Tenon — Paris

Публикации

• 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 20663536
• WHO Guidelines for Indoor Air Quality: Selected Pollutants. Geneva: World Health Organization; 2010. Available from http://www.ncbi.nlm.nih.gov/books/NBK138705/ PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 30139719

Идентификаторы

NCT: NCT07457502 · 2021-A03572-37

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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