Domestic Environmental Exposure and Progression of Fibrosing Interstitial Lung Diseases: An Exploratory Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- ILD development linked to exposure to indoor risk factors
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Case
Patients with progressive ILD criteria
干预措施: Environmental audit of patient housing (Other)
Control
Patients with non-progressive ILD criteria
干预措施: Environmental audit of patient housing (Other)
结局指标
主要结局
ILD development linked to exposure to indoor risk factors
时间窗: 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.
次要结局
- Determine the revision of the ILD diagnosis following the CMEI audit(6 months)
- Assess the impact of EHRA recommendations on patients' respiratory health 6 months after the audit(6 months)
研究者
Valerie BEX
Principal Engineer
Ville de Paris
