Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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Idiopathic Pulmonary Fibrosis(IPF) is the most common idiopathic interstitial lung disease whose cause is unknown. With age and gender, socio-economic factors are the most influential indicators of health. At present there is very little data on socio-economic factors in the IPF. The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF. The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.

Detailed Description
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Idiopathic Pulmonary Fibrosis is the most common idiopathic interstitial lung disease whose cause is unknown. However, it remains a rare disease, there is an incidence of approximately 4400 new patients per year in France. It is a serious disease with few therapeutic options and a median survival after diagnosis around 36 months. It is also responsible for high morbidity, with a marked deterioration in quality of life (dyspnea, cough, fatigue and anxiodepressive disorders) and significant functional impairment (respiratory failure) With age and gender, socio-economic factors are the most influential indicators of health. At present there is very little data on socio-economic factors in the IPF. The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF. The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.

Official Title
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Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis, Pulmonary Disease, Pulmonary Medicine

Intervention / Treatment
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* Diagnostic Test: Blood sample


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man woman over 18 years old Certain or probable Idiopathic Pulmonary Fibrosis determined by a multi-disciplinary discussion (ATS / ERS / JRS / ALAT 2018 criteria) Idiopathic Pulmonary Fibrosis with a diagnosis of less than 12 months Signed informed consent Patient affiliated to a social security scheme or universal health coverage or benefiting from state medical aid Exclusion Criteria: Known cause of Diffuse Interstitial Lung Disease (including connectivity, Hypersensitivity pneumonitis or pneumoconiosis authenticated) Patient unable to answer questionnaires Pregnant or lactating woman Persons under guardianship

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Longitudinal prospective cohort study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idiopathic Pulmonary Fibrosis<br>Blood sample were performed during the study for all patients. | Diagnostic Test: Blood sample<br>* Blood sample performed at the inclusion and during the follow-up.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if the household income is associated with the severity of the IPF at inclusion | Patients will be classified into three groups: lower standard of living, average level and higher level. These groups are respectively defined by wages : less than 1000 euros, greater than or equal to 1000 euros and less than 4000 euros, and greater than or equal to 4000 euros. The severity of the IPF at baseline will be defined by the respiratory functional impact: a forced vital capacity (FVC) of less than 50% and / or a Carbon monoxide diffusion capacity of less than 30%. | Enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the general and specific external environment of patients with IPF | Collection of data on the general and specific external environment on patients with IPF | Enrollment | 
| Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the severity of the IPF | Collection of data about socio-economic and environmental factors, and about severity on patients with IPF | Enrollment | 
| Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the quality of life | Collection of data about socio-economic and environmental factors, and about quality of life on patients with IPF | Enrollment | 
| Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the occurrence of an Acute Exacerbation | Collection of data about socio-economic and environmental factors, and about occurrence of an Acute Exacerbation on patients with IPF | 24 months | 
| Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the progress of the IPF | Collection of data about socio-economic and environmental factors, and about progression of IPF on patients with IPF | 24 months | 
| Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the mortality | Collection of data about socio-economic and environmental factors, and about mortality of patients with IPF | 24 months | 
| Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the existence and type of comorbidities | Collection of data about socio-economic and environmental factors, and about existence and type of comorbidities on patients with IPF | Enrollment | 
| Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the diagnostic and management delay | Collection of data about socio-economic and environmental factors, and about diagnostic and management delay on patients with IPF | Enrollment | 
| Determine the impact of socio-economic factors and environmental factors on therapeutic decisions: anti-fibrotic treatments, access to transplantation | Collection of data about socio-economic and environmental factors (occupational domestic exposures and air pollution), and about therapeutic decisions (anti-fibrotic treatments, access to transplantation) on patients with IPF | 24 months | 
| Determine if the deleterious effect of air pollutants on the decline of respiratory function is dependent on the size of the telomeres | Collection of data about deleterious effect of air pollutants on the decline of respiratory function and about the length of telomers calculated with T/S ratio. Blood samples will be performed for analysis of biomarkers and oxidative stress in IPF, measurement of telomere length, MUC5B, TOLLIP and GSTT1 polymorphisms. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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socioeconomic Status, air pollution, Environmental exposure, Occupational exposure, idiopathic pulmonary fibrosis