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Clinical Trials/NCT04619199
NCT04619199
Recruiting
Not Applicable

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

Assistance Publique - Hôpitaux de Paris16 sites in 1 country200 target enrollmentApril 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pulmonary Disease
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
200
Locations
16
Primary Endpoint
Determine if the household income is associated with the severity of the IPF at inclusion
Status
Recruiting
Last Updated
4 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2021
End Date
April 1, 2025
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Determine if the household income is associated with the severity of the IPF at inclusion

Time Frame: Enrollment

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%.

Secondary Outcomes

  • Describe the general and specific external environment of 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(Enrollment)
  • Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the progress of the IPF(24 months)
  • Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the severity of the 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(24 months)
  • Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the mortality(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(Enrollment)
  • Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the diagnostic and management delay(Enrollment)
  • Determine the impact of socio-economic factors and environmental factors on therapeutic decisions: anti-fibrotic treatments, access to transplantation(24 months)
  • Determine if the deleterious effect of air pollutants on the decline of respiratory function is dependent on the size of the telomeres(24 months)

Study Sites (16)

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