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

October 22, 2021 updated by: Assistance Publique - Hôpitaux de Paris
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Marseille, France
        • Not yet recruiting
        • 009 - Service Pneumologie
        • Principal Investigator:
          • Martine REYNAUT-GAUBERT, Pr
    • Avicenne
      • Bobigny, Avicenne, France
        • Recruiting
        • 001 - Service Pneumologie
        • Principal Investigator:
          • Hilario NUNES, Pr
      • Bobigny, Avicenne, France
        • Recruiting
        • 002 - Service Explorations Fonctionnelles Respiratoires
        • Principal Investigator:
          • Lucile SESE, Dr
    • Bichat
      • Paris, Bichat, France
        • Active, not recruiting
        • 003 - Service Pneumologie
    • CHU Caen Normandie
      • Caen, CHU Caen Normandie, France
        • Active, not recruiting
        • 016 - Service Pneumologie
    • CHU Dijon
      • Dijon, CHU Dijon, France
        • Active, not recruiting
        • 010 - Service Pneumologie
    • CHU Grenoble
      • Grenoble, CHU Grenoble, France
        • Active, not recruiting
        • 013 - Service Pneumologie
    • CHU Lille
      • Lille, CHU Lille, France
        • Active, not recruiting
        • 008 - Service Pneumologie
    • CHU Montpellier
      • Montpellier, CHU Montpellier, France
        • Not yet recruiting
        • 015 - Service Pneumologie
    • CHU Pontchaillou
      • Rennes, CHU Pontchaillou, France
        • Recruiting
        • 007 - Service Pneumologie
        • Principal Investigator:
          • Stéphane JOUNEAU, Pr
    • CHU Strasbourg
      • Strasbourg, CHU Strasbourg, France
        • Active, not recruiting
        • 011 - Service Pneumologie
    • CHU Tours
      • Tours, CHU Tours, France
        • Recruiting
        • 012 - Service Pneumologie
        • Principal Investigator:
          • Sylvain MARCHAND-ADAM, Pr
    • Ghef
      • Meaux, Ghef, France
        • Active, not recruiting
        • 014 - Service Pneumologie
    • Hegp
      • Paris, Hegp, France
        • Active, not recruiting
        • 005 - Service Pneumologie
    • Hospices Civils De Lyon
      • Lyon, Hospices Civils De Lyon, France
        • Active, not recruiting
        • 006 - Service Pneumologie
    • Tenon
      • Paris, Tenon, France
        • Recruiting
        • 004 - Service de Pneumologie
        • Principal Investigator:
          • Jacques CADRANEL, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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%.
Enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Describe the general and specific external environment of patients with IPF
Time Frame: Enrollment
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
Time Frame: Enrollment
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
Time Frame: Enrollment
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
Time Frame: 24 months
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
Time Frame: 24 months
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
Time Frame: 24 months
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
Time Frame: Enrollment
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
Time Frame: Enrollment
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
Time Frame: 24 months
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
Time Frame: 24 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique - Hôpitaux de Paris

Collaborators

Institut National de la Santé Et de la Recherche Médicale, France

Investigators

  • Principal Investigator: Lucile SESE, Dr, Assistance Publique - Hôpitaux de Paris
  • Study Director: Hilario NUNES, PHD, Assistance Publique - Hôpitaux de Paris

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2021

Primary Completion (Anticipated)

April 1, 2022

Study Completion (Anticipated)

April 1, 2025

Study Registration Dates

First Submitted

October 23, 2020

First Submitted That Met QC Criteria

November 2, 2020

First Posted (Actual)

November 6, 2020

Study Record Updates

Last Update Posted (Actual)

October 25, 2021

Last Update Submitted That Met QC Criteria

October 22, 2021

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • APHP180343
  • 2019-A00825-52 (Other Identifier: ANSM - IDRCB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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