search
Back to results

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

Primary Purpose

Idiopathic Pulmonary Fibrosis, Pulmonary Disease, Pulmonary Medicine

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Blood sample
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Idiopathic Pulmonary Fibrosis focused on measuring socioeconomic Status, air pollution, Environmental exposure, Occupational exposure, idiopathic pulmonary fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • 001 - Service PneumologieRecruiting
  • 002 - Service Explorations Fonctionnelles RespiratoiresRecruiting
  • 003 - Service Pneumologie
  • 016 - Service Pneumologie
  • 010 - Service Pneumologie
  • 013 - Service Pneumologie
  • 008 - Service Pneumologie
  • 015 - Service Pneumologie
  • 007 - Service PneumologieRecruiting
  • 011 - Service Pneumologie
  • 012 - Service PneumologieRecruiting
  • 014 - Service Pneumologie
  • 005 - Service Pneumologie
  • 006 - Service Pneumologie
  • 004 - Service de PneumologieRecruiting
  • 009 - Service Pneumologie

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Idiopathic Pulmonary Fibrosis

Arm Description

Blood sample were performed during the study for all patients.

Outcomes

Primary Outcome Measures

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%.

Secondary Outcome Measures

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
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
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
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
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
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
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
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
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
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.

Full Information

First Posted
October 23, 2020
Last Updated
October 22, 2021
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
search

1. Study Identification

Unique Protocol Identification Number
NCT04619199
Brief Title
Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis
Acronym
EXPOSOMFPI
Official Title
Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Pulmonary Disease, Pulmonary Medicine
Keywords
socioeconomic Status, air pollution, Environmental exposure, Occupational exposure, idiopathic pulmonary fibrosis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Longitudinal prospective cohort study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Idiopathic Pulmonary Fibrosis
Arm Type
Experimental
Arm Description
Blood sample were performed during the study for all patients.
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood sample
Intervention Description
Blood sample performed at the inclusion and during the follow-up.
Primary Outcome Measure Information:
Title
Determine if the household income is associated with the severity of the IPF at inclusion
Description
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%.
Time Frame
Enrollment
Secondary Outcome Measure Information:
Title
Describe the general and specific external environment of patients with IPF
Description
Collection of data on the general and specific external environment on patients with IPF
Time Frame
Enrollment
Title
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the severity of the IPF
Description
Collection of data about socio-economic and environmental factors, and about severity on patients with IPF
Time Frame
Enrollment
Title
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the quality of life
Description
Collection of data about socio-economic and environmental factors, and about quality of life on patients with IPF
Time Frame
Enrollment
Title
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the occurrence of an Acute Exacerbation
Description
Collection of data about socio-economic and environmental factors, and about occurrence of an Acute Exacerbation on patients with IPF
Time Frame
24 months
Title
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the progress of the IPF
Description
Collection of data about socio-economic and environmental factors, and about progression of IPF on patients with IPF
Time Frame
24 months
Title
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the mortality
Description
Collection of data about socio-economic and environmental factors, and about mortality of patients with IPF
Time Frame
24 months
Title
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the existence and type of comorbidities
Description
Collection of data about socio-economic and environmental factors, and about existence and type of comorbidities on patients with IPF
Time Frame
Enrollment
Title
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the diagnostic and management delay
Description
Collection of data about socio-economic and environmental factors, and about diagnostic and management delay on patients with IPF
Time Frame
Enrollment
Title
Determine the impact of socio-economic factors and environmental factors on therapeutic decisions: anti-fibrotic treatments, access to transplantation
Description
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
Time Frame
24 months
Title
Determine if the deleterious effect of air pollutants on the decline of respiratory function is dependent on the size of the telomeres
Description
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.
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nacira DARGHAL
Phone
(+33)148957473
Email
nacira.darghal@aphp.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Lucile SESE, Dr
Phone
(+33)148955923
Email
lucile.sese@aphp.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucile SESE, Dr
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Hilario NUNES, PHD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Study Director
Facility Information:
Facility Name
001 - Service Pneumologie
City
Bobigny
State/Province
Avicenne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hilario NUNES, Pr
Facility Name
002 - Service Explorations Fonctionnelles Respiratoires
City
Bobigny
State/Province
Avicenne
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucile SESE, Dr
Facility Name
003 - Service Pneumologie
City
Paris
State/Province
Bichat
Country
France
Individual Site Status
Active, not recruiting
Facility Name
016 - Service Pneumologie
City
Caen
State/Province
CHU Caen Normandie
Country
France
Individual Site Status
Active, not recruiting
Facility Name
010 - Service Pneumologie
City
Dijon
State/Province
CHU Dijon
Country
France
Individual Site Status
Active, not recruiting
Facility Name
013 - Service Pneumologie
City
Grenoble
State/Province
CHU Grenoble
Country
France
Individual Site Status
Active, not recruiting
Facility Name
008 - Service Pneumologie
City
Lille
State/Province
CHU Lille
Country
France
Individual Site Status
Active, not recruiting
Facility Name
015 - Service Pneumologie
City
Montpellier
State/Province
CHU Montpellier
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud BOURDIN, Pr
Facility Name
007 - Service Pneumologie
City
Rennes
State/Province
CHU Pontchaillou
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stéphane JOUNEAU, Pr
Facility Name
011 - Service Pneumologie
City
Strasbourg
State/Province
CHU Strasbourg
Country
France
Individual Site Status
Active, not recruiting
Facility Name
012 - Service Pneumologie
City
Tours
State/Province
CHU Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sylvain MARCHAND-ADAM, Pr
Facility Name
014 - Service Pneumologie
City
Meaux
State/Province
Ghef
Country
France
Individual Site Status
Active, not recruiting
Facility Name
005 - Service Pneumologie
City
Paris
State/Province
Hegp
Country
France
Individual Site Status
Active, not recruiting
Facility Name
006 - Service Pneumologie
City
Lyon
State/Province
Hospices Civils De Lyon
Country
France
Individual Site Status
Active, not recruiting
Facility Name
004 - Service de Pneumologie
City
Paris
State/Province
Tenon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacques CADRANEL, Pr
Facility Name
009 - Service Pneumologie
City
Marseille
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martine REYNAUT-GAUBERT, Pr

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28775045
Citation
Duchemann B, Annesi-Maesano I, Jacobe de Naurois C, Sanyal S, Brillet PY, Brauner M, Kambouchner M, Huynh S, Naccache JM, Borie R, Piquet J, Mekinian A, Virally J, Uzunhan Y, Cadranel J, Crestani B, Fain O, Lhote F, Dhote R, Saidenberg-Kermanac'h N, Rosental PA, Valeyre D, Nunes H. Prevalence and incidence of interstitial lung diseases in a multi-ethnic county of Greater Paris. Eur Respir J. 2017 Aug 3;50(2):1602419. doi: 10.1183/13993003.02419-2016. Print 2017 Aug.
Results Reference
background
PubMed Identifier
21471066
Citation
Raghu G, Collard HR, Egan JJ, Martinez FJ, Behr J, Brown KK, Colby TV, Cordier JF, Flaherty KR, Lasky JA, Lynch DA, Ryu JH, Swigris JJ, Wells AU, Ancochea J, Bouros D, Carvalho C, Costabel U, Ebina M, Hansell DM, Johkoh T, Kim DS, King TE Jr, Kondoh Y, Myers J, Muller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schunemann HJ; ATS/ERS/JRS/ALAT Committee on Idiopathic Pulmonary Fibrosis. An official ATS/ERS/JRS/ALAT statement: idiopathic pulmonary fibrosis: evidence-based guidelines for diagnosis and management. Am J Respir Crit Care Med. 2011 Mar 15;183(6):788-824. doi: 10.1164/rccm.2009-040GL.
Results Reference
background
PubMed Identifier
26177183
Citation
Raghu G, Rochwerg B, Zhang Y, Garcia CA, Azuma A, Behr J, Brozek JL, Collard HR, Cunningham W, Homma S, Johkoh T, Martinez FJ, Myers J, Protzko SL, Richeldi L, Rind D, Selman M, Theodore A, Wells AU, Hoogsteden H, Schunemann HJ; American Thoracic Society; European Respiratory society; Japanese Respiratory Society; Latin American Thoracic Association. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med. 2015 Jul 15;192(2):e3-19. doi: 10.1164/rccm.201506-1063ST. Erratum In: Am J Respir Crit Care Med. 2015 Sep 1;192(5):644. Dosage error in article text.
Results Reference
background
PubMed Identifier
29102032
Citation
Cottin V. [French recommendations for idiopathic pulmonary fibrosis: An updated working document for clinicians]. Rev Mal Respir. 2017 Oct;34(8):789-790. doi: 10.1016/j.rmr.2017.09.005. No abstract available. French.
Results Reference
background
PubMed Identifier
21719092
Citation
King TE Jr, Pardo A, Selman M. Idiopathic pulmonary fibrosis. Lancet. 2011 Dec 3;378(9807):1949-61. doi: 10.1016/S0140-6736(11)60052-4. Epub 2011 Jun 28.
Results Reference
background
PubMed Identifier
20935110
Citation
Ley B, Collard HR, King TE Jr. Clinical course and prediction of survival in idiopathic pulmonary fibrosis. Am J Respir Crit Care Med. 2011 Feb 15;183(4):431-40. doi: 10.1164/rccm.201006-0894CI. Epub 2010 Oct 8.
Results Reference
background
PubMed Identifier
27299520
Citation
Collard HR, Ryerson CJ, Corte TJ, Jenkins G, Kondoh Y, Lederer DJ, Lee JS, Maher TM, Wells AU, Antoniou KM, Behr J, Brown KK, Cottin V, Flaherty KR, Fukuoka J, Hansell DM, Johkoh T, Kaminski N, Kim DS, Kolb M, Lynch DA, Myers JL, Raghu G, Richeldi L, Taniguchi H, Martinez FJ. Acute Exacerbation of Idiopathic Pulmonary Fibrosis. An International Working Group Report. Am J Respir Crit Care Med. 2016 Aug 1;194(3):265-75. doi: 10.1164/rccm.201604-0801CI.
Results Reference
background
PubMed Identifier
22586007
Citation
Ley B, Ryerson CJ, Vittinghoff E, Ryu JH, Tomassetti S, Lee JS, Poletti V, Buccioli M, Elicker BM, Jones KD, King TE Jr, Collard HR. A multidimensional index and staging system for idiopathic pulmonary fibrosis. Ann Intern Med. 2012 May 15;156(10):684-91. doi: 10.7326/0003-4819-156-10-201205150-00004.
Results Reference
background
PubMed Identifier
26424523
Citation
Raghu G, Amatto VC, Behr J, Stowasser S. Comorbidities in idiopathic pulmonary fibrosis patients: a systematic literature review. Eur Respir J. 2015 Oct;46(4):1113-30. doi: 10.1183/13993003.02316-2014.
Results Reference
background
PubMed Identifier
9624022
Citation
Lantz PM, House JS, Lepkowski JM, Williams DR, Mero RP, Chen J. Socioeconomic factors, health behaviors, and mortality: results from a nationally representative prospective study of US adults. JAMA. 1998 Jun 3;279(21):1703-8. doi: 10.1001/jama.279.21.1703.
Results Reference
background
PubMed Identifier
22497534
Citation
Gershon AS, Dolmage TE, Stephenson A, Jackson B. Chronic obstructive pulmonary disease and socioeconomic status: a systematic review. COPD. 2012 Jun;9(3):216-26. doi: 10.3109/15412555.2011.648030. Epub 2012 Apr 12.
Results Reference
background
PubMed Identifier
16869805
Citation
Lederer DJ, Arcasoy SM, Barr RG, Wilt JS, Bagiella E, D'Ovidio F, Sonett JR, Kawut SM. Racial and ethnic disparities in idiopathic pulmonary fibrosis: A UNOS/OPTN database analysis. Am J Transplant. 2006 Oct;6(10):2436-42. doi: 10.1111/j.1600-6143.2006.01480.x. Epub 2006 Jul 26.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs