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RecruitingNCT04619199EXPOSOMFPIUpdated Oct 25, 2021

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

An interventional study of Blood sample in Idiopathic Pulmonary Fibrosis, Pulmonary Disease and Pulmonary Medicine, sponsored by Assistance Publique - Hôpitaux de Paris. Recruiting at 16 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-25.

Sponsored by Assistance Publique - Hôpitaux de Paris · Not applicable, Interventional, and Other

From the registry’s dates

  • Primary completion was expected by Apr 2022, 4 years 6 months ago, but the record still lists the study as recruiting.
  • Started Apr 2021; still recruiting 5 years 6 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Idiopathic Pulmonary Fibrosis
  • Pulmonary Disease
  • Pulmonary Medicine

Keywords

  • socioeconomic Status
  • air pollution
  • Environmental exposure
  • Occupational exposure
  • idiopathic pulmonary fibrosis
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    Idiopathic Pulmonary Fibrosis

    Blood sample were performed during the study for all patients.

    Diagnostic Test: Blood sample

Interventions

  • Diagnostic testBlood sample

    Blood sample performed at the inclusion and during the follow-up.

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What researchers measure

Primary outcomes

  1. 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%.

    Time frame: Enrollment

Secondary outcomes

  1. 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

    Time frame: Enrollment

  2. 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

    Time frame: Enrollment

  3. 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

    Time frame: Enrollment

  4. 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

    Time frame: 24 months

  5. 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

    Time frame: 24 months

  6. 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

    Time frame: 24 months

  7. 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

    Time frame: Enrollment

  8. 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

    Time frame: Enrollment

  9. 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

    Time frame: 24 months

  10. 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.

    Time frame: 24 months

07

Study locations

5 of 16 sites recruiting
  • 001 - Service Pneumologie
    Bobigny, Avicenne, France
    • Hilario NUNES, Pr · Principal investigator
    Recruiting
  • 002 - Service Explorations Fonctionnelles Respiratoires
    Bobigny, Avicenne, France
    • Lucile SESE, Dr · Principal investigator
    Recruiting
  • 003 - Service Pneumologie
    Paris, Bichat, France
    Active, not recruiting
  • 016 - Service Pneumologie
    Caen, CHU Caen Normandie, France
    Active, not recruiting
  • 010 - Service Pneumologie
    Dijon, CHU Dijon, France
    Active, not recruiting
  • 013 - Service Pneumologie
    Grenoble, CHU Grenoble, France
    Active, not recruiting
  • 008 - Service Pneumologie
    Lille, CHU Lille, France
    Active, not recruiting
  • 015 - Service Pneumologie
    Montpellier, CHU Montpellier, France
    • Arnaud BOURDIN, Pr · Principal investigator
    Not yet recruiting
  • 007 - Service Pneumologie
    Rennes, CHU Pontchaillou, France
    • Stéphane JOUNEAU, Pr · Principal investigator
    Recruiting
  • 011 - Service Pneumologie
    Strasbourg, CHU Strasbourg, France
    Active, not recruiting
  • 012 - Service Pneumologie
    Tours, CHU Tours, France
    • Sylvain MARCHAND-ADAM, Pr · Principal investigator
    Recruiting
  • 014 - Service Pneumologie
    Meaux, Ghef, France
    Active, not recruiting
  • 005 - Service Pneumologie
    Paris, Hegp, France
    Active, not recruiting
  • 006 - Service Pneumologie
    Lyon, Hospices Civils De Lyon, France
    Active, not recruiting
  • 004 - Service de Pneumologie
    Paris, Tenon, France
    • Jacques CADRANEL, Pr · Principal investigator
    Recruiting
  • 009 - Service Pneumologie
    Marseille, France
    • Martine REYNAUT-GAUBERT, Pr · Principal investigator
    Not yet recruiting
08

References and documents

Publications

  • 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. PubMed 28775045 ↗
  • 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. PubMed 21471066 ↗
  • 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. doi: 10.1164/rccm.1925erratum.. Dosage error in article text. PubMed 26177183 ↗
  • 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. PubMed 29102032 ↗
  • 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. PubMed 21719092 ↗
  • 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. PubMed 20935110 ↗
  • 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. PubMed 27299520 ↗
  • 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. PubMed 22586007 ↗
  • 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. PubMed 26424523 ↗
  • 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. PubMed 9624022 ↗
  • 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. PubMed 22497534 ↗
  • 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. PubMed 16869805 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 25, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04619199
Lead sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
Responsible party
Sponsor
First posted
Nov 6, 2020
Start date
Apr 1, 2021
Primary completion
Apr 1, 2022 (estimated)
Completion
Apr 1, 2025 (estimated)
Last update
Oct 25, 2021

Study contacts

Nacira DARGHAL
Contact
nacira.darghal@aphp.fr
(+33)148957473
Lucile SESE, Dr
Contact
lucile.sese@aphp.fr
(+33)148955923
Lucile SESE, Dr
principal investigator · Assistance Publique - Hôpitaux de Paris
Hilario NUNES, PHD
study director · Assistance Publique - Hôpitaux de Paris

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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