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Idiopathic Pulmonary FibrosisEXPOSOMFPINCT04619199

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

A study testing Blood sample in people with Idiopathic Pulmonary Fibrosis and Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 16 sites in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Blood sample
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
16 sitesFrance
Study dates
1 Apr 2021to 1 Apr 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

16 sites in 1 country.

Nacira DARGHAL contact

(+33)148957473

nacira.darghal@aphp.fr

Lucile SESE, Dr contact

(+33)148955923

lucile.sese@aphp.fr

16 sites in 1 country

France16 sites, 7 recruiting

  • 001 - Service Pneumologie

    Bobigny, Avicenne

    Hilario NUNES, Pr

    Recruiting

  • 002 - Service Explorations Fonctionnelles Respiratoires

    Bobigny, Avicenne

    Lucile SESE, Dr

    Recruiting

  • 016 - Service Pneumologie

    Caen, CHU Caen Normandie

    Active, not recruiting

  • 010 - Service Pneumologie

    Dijon, CHU Dijon

    Active, not recruiting

  • 013 - Service Pneumologie

    Grenoble, CHU Grenoble

    Active, not recruiting

  • 008 - Service Pneumologie

    Lille, CHU Lille

    Active, not recruiting

  • 006 - Service Pneumologie

    Lyon, Hospices Civils de Lyon

    Active, not recruiting

  • 009 - Service Pneumologie

    Marseille

    Martine REYNAUT-GAUBERT, Pr

    Not yet recruiting

  • 014 - Service Pneumologie

    Meaux, GHEF

    Active, not recruiting

  • 015 - Service Pneumologie

    Montpellier, CHU Montpellier

    Arnaud BOURDIN, Pr

    Not yet recruiting

  • 003 - Service Pneumologie

    Paris, Bichat

    Active, not recruiting

  • 005 - Service Pneumologie

    Paris, HEGP

    Active, not recruiting

  • 004 - Service de Pneumologie

    Paris, Tenon

    Jacques CADRANEL, Pr

    Recruiting

  • 007 - Service Pneumologie

    Rennes, CHU Pontchaillou

    Stéphane JOUNEAU, Pr

    Recruiting

  • 011 - Service Pneumologie

    Strasbourg, CHU Strasbourg

    Active, not recruiting

  • 012 - Service Pneumologie

    Tours, CHU Tours

    Sylvain MARCHAND-ADAM, Pr

    Recruiting

Other trials in France

About this study

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.

Being tested
Blood sample
Keywords
socioeconomic Status, air pollution, Environmental exposure, Occupational exposure, idiopathic pulmonary fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Blood sampleDiagnostic test

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

Study groups in NCT04619199
Study groupRoleWhat they receive
Idiopathic Pulmonary FibrosisExperimentalBlood sample were performed during the study for all patients.
Receives: Diagnostic Test: Blood sample

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: Enrollment

Secondary outcomes (10)

  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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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.

    Measured: 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Nov 2020
  2. Study start1 Apr 2021
  3. Primary completion1 Apr 2022 (estimated)
  4. Study completion1 Apr 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Longitudinal prospective cohort study
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04619199
Sponsor's protocol ID
APHP180343
Other IDs
2019-A00825-52
Acronym
EXPOSOMFPI
Status last verified
Oct 2020
First submitted
23 Oct 2020
Last updated
25 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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.

    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

Questions about this trial

What is this clinical trial studying?

A study testing Blood sample in people with Idiopathic Pulmonary Fibrosis and Pulmonary Disease, run by Assistance Publique - Hôpitaux de Paris at 16 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Nacira DARGHAL ((+33)148957473, nacira.darghal@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determine if the household income is associated with the severity of the IPF at inclusion (time frame: Enrollment). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04619199, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2021.

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