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

NCT04619199 | Unknown

• 2 other identifiers: APHP1803432019-A00825-52
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 16

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.

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Disease; Pulmonary Medicine

Keywords

socioeconomic Status; air pollution; Environmental exposure; Occupational exposure; idiopathic pulmonary fibrosis

Outcome Measures

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%.

  Enrollment

Secondary Outcomes (10)

• 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 severity of the 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 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 progress of the IPF

  24 months

Study Arms (1)

Idiopathic Pulmonary Fibrosis

EXPERIMENTAL

Blood sample were performed during the study for all patients.

Diagnostic Test: Blood sample

Interventions

Blood sample DIAGNOSTIC_TEST

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

Idiopathic Pulmonary Fibrosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (16)

001 - Service Pneumologie

Bobigny, Avicenne, France

RECRUITING

002 - Service Explorations Fonctionnelles Respiratoires

Bobigny, Avicenne, France

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

NOT YET RECRUITING

007 - Service Pneumologie

Rennes, CHU Pontchaillou, France

RECRUITING

011 - Service Pneumologie

Strasbourg, CHU Strasbourg, France

ACTIVE NOT RECRUITING

012 - Service Pneumologie

Tours, CHU Tours, France

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

RECRUITING

009 - Service Pneumologie

Marseille, France

NOT YET RECRUITING

Related Publications (12)

• 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.

  PMID: 28775045 BACKGROUND

• 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.

  PMID: 21471066 BACKGROUND

• 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.

  PMID: 26177183 BACKGROUND

• 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.

  PMID: 29102032 BACKGROUND

• 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.

  PMID: 21719092 BACKGROUND

• 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.

  PMID: 20935110 BACKGROUND

• 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.

  PMID: 27299520 BACKGROUND

• 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.

  PMID: 22586007 BACKGROUND

• 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.

  PMID: 26424523 BACKGROUND

• 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.

  PMID: 9624022 BACKGROUND

• 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.

  PMID: 22497534 BACKGROUND

• 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.

  PMID: 16869805 BACKGROUND

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Lung Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Lucile SESE, Dr

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Hilario NUNES, PHD

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Central Study Contacts

Nacira DARGHAL

CONTACT

(+33)148957473; nacira.darghal@aphp.fr

Lucile SESE, Dr

CONTACT

(+33)148955923; lucile.sese@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Longitudinal prospective cohort study

Study Record Dates

• First Submitted: October 23, 2020
• First Posted: November 6, 2020
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2025
• Last Updated: October 25, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (16)