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

Idiopathic Pulmonary Fibrosis Clinical Trial

— EXPOSOMFPI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04619199
• Other study ID #: APHP180343
• Secondary ID: 2019-A00825-52
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2021
• Est. completion date: April 1, 2025

Study information

• Verified date: October 2020
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Nacira DARGHAL
• Phone: (+33)148957473
• Email: nacira.darghal[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Disease
• Pulmonary Fibrosis
• Pulmonary Medicine

Intervention

Diagnostic Test:
• Blood sample
Blood sample performed at the inclusion and during the follow-up.

Locations

Country	Name	City	State
France	001 - Service Pneumologie	Bobigny	Avicenne
France	002 - Service Explorations Fonctionnelles Respiratoires	Bobigny	Avicenne
France	016 - Service Pneumologie	Caen	CHU Caen Normandie
France	010 - Service Pneumologie	Dijon	CHU Dijon
France	013 - Service Pneumologie	Grenoble	CHU Grenoble
France	008 - Service Pneumologie	Lille	CHU Lille
France	006 - Service Pneumologie	Lyon	Hospices Civils De Lyon
France	009 - Service Pneumologie	Marseille
France	014 - Service Pneumologie	Meaux	Ghef
France	015 - Service Pneumologie	Montpellier	CHU Montpellier
France	003 - Service Pneumologie	Paris	Bichat
France	004 - Service de Pneumologie	Paris	Tenon
France	005 - Service Pneumologie	Paris	Hegp
France	007 - Service Pneumologie	Rennes	CHU Pontchaillou
France	011 - Service Pneumologie	Strasbourg	CHU Strasbourg
France	012 - Service Pneumologie	Tours	CHU Tours

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Institut National de la Santé Et de la Recherche Médicale, France

Country where clinical trial is conducted

France, 

References & Publications (12)

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. Review. — View 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. French. — View 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). pii: 1602419. doi: 10.1183/13993003.02419-2016. Print 2017 Aug. — View 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. Review. — View 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. Review. — View 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. — View 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. Epub 2006 Jul 26. — View 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. Review. — View 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. — View 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. Review. — View 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, Müller NL, Nicholson AG, Richeldi L, Selman M, Dudden RF, Griss BS, Protzko SL, Schünemann 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. — View 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, Schünemann 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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Enrollment
Secondary	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	Enrollment
Secondary	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	Enrollment
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	24 months
Secondary	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	Enrollment
Secondary	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	Enrollment
Secondary	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	24 months
Secondary	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.	24 months