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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04619199
Acronym
EXPOSOMFPI
Enrollment
200
Registered
2020-11-06
Start date
2021-04-01
Completion date
2025-04-01
Last updated
2021-10-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Pulmonary Fibrosis, Pulmonary Disease, Pulmonary Medicine

Keywords

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

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.

Interventions

DIAGNOSTIC_TESTBlood sample

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

Sponsors

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

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Longitudinal prospective cohort study

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Determine if the household income is associated with the severity of the IPF at inclusionEnrollmentPatients 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

MeasureTime frameDescription
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the severity of the IPFEnrollmentCollection 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 lifeEnrollmentCollection 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 Exacerbation24 monthsCollection 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 IPF24 monthsCollection of data about socio-economic and environmental factors, and about progression of IPF on patients with IPF
Describe the general and specific external environment of patients with IPFEnrollmentCollection 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 existence and type of comorbiditiesEnrollmentCollection 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 delayEnrollmentCollection 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 transplantation24 monthsCollection 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 telomeres24 monthsCollection 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.
Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the mortality24 monthsCollection of data about socio-economic and environmental factors, and about mortality of patients with IPF

Countries

France

Contacts

Primary ContactNacira DARGHAL
nacira.darghal@aphp.fr(+33)148957473
Backup ContactLucile SESE, Dr
lucile.sese@aphp.fr(+33)148955923

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026