Clinical trial NCT04619199: Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis
Official title: Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Idiopathic Pulmonary Fibrosis
Pulmonary Disease
Pulmonary Medicine
Keywords: socioeconomic Status
air pollution
Environmental exposure
Occupational exposure
idiopathic pulmonary fibrosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2020-11-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Longitudinal prospective cohort study
Primary purpose: OTHER

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.

Eligibility criteria: 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

Primary outcomes:
measure: Determine if the household income is associated with the severity of the IPF at inclusion
timeFrame: Enrollment
Secondary outcomes:
measure: Describe the general and specific external environment of patients with IPF
timeFrame: Enrollment
measure: Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the severity of the IPF
timeFrame: Enrollment
measure: Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the quality of life
timeFrame: Enrollment
measure: Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the occurrence of an Acute Exacerbation
timeFrame: 24 months
measure: Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the progress of the IPF
timeFrame: 24 months
measure: Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution) on the mortality
timeFrame: 24 months
measure: Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the existence and type of comorbidities
timeFrame: Enrollment
measure: Determine the impact of socio-economic factors and environmental factors (occupational domestic exposures and air pollution)on the diagnostic and management delay
timeFrame: Enrollment
measure: Determine the impact of socio-economic factors and environmental factors on therapeutic decisions: anti-fibrotic treatments, access to transplantation
timeFrame: 24 months
measure: Determine if the deleterious effect of air pollutants on the decline of respiratory function is dependent on the size of the telomeres
timeFrame: 24 months
Other outcomes:
Locations:
city: Bobigny
country: France
facility: 001 - Service Pneumologie
state: Avicenne
city: Bobigny
country: France
facility: 002 - Service Explorations Fonctionnelles Respiratoires
state: Avicenne
city: Paris
country: France
facility: 003 - Service Pneumologie
state: Bichat
city: Caen
country: France
facility: 016 - Service Pneumologie
state: CHU Caen Normandie
city: Dijon
country: France
facility: 010 - Service Pneumologie
state: CHU Dijon
city: Grenoble
country: France
facility: 013 - Service Pneumologie
state: CHU Grenoble
city: Lille
country: France
facility: 008 - Service Pneumologie
state: CHU Lille
city: Montpellier
country: France
facility: 015 - Service Pneumologie
state: CHU Montpellier
city: Rennes
country: France
facility: 007 - Service Pneumologie
state: CHU Pontchaillou
city: Strasbourg
country: France
facility: 011 - Service Pneumologie
state: CHU Strasbourg
city: Tours
country: France
facility: 012 - Service Pneumologie
state: CHU Tours
city: Meaux
country: France
facility: 014 - Service Pneumologie
state: Ghef
city: Paris
country: France
facility: 005 - Service Pneumologie
state: Hegp
city: Lyon
country: France
facility: 006 - Service Pneumologie
state: Hospices Civils De Lyon
city: Paris
country: France
facility: 004 - Service de Pneumologie
state: Tenon
city: Marseille
country: France
facility: 009 - Service Pneumologie
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Lucile SESE, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Hilario NUNES, PHD
role: STUDY_DIRECTOR
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