Non-interventional Study Describing Epidemiology, Prognosis and Patient Healthcare Costs in France, 2010-2017

• Conditions: Lung Diseases, Interstitial; Lung Disease With Systemic Sclerosis
• Interventions: Other: epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD

• Registration Number: NCT03858842
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

Interstitial lung diseases (ILDs) are a heterogeneous group of disorders, which encompass a wide range of conditions. In some patients with fibrosing ILDs, a progressive phenotype similar to that observed in idiopathic pulmonary fibrosis (IPF) may develop during the course of the disease (PF-ILD), including patients with systemic sclerosis (SSc)-related ILD.

The aim of the study is to estimate the incidence and prevalence and to describe the characteristics of patients diagnosed with non-IPF PF-ILD and SSc-ILD, to describe the natural course of disease, and to explore the correlation between mortality and Forced Vital Capacity (FVC) of the patients with non-IPF PF-ILD.

This study will be based on two data sources: the French national medico administrative database (SNDS) and the ILD cohort from the National French center for rare pulmonary diseases in Lyon, France.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-02
• Study First Submitted: 2019-02-27
• Study First Submitted QC: 2019-02-27
• Study Start: 2019-03
• Study First Posted: 2019-03-01
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients hospitalized for PF-ILD and SSc-ILD in France between 01/01/2010 and 31/12/2017
• Men or women aged ≥ 18 years old at diagnosis

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Exclusion Criteria

• Patients treated by anti-fibrotic
• Patients diagnosed with IPF

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PF-ILD and SSc-ILD patients	epidemiology, healthcare costs in non-IPF PF-ILD and SSc-ILD	PF-ILD and SSc-ILD patients

Primary Outcome Measures

Name	Time	Method
Incidence of PF-ILD and SSc-ILD patients	Between 2010 and 2017	The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: * the epidemiology (incidence and prevalence),; * the characteristics of patients,; * the healthcare resource use and associated costs
Prevalence of PF-ILD and SSc-ILD patients	Between 2010 and 2017	The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: * the epidemiology (incidence and prevalence),; * the characteristics of patients,; * the healthcare resource use and associated costs
characteristics of PF-ILD and SSc-ILD patients	Between 2010 and 2017	The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: * the epidemiology (incidence and prevalence),; * the characteristics of patients,; * the healthcare resource use and associated costs
associated costs of PF-ILD and SSc-ILD patients	Between 2010 and 2017	The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: * the epidemiology (incidence and prevalence),; * the characteristics of patients,; * the healthcare resource use and associated costs
healthcare resource use of PF-ILD and SSc-ILD patients	Between 2010 and 2017	The study will describe for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) and Systemic Sclerosis-Associated Interstitial Lung Disease (SSc-ILD) patients in France.: * the epidemiology (incidence and prevalence),; * the characteristics of patients,; * the healthcare resource use and associated costs

Secondary Outcome Measures

Name	Time	Method
mortality for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.	Between 2010 and 2017	correlation between mortality and FVC for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.
Forced Vital Capacity for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.	Between 2010 and 2017	correlation between mortality and FVC for the non-idiopathic pulmonary fibrosis (IPF) progressive fibrosing interstitial lung (PF-ILD) in France.

Trial Locations

Locations (1)

Hôpital Cardiologique Louis Pradel; 🇫🇷 Bron, France