Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34960 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-20

Study Completion Date

2023-05-01

Brief Summary

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The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan.

The secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.

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Detailed Description

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Conditions

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Lung Diseases, Interstitial

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with an ILD other than IPF

Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Patients diagnosed with at least two fibrosing Interstitial Lung Disease (ILD) codes on different dates in the patient identification period
2. Patients aged 18 years and older on the index date
3. Patients for whom data for the 12 months prior to the index date can be extracted as baseline data

Exclusion Criteria

1. Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF)
2. Patients who have met PF-ILD progression criteria during the baseline period

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No