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NCT05875532 Clinical Trial

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

Lung Diseases, Interstitial Clinical Trial

Official title:
Incidence Probability of Progression to Progressive Fibrosing Interstitial Lung Diseases and Status of Management and Treatments in Patients With Fibrosing Interstitial Lung Diseases Other Than Idiopathic Pulmonary Fibrosis in Japan

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05875532
Other study ID # 1199-0523
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 20, 2023
Est. completion date May 1, 2023

Study information
Verified date May 2023
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 200000
Est. completion date May 1, 2023
Est. primary completion date May 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United States Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield Connecticut

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence probability of progression to PF-ILDs up to 24 months
Secondary Frequeny of patients with treatment of interest e. g. with corticosteroids or immunosuppressive drugs up to 7 years + 5 months
Secondary Frequency of patients with Disease Management of interest e. g. Oxygen therapy, Lung transplant, Palliative care up to 7 years + 5 months
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