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

NCT05875532 | Completed Results

• 1 other identifier: 1199-0523
• Study Type: observational
• Target: 34,960
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Lung Diseases, Interstitial

Outcome Measures

Primary Outcomes (1)

• Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)

  The cumulative incidence probability is the estimate of the risk a patient will experience by 6, 12, 18 and 24 months after the second diagnosis of fibrosing ILD (index date) of progression to PF-ILDs. It is the complement of the Kaplan-Meier estimates. The Greenwood's variance estimate was used to calculate the 95% confidence interval. Disease progression was defined as 3 or more pulmonary function tests within 365 days, 3 or more tomographies within 365 days, 1 or more claims for oxygen therapy during follow-up, 1 or more respiratory hospitalizations during follow-up, 1 or more claims for palliative care during follow-up, 1 or more lung transplant during follow-up, 1 or more claims for immunosuppressive drugs during follow-up, 1 or more claims for oral corticosteroid during follow-up, and 1 or more claims for Nintedanib during follow-up. Follow-up was between 1-Jan-2013 to 28-May-2020, the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.

  At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020

Secondary Outcomes (2)

• Number of Patients With Treatment of Interest During Follow-up Period

  Up to 7.43 years, from 01-Jan-2013 to 28-May-2020

• Number of Patients With Management of Interest During Follow-up Period

  Up to 7.43 years, from 01-Jan-2013 to 28-May-2020

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with at least two fibrosing ILD codes (International Statistical Classification of Diseases and Related Health Problems (ICD-10) code or disease code)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (1)

Boehringer Ingelheim Pharmaceuticals, Inc.

Ridgefield, Connecticut, 06877, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Limitations and Caveats

The Medical Data Vision (MDV) database did not have pulmonary function test results and there was no evidence of using claims data to define the events fibrosing Interstitial Lung Disease (ILD) patients other than Idiopathic Pulmonary Fibrosis (IPF) and progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in the validated algorithm. Data generated in the clinics/hospitals other than hospitals included in the MDV database were not captured.

Results Point of Contact

• Title: Boehringer Ingelheim, Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 30, 2023
• First Posted: May 25, 2023
• Study Start: April 20, 2023
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)