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

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

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases, Interstitial

• Study Type: Observational
• Enrollment (Actual): 34960

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Ridgefield, Connecticut, United States, 06877
      • Boehringer Ingelheim Pharmaceuticals, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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)

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Patients With Treatment of Interest During Follow-up Period	Number of patients treated with immunosuppressive drugs (Rituximab, Tacrolimus, Mycophenolate, Cyclosporine, Cyclophosphamide, Azathioprine, Tocilizumab), oral corticosteroids, or nintedanib during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.	Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
Number of Patients With Management of Interest During Follow-up Period	Number of patients with oxygen therapy (HOT), lung transplant and palliative care (oxygen inhalation, opioid use) as disease management during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.	Up to 7.43 years, from 01-Jan-2013 to 28-May-2020

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2023
• Primary Completion (Actual): May 1, 2023
• Study Completion (Actual): May 1, 2023

Study Registration Dates

• First Submitted: April 30, 2023
• First Submitted That Met QC Criteria: May 16, 2023
• First Posted (Actual): May 25, 2023

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 1199-0523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).

For more details refer to: https://www.mystudywindow.com/msw/datatransparency

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No