Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment
- Conditions
- Lung Diseases, Interstitial
- Registration Number
- NCT05875532
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200000
- 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
- Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF)
- Patients who have met PF-ILD progression criteria during the baseline period
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs) At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020 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.
- Secondary Outcome Measures
Name Time Method 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 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.
Number of Patients With Management of Interest During Follow-up Period Up to 7.43 years, from 01-Jan-2013 to 28-May-2020 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.
Trial Locations
- Locations (1)
Boehringer Ingelheim Pharmaceuticals, Inc.
🇺🇸Ridgefield, Connecticut, United States