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
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 |
Verified date | May 2023 |
Source | Boehringer Ingelheim |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Boehringer Ingelheim Pharmaceuticals, Inc. | Ridgefield | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Boehringer Ingelheim |
United States,
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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