progressive fibrosing interstitial lung diseases
Conditions
Interventions
None listed
Sponsors
Japanese Red Cross Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients diagnosed with PF-ILD other than IPF based on the 2018 ATS / ERS / JRS / ALAT international guidelines 2) Patients with fibrotic lesions of 10% or more on HRCT and progress of the condition within 24 months before enrollment despite standard treatment other than nintedanib 3) Nintedanib-free patients 4) Patients aged 18 years or older at the time of obtaining consent 5) Patients with written consent
Exclusion criteria
Exclusion criteria: 1) Patients who have been treated with nintedanib 2) Patients requiring treatment with anticoagulants and high-dose antiplatelet drugs 3) Patients with a history of acute exacerbations within 6 months 4) Complications of poor control 5) Patients who cannot perform respiratory function test 6) Pregnant patients 7) Other patients who the doctor in charge deems inappropriate for safe administration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| rate of acute exacerbation or death in 52 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| the rate of forced vital capacity decrease over 10% | — |
Countries
Japan
Contacts
Public ContactNaoyuki Kuse
Japanese Red Cross Medical Center Department of Respiratory Medicine
Outcome results
None listed