idiopathic pulmonary fibrosis
Conditions
Interventions
administration of 150mg of nintedanib twice daily
Sponsors
Kanagawa Cardiovascular and Respiratory Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients who fulfilled all of the following criteria 1. Age is more than 40 years old. 2. After receiving enough explanations about participation in this study, the document consents by free will of patient were received thorough his understanding. 3)Satisfy the diagnostic official ATS/ERS/JRS/ALAT statement criteria of IPF, using HRCT or surgical biopsy. 4)Disease activity is stable at registration 5)Patient who need treatment with nintedanib and agree to the administration. 6)Cases who are expected 12 months or more survival after the treatment of nintedanib.
Exclusion criteria
Exclusion criteria: 1) AST/ALT/T-bil are is more than reference value 2.5 times 2)Patient who was determined as ineligible by the investigator or the subinvestigator. 3) The patients who has already received corticosteroid (over 10mg/day), immunosupressant, N-acetylcysteine , pirfenidone, and other treatment for IPF 4) Active infection and other severe complication 5) Malignant tumor 6) case was determined as ineligible by attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in fibrosis score of computed tomography over 52-week after treatment with Nintedanib | — |
Secondary
| Measure | Time frame |
|---|---|
| the change in distance and the lowest SpO2 during 6-minute walk test, pulmonary function tests (FVC and diffusing capacity of the lung for carbon monoxide),serum levels of the markers (KL-6 and surfactant protein -D), quality of life, the rate of acute exacerbation, the time to the first acute exacerbation, progression-free survival time and survival time over 52-week after treatment with Nintedanib | — |
Countries
Japan
Contacts
Public ContactHideya Kitamura
Kanagawa Cardiovascular and Respiratory Center Department of Respiratory Medicine
Outcome results
None listed