Idiopathic pulmonary fibrosis (IPF)
Conditions
Interventions
None listed
Sponsors
Respiratory Medicine, Nagasaki University Graduate School of Biomedical Sciences
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Diagnosis of IPF according to the ATS/ERS/JRS/ALAT guidelines. 2) Stage I or II IPF based on the Japanese IPF disease severity classification. Stage I:PaO2 at rest 80 torr and more Stage II: PaO2 at rest 70-80 torr, and SpO2 90% and more during a 6-minute walk test 3) Patients who will start nintedanib for IPF. 4) Patients who are able and willing to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1)Patients who have initiated therapy with any antifibrotic agent for IPF. 2)Patients treated with corticosteroids (more than a prednisolone equivalent, 10 mg/day) or immunosuppressive agents. 3)Patients who are participating in any other interventional clinical trials. 4)Patients who are undergoing malignant tumor treatment. 5)Patients with a contraindication for nintedanib treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in FVC at 156 week Occurrence of adverse events in each SOC/PT | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoint(s) / Outcome: 1) Time to incidence of adverse events leading to nintedanib treatment discontinuation. 2) Time to incidence of adverse events leading to nintedanib dose reduction. 3) Incidence of adverse events leading to nintedanib treatment discontinuation. 4) Incidence of adverse events leading to nintedanib dose reduction. | — |
Countries
Japan
Contacts
Public ContactNoriho Sakamoto
Nagasaki University Graduate School of Biomedical Sciences Respiratory Medicine
Outcome results
None listed