idiopathic pulmonary fibrosis
Conditions
Interventions
48 weeks of observational period, administration of nintedanib, 100mg or 150mg twice a day and pirfenidone, 200mg, 400mg, or 600mg 3 times a day
Sponsors
Japanese Red Cross Medical Canter
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1)IPF diagnosed on IPF diagnosis guidelines published by American Thoracic Society, European Respiratory Society, Japanese Respiratory Society, and Latin American Thoracic Association 2018 2)Patients who continue nintedanib 3)Patients whose FVC declined before initiation of combination therapy of anti-fibrotic agents 4)Patients with FVC > = 50% 5)Patients with DLCO > = 30% 6)Patients > = 40 year-old 7)Patients able to give informed consent
Exclusion criteria
Exclusion criteria: 1)Patients with FEV1/FVC < 0.7 2)Patients who have treated with combination therapy of anti-fibrotic agents 3)Patients who require fibrinolysis, full-dose therapeutic anticoagulation, or high dose antiplatelet therapy 4)Patients who had acute exacerbation of IPF within 6 months 5)Patients who have uncontrolled complications (unstable angina, acute myocardial infarction, severe bronchial asthma, heart failure, bleeding tendency) 6)Patients who cannot perform pulmonary function test 7)Patients who are pregnant 8)Other patients who are judged to be inappropriate as a target by the doctor's judgment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients whose annual decline of FVC was more than 10% | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Comparison of decline of FVC before and after initiation of combination therapy 2. Proportion of incidence of acute exacerbation of IPF 3. Time to the acute exacerbation of IPF 4. Survival rate at 48 weeks 5. Proportion of incidence of adverse events | — |
Countries
Japan
Contacts
Public ContactMinoru Inomata
Japanese Red Cross Medical Canter Department of Respiratory Medicine
Outcome results
None listed