Idiopathic pulmonary fibrosis
Conditions
Interventions
pirfenidone 12 months 200-600mg t.i.d or b.i.d
nintedanib 12 months 100-150mg b.i.d
Sponsors
National Hospital Organization Ibarakihigashi National Hospital The center of Chest Diseases and Severe Motor&Intellectual Disabilities
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Eligible patients are diagnosed as having idiopathic pulmonary fibrosis using the official American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Association (ALAT) statement.
Exclusion criteria
Exclusion criteria: the patients with coexisting lung cancer, acute exacerbation of idiopathic pulmonary fibrosis, severe cardiac or hepatic diseases, pulmonary arterial hypertension, sarcoidosis and respiratory infection, the patients who cannot perform pulmonary function test, pregnant women, use of prednisone greater than 20mg/day and immunosuppressives during the preceding 3 months, the patients who participated in other clinical trials in the last 3 months, the patients who are judged inappropriate for this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in vital capacity from baseline to months 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| dyspnea, KL-6, SP-D, %DLCO, changes in the lowest peripheral oxygen saturation during the 6-minute walk test, arterial blood gas, the reduction of ground-glass and reticular opacities, echocardiogram, bronchoalveolar lavage, first occurence of acute exacerbation, the development of lung cancer, survival at 12 months | — |
Countries
Japan
Contacts
Public ContactYukiko Miura
National Hospital Organization Ibarakihigashi National Hospital Department of Respiratory medicine
Outcome results
None listed