Randomized Phase 2 study of Nintedanib and Pirfenidone versus Nintedanib following a clinically meaningful decline in forced vital capacity in patients with idiopathic pulmonary fibrosis administering pirfenidone
Phase 2
- Conditions
- idiopathic pulmonary fibrosis
- Registration Number
- JPRN-UMIN000019436
- Lead Sponsor
- Kanagawa Cardiovascular and Respiratory Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1) AST/ALT/T-bil >= reference value * 2.5 2) The patients who has already received corticosteroid (<=15mg/day), immuno-supressant, NAC, pulmonary vasodilators, and other treatment for IPF 3) Active infection 4) Malignant tumor 5) Other severe complication 6) pregnant or lactating woman 7) severe drug allergy 8) It is determined that it is not suited
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The ratio of patients who experienced >5% absolute decline in %FVC or death during the first 6-months
- Secondary Outcome Measures
Name Time Method 1) The ratio of patients who experienced >10% absolute decline in %FVC or death during the first 6-months 2) Decline of FVC at 1,3,6,9,12 months 3) The occurence rate of acute excerbation 4) Change in %FVC and %DLco 5) 6 minutes walk test 6) Serum biomarker 7) HRCT findings 8) Toxicity 9) Progression free survival 10) Survival