Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial
Not Applicable
Recruiting
- Conditions
- Idiopathic pulmonary fibrosis
- Registration Number
- JPRN-UMIN000019826
- Lead Sponsor
- HO Kinki-Chuo Chest Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Not provided
Exclusion Criteria
1) Patients with contraindication of anti-fibrotic drugs. Pirfenidone: hypersensitivity. NIntedanib: hypersensitivity and pregnancy. 2) Patients improper to the trial according to the decision of a chief doctor.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Predictive factors of 5% or 10% decrease in forced vital capacity (FVC) of IPF one year after the start of anti-fibrotic drug. Whether or not annual FVC decline before the start of anti-fibrotic drugs can predict the effectiveness of the drugs in IPF cases, FVC is measured before the start of the drugs.
- Secondary Outcome Measures
Name Time Method 1) Safety of anti-fibrotic drugs: adverse events between the two anti-fibrotic drugs. predictive factors of adverse events. 2) Prognosis and frequency of acute exacerbation within one year after the start of anti-fibrotic drugs. 3) Predictive factors to determine the change of annual FVC decline before and after the anti-fibrotic drugs. 4) Comparison of annual FVC decline between IPF with/without a pre-anti-fibrotic drug. 5) New serum parameters to determine effects of anti-fibrotic drugs.