Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial

Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial - Idiopathic Pulmonary Fibrosis treated with Anti-fibrotic Drugs Prospective Observational Trial (PREDICT trial)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000019826

Enrollment

100

Registered

2015-11-18

Start date

2015-11-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic pulmonary fibrosis

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Satisfy the diagnostic criteria of IPF. 2) Anti-fibrotic drugs, pirfenidone or nintedanib, are newly administered. Or Anti-fibrotic drug is changed to the other fibrotic drug. 3) Written informed consent.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Japan

Contacts

Public ContactToru Arai

NHO Kinki-Chuo Chest Medical Center Clinical Research Center

arai.toru.cp@mail.hosp.go.jp072-252-3021

Outcome results