Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada

Roche

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Other: No intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT02552849

ML29808

Details and patient eligibility

About

This is a multi-center, non-interventional study to assess and describe course and outcomes in patients diagnosed with Idiopathic Pulmonary Fibrosis (IPF) who are treated with Esbriet (pirfenidone) in Canada, by measuring and reporting observed predicted forced vital capacity (FVC) change from baseline on an ongoing basis.

Enrollment: 305 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• > or = 18 years of age
• Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
• Prescribed and/or currently taking Esbriet (pirfenidone) for the treatment of IPF

Exclusion criteria

• Hypersensitivity to Esbriet (pirfenidone)
• Concomitant use of fluvoxamine
• Severe hepatic impairment or end-stage liver disease
• Severe renal impairment or end-stage renal disease requiring dialysis

Trial design

305 participants in 1 patient group

Overall study

Description:

Specific treatment, dose, and treatment duration will be decided by the investigator independently of the participation of a patient in the study.

Treatment:

Other: No intervention