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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02552849

Enrollment

305

Registered

2015-09-17

Start date

2013-04-25

Completion date

2017-08-15

Last updated

2017-11-17

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

Conditions

Idiopathic Pulmonary Fibrosis

Brief summary

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.

Interventions

OTHERNo intervention

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Change in Observed Predicted Forced Vital Capacity	Up to 4 years

Secondary

Measure	Time frame
Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)	Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF)	Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL)	Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH)	Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D)	Up to 4 years
Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)	Up to 4 years
Progression-Free Survival (PFS)	Up to 4 years
Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)	Up to 4 years

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026