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

Hoffmann-La Roche305 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

305

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

No interventionOTHER

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (26)

Outcomes

Primary Outcomes

Change in Observed Predicted Forced Vital Capacity

Time frame: Up to 4 years

Secondary Outcomes

Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)

Time frame: Up to 4 years

Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF)

Time frame: Up to 4 years

Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL)

Time frame: 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)

Time frame: Up to 4 years

Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D)

Time frame: Up to 4 years

Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)

Time frame: Up to 4 years

Progression-Free Survival (PFS)

Time frame: Up to 4 years

Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)

Time frame: Up to 4 years

Data from ClinicalTrials.gov

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South Health Campus/Alberta Health Services/ University of Calgary

Calgary, Alberta, Canada

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Grey Nuns Community Hospital

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Synergy Respiratory Care

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Kelowna Respiratory and Allergy Cllinic

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Mainra Rajesh R, Respirology

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Vancouver General Hospital

Vancouver, British Columbia, Canada

St. Paul's Hospital University of British Colambia Division of Hematology

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Winnipeg Clinic

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Clinique de pneumologie de Moncton Respiratory Clinic

Moncton, New Brunswick, Canada

...and 16 more locations