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

Completed

• Conditions: Idiopathic Pulmonary Fibrosis

• Registration Number: NCT02552849
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-04-25
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-16
• Study First Posted: 2015-09-17
• Primary Completion: 2017-08-15
• Study Completion: 2017-08-15
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-14
• Last Update Posted: 2017-11-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 305

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Observed Predicted Forced Vital Capacity	Up to 4 years

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (26)

South Health Campus/Alberta Health Services/ University of Calgary; 🇨🇦 Calgary, Alberta, Canada

Edmonton Respiratory Consultants & Edmonton Sleep Lab; 🇨🇦 Edmonton, Alberta, Canada

Grey Nuns Community Hospital; 🇨🇦 Edmonton, Alberta, Canada

Synergy Respiratory Care; 🇨🇦 Sherwood Park, Alberta, Canada

Kelowna Respiratory and Allergy Cllinic; 🇨🇦 Kelowna, British Columbia, Canada

Mainra Rajesh R, Respirology; 🇨🇦 North Vancouver, British Columbia, Canada

Vancouver General Hospital; 🇨🇦 Vancouver, British Columbia, Canada

St. Paul's Hospital University of British Colambia Division of Hematology; 🇨🇦 Vancouver, British Columbia, Canada

Winnipeg Clinic; 🇨🇦 Winnipeg, Manitoba, Canada

Clinique de pneumologie de Moncton Respiratory Clinic; 🇨🇦 Moncton, New Brunswick, Canada

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