Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada
1 other identifier
observational
305
1 country
26
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2013
Longer than P75 for all trials
26 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 25, 2013
CompletedFirst Submitted
Initial submission to the registry
September 16, 2015
CompletedFirst Posted
Study publicly available on registry
September 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2017
CompletedNovember 17, 2017
November 1, 2017
4.3 years
September 16, 2015
November 14, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change in Observed Predicted Forced Vital Capacity
Up to 4 years
Secondary Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
Overall study
Specific treatment, dose, and treatment duration will be decided by the investigator independently of the participation of a patient in the study.
Interventions
Eligibility Criteria
Patients with Idiopathic Pulmonary Fibrosis (IPF)
You may qualify if:
- \> or = 18 years of age
- Diagnosis of Idiopathic Pulmonary Fibrosis (IPF)
- Prescribed and/or currently taking Esbriet (pirfenidone) for the treatment of IPF
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (26)
South Health Campus/Alberta Health Services/ University of Calgary
Calgary, Alberta, T3M 1M4, Canada
Edmonton Respiratory Consultants & Edmonton Sleep Lab
Edmonton, Alberta, T5J 3S9, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8, Canada
Synergy Respiratory Care
Sherwood Park, Alberta, T8H ON2, Canada
Kelowna Respiratory and Allergy Cllinic
Kelowna, British Columbia, V1W 1V3, Canada
Mainra Rajesh R, Respirology
North Vancouver, British Columbia, V7M 2H9, Canada
Vancouver General Hospital
Vancouver, British Columbia, V5Z 2S3, Canada
St. Paul's Hospital University of British Colambia Division of Hematology
Vancouver, British Columbia, V6Z 1Y6, Canada
Winnipeg Clinic
Winnipeg, Manitoba, R3C ON2, Canada
Clinique de pneumologie de Moncton Respiratory Clinic
Moncton, New Brunswick, E1C 5K4, Canada
Dr. Graham W. Bishop Clinic
Saint John, New Brunswick, E2M 5J7, Canada
Professional Medical Corporation
St. John's, Newfoundland and Labrador, A1C 2H3, Canada
St. Clare'S Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8, Canada
Burlington Lung Clinic
Burlington, Ontario, L7N 3V2, Canada
Firestone Institute for Respiratory Health
Hamilton, Ontario, L8N 4A6, Canada
Hotel Dieu Hospital
Kingston, Ontario, K7L 2V7, Canada
Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
London, Ontario, N6C 2R5, Canada
Credit Valley Professional Building
Mississauga, Ontario, L5M 2V8, Canada
Oshawa Clinic
Oshawa, Ontario, L1H 1B9, Canada
Carling Respiratory Services
Ottawa, Ontario, K1Y 4G2, Canada
Dr. Marc Newton Respirology
Owen Sound, Ontario, N4K 3M6, Canada
Toronto General Hospital; Investigational Pharmacy Services ENB - 217 (Pharmacy Receiving)
Toronto, Ontario, M5G 2C4, Canada
Dr. Syed Anees Medicine Profession Corporation
Windsor, Ontario, N8X 5A6, Canada
Dr Anil Dhar Professional Medicine Corporation
Windsor, Ontario, N8X-5A6, Canada
Hopital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Clinique de pneumologie et du sommeil de Lanaudiere
Saint-Charles-Borromée, Quebec, J6E 2B4, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 16, 2015
First Posted
September 17, 2015
Study Start
April 25, 2013
Primary Completion
August 15, 2017
Study Completion
August 15, 2017
Last Updated
November 17, 2017
Record last verified: 2017-11