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

November 14, 2017 updated by: Hoffmann-La Roche
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

305

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3M 1M4
        • South Health Campus/Alberta Health Services/ University of Calgary
      • Edmonton, Alberta, Canada, T5J 3S9
        • Edmonton Respiratory Consultants & Edmonton Sleep Lab
      • Edmonton, Alberta, Canada, T6L 5X8
        • Grey Nuns Community Hospital
      • Sherwood Park, Alberta, Canada, T8H ON2
        • Synergy Respiratory Care
    • British Columbia
      • Kelowna, British Columbia, Canada, V1W 1V3
        • Kelowna Respiratory and Allergy Cllinic
      • North Vancouver, British Columbia, Canada, V7M 2H9
        • Mainra Rajesh R, Respirology
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • St. Paul's Hospital University of British Colambia Division of Hematology
      • Vancouver, British Columbia, Canada, V5Z 2S3
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3C ON2
        • Winnipeg Clinic
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C 5K4
        • Clinique de pneumologie de Moncton Respiratory Clinic
      • Saint John, New Brunswick, Canada, E2M 5J7
        • Dr. Graham W. Bishop Clinic
    • Newfoundland and Labrador
      • St John's, Newfoundland and Labrador, Canada, A1C 5B8
        • St. Clare's Mercy Hospital
      • St. John's, Newfoundland and Labrador, Canada, A1C 2H3
        • Professional Medical Corporation
    • Ontario
      • Burlington, Ontario, Canada, L7N 3V2
        • Burlington Lung Clinic
      • Hamilton, Ontario, Canada, L8N 4A6
        • Firestone Institute for Respiratory Health
      • Kingston, Ontario, Canada, K7L 2V7
        • Hotel Dieu Hospital
      • London, Ontario, Canada, N6C 2R5
        • Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
      • Mississauga, Ontario, Canada, L5M 2V8
        • Credit Valley Professional Building
      • Oshawa, Ontario, Canada, L1H 1B9
        • Oshawa Clinic
      • Ottawa, Ontario, Canada, K1Y 4G2
        • Carling Respiratory Services
      • Owen Sound, Ontario, Canada, N4K 3M6
        • Dr. Marc Newton Respirology
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital; Investigational Pharmacy Services ENB - 217 (Pharmacy Receiving)
      • Windsor, Ontario, Canada, N8X 5A6
        • Dr. Syed Anees Medicine Profession Corporation
      • Windsor, Ontario, Canada, N8X-5A6
        • Dr Anil Dhar Professional Medicine Corporation
    • Quebec
      • Montreal, Quebec, Canada, H2L 4M1
        • Hôpital Notre-Dame
      • Saint-Charles-Borromee, Quebec, Canada, J6E 2B4
        • Clinique de pneumologie et du sommeil de Lanaudiere

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Idiopathic Pulmonary Fibrosis (IPF)

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Overall study
Specific treatment, dose, and treatment duration will be decided by the investigator independently of the participation of a patient in the study.
Other: No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Observed Predicted Forced Vital Capacity
Time Frame: Up to 4 years
Up to 4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)
Time Frame: Up to 4 years
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
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
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
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
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
Up to 4 years
Progression-Free Survival (PFS)
Time Frame: Up to 4 years
Up to 4 years
Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)
Time Frame: Up to 4 years
Up to 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2013

Primary Completion (Actual)

August 15, 2017

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

September 16, 2015

First Submitted That Met QC Criteria

September 16, 2015

First Posted (Estimate)

September 17, 2015

Study Record Updates

Last Update Posted (Actual)

November 17, 2017

Last Update Submitted That Met QC Criteria

November 14, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML29808

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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