ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02552849
Recruitment Status : Completed
First Posted : September 17, 2015
Last Update Posted : November 17, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Idiopathic Pulmonary Fibrosis Other: No intervention

Study Type : Observational
Actual Enrollment : 305 participants
Observational Model: Cohort
Time Perspective: Prospective
Actual Study Start Date : April 25, 2013
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017


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



Primary Outcome Measures :
  1. Change in Observed Predicted Forced Vital Capacity [ Time Frame: Up to 4 years ]

Secondary Outcome Measures :
  1. Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone) [ Time Frame: Up to 4 years ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D) [ Time Frame: Up to 4 years ]
  6. Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ) [ Time Frame: Up to 4 years ]
  7. Progression-Free Survival (PFS) [ Time Frame: Up to 4 years ]
  8. Proportion of Patients Taking Full Dose of Esbriet (pirfenidone) [ Time Frame: Up to 4 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with Idiopathic Pulmonary Fibrosis (IPF)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02552849


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

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02552849     History of Changes
Other Study ID Numbers: ML29808
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Lung Diseases, Interstitial