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

Idiopathic Pulmonary Fibrosis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02552849
• Other study ID #: ML29808
• Status: Completed
• Phase: N/A
• First received: September 16, 2015
• Last updated: November 14, 2017
• Start date: April 25, 2013
• Est. completion date: August 15, 2017

Study information

• Verified date: November 2017
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 305
• Est. completion date: August 15, 2017
• Est. primary completion date: August 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Other:
• No intervention

Locations

Country	Name	City	State
Canada	Burlington Lung Clinic	Burlington	Ontario
Canada	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	Firestone Institute for Respiratory Health	Hamilton	Ontario
Canada	Kelowna Respiratory and Allergy Cllinic	Kelowna	British Columbia
Canada	Hotel Dieu Hospital	Kingston	Ontario
Canada	Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute	London	Ontario
Canada	Credit Valley Professional Building	Mississauga	Ontario
Canada	Clinique de pneumologie de Moncton Respiratory Clinic	Moncton	New Brunswick
Canada	Hopital Notre-Dame	Montreal	Quebec
Canada	Mainra Rajesh R, Respirology	North Vancouver	British Columbia
Canada	Oshawa Clinic	Oshawa	Ontario
Canada	Carling Respiratory Services	Ottawa	Ontario
Canada	Dr. Marc Newton Respirology	Owen Sound	Ontario
Canada	Dr. Graham W. Bishop Clinic	Saint John	New Brunswick
Canada	Clinique de pneumologie et du sommeil de Lanaudiere	Saint-Charles-Borromee	Quebec
Canada	Synergy Respiratory Care	Sherwood Park	Alberta
Canada	St. Clare'S Mercy Hospital	St John's	Newfoundland and Labrador
Canada	Professional Medical Corporation	St. John's	Newfoundland and Labrador
Canada	Toronto General Hospital; Investigational Pharmacy Services ENB - 217 (Pharmacy Receiving)	Toronto	Ontario
Canada	St. Paul's Hospital University of British Colambia Division of Hematology	Vancouver	British Columbia
Canada	Vancouver General Hospital	Vancouver	British Columbia
Canada	Dr Anil Dhar Professional Medicine Corporation	Windsor	Ontario
Canada	Dr. Syed Anees Medicine Profession Corporation	Windsor	Ontario
Canada	Winnipeg Clinic	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Observed Predicted Forced Vital Capacity		Up to 4 years
Secondary	Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)		Up to 4 years
Secondary	Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF)		Up to 4 years
Secondary	Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL)		Up to 4 years
Secondary	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
Secondary	Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D)		Up to 4 years
Secondary	Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)		Up to 4 years
Secondary	Progression-Free Survival (PFS)		Up to 4 years
Secondary	Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)		Up to 4 years