Clinical trial NCT02552849: Observational Study to Evaluate Disease Course and Outcomes in Patients Treated With Esbriet (Pirfenidone) for Idiopathic Pulmonary Fibrosis (IPF) in Canada
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 305
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Idiopathic Pulmonary Fibrosis (IPF)

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.


Eligibility 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

Primary outcomes:
measure: Change in Observed Predicted Forced Vital Capacity
timeFrame: Up to 4 years
Secondary outcomes:
measure: Proportion of Patients Not Taking Full Dose of Esbriet (pirfenidone)
timeFrame: Up to 4 years
measure: Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the A Tool Quality of Life Questionnaire (ATAQ-IPF)
timeFrame: Up to 4 years
measure: Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Health-Related Quality of Life Questionnaire (HRQOL)
timeFrame: Up to 4 years
measure: Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the Work Productivity and Activity Impairment Questionnaire-General Health (WPAI-GH)
timeFrame: Up to 4 years
measure: Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the EuroQol-5 Dimension Questionnaire (EQ-5D)
timeFrame: Up to 4 years
measure: Patient-Reported Outcome (PRO) Measure that Capture Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Up to 4 years
measure: Progression-Free Survival (PFS)
timeFrame: Up to 4 years
measure: Proportion of Patients Taking Full Dose of Esbriet (pirfenidone)
timeFrame: Up to 4 years
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: South Health Campus/Alberta Health Services/ University of Calgary
state: Alberta
city: Edmonton
country: Canada
facility: Edmonton Respiratory Consultants & Edmonton Sleep Lab
state: Alberta
city: Edmonton
country: Canada
facility: Grey Nuns Community Hospital
state: Alberta
city: Sherwood Park
country: Canada
facility: Synergy Respiratory Care
state: Alberta
city: Kelowna
country: Canada
facility: Kelowna Respiratory and Allergy Cllinic
state: British Columbia
city: North Vancouver
country: Canada
facility: Mainra Rajesh R, Respirology
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: St. Paul's Hospital University of British Colambia Division of Hematology
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Clinic
state: Manitoba
city: Moncton
country: Canada
facility: Clinique de pneumologie de Moncton Respiratory Clinic
state: New Brunswick
city: Saint John
country: Canada
facility: Dr. Graham W. Bishop Clinic
state: New Brunswick
city: St John's
country: Canada
facility: St. Clare'S Mercy Hospital
state: Newfoundland and Labrador
city: St. John's
country: Canada
facility: Professional Medical Corporation
state: Newfoundland and Labrador
city: Burlington
country: Canada
facility: Burlington Lung Clinic
state: Ontario
city: Hamilton
country: Canada
facility: Firestone Institute for Respiratory Health
state: Ontario
city: Kingston
country: Canada
facility: Hotel Dieu Hospital
state: Ontario
city: London
country: Canada
facility: Lawson Health Research Institute a joint venture of LHSC Research Inc and Lawson Research Institute
state: Ontario
city: Mississauga
country: Canada
facility: Credit Valley Professional Building
state: Ontario
city: Oshawa
country: Canada
facility: Oshawa Clinic
state: Ontario
city: Ottawa
country: Canada
facility: Carling Respiratory Services
state: Ontario
city: Owen Sound
country: Canada
facility: Dr. Marc Newton Respirology
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital; Investigational Pharmacy Services ENB - 217 (Pharmacy Receiving)
state: Ontario
city: Windsor
country: Canada
facility: Dr. Syed Anees Medicine Profession Corporation
state: Ontario
city: Windsor
country: Canada
facility: Dr Anil Dhar Professional Medicine Corporation
state: Ontario
city: Montreal
country: Canada
facility: Hopital Notre-Dame
state: Quebec
city: Saint-Charles-Borromee
country: Canada
facility: Clinique de pneumologie et du sommeil de Lanaudiere
state: Quebec
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: