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OpenTrials
Completed

NCT Number: NCT02552849

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

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.

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

South Health Campus/Alberta Health Services/ University of Calgary, Calgary, Alberta, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

Primary outcomes

  1. Change in Observed Predicted Forced Vital Capacity

    Time frame: Up to 4 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Sep 17, 2015
Registry last updated
Nov 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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