Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

Hoffmann-La Roche102 enrolled

Overview

This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).

Study Type

OBSERVATIONAL

Enrollment

102

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

PirfenidoneDRUG

Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Adult participants for whom pirfenidone has already been prescribed for IPF no more than 4 weeks prior to enrollment, according to their physicians' clinical decision and the terms in the SmPC Exclusion Criteria: * Participants who are participating in an interventional study or have received any investigational agent in the past 4 weeks

Locations (7)

Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology

Athens, Greece

University General Hospital of Athens "Attikon", B' University Pulmonary Clinic

Chaïdári, Greece

University General Hospital of Heraklio, Pulmonary Clinic

Heraklio, Greece

University General Hospital of Ioannina

Outcomes

Primary Outcomes

Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment

Time frame: Baseline, end of treatment (up to Week 52)

Secondary Outcomes

Change From Baseline in Dyspnoea as Assessed by Medical Research Council (MRC) Breathlessness Scale Level at the End of Treatment

Time frame: Baseline, end of treatment (up to Week 52)

Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment

Time frame: Baseline, end of treatment (up to Week 52)

Change From Baseline in Annual FVC

Time frame: From Baseline up to end of treatment (up to Week 52)

Change From Baseline in % Predicted Diffusing Lung Capacity for Carbon Monoxide (DLCO) at the End of Treatment

Time frame: Baseline, end of treatment (up to Week 52)

Percentage of participants With Acute IPF Exacerbations, IPF-Related Death, Lung Transplant, or Respiratory-Related Hospitalization

Time frame: from Baseline up to end of treatment (up to Week 52)

Percentage of Participants who are Compliant to Treatment

Treatment compliance will be assessed by the total number of dose reductions, dose interruptions, and the administered dosing intensity relative to the projected dose intensity during treatment.

Time frame: From Baseline up to end of treatment (up to Week 52)

Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interests

Data from ClinicalTrials.gov

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