Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

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

Official Title
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A Multicenter, Post-Marketing, Non-Interventional, Observational Study to Evaluate Quality of Life in Patients in Greece With Idiopathic Pulmonary Fibrosis Under Treatment With Pirfenidone - The Pneumon Study

Conditions
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Idiopathic Pulmonary Fibrosis

Intervention / Treatment
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* Drug: Pirfenidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Participants With IPF<br>Observational data of participants with IPF under treatment with pirfenidone will be collected from the medical records as a part of their routine clinical visits at 12-week interval until study completion or early withdrawal (up to Week 52). | Drug: Pirfenidone<br>* Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).<br>* Other names: Esbriet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment |  | Baseline, end of treatment (up to Week 52) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Dyspnoea as Assessed by Medical Research Council (MRC) Breathlessness Scale Level at the End of Treatment |  | Baseline, end of treatment (up to Week 52) | 
| Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment |  | Baseline, end of treatment (up to Week 52) | 
| Change From Baseline in Annual FVC |  | 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 |  | Baseline, end of treatment (up to Week 52) | 
| Percentage of participants With Acute IPF Exacerbations, IPF-Related Death, Lung Transplant, or Respiratory-Related Hospitalization |  | 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. | 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 |  | From Baseline up to end of treatment (up to Week 52) |