Quality of Life Study in Participants With IPF Under Pirfenidone Treatment (PNEUMON)

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

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

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Pirfenidone

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• Greece
  • Athens, Greece, 115 27
    • Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology
  • Chaidari, Greece, 124 62
    • University General Hospital of Athens "Attikon", B' University Pulmonary Clinic
  • Heraklio, Greece, 711 10
    • University General Hospital of Heraklio, Pulmonary Clinic
  • Ioannina, Greece, 455 00
    • University General Hospital of Ioannina
  • Larissa, Greece, 413 34
    • General University Hospital of Larisa; Pneumonology Clinic
  • Thessaloniki, Greece, 570 10
    • General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.
  • Thessaloniki, Greece, 570 10
    • Papanikolaou Hospital; Pneumonology Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants in Greece with IPF under treatment with pirfenidone.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants With IPF; 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; Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).; Other Names: Esbriet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 18, 2017
• Primary Completion (ACTUAL): January 10, 2020
• Study Completion (ACTUAL): January 10, 2020

Study Registration Dates

• First Submitted: April 12, 2017
• First Submitted That Met QC Criteria: April 12, 2017
• First Posted (ACTUAL): April 14, 2017

Study Record Updates

• Last Update Posted (ACTUAL): August 21, 2020
• Last Update Submitted That Met QC Criteria: August 20, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Physiological Effects of Drugs; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antineoplastic Agents; Pirfenidone
• Other Study ID Numbers: ML39259

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No