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

Hoffmann-La Roche7 sites in 1 country102 target enrollmentApril 18, 2017

ConditionsIdiopathic Pulmonary Fibrosis

InterventionsPirfenidone

DrugsPirfenidone

Overview

Phase: Not Applicable
Intervention: Pirfenidone
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Hoffmann-La Roche
Enrollment: 102
Locations: 7
Primary Endpoint: Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

April 18, 2017

End Date

January 10, 2020

Last Updated

5 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility Criteria

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

Arms & Interventions

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).

Intervention: Pirfenidone

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

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))
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))
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))
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 who are Compliant to Treatment(From Baseline up to end of treatment (up to Week 52))