Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

Idiopathic Pulmonary Fibrosis Clinical Trial

— PNEUMON  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03115619
• Other study ID #: ML39259
• Status: Completed
• Start date: April 18, 2017
• Est. completion date: January 10, 2020

Study information

• Verified date: August 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 10, 2020
• Est. primary completion date: January 10, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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

Locations

Country	Name	City	State
Greece	Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology	Athens
Greece	University General Hospital of Athens "Attikon", B' University Pulmonary Clinic	Chaidari
Greece	University General Hospital of Heraklio, Pulmonary Clinic	Heraklio
Greece	University General Hospital of Ioannina	Ioannina
Greece	General University Hospital of Larisa; Pneumonology Clinic	Larissa
Greece	General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.	Thessaloniki
Greece	Papanikolaou Hospital; Pneumonology Clinic	Thessaloniki

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment		Baseline, end of treatment (up to Week 52)
Secondary	Change From Baseline in Annual FVC		From Baseline up to end of treatment (up to Week 52)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)