Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Pirfenidone

• Registration Number: NCT03115619
• Lead Sponsor: Hoffmann-La Roche

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-04-12
• Study First Submitted QC: 2017-04-12
• Study First Posted: 2017-04-14
• Study Start: 2017-04-18
• Primary Completion: 2020-01-10
• Study Completion: 2020-01-10
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-20
• Last Update Posted: 2020-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

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Exclusion Criteria

• Participants who are participating in an interventional study or have received any investigational agent in the past 4 weeks

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Participants With IPF	Pirfenidone	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).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)	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.

Trial Locations

Locations (7)

University General Hospital of Ioannina; 🇬🇷 Ioannina, 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

General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.; 🇬🇷 Thessaloniki, Greece

General University Hospital of Larisa; Pneumonology Clinic; 🇬🇷 Larissa, Greece

Papanikolaou Hospital; Pneumonology Clinic; 🇬🇷 Thessaloniki, Greece