Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

NCT03115619 | Completed FDA Drug

• 1 other identifier: ML39259
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 7

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).

Conditions

Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• 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)

Study Arms (1)

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

Interventions

Pirfenidone DRUG

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

Also known as: Esbriet

Participants With IPF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants in Greece with IPF under treatment with pirfenidone.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (7)

Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology

Athens, 115 27, Greece

Location

University General Hospital of Athens "Attikon", B' University Pulmonary Clinic

Chaïdári, 124 62, Greece

Location

University General Hospital of Heraklio, Pulmonary Clinic

Heraklio, 711 10, Greece

Location

University General Hospital of Ioannina

Ioannina, 455 00, Greece

Location

General University Hospital of Larisa; Pneumonology Clinic

Larissa, 413 34, Greece

Location

General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.

Thessaloniki, 570 10, Greece

Location

Papanikolaou Hospital; Pneumonology Clinic

Thessaloniki, 570 10, Greece

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

pirfenidone

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2017
• First Posted: April 14, 2017
• Study Start: April 18, 2017
• Primary Completion: January 10, 2020
• Study Completion: January 10, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Locations

GR (7)