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Completed

NCT Number: NCT03115619

Quality of Life Study in Participants With IPF Under Pirfenidone Treatment

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pirfenidone

Drug

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

Other names: Esbriet

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

    Time frame: Baseline, end of treatment (up to Week 52)

Secondary outcomes

  1. Change From Baseline in Dyspnoea as Assessed by Medical Research Council (MRC) Breathlessness Scale Level at the End of Treatment

    Time frame: Baseline, end of treatment (up to Week 52)

  2. Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment

    Time frame: Baseline, end of treatment (up to Week 52)

  3. Change From Baseline in Annual FVC

    Time frame: From Baseline up to end of treatment (up to Week 52)

  4. Change From Baseline in % Predicted Diffusing Lung Capacity for Carbon Monoxide (DLCO) at the End of Treatment

    Time frame: Baseline, end of treatment (up to Week 52)

  5. Percentage of participants With Acute IPF Exacerbations, IPF-Related Death, Lung Transplant, or Respiratory-Related Hospitalization

    Time frame: from Baseline up to end of treatment (up to Week 52)

  6. Percentage of Participants who are Compliant to Treatment

    Time frame: 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.

  7. Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interests

    Time frame: From Baseline up to end of treatment (up to Week 52)

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Acronym: PNEUMON

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 14, 2017
Registry last updated
Aug 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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