Idiopathic Pulmonary Fibrosis
Conditions
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).
Interventions
DRUGPirfenidone
Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC).
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | — |
| 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) | — |
| 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. |
| 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) | — |
| 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) | — |
Countries
Greece
Outcome results
None listed