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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pirfenidone | Drug | Participants will receive pirfenidone therapy as per clinical practice or summary of product characteristics (SmPC). |
|
| Measure | Description | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Participants in Greece with IPF under treatment with pirfenidone.
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology | Athens | 115 27 | Greece | |||
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C093844 | pirfenidone |
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| 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) |
| 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) |
| 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) |
| University General Hospital of Athens "Attikon", B' University Pulmonary Clinic |
| Chaïdári |
| 124 62 |
| Greece |
| University General Hospital of Heraklio, Pulmonary Clinic | Heraklio | 711 10 | Greece |
| University General Hospital of Ioannina | Ioannina | 455 00 | Greece |
| General University Hospital of Larisa; Pneumonology Clinic | Larissa | 413 34 | Greece |
| General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept. | Thessaloniki | 570 10 | Greece |
| Papanikolaou Hospital; Pneumonology Clinic | Thessaloniki | 570 10 | Greece |