Idiopathic Pulmonary Fibrosis Clinical Trial
— PNEUMONOfficial 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
NCT number | NCT03115619 |
Other study ID # | ML39259 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 18, 2017 |
Est. completion date | January 10, 2020 |
Verified date | August 2020 |
Source | Hoffmann-La Roche |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This multicenter, post-marketing, observational study will evaluate quality of life in participants with Idiopathic Pulmonary Fibrosis (IPF) under treatment with pirfenidone (Esbriet).
Status | Completed |
Enrollment | 102 |
Est. completion date | January 10, 2020 |
Est. primary completion date | January 10, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
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 | University General Hospital of Ioannina | Ioannina | |
Greece | General University Hospital of Larisa; Pneumonology Clinic | Larissa | |
Greece | General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept. | Thessaloniki | |
Greece | Papanikolaou Hospital; Pneumonology Clinic | Thessaloniki |
Lead Sponsor | Collaborator |
---|---|
Hoffmann-La Roche |
Greece,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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) | ||
Secondary | Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment | Baseline, end of treatment (up to Week 52) | ||
Secondary | Change From Baseline in Annual FVC | From Baseline up to end of treatment (up to Week 52) | ||
Secondary | 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) | ||
Secondary | 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) | ||
Secondary | 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) | |
Secondary | 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) |
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