Clinical trial NCT03115619: Quality of Life Study in Participants With IPF Under Pirfenidone Treatment
Official 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants in Greece with IPF under treatment with pirfenidone.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline in Quality of Life of Participants as Assessed by Saint George's Respiratory Questionnaire (SGQR) Score at the End of Treatment
timeFrame: Baseline, end of treatment (up to Week 52)
Secondary outcomes:
measure: Change From Baseline in Dyspnoea as Assessed by Medical Research Council (MRC) Breathlessness Scale Level at the End of Treatment
timeFrame: Baseline, end of treatment (up to Week 52)
measure: Change From Baseline in Percent (%) Predicted Forced Vital Capacity (FVC) at the End of Treatment
timeFrame: Baseline, end of treatment (up to Week 52)
measure: Change From Baseline in Annual FVC
timeFrame: From Baseline up to end of treatment (up to Week 52)
measure: Change From Baseline in % Predicted Diffusing Lung Capacity for Carbon Monoxide (DLCO) at the End of Treatment
timeFrame: Baseline, end of treatment (up to Week 52)
measure: Percentage of participants With Acute IPF Exacerbations, IPF-Related Death, Lung Transplant, or Respiratory-Related Hospitalization
timeFrame: from Baseline up to end of treatment (up to Week 52)
measure: Percentage of Participants who are Compliant to Treatment
timeFrame: From Baseline up to end of treatment (up to Week 52)
measure: Percentage of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs), and AEs of Special Interests
timeFrame: From Baseline up to end of treatment (up to Week 52)
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Sotiria Hospital for Diseases of the Chest, Academic Department of Pneumonology
city: Chaidari
country: Greece
facility: University General Hospital of Athens "Attikon", B' University Pulmonary Clinic
city: Heraklio
country: Greece
facility: University General Hospital of Heraklio, Pulmonary Clinic
city: Ioannina
country: Greece
facility: University General Hospital of Ioannina
city: Larissa
country: Greece
facility: General University Hospital of Larisa; Pneumonology Clinic
city: Thessaloniki
country: Greece
facility: General Hospital of Thessaloniki Papanikolaou; Uni Pneumonology Dept.
city: Thessaloniki
country: Greece
facility: Papanikolaou Hospital; Pneumonology Clinic
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: