Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis, Pulmonary Fibrosis
Conditions
Keywords
Antifibrotic therapy, Pulmonary fibrosis (PF), Idiopathic pulmonary fibrosis (IPF), Progressive pulmonary fibrosis (PPF)
Brief summary
This study will explore how adults in Japan with pulmonary fibrosis decide whether to continue or discontinue antifibrotic therapy after experiencing antifibrotic therapy-related adverse events.
Interventions
DRUGAntifibrotic therapy
As per product label prescribed by treating physician
Sponsors
Bristol-Myers Squibb
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following criteria to be eligible for inclusion in this study: 1. Pulmonary fibrosis (PF) participants in Japan. Note: This includes those clinically recognized as having idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). 2. Participants who are ≥18 years of age at the time of providing informed consent via the web-based system. 3. Participants receiving outpatient care for pulmonary fibrosis (PF) who have been introduced to this study by a referring physician. 4. Participants who have a history of taking, or are currently taking, pirfenidone, nintedanib, or nerandomilast. 5. Participants who have experienced at least one antifibrotic (AF) therapy-related adverse event (AE). * Discontinuation group only 1\) Participants who have not received AF therapy for at least 1 month prior to enrollment. 2\) Participants whose AF therapy was discontinued within 6 months prior to enrollment. 3\) Participants whose reason for discontinuing AF therapy includes at least one AF therapy-related AE. * Continuation group only 1. Participants who feel or have felt burdened by the experienced AE. 2. Participants who have continued AF therapy for a specific period (≥6 months) at the time of enrollment.
Exclusion criteria
Participants meeting any of the following criteria will be excluded from the study: <!-- --> 1. Participants currently participating in any interventional clinical trials (regardless of the study drug, excluding observational studies). 2. Participants who have undergone lung transplantation. * Discontinuation group only 1) Participants who discontinued AF therapy solely for reasons other than AE (e.g., financial reasons, disease progression).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant reported decision-making process for antifibrotic therapy persistence or discontinuation when considering the impact of tolerability and adverse events collected via semi-structured qualitative participant interviews | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Participant reported psychological and clinical processes of perceiving/managing adverse event-related burdens, and factors influencing the will to continue therapy collected via semi-structured qualitative participant interviews | Day 1 |
Countries
Japan
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol-Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed