Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antifibrotic therapy.
- Who it may be relevant to
- Registry conditions: Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Understanding Pulmonary Fibrosis Through Web-Based Qualitative In-Depth Interviews on Antifibrotic TheRapy Decision-Making
Overview
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
- Drug Antifibrotic therapy
As per product label prescribed by treating physician
Primary outcome measures
- 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 [Time frame: Day 1]
Secondary outcome measures (1)
- 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 [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
Participants must meet all the following criteria to be eligible for inclusion in this study:
- Pulmonary fibrosis (PF) participants in Japan. Note: This includes those clinically recognized as having idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF).
- Participants who are ≥18 years of age at the time of providing informed consent via the web-based system.
- Participants receiving outpatient care for pulmonary fibrosis (PF) who have been introduced to this study by a referring physician.
- Participants who have a history of taking, or are currently taking, pirfenidone, nintedanib, or nerandomilast.
- 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
- Participants who feel or have felt burdened by the experienced AE.
- 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:
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- Participants currently participating in any interventional clinical trials (regardless of the study drug, excluding observational studies).
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
Japan · 1 center
- Mebix, Inc. — Tokyo
Identifiers
NCT: NCT07722507 · IM027-1062