Clinical Trials in Japan / NCT07722507
Starting soon
Observational
Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis
NCT07722507 · tracked via the Priya Life Science Japan tracker
Condition(s) studied
Pulmonary FibrosisIdiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis
Investigational drug(s) / intervention(s)
Antifibrotic therapy
Antifibrotic therapy: As per product label prescribed by treating physician
Study 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.
Eligibility
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:
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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).
Primary outcome measure(s)
- 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
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| Mebix, Inc. | Tokyo | Japan |
More Bristol-Myers Squibb trials in Japan
Other trials for the same condition
Application of Transbronchial Cryobiopsy in the Diagnosis of Progressive Pulmonary Fibrosis
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A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast
Active, not recruiting
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07722507 on ClinicalTrials.gov ↗ ← All trials in Japan