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Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis
Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis
Not Yet RecruitingN/A
Sponsor: Bristol-Myers Squibb
Conditions: Pulmonary Fibrosis, Idiopathic Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Interventions: Antifibrotic therapy
Countries: Japan
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 overview
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: OBSERVATIONAL
Eligibility criteria
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).Locations (1)
- Tokyo, Japan