NCT07722507尚未招募不适用
Understanding Pulmonary Fibrosis Through Web-Based Qualitative In-Depth Interviews on Antifibrotic TheRapy Decision-Making
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 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
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Participants meeting any of the following criteria will be excluded from the study:
- •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).
结局指标
主要结局
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
时间窗: Day 1
次要结局
- 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)
研究者
研究点 (1)
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