Antifibrotic Therapy Decision-Making in Pulmonary Fibrosis (UPWARD)
Understanding Pulmonary Fibrosis Through Web-Based Qualitative In-Depth Interviews on Antifibrotic TheRapy Decision-Making
研究概览
研究类型
注册 (估计的)
联系人和位置
学习联系方式
- 姓名:First line of the email MUST contain NCT # and Site #.
研究联系人备份
- 姓名:BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
- 电话号码:855-907-3286
- 邮箱:Clinical.Trials@bms.com
学习地点
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Tokyo、日本
- Mebix, Inc.
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
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:
- 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).
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Continuation group
Participants who have continued at least one antifibrotic therapy for a specific period (≥6 months) at the time of enrollment.
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As per product label prescribed by treating physician
其他名称:
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Discontinuation group
Participants who have completely ceased all antifibrotic therapies for at least 1 month prior to enrollment.
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As per product label prescribed by treating physician
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
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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
大体时间:Day 1
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Day 1
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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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
大体时间:Day 1
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Day 1
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合作者和调查者
调查人员
- 研究主任:Bristol-Myers Squibb、Bristol-Myers Squibb
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- IM027-1062
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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