VENTASWITCH, Examination of Ventavis® (Iloprost) Inhalation Behavior Using the I-Neb® AAD® System in Patients With Pulmonary Arterial Hypertension When Switching the Iloprost Nebulizer Solution for Inhalation From 10 μg/mL (V10) to 20 μg/mL (V20)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 64
- 主要终点
- Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL
研究概览
简要总结
The aim of this study is to examine inhalation behavior in patients enrolled in the German Ventavis patient support program Ventaplus when these patients are switched from Ventavis (Iloprost) 10 μg/mL to Ventavis (Iloprost) 20 μg/mL formulation.
详细描述
The VENTASWITCH study will be a local, prospective and retrospective, observational, case-crossover study. Data are collected and downloaded from the I-Neb AAD (Adaptive Aerosol Delivery) System. Two data collection periods are planned: period one; data collection from the last 3 months using Ventavis (Iloprost) 10 μg/mL (V10) before the index date of switching to Ventavis (Iloprost) 20 μg/mL (V20) (retrospective part) and period two; data collection for 3 months using V20 from index date (prospective part).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Other
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
- •Patients aged ≥18 years at time of signing informed consent.
- •Patients, diagnosed with group 1 PAH.
- •Patients must be enrolled in the German Ventavis patient support program Ventaplus.
- •Patients who either already switched from V10 to V20 therapy or who agreed to do so according to their physician's decision.
- •Patients must have been on V10 therapy for at least 2 weeks.
- •Written informed consent must be obtained.
排除标准
- •participation in other clinical or interventional study.
研究组 & 干预措施
Ventavis
The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus.
干预措施: I-Neb AAD system (Device)
Ventavis
The study will be conducted in patients who are enrolled in the German Ventavis patient support program Ventaplus.
干预措施: Iloprost,(Ventavis, BAYQ6256) (Drug)
结局指标
主要结局
Number of delivered doses (none/partial/full) on Iloprost 10 ug/mL and 20 ug/mL
时间窗: Up to 6 months
Number of inhalations on Iloprost 10 ug/mL and 20 ug/mL
时间窗: Up to 6 months
次要结局
- Inhalation durations (min) per session on Iloprost 10 ug/mL and 20 ug/mL(Up to 6 months)