NCT01781052已完成不适用
DAILY: Observational Description of Compliance for the Daily Ventavis® Use Via the Insight Program in Class III Pulmonary Arterial Hypertension Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 17
- 主要终点
- Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
研究概览
简要总结
This prospective, non-interventional, multi-center study documents observational data on subjects under routine treatment of Pulmonary Arterial Hypertension, functional class III with inhaled Iloprost administered with I-Neb AAD (Adaptive Aerosol Delivery) device. The observation period for each subject covers a one year treatment period with inhaled Ventavis. For each subject, the investigator or a delegate collects data as defined in the case report form at an initial visit, routine follow-up visit at 6 months and final visit at 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female subjects aged ≥18 years
- •Newly Treated with Ventavis or treated with Ventavis for less than 6 months, with I Neb AAD device for the application, as described in the SmPC (Summary of Product Characteristics), complemented by the Insight
- •With Pulmonary Arterial Hypertension, Group I of the Dana point Pulmonary Hypertension Classification.
- •WHO (World Health Organization) /NYHA (New York Heart Association) Functional class III
- •Able and willing to give written informed consent for participation in the study
排除标准
- •Key contra indications:
- •Hypersensitivity to the active substance or to any of the excipients.
- •Conditions where the effects of Ventavis on platelets might increase the risk of haemorrhage (e.g. active peptic ulcers, trauma, intracranial haemorrhage).
- •Severe coronary heart disease or unstable angina;
- •Myocardial infarction within the last six months;
- •Decompensated cardiac failure if not under close medical supervision;
- •Severe arrhythmias;
- •Cerebrovascular events (e.g. transient ischaemic attack, stroke) within the last 3 months.
- •Pulmonary hypertension due to venous occlusive disease.
- •Congenital or acquired valvular defects with clinically relevant myocardial function disorders not related to pulmonary hypertension
研究组 & 干预措施
Group 1
干预措施: Ventavis (Iloprost, BAYQ6256) (Drug)
结局指标
主要结局
Compliance for each subject assessed by the mean daily number of inhalations of Ventavis.
时间窗: Up to 12 months
次要结局
- Investigator and patient satisfaction in the use of I-neb Insight tool assessed by a five level likert scale(Up to 12 months)
- Compliance for each subject assessed by the mean daily number of inhalations of Ventavis(Up to 6 months)
- Total distance (meters) walked within 6 minutes assessed by the 6 Minutes Walking Distance Test(6 and 12 months)
- Quality of Life (EQ5D and LPH [Living with Pulmonary Hypertension] questionnaires)(6 and 12 months)
- Population characteristics(At baseline)
- Dyspnea Borg Category Ration 10 Scale values(6 and 12 months)
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