Prospective Multicentre Non-interventional Study on Compliance of Inhaled Treatment With Ventavis in Patient With Pulmonary Hypertension
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 89
- 主要终点
- Number of missed doses per day as recommended
研究概览
简要总结
Local, prospective, multicenter, non-comparative, non-interventional, observational study. It is planed to assess compliance of patients with PH (pulmonary hypertension) with the physician's recommendation in real practice.
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 and female patients ≥ 18 years old
- •Diagnosis of PH
- •Planned or current treatment with Ventavis (not more than 6 month)
排除标准
- •Contraindications for the use of Ventavis in accordance with the local product information
研究组 & 干预措施
Iloprost
The patients with pulmonary hypertension with inhaled treatment with Ventavis according to routine practice meeting the criteria of inclusion.
干预措施: Iloprost (Ventavis, BAYQ6256) (Drug)
结局指标
主要结局
Number of missed doses per day as recommended
时间窗: Up to 12 months
Number of days without any drug administration at all
时间窗: Up to 12 months
Number of fully inhaled doses in relation to the total number of inhalations per day
时间窗: Up to 12 months
Number of actually inhaled doses per day vs. the recommended number of inhalations - either as recommended by the treating physician or as recommended by the label
时间窗: Up to 12 months
次要结局
- Score on dyspnea Borg CR (category ratio) 10 scale(Up to 12 months)
- Patients' quality of life, assessed by validated questionnaire(Up to 12 months)
- Assessment of lung haemodynamics using the data of echocardiography(Up to 12 months)
- Severity of AEs(Up to 12 months)
- AE relation to treatment(Up to 12 months)
- Assessment of the structural changes in the lungs using X-ray examination of the lungs(Up to 12 months)
- Reason for omission of inhalation as assessed by the physician(Up to 12 months)
- 6 minute walking distance test (MWDT) value(Up to 12 months)
- Assessment of the structural changes in the lungs using spirography(Up to 12 months)
- Concomitant medication for other indications than pulmonary hypertension(Up to 12 months)
- Number of participants with adverse events (AEs)(Up to 12 months)
- AE treatment(Up to 12 months)
- Assessment of lung haemodynamics using the data of catheterization(Up to 12 months)
- AE outcomes(Up to 12 months)