Study to Assess the Compliance of Patients With Pulmonary Arterial Hypertension Treated With Inhaled Iloprost.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 13
- 主要终点
- Percentage of compliant patients
研究概览
简要总结
This pilot, non-interventional, company-sponsored, multi-center study documents observational data on patients under routine treatment of Pulmonary Arterial Hypertension (PAH) with inhaled iloprost (using I-Neb device for the inhalation).
The planned study recruitment time is 18 months. The maximum follow up period in this study will be 12 months.
The data will be collected from patients who have initiated the treatment mentioned above (inhaled iloprost using I-Neb device) since February 1st, 2013.
Frequency of visits and procedures will be performed under routine conditions. The primary objective of this study is to assess the compliance of patients with WHO/NYHA (World Health Organization/New York Heart Association) functional Class III Pulmonary Arterial Hypertension treated with Inhaled Iloprost in clinical practice, using the I-neb Insight tool.
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
- •Adult patients (age ≥ 18years old), male or female
- •Diagnosis of Pulmonary Arterial Hypertension, Group I of the Dana Point Pulmonary Hypertension classification (Diagnosis made at the discretion of the attending investigator, including mPAP ≥ 25 mmHg at rest, as measured by right heart catheterization.)
- •The treating physician has chosen to initiate the treatment with inhaled iloprost with I-Neb device for the application, as described in the Summary of Product characteristics (SmPC).
- •WHO/NYHA functional class III
- •Willing to participate in the study (Informed Consent Sign)
- •Patients who received the first inhaled iloprost treatment with I-Neb from February 1st, 2013.
排除标准
- •Any contraindication for the treatment with Ventavis as described in the Summary of Product characteristics (SmPC)
- •Patients are not to be enrolled if they were treated with inhaled iloprost with I-Neb or any other device for the application in the past, before the start of the observation period (February 1st, 2013)
研究组 & 干预措施
Group 1
干预措施: Iloprost (Ventavis, BAYQ 6256) (Drug)
结局指标
主要结局
Percentage of compliant patients
时间窗: Up to 12 months
The compliance will be assessed by the mean daily number of Inhalations and mean daily dose of Ventavis at around months 6 and 12 for each patient (Data will be collected via the I-neb Insight). For this observational study, a patient is considered compliant if the mean daily number of inhalations and mean daily dose are within 80 to 120% of prescribed. Otherwise, the patient will be considered as non-compliant.
次要结局
- Changes in WHO/ NYHA Functional Class(Up to 12 months)
- Adjusted percentage treatment duration(Up to 12 months)
- Observed treatment duration days(Up to 12 months)
- Expected treatment duration days(Up to 12 months)
- Change in 6 MWDT (6 minute walking distance test) scale value(Up to 12 months)
- Change in Dyspnea Borg CR (category ratio) 10 scale value(Up to 12 months)
- Quality of life using validated scales (EuroQol questionnaire [EQ-5D], Living with Pulmonary Hypertension questionnaire [LPH])(Up to 12 months)