A Postmarketing Observational Study to Assess Respiratory Tract Adverse Events in Pulmonary Arterial Hypertension Patients Treated With Tyvaso® (Treprostinil) Inhalation Solution
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,333
- 试验地点
- 88
- 主要终点
- Prevalence of Respiratory Tract-Related Adverse Events of Interest
研究概览
简要总结
A surveillance of respiratory tract related adverse events in patients treated with Tyvaso®(treprostinil) Inhalation Solution versus other FDA approved therapies
详细描述
A post marketing surveillance to determine the type and incidence of oro/nasopharyngeal or pulmonary adverse events that may occur in patients treated with commercially available Tyvaso®(treprostinil) Inhalation Solution. A comparison will be made to the type and incidence of events in patients receiving other FDA approved therapies for pulmonary arterial hypertension, as a control measure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of PAH, WHO GROUP I
- •Prescribed and is currently receiving Tyvaso and/or other FDA-approved therapy for the treatment of PAH
- •Willing and able to provide written informed consent
排除标准
- •Previous initiation and permanent discontinuation of Tyvaso
- •Participation in an investigational clinical drug or device trial within 30 days of enrollment
- •Current or past diagnosis of lung neoplasm
- •Active gastrointestinal or pulmonary bleed at enrollment
- •Planned surgical intervention for treatment of PAH e.g., atrial septostomy or transplant
研究组 & 干预措施
Tyvaso
The Tyvaso group will consist of patients receiving Tyvaso and may be receiving another FDA approved PAH therapy as part of routine care.
干预措施: inhaled prostacyclin (Drug)
Control
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
干预措施: inhaled prostacyclin (Drug)
Control
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
干预措施: prostacyclin (Drug)
Control
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
干预措施: subcutaneous and intravenous prostacyclin (Drug)
Control
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
干预措施: oral ERA (Drug)
Control
The control group will consist of patients with no previous Tyvaso exposure and not taking Tyvaso at the time of the Baseline visit, but receiving any other FDA approved PAH therapy as part of routine care.
干预措施: oral PDE5 inhibitors (Drug)
结局指标
主要结局
Prevalence of Respiratory Tract-Related Adverse Events of Interest
时间窗: Follow-up every 3 months
Percentage of patients who experienced a respiratory tract-related adverse event (grouped by category of interest) during the study.
次要结局
未报告次要终点