A Comparison of Safety and Inhalation Times of Ventavis (Iloprost) Inhalation Solution Delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 62
- 试验地点
- 12
- 主要终点
- Inhalation-times Rate - Iloprost PD-6 (Period I)
研究概览
简要总结
A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, aged 18-85 years
- •Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: a) idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with human immunodeficiency virus (HIV), or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine)
- •On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power Disc-6
排除标准
- •Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12 weeks preceding the Screening visit
- •Receipt of atrial septostomy within the 6 months preceding Screening
- •History of left-sided heart disease
- •Clinically relevant obstructive lung disease
- •Chronic renal or liver disease
- •Uncontrolled systemic hypertension or hypotension
- •Cerebrovascular event within the 6 months preceding Screening
研究组 & 干预措施
Iloprost
The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control.
干预措施: Iloprost PD-6 (Drug)
Iloprost
The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control.
干预措施: Iloprost PD-15 (Drug)
结局指标
主要结局
Inhalation-times Rate - Iloprost PD-6 (Period I)
时间窗: 37 days prior to first dose of iloprost PD-15
Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)
Inhalation-times Rate - Iloprost PD-15 (Period II)
时间窗: 37 days following first dose of iloprost PD-15
Defined as the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)
Change in Inhalation-times Rate From Period I (Iloprost PD-6) to Period II (Iloprost PD-15)
时间窗: 37 days prior to first dose of iloprost PD-15/37 days following first dose of iloprost PD-15
Change in the percentage of full doses (5 µg) of iloprost delivered within the recommended time frame for receiving a full dose of iloprost (4-10 minutes). Iloprost dosing information was available from the I-neb® device, which recorded the date and time of each inhalation, the duration of each inhalation, as well as the inhalation completion status (\< 12.5%, ≥ 12.5% to \< 100%, and Full)
次要结局
- Number of Daily Inhalations - Iloprost PD-6 (Period I)(37 days prior to first dose of iloprost PD-15)
- Number of Daily Inhalations - Iloprost PD-15 (Period II)(37 days following first dose of iloprost PD-15)
- Daily Inhalation Duration - Iloprost PD-6 (Period I)(37 days prior to first dose of iloprost PD-15)
- Daily Inhalation Duration - Iloprost PD-15 (Period II)(37 days following first dose of iloprost PD-15)
- Percentage of Complete Doses Administered - Iloprost PD-6 (Period I)(37 days prior to first dose of iloprost PD-15)
- Percentage of Complete Doses Administered - Iloprost PD-15 (Period II)(37 days following first dose of iloprost PD-15)
- Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-6 (Period I)(37 days prior to first dose of iloprost PD-15)
- Percentage of Daily Doses Within the 6-9 Times/Day Treatment Regimen - Iloprost PD-15 (Period II)(37 days following first dose of iloprost PD-15)
- Systolic Blood Pressure - Iloprost PD-6 (Period I)(Day 1, prior to first dose of iloprost PD-15)
- Systolic Blood Pressure (SBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)(Day 1 and Day 7, following the first dose of iloprost PD-15)
- Diastolic Blood Pressure (DBP) - Iloprost PD-6 (Period I)(Day 1, prior to first dose of iloprost PD-15)
- Diastolic Blood Pressure (DBP) - Iloprost PD-15 (Day 1 and Day 7, Period II)(Day 1 and Day 7, following the first dose of iloprost PD-15)
- Heart Rate (HR) - Iloprost PD-6 (Period I)(Day 1, prior to first dose of iloprost PD-15)
- Heart Rate (HR) - Iloprost PD-15 (Day 1 and Day 7, Period II)(Day 1 and Day 7, following the first dose of iloprost PD-15)