Use of ARINA-1 in an Intermediate Size Patient Population of Bilateral Lung Transplant Patients With CLAD Grade 0 at Duke University to Improve FEV1
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Changes in FEV1
研究概览
简要总结
To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0.
详细描述
To treat an intermediate size patient population of bilateral lung transplant patients with CLAD-0. Treating physicians will follow standard of care for patients and monitor pulmonary function, fractional exhaled nitric oxide and quality of life of the patients.
Patient safety will be monitored by assessing changes in these parameters, as well as changes in standard of care measurements (e.g., laboratory values and x-ray images).
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>6 months post-bilateral lung transplant
- •Any patient with a stable FEV1 or a decline that is < 20% from baseline.
- •No current signs of infection
- •No current signs of rejection
- •>21 years old
- •Routinely followed at the enrolling site
- •Capable of giving informed consent
排除标准
- •Interstitial or peribronchial/peribronchiolar fibrosis on transbronchial biopsy
- •Evidence of active congestive heart failure or symptomatic coronary artery disease, in the opinion of the site investigator
- •CLAD grade 1 or higher
- •Currently on any ICS therapy
- •Initiation of chronic azithromycin within 1 month of study enrollment (chronic azithromycin use defined as azithromycin 250mg or 500mg daily or every Monday, Wednesday, Friday)
- •Positive pregnancy test at screening, if female and of child bearing potential
研究组 & 干预措施
ARINA-1
Ascorbic acid (ARINA-1) (inhaled ascorbic acid 88 mg/ml) will be nebulized twice daily for 3 months using a PARI eFlow nebulizer
干预措施: Ascorbic Acid (Drug)
结局指标
主要结局
Changes in FEV1
时间窗: Baseline, 1 month, 3 months, 6 months, 12 months
Each individual's changes in pulmonary function will be assessed using the linear slope of FEV1 change from enrollment to the end of the treatment period.
Changes in FENO
时间窗: Baseline
Each individual's changes in FENO will be assessed using the change in mean baseline FENO measurements to the mean measurements post-ARINA-1 use.
Changes in Quality of Life
时间窗: Baseline, 12 months
Patient-reported quality of life measures assessed pre- and post-ARINA-1 will be compared for each participant.
次要结局
未报告次要终点