Xenon Xe 129 Hyperpolarized MRI Ventilation Imaging for the Evaluation of Treatment Response Comparing Three Different Bronchodilator Aerosol Delivery Methods in Patients With COPD: A Pilot Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Ventilation Defect Percent
研究概览
简要总结
The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is whether there are differences in lung ventilation following treatment with each of the three methods as measured using hyperpolarized Xe 129 with MRI.
Participants will:
Receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices. In total, participants will receive three treatments separated by at least 1 week each.
Following each treatment, participants will have inhale an MRI contrast agent called hyperpolarized Xe 129 and will have images of their lungs taken with an MRI.
Researchers will compare the different lung images taken after each treatment to see if there are differences in the distribution of air in the lungs (known as ventilation).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •Age ≥18 years at enrollment.
- •Participant (or legally acceptable representative) willing and able to provide written informed consent.
- •Able (in the Investigator's opinion) and willing to comply with all study requirements.
- •Documented diagnosis of COPD limited to:
- •a. Pulmonary function tests (PFT) value of forced expiratory volume at 1 second/forced vital capacity (FEV₁ / FVC) <70%
- •Receiving standard of care (SOC) background drug therapy as per current guidance for COPD for at least 6 months to screening Visit
- •Participants enrolled as bronchodilator responder:
- •a. Increase of ≥12% and ≥200 mL as an absolute value compared with a baseline measure in either forced expiratory volume at 1 second or FVC at screening.
- •Participants enrolled as non-bronchodilator responder:
- •a. Increase of ≤12% and ≤200 mL as an absolute value compared with a baseline in either FEV1 or FVC at screening.
- •Stable baseline conditions and no medication changes within 6 weeks of planned imaging visit.
- •Female participants of childbearing potential must be confirmed non-pregnant via serum or dip-stick urine test at baseline (Screening) and prior to each Xe MRI.
排除标准
- •Participant with life expectancy <1-2 years or significant diseases other than COPD.
- •A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study.
- •Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the patients to undergo MRI (for example: presence of an implanted or external MRI unsafe device that cannot be removed, body weight exceeding table limitations, inability to lie flat, or severe claustrophobia).
- •Inability to hold breath 10-15 seconds for required imaging or for completion of diffusing capacity of lung for carbon monoxide (DLCO) measurements.
- •Respiratory infection of exacerbation of COPD within the 6 weeks prior to screening.
- •Malignancy for which the patient has undergone resection, radiation, or chemotherapy within the last 5 years. Patients with treated basal cell carcinoma are allowed.
- •Known hypersensitivity to any of the study products.
- •Known or planned pregnancy.
- •Participation in another study which, in the opinion of the Investigator, would interfere with the study compliance, or outcome assessments or would prohibit the collection of the required data points.
研究组 & 干预措施
Vibrating Mesh Nebulizer First
Participants will receive albuterol delivered via vibrating mesh nebulizer as their first treatment, followed by albuterol delivered via metered dose inhaler and then albuterol delivered via jet nebulizer.
干预措施: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution (Drug)
Vibrating Mesh Nebulizer First
Participants will receive albuterol delivered via vibrating mesh nebulizer as their first treatment, followed by albuterol delivered via metered dose inhaler and then albuterol delivered via jet nebulizer.
干预措施: Vibrating Mesh Nebulizer (Device)
Vibrating Mesh Nebulizer First
Participants will receive albuterol delivered via vibrating mesh nebulizer as their first treatment, followed by albuterol delivered via metered dose inhaler and then albuterol delivered via jet nebulizer.
干预措施: Metered Dose Inhaler (Device)
Vibrating Mesh Nebulizer First
Participants will receive albuterol delivered via vibrating mesh nebulizer as their first treatment, followed by albuterol delivered via metered dose inhaler and then albuterol delivered via jet nebulizer.
干预措施: Jet Nebulizer (Device)
Jet Nebulizer First
Participants will receive albuterol delivered via jet nebulizer as their first treatment, followed by albuterol delivered via vibrating mesh nebulizer and then albuterol delivered via metered dose inhaler.
干预措施: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution (Drug)
Jet Nebulizer First
Participants will receive albuterol delivered via jet nebulizer as their first treatment, followed by albuterol delivered via vibrating mesh nebulizer and then albuterol delivered via metered dose inhaler.
干预措施: Vibrating Mesh Nebulizer (Device)
Jet Nebulizer First
Participants will receive albuterol delivered via jet nebulizer as their first treatment, followed by albuterol delivered via vibrating mesh nebulizer and then albuterol delivered via metered dose inhaler.
干预措施: Metered Dose Inhaler (Device)
Jet Nebulizer First
Participants will receive albuterol delivered via jet nebulizer as their first treatment, followed by albuterol delivered via vibrating mesh nebulizer and then albuterol delivered via metered dose inhaler.
干预措施: Jet Nebulizer (Device)
Metered Dose Inhaler First
Participants will receive albuterol delivered via metered dose inhaler as their first treatment, followed by albuterol delivered via jet nebulizer and then albuterol delivered via vibrating mesh nebulizer.
干预措施: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution (Drug)
Metered Dose Inhaler First
Participants will receive albuterol delivered via metered dose inhaler as their first treatment, followed by albuterol delivered via jet nebulizer and then albuterol delivered via vibrating mesh nebulizer.
干预措施: Vibrating Mesh Nebulizer (Device)
Metered Dose Inhaler First
Participants will receive albuterol delivered via metered dose inhaler as their first treatment, followed by albuterol delivered via jet nebulizer and then albuterol delivered via vibrating mesh nebulizer.
干预措施: Metered Dose Inhaler (Device)
Metered Dose Inhaler First
Participants will receive albuterol delivered via metered dose inhaler as their first treatment, followed by albuterol delivered via jet nebulizer and then albuterol delivered via vibrating mesh nebulizer.
干预措施: Jet Nebulizer (Device)
结局指标
主要结局
Ventilation Defect Percent
时间窗: measured immediately postdose
A measure of the percentage of lung area with low ventilation measured using hyperpolarized Xe 129 MRI
次要结局
- Distribution of ventilated space(measured at baseline and immediately postdose)
- Red blood cell Xe 129 transfer(measured at baseline and immediately postdose)
- Membrane uptake of Xe 129(measured at baseline and immediately postdose)