Effects of Glycopyrrolate/Formoterol (Bevespi) on Ventilation and Gas Exchange Abnormalities in COPD Assessed by 129Xe MRI
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Barrier Uptake.
研究概览
简要总结
The purpose of this study is to determine whether the new inhaler, Bevespi improves lung function. Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas, that can provide useful images of the functioning of the lung will be used as a new measure to determine change in function. The investigator anticipate these images will provide more specific information about lung disease than standard lung function tests in response to treatment.
详细描述
The study will characterize ventilation and gas transfer distributions in GOLD II and III COPD patients and assess the potential for these physiological parameters as a novel phenotyping method using Magnetic resonance imaging (MRI) using inhaled hyperpolarized 129Xe gas.
The study will additionally quantify regional ventilation and gas transfer response to glycopyrrolate/formoterol in GOLD II and III COPD patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of COPD confirmed by post-bronchodilator spirometry demonstrating (forced expiratory volume at 1 second(FEV1)/forced vital capacity (FVC) < 0.70 and forced expiratory volume at 1 second (FEV1) in GOLD 2 or 3 stage (30%≤ (forced expiratory volume at 1 second [FEV1] < 80%)
- •Willing and able to give informed consent and adhere to visit/protocol schedules
- •Women of childbearing potential must have a negative urine pregnancy test
排除标准
- •Upper respiratory tract infection within 6 weeks
- •Chronic systemic corticosteroid use > 10 mg/day of prednisone
- •Chronic oxygen use (intermittent or continuous)
- •Previous lung resection surgery or decortication
- •Previous history of pneumothorax
- •Evidence of interstitial, occupational or chronic infectious lung disease by imaging studies
- •History of exposure to occupational or environmental hazards that are known to cause lung diseases
- •For women of child bearing potential, positive pregnancy test
- •Major chronic illnesses which in the judgement of the study physician would interfere with participation in the study
- •Patients who are not willing to withhold COPD inhalers for the run-in period.
- •MRI is contraindicated based on responses to MRI screening questionnaire
- •Subject is pregnant or lactating
- •Respiratory illness of a bacterial or viral etiology within 30 days of MRI
- •Subject has any form of known cardiac arrhythmia
- •Subject does not fit into 129Xe vest coil used for MRI
- •Subject cannot hold his/her breath for 15 seconds
- •Subject deemed unlikely to be able to comply with instructions during imaging
研究组 & 干预措施
single arm
glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study XeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.
干预措施: hyperpolarized 129Xe gas MRI (Drug)
single arm
glycopyrrolate/formoterol (Bevespi) 2 puffs twice a day taken for two weeks, started after completion of the study XeMRI. A follow up xeMRI occurs at the end of the two weeks of taking the Bevespi in a Pre-post study design.
干预措施: Bevespi Aerosphere (Drug)
结局指标
主要结局
Barrier Uptake.
时间窗: 2 weeks
Diffusion of Xe gas across the lung membrane into the blood. This measures how well oxygen goes through the lung into the blood.
Red Blood Cell (RBC) Uptake
时间窗: 2 weeks
Amount of Xe gas that enters the blood stream after it diffuses across the lung membrane
Ventilation Distribution as Measured by Ventilation Defect+Low Percent
时间窗: Week 2
The ventilation distribution as measured by ventilation defect+low percent is to measure the area of the lung that has no air.
次要结局
- Rating of Perceived Dyspnea (RPD) Scale(2 weeks)
- Pulmonary Function Test - Forced Expiratory Volume-one Second (FEV1)(2 weeks)
- St. George's Respiratory Questionnaire (SGRQ) Score(2 weeks)
- Pulmonary Function Test - Total Lung Capacity (TLC)(2 weeks)
- Pulmonary Function Test - Diffusing Capacity of the Lung for Carbon Monoxide (DLCO)(2 weeks)
- 6-minute Walk Test (6MWT)(2 weeks)
- Pulmonary Function Test - Forced Vital Capacity (FVC)(2 weeks)
- Pulmonary Function Test - Residual Volume (RV)(2 weeks)
- COPD Assessment Test (CAT) Score(2 weeks)
研究者
Bastiaan Driehuys
Professor of Radiology
Duke University