Assessment of Arformoterol for COPD Using Hyperpolarized 3He MRI
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Total Ventilation Volume
研究概览
简要总结
The purpose of this study is to determine efficacy of MR imaging with hyperpolarized helium-3 gas in COPD patients both before and after treatment.
详细描述
Hyperpolarized Helium Lung imaging has already been tested and proven to be scientifically possible in patients with a number of pulmonary disorders. However there is limited data on the sensitivity of this imaging technique, which would be essential for clinical use. This study is a double blinded study with two cohorts, each cohort being made up of patients with confirmed diagnosis of COPD. One group will receive a placebo while the other will receive treatment. A comparison of the data will resume once twenty patients have been consented and completed the study procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are male or female and are 50 years or older
- •Consent from the patient
- •Have been diagnosed with COPD
- •Must be able to hold their breath for up to 12 seconds
- •Must have a baseline FEV1 ≤ 80% of predicted but FEV1 > 0.70 L
- •Must have a smoking history of 15 or more packs per year
- •Must have a breathlessness severity of ≥ 2 on the Medical Research Council dyspnea scale
- •Must be able to safely discontinue their respiratory medications for at least 12 hours.
排除标准
- •Have any contraindications to an MR exam such as a pace-maker, metallic cardiac valves, magnetic material (i.e., surgical clips) implanted electronic infusion pumps or any other conditions that would preclude proximity to a strong magnetic field
- •Are undergoing the MR exam in an emergency situation
- •Are pregnant or become pregnant at any point within the study time.
- •People with psychiatric disorders will be excluded from the study.
- •Are claustrophobic and can not tolerate the imaging.
- •Uses supplemental oxygen
- •Have life-threatening or unstable respiratory status within 30 days before screening
- •Have a diagnosis of asthma and/or any chronic respiratory disease other than COPD
- •Have a lung resection greater than 1 full lobe
- •Have coronary artery disease or congestive heart failure
- •Are allergic to Arformoterol or similarly related drugs.
- •Are taking any of the drugs listed in the risks section and are unable to stop taking them.
研究组 & 干预措施
Drug Subjects
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
干预措施: Hyperpolarized Helium-3 (Drug)
Drug Subjects
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
干预措施: Aformoterol (Drug)
Saline
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo (nebulized saline solution) will be administered (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
干预措施: Hyperpolarized Helium-3 (Drug)
Saline
Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the placebo (nebulized saline solution) will be administered (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Total Ventilation Volume
时间窗: 2 hours
Subjects had hyperpolarized helium-3 MR scans completed before administration of an intervention and 2 hours after administration. These images were compared as described: The change in the total ventilation volume (Litres) measured in the hyperpolarized helium-3 MR image from pre-nebulizer inhalation to post-nebulizer inhalation.
次要结局
- Change in FEV1(2 hours)
研究者
Mitchell Albert
Director of Advanced MRI Center, UMASS Medical Sch
University of Massachusetts, Worcester