Assessment of Arformoterol for Chronic Obstructive Pulmonary Disease (COPD) Using Hyperpolarized 3He MRI
Chronic Obstructive Pulmonary Disease
About this trial
This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, aformoterol, Helium, Hyperpolarized helium, Hyperpolarized Noble Gas, MRI
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- UMASS Medical School Advanced MRI Center
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Drug Subjects
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 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.
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.