Assessment of Arformoterol for Chronic Obstructive Pulmonary Disease (COPD) Using Hyperpolarized 3He MRI

Assessment of Arformoterol for COPD Using Hyperpolarized 3He MRI

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.

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.

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.