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

• Status: Completed
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Massachusetts, Worcester
• Treatments: Formoterol Fumarate

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.