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

Completed · Not applicable · Has a placebo group

Conditions studied: Chronic Obstructive Pulmonary Disease

In brief

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.

Key facts

Study ID

NCT00846287

Run by

University of Massachusetts, Worcester

People needed

16

Starts

2008-11-01

Expected to finish

2011-04-01

Last updated by the study team

2012-11-01

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UMASS Medical School Advanced MRI Center — Worcester, Massachusetts, United States

Full record on ClinicalTrials.gov

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