Status:
COMPLETED
Assessment of Arformoterol for Chronic Obstructive Pulmonary Disease (COPD) Using Hyperpolarized 3He MRI
Lead Sponsor:
University of Massachusetts, Worcester
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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.
Detailed Description
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 o...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT00846287
Start Date
November 1 2008
End Date
April 1 2011
Last Update
November 1 2012
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
UMASS Medical School Advanced MRI Center
Worcester, Massachusetts, United States