Clinical trial NCT00846287: Assessment of Arformoterol for Chronic Obstructive Pulmonary Disease (COPD) Using Hyperpolarized 3He MRI
Official title: Assessment of Arformoterol for COPD Using Hyperpolarized 3He MRI
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD
aformoterol
Helium
Hyperpolarized helium
Hyperpolarized Noble Gas
MRI
Lead sponsor: University of Massachusetts, Worcester
Sponsor class: OTHER
First posted: 2009-02-18
Enrollment: 16
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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 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.

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.

Primary outcomes:
measure: Change in Total Ventilation Volume
timeFrame: 2 hours
Secondary outcomes:
measure: Change in FEV1
timeFrame: 2 hours
Other outcomes:
Locations:
city: Worcester
country: United States
facility: UMASS Medical School Advanced MRI Center
state: Massachusetts
Study officials:
affiliation: UMASS Medical School
name: Mitchell S Albert, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: