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

University of Massachusetts, Worcester

Status

Completed

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Placebo

Drug: Aformoterol

Drug: Hyperpolarized Helium-3

Study type

Interventional

Funder types

Other

Identifiers

NCT00846287

Docket # 12830

Details and patient eligibility

About

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.

Full 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.

Enrollment

16 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

16 participants in 2 patient groups, including a placebo group

Drug Subjects

Active Comparator group

Description:

Patients will be required to breath in individual 1 liter bags of gas while in an MRI to produce lung images. These bags of gas are each made up of 333mL of Helium-3 gas and 667mL of Nitrogen. The first three bags will be administered with a break between each of five to ten minutes. Then the drug aformoterol will be administered and an hour will pass. BROVANA (arformoterol tartrate) Inhalation Solution is supplied as 2 mL of arformoterol tartrate solution packaged in 2.1 mL unit-dose, low-density polyethylene (LDPE) unit-dose vials. Each unit-dose vial contains 15 mcg of arformoterol (equivalent to 22 mcg of arformoterol tartrate) in a sterile, isotonic saline solution, pH-adjusted to 5.0 with citric acid and sodium citrate. After administration of the drug, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.

Treatment:

Drug: Hyperpolarized Helium-3

Drug: Aformoterol

Saline

Placebo Comparator group

Description:

Treatment:

Drug: Hyperpolarized Helium-3

Drug: Placebo