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

NCT ID: NCT00846287

Last Updated: 2012-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-11-30
• Study Completion Date: 2011-04-30

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; aformoterol; Helium; Hyperpolarized helium; Hyperpolarized Noble Gas; MRI

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: QUADRUPLE

Study Groups

Drug Subjects

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.

Group Type: ACTIVE_COMPARATOR

Hyperpolarized Helium-3

Intervention Type: DRUG

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 intervention (drug or placebo) will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag.

Aformoterol

Intervention Type: DRUG

Subjects will receive the drug arformoterol prior to scanning

Saline

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 placebo (nebulized saline solution) will be administered (2.1 mL). After administration of the placebo, three additional bags of hyperpolarized helium-3 will be administered, again with five to ten minutes between each bag.

Group Type: PLACEBO_COMPARATOR

Hyperpolarized Helium-3

Intervention Type: DRUG

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 intervention (drug or placebo) will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag.

Placebo

Intervention Type: DRUG

Subject will inhale a placebo (nebulized saline) with no drug.

Interventions

Hyperpolarized Helium-3

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 intervention (drug or placebo) will be administered and an hour will pass. Then three additional bags will be administered, again with five to ten minutes between each bag.

Intervention Type: DRUG

Placebo

Subject will inhale a placebo (nebulized saline) with no drug.

Intervention Type: DRUG

Aformoterol

Subjects will receive the drug arformoterol prior to scanning

Intervention Type: DRUG

Other Intervention Names

HP 3He; Saline; Brovana

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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Massachusetts, Worcester

OTHER

Sponsor Role: lead

Responsible Party

Mitchell Albert

Director of Advanced MRI Center, UMASS Medical Sch

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mitchell S Albert, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

UMASS Medical School

Locations

UMASS Medical School Advanced MRI Center

Worcester, Massachusetts, United States

Countries

United States

Other Identifiers

Docket # 12830

Identifier Type: -

Identifier Source: org_study_id