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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hyperpolarized Helium-3
Placebo
Aformoterol
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, aformoterol, Helium, Hyperpolarized helium, Hyperpolarized Noble Gas, MRI

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • UMASS Medical School Advanced MRI Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Drug Subjects

Saline

Arm 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.

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.

Outcomes

Primary Outcome Measures

Change in Total Ventilation Volume
Subjects had hyperpolarized helium-3 MR scans completed before administration of an intervention and 2 hours after administration. These images were compared as described: The change in the total ventilation volume (Litres) measured in the hyperpolarized helium-3 MR image from pre-nebulizer inhalation to post-nebulizer inhalation.

Secondary Outcome Measures

Change in FEV1
Spirometry was taken which measures FEV1 (in Litres), before administration of an intervention and again 2 hours after administration of an intervention. The change in FEV1 (Litres) from pre-nebulizer inhalation to post-nebulizer inhalation was compared.

Full Information

First Posted
February 16, 2009
Last Updated
October 3, 2012
Sponsor
University of Massachusetts, Worcester
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1. Study Identification

Unique Protocol Identification Number
NCT00846287
Brief Title
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

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, aformoterol, Helium, Hyperpolarized helium, Hyperpolarized Noble Gas, MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drug Subjects
Arm Type
Active Comparator
Arm 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.
Arm Title
Saline
Arm Type
Placebo Comparator
Arm 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 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.
Intervention Type
Drug
Intervention Name(s)
Hyperpolarized Helium-3
Other Intervention Name(s)
HP 3He
Intervention 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 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
Intervention Name(s)
Placebo
Other Intervention Name(s)
Saline
Intervention Description
Subject will inhale a placebo (nebulized saline) with no drug.
Intervention Type
Drug
Intervention Name(s)
Aformoterol
Other Intervention Name(s)
Brovana
Intervention Description
Subjects will receive the drug arformoterol prior to scanning
Primary Outcome Measure Information:
Title
Change in Total Ventilation Volume
Description
Subjects had hyperpolarized helium-3 MR scans completed before administration of an intervention and 2 hours after administration. These images were compared as described: The change in the total ventilation volume (Litres) measured in the hyperpolarized helium-3 MR image from pre-nebulizer inhalation to post-nebulizer inhalation.
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Change in FEV1
Description
Spirometry was taken which measures FEV1 (in Litres), before administration of an intervention and again 2 hours after administration of an intervention. The change in FEV1 (Litres) from pre-nebulizer inhalation to post-nebulizer inhalation was compared.
Time Frame
2 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mitchell S Albert, Ph.D.
Organizational Affiliation
UMASS Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMASS Medical School Advanced MRI Center
City
Worcester
State/Province
Massachusetts
Country
United States

12. IPD Sharing Statement

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

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