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

Sponsored by:	University of Massachusetts
Information provided by:	University of Massachusetts
ClinicalTrials.gov Identifier:	NCT00846287

Purpose

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.

Condition	Intervention
Chronic Obstructive Pulmonary Disease	Drug: Helium-3, Arformoterol

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Gas

Drug Information available for: Formoterol fumarate Arformoterol Formoterol Arformoterol Tartrate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Assessment of Arformoterol for COPD Using Hyperpolarized 3He MRI

Further study details as provided by University of Massachusetts:

Primary Outcome Measures:

Hyperpolarized Helium-3 sensitivity both pre and post treatment [ Time Frame: 2 hours ] [ Designated as safety issue: No ]

Estimated Enrollment:	24
Study Start Date:	November 2008
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Placebo Comparator Ten subjects will receive a placebo instead of the drug.	Drug: Helium-3, Arformoterol 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. Then three additional bags will be administered, again with five to ten minutes between each bag.
2: Experimental Ten subjects will receive the drug arformoterol	Drug: Helium-3, Arformoterol 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. Then three additional bags will be administered, again with five to ten minutes between each bag.

Arms

Assigned Interventions

1: Placebo Comparator

Ten subjects will receive a placebo instead of the drug.

Drug: Helium-3, Arformoterol

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. Then three additional bags will be administered, again with five to ten minutes between each bag.

2: Experimental

Ten subjects will receive the drug arformoterol

Drug: Helium-3, Arformoterol

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. Then three additional bags will be administered, again with five to ten minutes between each bag.

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

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846287

Contacts

Contact: Austin LR Reno, BA	508-856-5154	austin.reno@umassmed.edu
Contact: Mitchell S Albert, Ph.D.	508-856-1096	mitchell.albert@umassmed.edu

Locations

United States, Massachusetts
UMASS Medical School Advanced MRI Center	Recruiting
Worcester, Massachusetts, United States, 01655
Contact: Austin LR Reno, BA 508-856-5154 austin.reno@umassmed.edu
Contact: Mitchell S Albert, Ph.D. 508-856-1096 Mitchell.Albert@umassmed.edu
Sub-Investigator: Yanping Sun, Ph.D.
Sub-Investigator: John M Madison, MD
Sub-Investigator: Stephen Krinzman, MD

Sponsors and Collaborators

University of Massachusetts

Investigators

Principal Investigator:

Mitchell S Albert, Ph.D.

UMASS Medical School

More Information

No publications provided

Responsible Party:	UMASS Medical School ( Mitchell S. Albert, Ph.D. / Director of Advanced MRI Center )
Study ID Numbers:	Docket # 12830
Study First Received:	February 16, 2009
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00846287 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by University of Massachusetts:

COPD
aformoterol
Helium

Hyperpolarized helium
Hyperpolarized Noble Gas
MRI

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Adrenergic beta-Agonists
Respiration Disorders
Anti-Asthmatic Agents
Adrenergic Agonists
Lung Diseases, Obstructive

Respiratory Tract Diseases
Lung Diseases
Formoterol
Flatulence
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

Additional relevant MeSH terms:

Respiratory System Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
Respiration Disorders
Physiological Effects of Drugs
Anti-Asthmatic Agents
Adrenergic Agonists
Pharmacologic Actions

Lung Diseases, Obstructive
Respiratory Tract Diseases
Autonomic Agents
Therapeutic Uses
Lung Diseases
Formoterol
Peripheral Nervous System Agents
Bronchodilator Agents
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on May 07, 2009