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

NCT00846287 | Completed Results

• 1 other identifier: Docket # 12830
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  2 hours

Secondary Outcomes (1)

• Change in FEV1

  2 hours

Study Arms (2)

Drug Subjects

ACTIVE COMPARATOR

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.

Drug: Hyperpolarized Helium-3; Drug: Aformoterol

Saline

PLACEBO COMPARATOR

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.

Drug: Hyperpolarized Helium-3; Drug: Placebo

Interventions

Hyperpolarized Helium-3 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.

Also known as: HP 3He

Drug Subjects; Saline

Placebo DRUG

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

Also known as: Saline

Saline

Aformoterol DRUG

Subjects will receive the drug arformoterol prior to scanning

Also known as: Brovana

Drug Subjects

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead

Study Sites (1)

UMASS Medical School Advanced MRI Center

Worcester, Massachusetts, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Sodium Chloride; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Results Point of Contact

• Title: Dr. Mitchell Albert
• Organization: UMass Medical School

albertmi@tbh.net

(807) 684-7270

Study Officials

• Mitchell S Albert, Ph.D.

  UMASS Medical School

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Advanced MRI Center, UMASS Medical Sch

Study Record Dates

• First Submitted: February 16, 2009
• First Posted: February 18, 2009
• Study Start: November 1, 2008
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: November 1, 2012
• Results First Posted: November 1, 2012

Record last verified: 2012-10

Locations

US (1)