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Completed

NCT Number: NCT00846287

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

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.

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Key information

Conditions

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

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMASS Medical School Advanced MRI Center

Worcester, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: HP 3He

Placebo

Drug

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

Other names: Saline

Aformoterol

Drug

Subjects will receive the drug arformoterol prior to scanning

Other names: Brovana

Primary outcomes

  1. Change in Total Ventilation Volume

    Time frame: 2 hours

    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 outcomes

  1. Change in FEV1

    Time frame: 2 hours

    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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Registry information

Official study title

Assessment of Arformoterol for COPD Using Hyperpolarized 3He MRI

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Feb 18, 2009
Registry last updated
Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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