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New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)

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ClinicalTrials.gov Identifier: NCT02826343
Recruitment Status : Recruiting
First Posted : July 11, 2016
Last Update Posted : October 19, 2017
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Y. Michael Shim, MD, University of Virginia

Brief Summary:

First, the investigators will image patients with hyperpolarized xenon (Xe) magnetic resonance imaging (MRI) to develop the technique of hyperpolarized xenon MRI at the University of Virginia (UVA). Magnetic Resonance (MR) sequences will need to be developed and optimized for the equipment at UVA. These sequences will need to be evaluated in healthy adults for comparison with results obtained and in adults with lung diseases to optimize the sequences for the detection and evaluation of lung diseases. The MR pulse sequences need to be optimized for the parameters of a human MR coil and the gas exchange characteristics in healthy and diseased lungs.

Second, the investigators propose to exploit the power of Xe129 MRI as a diagnostic tool to monitor therapeutic responses of a combination inhaler, Advair, which contains a long-acting beta-adrenoceptor agonist (LABA) and an inhaled corticosteroid (ICS) - two major classes of the current COPD therapeutics. The investigators will characterize the functional changes of the lungs with COPD at baseline, and investigate the responses of the lungs to the treatment after a three-month trial. Also the investigators will compare corresponding results obtained by Xe129 dissolved phase (DP) MRI to the results obtained by gadolinium-based dynamic contrast-enhanced perfusion MRI (perfusion MRI) and high resolution computed tomography (HRCT) of the lung to indirectly validate the Xe129 DP MRI technique. The investigators anticipate that the results from this project will greatly improve the investigators understanding of the lung functional responses of COPD subjects to current therapeutics. Also, the investigators expect that this project will provide evidence to consider Xe129 MRI as a diagnostic strategy to assess and monitor therapeutic responses of existing and new pharmaceuticals, and thus Xe129 MRI will stimulate development of novel therapies for COPD in the future


Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: Xenon129 MRI imaging Drug: Gadolinium MRI Drug: Advair (250mcg/50mcg) one puff twice a day Early Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Xe129 Magnetic Resonance Imaging of the Lung: A New Technology to Assess Treatment for COPD
Study Start Date : May 2016
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Xenon

Arm Intervention/treatment
COPD Advair

Subjects will undergo hyperpolarized xenon MRI with perfusion imaging, before and after a 90 day course of Adair.

All subjects belong to one arm and will receive same treatment. Then they are compared at baseline and 3 month post intervention (described below) for within same-subject changes.

Subjects will be administered with

  1. Hyperpolarized Xenon129 inhalation during MRI twice (at baseline and post 3 month Advair)
  2. Gadolinium intravenous contrast during MRI twice (at baseline and post 3 month Advair)
  3. Advair diskus: strength 250mcg/50mcg, one puff twice a day for 3 months.
Drug: Xenon129 MRI imaging
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)

Drug: Gadolinium MRI
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)

Drug: Advair (250mcg/50mcg) one puff twice a day
subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI.




Primary Outcome Measures :
  1. Improvement in pulmonary airflow physiology detected by Xenon129 MRI [ Time Frame: From baseline to 3 month post treatment with Advair ]
    MRI will determine anticipated improvement in patients' airflow limitation correlation ventilation defect.

  2. Improvement in pulmonary gas exchange physiology detected by Xenon129 MRI [ Time Frame: From baseline to 3 month post treatment with Advair ]
    Dissolved phase Xe129 of the MRI will determine anticipated improvement in patients' gas exchange capacity in lung tissues correlating with tissue damage caused by COPD.


Secondary Outcome Measures :
  1. Improvement in clinical pulmonary function test [ Time Frame: From baseline to 3 month post treatment with Advair ]
    Pulmonary function test will measure anticipated improvement in patients lung function after using Advair.

  2. St. George's Respiratory Questionnaire [ Time Frame: From baseline to 3 month post treatment with Advair ]
    St. George's Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.

  3. Baseline Dyspnea Index [ Time Frame: From baseline to 3 month post treatment with Advair ]
    Baseline Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.

  4. Transition Dyspnea Index [ Time Frame: From baseline to 3 month post treatment with Advair ]
    Transition Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.

  5. Chronic Respiratory Questionnaire [ Time Frame: From baseline to 3 month post treatment with Advair ]
    Chronic Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.

  6. BODE score [ Time Frame: From baseline to 3 month post treatment with Advair ]
    BODE score will measure anticipated improvement in subjective symptoms of patients.

  7. GOLD Stage [ Time Frame: From baseline to 3 month post treatment with Advair ]
    GOLD Stage will measure anticipated improvement in subjective symptoms of patients.



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects should be at their clinical baseline on the day of imaging
  • Subjects must be clinically stable in order to participate in the study
  • Smoking history >10 pack years
  • Subjects must not be currently taking Advair or have taken it within 4 weeks prior to screening
  • No subject will be withdrawn from Advair to participate in this study

The subjects with COPD will be categorized according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD severity classification:

  • Class 1: forced expiratory volume at one second (FEV1)/forced vital capacity (FVC) < 70 and FEV1 > 80% predicted;
  • Class 2: FEV1/FVC < 70 and 50% < FEV1 < 80% predicted;
  • Class 3: FEV1/FVC < 70 and 30% < FEV1 < 50% predicted;
  • Class 4: FEV1/FVC < 70 and FEV1 < 30% predicted

Exclusion Criteria:

  • Continuous oxygen use at home
  • Blood oxygen saturation of 92% less than as measured by pulse oximetry on the day of imaging
  • FEV1 percent predicted less than 25%
  • Pregnancy or lactation
  • Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning
  • Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
  • Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
  • History of congenital cardiac disease, chronic renal failure, or cirrhosis.
  • Inability to understand simple instructions or to hold still for approximately 10 seconds.
  • History of respiratory infection within 2 weeks prior to the MR scan
  • History of myocardial infarction (MI) , stroke and/or poorly controlled hypertension.
  • Known hypersensitivity to albuterol or any of its components, or levalbuterol
  • Glomerular filtration rate (GFR) < 60 ml/min/1.73 m2 or known hypersensitivity to Gd-contrast agents based on a serum creatinine drawn within 30 days of the MRI
  • Acute kidney injury
  • History of paraproteinemia syndromes such as multiple myeloma
  • Hepatorenal syndrome
  • Liver transplant

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02826343


Contacts
Contact: Rachel D Dieterich, RN 434-243-6074 rdd8w@virginia.edu
Contact: Marie D Burdick 434-243-7363 mdb5b@virginia.edu

Locations
United States, Virginia
University of Virginia Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Rachel Dieterich, RN    434-243-6074    rrd8w@virginia.edu   
Contact: Marie Burdick    434-243-7363    mdb5b@virginia.edu   
Principal Investigator: Mike Shim, MD         
Sponsors and Collaborators
University of Virginia
National Institutes of Health (NIH)
Investigators
Principal Investigator: Y Michael Shim, MD University of Virginia

Responsible Party: Y. Michael Shim, MD, Associate Professor, University of Virginia
ClinicalTrials.gov Identifier: NCT02826343     History of Changes
Other Study ID Numbers: 18667
First Posted: July 11, 2016    Key Record Dates
Last Update Posted: October 19, 2017
Last Verified: October 2017

Keywords provided by Y. Michael Shim, MD, University of Virginia:
COPD

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Chronic Disease
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes
Xenon
Fluticasone Propionate, Salmeterol Xinafoate Drug Combination
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics