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

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Xenon129 MRI imaging
Gadolinium MRI
Advair (250mcg/50mcg) one puff twice a day
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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  • No subject will be withdrawn from Advair to participate in this study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

Sites / Locations

  • University of Virginia

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

COPD Advair

Arm Description

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 Hyperpolarized Xenon129 inhalation during MRI twice (at baseline and post 3 month Advair) Gadolinium intravenous contrast during MRI twice (at baseline and post 3 month Advair) Advair diskus: strength 250mcg/50mcg, one puff twice a day for 3 months.

Outcomes

Primary Outcome Measures

Improvement in pulmonary airflow physiology detected by Xenon129 MRI
MRI will determine anticipated improvement in patients' airflow limitation correlation ventilation defect.
Improvement in pulmonary gas exchange physiology detected by Xenon129 MRI
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

Improvement in clinical pulmonary function test
Pulmonary function test will measure anticipated improvement in patients lung function after using Advair.
St. George's Respiratory Questionnaire
St. George's Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
Baseline Dyspnea Index
Baseline Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.
Transition Dyspnea Index
Transition Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.
Chronic Respiratory Questionnaire
Chronic Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
BODE score
BODE score will measure anticipated improvement in subjective symptoms of patients.
GOLD Stage
GOLD Stage will measure anticipated improvement in subjective symptoms of patients.

Full Information

First Posted
May 10, 2016
Last Updated
November 2, 2020
Sponsor
University of Virginia
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT02826343
Brief Title
New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Xe129 Magnetic Resonance Imaging of the Lung: A New Technology to Assess Treatment for COPD
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2016 (Actual)
Primary Completion Date
June 15, 2018 (Actual)
Study Completion Date
June 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive
Keywords
COPD

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
COPD Advair
Arm Type
Other
Arm Description
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 Hyperpolarized Xenon129 inhalation during MRI twice (at baseline and post 3 month Advair) Gadolinium intravenous contrast during MRI twice (at baseline and post 3 month Advair) Advair diskus: strength 250mcg/50mcg, one puff twice a day for 3 months.
Intervention Type
Drug
Intervention Name(s)
Xenon129 MRI imaging
Intervention Description
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
Intervention Type
Drug
Intervention Name(s)
Gadolinium MRI
Intervention Description
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
Intervention Type
Drug
Intervention Name(s)
Advair (250mcg/50mcg) one puff twice a day
Intervention Description
subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI.
Primary Outcome Measure Information:
Title
Improvement in pulmonary airflow physiology detected by Xenon129 MRI
Description
MRI will determine anticipated improvement in patients' airflow limitation correlation ventilation defect.
Time Frame
From baseline to 3 month post treatment with Advair
Title
Improvement in pulmonary gas exchange physiology detected by Xenon129 MRI
Description
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.
Time Frame
From baseline to 3 month post treatment with Advair
Secondary Outcome Measure Information:
Title
Improvement in clinical pulmonary function test
Description
Pulmonary function test will measure anticipated improvement in patients lung function after using Advair.
Time Frame
From baseline to 3 month post treatment with Advair
Title
St. George's Respiratory Questionnaire
Description
St. George's Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
Time Frame
From baseline to 3 month post treatment with Advair
Title
Baseline Dyspnea Index
Description
Baseline Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.
Time Frame
From baseline to 3 month post treatment with Advair
Title
Transition Dyspnea Index
Description
Transition Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.
Time Frame
From baseline to 3 month post treatment with Advair
Title
Chronic Respiratory Questionnaire
Description
Chronic Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
Time Frame
From baseline to 3 month post treatment with Advair
Title
BODE score
Description
BODE score will measure anticipated improvement in subjective symptoms of patients.
Time Frame
From baseline to 3 month post treatment with Advair
Title
GOLD Stage
Description
GOLD Stage will measure anticipated improvement in subjective symptoms of patients.
Time Frame
From baseline to 3 month post treatment with Advair

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Y Michael Shim, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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