- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02826343
New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)
Xe129 Magnetic Resonance Imaging of the Lung: A New Technology to Assess Treatment for COPD
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
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
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Virginia
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Charlottesville, Virginia, United States, 22908
- University of Virginia
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: DIAGNOSTIC
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
OTHER: 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
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subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
subjects will receive at baseline and 3 month post Advair intervention (See next intervention)
subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in pulmonary airflow physiology detected by Xenon129 MRI
Time Frame: From baseline to 3 month post treatment with Advair
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MRI will determine anticipated improvement in patients' airflow limitation correlation ventilation defect.
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From baseline to 3 month post treatment with Advair
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Improvement in pulmonary gas exchange physiology detected by Xenon129 MRI
Time Frame: From baseline to 3 month post treatment with Advair
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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.
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From baseline to 3 month post treatment with Advair
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in clinical pulmonary function test
Time Frame: From baseline to 3 month post treatment with Advair
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Pulmonary function test will measure anticipated improvement in patients lung function after using Advair.
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From baseline to 3 month post treatment with Advair
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St. George's Respiratory Questionnaire
Time Frame: From baseline to 3 month post treatment with Advair
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St. George's Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
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From baseline to 3 month post treatment with Advair
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Baseline Dyspnea Index
Time Frame: From baseline to 3 month post treatment with Advair
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Baseline Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.
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From baseline to 3 month post treatment with Advair
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Transition Dyspnea Index
Time Frame: From baseline to 3 month post treatment with Advair
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Transition Dyspnea Index will measure anticipated improvement in subjective symptoms of patients.
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From baseline to 3 month post treatment with Advair
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Chronic Respiratory Questionnaire
Time Frame: From baseline to 3 month post treatment with Advair
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Chronic Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
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From baseline to 3 month post treatment with Advair
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BODE score
Time Frame: From baseline to 3 month post treatment with Advair
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BODE score will measure anticipated improvement in subjective symptoms of patients.
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From baseline to 3 month post treatment with Advair
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GOLD Stage
Time Frame: From baseline to 3 month post treatment with Advair
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GOLD Stage will measure anticipated improvement in subjective symptoms of patients.
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From baseline to 3 month post treatment with Advair
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Y Michael Shim, MD, University of Virginia
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases, Obstructive
- Lung Diseases
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Autonomic Agents
- Peripheral Nervous System Agents
- Anesthetics, General
- Anesthetics
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anesthetics, Inhalation
- Sympathomimetics
- Fluticasone-Salmeterol Drug Combination
- Xenon
Other Study ID Numbers
- 18667
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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