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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COPD Advair | Other | 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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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenon129 MRI imaging | Drug | subjects will receive at baseline and 3 month post Advair intervention (See next intervention) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in pulmonary airflow physiology detected by Xenon129 MRI | MRI will determine anticipated improvement in patients' airflow limitation correlation ventilation defect. | From baseline to 3 month post treatment with Advair |
| 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. | From baseline to 3 month post treatment with Advair |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in clinical pulmonary function test | Pulmonary function test will measure anticipated improvement in patients lung function after using Advair. | From baseline to 3 month post treatment with Advair |
| St. George's Respiratory Questionnaire |
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Inclusion Criteria:
The subjects with COPD will be categorized according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) COPD severity classification:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Y Michael Shim, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
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| Gadolinium MRI | Drug | subjects will receive at baseline and 3 month post Advair intervention (See next intervention) |
|
| Advair (250mcg/50mcg) one puff twice a day | Drug | subjects will receive for 3 month duration between baseline and 3 month post Xenon129 MRI imaging and Gadolinium MRI. |
|
St. George's Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients.
| From baseline to 3 month post treatment with Advair |
| Baseline Dyspnea Index | Baseline Dyspnea Index will measure anticipated improvement in subjective symptoms of patients. | From baseline to 3 month post treatment with Advair |
| Transition Dyspnea Index | Transition Dyspnea Index will measure anticipated improvement in subjective symptoms of patients. | From baseline to 3 month post treatment with Advair |
| Chronic Respiratory Questionnaire | Chronic Respiratory Questionnaire will measure anticipated improvement in subjective symptoms of patients. | From baseline to 3 month post treatment with Advair |
| BODE score | BODE score will measure anticipated improvement in subjective symptoms of patients. | From baseline to 3 month post treatment with Advair |
| GOLD Stage | GOLD Stage will measure anticipated improvement in subjective symptoms of patients. | From baseline to 3 month post treatment with Advair |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000438 |
| Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000068298 | Fluticasone |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |