New Technology to Assess Treatment for Chronic Obstructive Pulmonary Disease (COPD)
Pulmonary Disease, Chronic Obstructive
About this trial
This is an interventional diagnostic trial for Pulmonary Disease, Chronic Obstructive focused on measuring COPD
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- No subject will be withdrawn from Advair to participate in this study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
Sites / Locations
- University of Virginia
Arms of the Study
Arm 1
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 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.