Xenon Xe 129 Hyperpolarized MRI Ventilation Imaging for the Evaluation of Treatment Response Comparing Three Different Bronchodilator Aerosol Delivery Methods in Patients With COPD: A Pilot Study
The goal of this clinical trial is to compare responses to bronchodilator treatment delivered by three different aerosol delivery methods in patients with chronic obstructive pulmonary disease (COPD). The main question it aims to answer is whether there are differences in lung ventilation following treatment with each of the three methods as measured using hyperpolarized Xe 129 with MRI. Participants will: Receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices. In total, participants will receive three treatments separated by at least 1 week each. Following each treatment, participants will have inhale an MRI contrast agent called hyperpolarized Xe 129 and will have images of their lungs taken with an MRI. Researchers will compare the different lung images taken after each treatment to see if there are differences in the distribution of air in the lungs (known as ventilation).
• Age ≥18 years at enrollment.
• Participant (or legally acceptable representative) willing and able to provide written informed consent.
• Able (in the Investigator's opinion) and willing to comply with all study requirements.
• Documented diagnosis of COPD limited to:
• a. Pulmonary function tests (PFT) value of forced expiratory volume at 1 second/forced vital capacity (FEV₁ / FVC) \<70%
• Receiving standard of care (SOC) background drug therapy as per current guidance for COPD for at least 6 months to screening Visit 1.
• Participants enrolled as bronchodilator responder:
• a. Increase of ≥12% and ≥200 mL as an absolute value compared with a baseline measure in either forced expiratory volume at 1 second or FVC at screening.
• Participants enrolled as non-bronchodilator responder:
• a. Increase of ≤12% and ≤200 mL as an absolute value compared with a baseline in either FEV1 or FVC at screening.
• Stable baseline conditions and no medication changes within 6 weeks of planned imaging visit.
• Female participants of childbearing potential must be confirmed non-pregnant via serum or dip-stick urine test at baseline (Screening) and prior to each Xe MRI.