Clinical trial NCT06271408: Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: Polarean, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Aerogen
First posted: 2024-02-21
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years at enrollment.
2. Participant (or legally acceptable representative) willing and able to provide written informed consent.
3. Able (in the Investigator's opinion) and willing to comply with all study requirements.
4. 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%
5. Receiving standard of care (SOC) background drug therapy as per current guidance for COPD for at least 6 months to screening Visit 1.
6. 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.
7. 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.
8. Stable baseline conditions and no medication changes within 6 weeks of planned imaging visit.
9. 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.

Exclusion Criteria:

1. Participant with life expectancy \<1-2 years or significant diseases other than COPD.

   A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients' ability to participate in the study.
2. Any condition which, in the opinion of the Investigator, would make it unsafe or unsuitable for the patients to undergo MRI (for example: presence of an implanted or external MRI unsafe device that cannot be removed, body weight exceeding table limitations, inability to lie flat, or severe claustrophobia).
3. Inability to hold breath 10-15 seconds for required imaging or for completion of diffusing capacity of lung for carbon monoxide (DLCO) measurements.
4. Respiratory infection of exacerbation of COPD within the 6 weeks prior to screening.
5. Malignancy for which the patient has undergone resection, radiation, or chemotherapy within the last 5 years. Patients with treated basal cell carcinoma are allowed.
6. Known hypersensitivity to any of the study products.
7. Known or planned pregnancy.
8. Participation in another study which, in the opinion of the Investigator, would interfere with the study compliance, or outcome assessments or would prohibit the collection of the required data points.

Primary outcomes:
measure: Ventilation Defect Percent
timeFrame: measured immediately postdose
Secondary outcomes:
measure: Distribution of ventilated space
timeFrame: measured at baseline and immediately postdose
measure: Membrane uptake of Xe 129
timeFrame: measured at baseline and immediately postdose
measure: Red blood cell Xe 129 transfer
timeFrame: measured at baseline and immediately postdose
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Sheridan Snyder Translational Fontaine Research Unit
state: Virginia
Study officials:
affiliation: University of Virginia
name: Jaime Mata, PhD
role: PRINCIPAL_INVESTIGATOR
References: