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ACTIVE NOT RECRUITING
NCT06271408
PHASE1

Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging

Sponsor: Polarean, Inc.

View on ClinicalTrials.gov

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).

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

6

Start Date

2024-03-19

Completion Date

2026-12-31

Last Updated

2026-10-27

Healthy Volunteers

No

Interventions

DRUG

Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution

Aerosolized albuterol

DEVICE

Vibrating Mesh Nebulizer

A vibrating mesh nebulizer will be used to deliver aerosolized albuterol

DEVICE

Metered Dose Inhaler

A metered dose inhaler will be used to deliver aerosolized albuterol

DEVICE

Jet Nebulizer

A jet nebulizer will be used to deliver aerosolized albuterol

Locations (1)

University of Virginia Sheridan Snyder Translational Fontaine Research Unit

Charlottesville, Virginia, United States