NCT06271408

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

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Polarean, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Chronic Obstructive Pulmonary Disease

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-02-01
• Primary completion: 2024-04-01
• Completion: 2024-04-01
• First posted: 2024-02-21
• Last updated: 2024-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study