MedTrace Logo

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

NCT06271408 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2024-02-21

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Aerogen

    collaborator INDUSTRY

  • Polarean, Inc.

    lead INDUSTRY

Principal Investigators

  • Jaime Mata, PhD · University of Virginia

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-29
Primary Completion
2024-04-30
Completion
2024-04-30
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06271408 on ClinicalTrials.gov