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

NCT06271408 | Recruiting Phase 1 FDA Drug FDA Device

• 1 other identifier: POL-Xe-005
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Ventilation Defect Percent

  A measure of the percentage of lung area with low ventilation measured using hyperpolarized Xe 129 MRI

  measured immediately postdose

Secondary Outcomes (3)

• Distribution of ventilated space

  measured at baseline and immediately postdose

• Membrane uptake of Xe 129

  measured at baseline and immediately postdose

• Red blood cell Xe 129 transfer

  measured at baseline and immediately postdose

Study Arms (3)

Vibrating Mesh Nebulizer First

EXPERIMENTAL

Participants will receive albuterol delivered via vibrating mesh nebulizer as their first treatment, followed by albuterol delivered via metered dose inhaler and then albuterol delivered via jet nebulizer.

Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution; Device: Vibrating Mesh Nebulizer; Device: Metered Dose Inhaler; Device: Jet Nebulizer

Jet Nebulizer First

EXPERIMENTAL

Participants will receive albuterol delivered via jet nebulizer as their first treatment, followed by albuterol delivered via vibrating mesh nebulizer and then albuterol delivered via metered dose inhaler.

Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution; Device: Vibrating Mesh Nebulizer; Device: Metered Dose Inhaler; Device: Jet Nebulizer

Metered Dose Inhaler First

EXPERIMENTAL

Participants will receive albuterol delivered via metered dose inhaler as their first treatment, followed by albuterol delivered via jet nebulizer and then albuterol delivered via vibrating mesh nebulizer.

Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution; Device: Vibrating Mesh Nebulizer; Device: Metered Dose Inhaler; Device: Jet Nebulizer

Interventions

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

Aerosolized albuterol

Jet Nebulizer First; Metered Dose Inhaler First; Vibrating Mesh Nebulizer First

Vibrating Mesh Nebulizer DEVICE

A vibrating mesh nebulizer will be used to deliver aerosolized albuterol

Also known as: Solo VMN

Jet Nebulizer First; Metered Dose Inhaler First; Vibrating Mesh Nebulizer First

Metered Dose Inhaler DEVICE

A metered dose inhaler will be used to deliver aerosolized albuterol

Also known as: pMDI-aerosol metered dose inhaler

Jet Nebulizer First; Metered Dose Inhaler First; Vibrating Mesh Nebulizer First

Jet Nebulizer DEVICE

A jet nebulizer will be used to deliver aerosolized albuterol

Also known as: JN nebulizer

Jet Nebulizer First; Metered Dose Inhaler First; Vibrating Mesh Nebulizer First

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).
• Inability to hold breath 10-15 seconds for required imaging or for completion of diffusing capacity of lung for carbon monoxide (DLCO) measurements.
• Respiratory infection of exacerbation of COPD within the 6 weeks prior to screening.
• Malignancy for which the patient has undergone resection, radiation, or chemotherapy within the last 5 years. Patients with treated basal cell carcinoma are allowed.
• Known hypersensitivity to any of the study products.
• Known or planned pregnancy.
• 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.

Sponsors & Collaborators

• Polarean, Inc.: lead
• Aerogen: collaborator

Study Sites (1)

University of Virginia Sheridan Snyder Translational Fontaine Research Unit

Charlottesville, Virginia, 22947, United States

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol; Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Nebulizers and Vaporizers; Equipment and Supplies

Study Officials

• Jaime Mata, PhD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2024
• First Posted: February 21, 2024
• Study Start: February 1, 2024
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: February 21, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)