Recruiting
Phase 1

Bronchodilator Response

Sponsor:

Polarean, Inc.

Code:

NCT06271408

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Vibrating Mesh Nebulizer

Metered Dose Inhaler

Jet Nebulizer

Study Details

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

Study ID

NCT06271408

Start date

Feb, 2024

Status verified date

Feb, 2024

Completion date

Apr, 2024

Anticipated

Primary completion date

Apr, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

6 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vibrating Mesh Nebulizer First

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.

experimental: Jet Nebulizer First

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.

experimental: Metered Dose Inhaler First

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.

Interventions

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

Aerosolized albuterol

Vibrating Mesh Nebulizer

A vibrating mesh nebulizer will be used to deliver aerosolized albuterol

Metered Dose Inhaler

A metered dose inhaler will be used to deliver aerosolized albuterol

Jet Nebulizer

A jet nebulizer will be used to deliver aerosolized albuterol

Primary outcome measure

  • Ventilation Defect Percent [ Time Frame: measured immediately postdose ]

Central Contacts and Locations

Locations

University of Virginia Sheridan Snyder Translational Fontaine Research Unit

Recruiting

Charlottesville, Virginia, United States, 22947

Contacts

Roselove Roselove Nunoo-Asare

434-243-6074rnn3b@virginia.edu

More Information

Sponsor

Polarean, Inc.

Last update posted

Feb 21, 2024

Last verified

Feb, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Polarean, Inc. on 2024-02-21.