Chronic Obstructive Pulmonary DiseasePhase 1NCT06271408
Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging
A Phase 1 study testing Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Vibrating Mesh Nebulizer and Metered Dose Inhaler in people with Chronic Obstructive Pulmonary Disease, run by Polarean, Inc. at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Vibrating Mesh Nebulizer and Metered Dose Inhaler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2024to 31 Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- 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.
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- Participants enrolled as bronchodilator responder:
- 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:
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Sheridan Snyder Translational Fontaine Research Unit
Charlottesville, Virginia, 22947
About this study
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
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:
Read more
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
- Being tested
- Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Vibrating Mesh Nebulizer, Metered Dose Inhaler, Jet Nebulizer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation SolutionDrug
Aerosolized albuterol
Vibrating Mesh NebulizerDevice
Also called Solo VMN
A vibrating mesh nebulizer will be used to deliver aerosolized albuterol
Metered Dose InhalerDevice
Also called pMDI-aerosol metered dose inhaler
A metered dose inhaler will be used to deliver aerosolized albuterol
Jet NebulizerDevice
Also called JN nebulizer
A jet nebulizer will be used to deliver aerosolized albuterol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution; Device: Vibrating Mesh Nebulizer; Device: Metered Dose Inhaler; Device: Jet Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation Defect Percent
A measure of the percentage of lung area with low ventilation measured using hyperpolarized Xe 129 MRI
Measured: measured immediately postdose
Secondary outcomes (3)
Distribution of ventilated space
A measure of distribution of lung ventilation measured using hyperpolarized Xe 129 MRI
Measured: measured at baseline and immediately postdose
Membrane uptake of Xe 129
A measure of lung membrane air conductance measured using hyperpolarized Xe 129 MRI
Measured: measured at baseline and immediately postdose
Red blood cell Xe 129 transfer
A measure of red blood cell uptake of Xe 129 measured using hyperpolarized Xe 129 MRI
Measured: measured at baseline and immediately postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start19 Mar 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Polarean, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aerogen
- Responsible party
- Sponsor
- Investigators
- Jaime Mata, PhD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06271408
- Sponsor's protocol ID
- POL-Xe-005
- Status last verified
- Oct 2026
- First submitted
- 14 Feb 2024
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06271408
- Acronym / sponsor ID
- POL-Xe-005
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Polarean, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Aerogen
- Study start
- 19 Mar 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Vibrating Mesh Nebulizer First | Experimental | Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Device: Vibrating Mesh Nebulizer, Device: Metered Dose Inhaler, Device: Jet NebulizerParticipants 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. |
| Jet Nebulizer First | Experimental | Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Device: Vibrating Mesh Nebulizer, Device: Metered Dose Inhaler, Device: Jet NebulizerParticipants 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. |
| Metered Dose Inhaler First | Experimental | Drug: Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Device: Vibrating Mesh Nebulizer, Device: Metered Dose Inhaler, Device: Jet NebulizerParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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:
- Receiving standard of care (SOC) background drug therapy as per current guidance for COPD for at least 6 months to screening Visit 1.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation SolutionAerosolized albuterol | Drug | Jet Nebulizer First, Metered Dose Inhaler First, Vibrating Mesh Nebulizer First |
| Vibrating Mesh NebulizerAlso: Solo VMNA vibrating mesh nebulizer will be used to deliver aerosolized albuterol | Device | Jet Nebulizer First, Metered Dose Inhaler First, Vibrating Mesh Nebulizer First |
| Metered Dose InhalerAlso: pMDI-aerosol metered dose inhalerA metered dose inhaler will be used to deliver aerosolized albuterol | Device | Jet Nebulizer First, Metered Dose Inhaler First, Vibrating Mesh Nebulizer First |
| Jet NebulizerAlso: JN nebulizerA jet nebulizer will be used to deliver aerosolized albuterol | Device | Jet Nebulizer First, Metered Dose Inhaler First, Vibrating Mesh Nebulizer First |
Primary outcome
Ventilation Defect Percent
Time frame: measured immediately postdose
A measure of the percentage of lung area with low ventilation measured using hyperpolarized Xe 129 MRI
3 secondary outcomes
Distribution of ventilated space
Time frame: measured at baseline and immediately postdose
Membrane uptake of Xe 129
Time frame: measured at baseline and immediately postdose
Red blood cell Xe 129 transfer
Time frame: measured at baseline and immediately postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jaime Mata, PhD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Albuterol Sulfate, 2.5 Mg/3 mL (0.083%) Inhalation Solution, Vibrating Mesh Nebulizer and Metered Dose Inhaler in people with Chronic Obstructive Pulmonary Disease, run by Polarean, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ventilation Defect Percent (time frame: measured immediately postdose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.