Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging
NCT ID: NCT06271408
Last Updated: 2024-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
6 participants
INTERVENTIONAL
2024-02-29
2024-04-30
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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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.
Jet Nebulizer
A jet nebulizer will be used to deliver aerosolized albuterol
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 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.
Jet Nebulizer
A jet nebulizer will be used to deliver aerosolized albuterol
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
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.
Jet Nebulizer
A jet nebulizer will be used to deliver aerosolized albuterol
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
Interventions
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Jet Nebulizer
A jet nebulizer will be used to deliver aerosolized albuterol
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Aerogen
INDUSTRY
Polarean, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Jaime Mata, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Locations
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University of Virginia Sheridan Snyder Translational Fontaine Research Unit
Charlottesville, Virginia, United States
Countries
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Facility Contacts
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Other Identifiers
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POL-Xe-005
Identifier Type: -
Identifier Source: org_study_id
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