Comparing different methods of delivering bronchodilator treatment for COPD

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

This study tests which of three different ways to deliver a common COPD medication helps improve lung function the best for people with chronic obstructive pulmonary disease.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Polarean, Inc. (Industry-sponsored)
• Drugs / interventions: chemotherapy, radiation
• Locations: 1 site (Charlottesville, Virginia)
• Trial ID: NCT06271408 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of three different aerosol delivery methods for administering bronchodilator treatment in patients with chronic obstructive pulmonary disease (COPD). Participants will receive a standard dose of albuterol through each method, with treatments spaced at least one week apart. Following each treatment, lung ventilation will be assessed using hyperpolarized Xe 129 MRI imaging to determine any differences in lung function. The study seeks to provide insights into the most effective delivery method for improving lung ventilation in COPD patients.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with a documented diagnosis of COPD who are stable on their current medication regimen.

Not a fit: Patients who do not have a diagnosis of COPD or those who are not stable on their current medication may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment strategies for COPD patients, enhancing their lung function and overall quality of life.

How similar studies have performed: Other studies have explored aerosol delivery methods in COPD, but this specific approach using hyperpolarized Xe 129 MRI imaging is relatively novel.

Eligibility criteria

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.

Where this trial is running

Charlottesville, Virginia

• University of Virginia Sheridan Snyder Translational Fontaine Research Unit — Charlottesville, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: Jaime Mata, PhD — University of Virginia

Conditions Chronic Obstructive Pulmonary Disease