Aerosol Delivery Methods for Chronic Obstructive Pulmonary Disease

Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Polarean, Inc.
Must be taking: COPD standard care
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different delivery methods of albuterol (also known as Salbutamol or Ventolin) might affect breathing in people with chronic obstructive pulmonary disease (COPD). The researchers aim to determine if using various inhalation devices alters airflow through the lungs. Participants will use each device and undergo MRI scans to assess lung function. The trial suits those with COPD who have been on standard treatments for at least six months and have not experienced recent breathing issues or medication changes. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to foundational knowledge about their condition.

What prior data suggests that these aerosol delivery methods are safe for COPD patients?

Research has shown that albuterol, a medicine that helps people breathe easier, is usually safe when inhaled in different ways. Studies have tested albuterol with both jet nebulizers and metered dose inhalers, finding it safe and effective for many people. In these studies, hundreds of people used albuterol, and most did not experience serious side effects. The most common mild side effects included a fast heartbeat and feeling shaky, but these effects were short-lived.

However, less information exists about using albuterol with vibrating mesh nebulizers. Still, similar devices have been used safely before, suggesting they are likely safe as well. Since this trial is in the early stages (Phase 1), it focuses on checking safety in people. Researchers will closely monitor for any side effects to ensure participant safety during the study.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different aerosol delivery methods impact the effectiveness of albuterol in treating COPD. Albuterol is a common bronchodilator used to open airways, but this trial specifically compares delivery via a jet nebulizer, a metered dose inhaler, and a vibrating mesh nebulizer. Each method could potentially optimize how quickly and efficiently the medication reaches the lungs, leading to better symptom control. By using advanced MRI imaging with hyperpolarized xenon, researchers hope to understand which method offers the best improvement in lung ventilation, potentially setting the stage for more personalized COPD treatments.

What evidence suggests that these aerosol delivery methods are effective for COPD?

Studies have shown that albuterol improves lung function in people with breathing problems. In this trial, participants will receive albuterol through various delivery methods. Research suggests that a jet nebulizer can enhance lung function more effectively than other methods. The vibrating mesh nebulizer also shows promise, delivering medication efficiently and leading to quicker improvement. Albuterol delivered by a metered dose inhaler provides fast relief for breathing issues. Overall, each method has proven effective in improving breathing, which is crucial for individuals with chronic obstructive pulmonary disease (COPD).678910

Who Is on the Research Team?

JM

Jaime Mata, PhD

Principal Investigator

University of Virginia

Are You a Good Fit for This Trial?

This trial is for individuals with COPD, a type of lung disease that makes it hard to breathe. Participants should be able to undergo MRI scans and use inhalers. Specific details on who can or cannot join are not provided here.

Inclusion Criteria

My lung function test shows COPD with FEV₁/FVC below 70%.
My lung function improved significantly after a bronchodilator test.
Able (in the Investigator's opinion) and willing to comply with all study requirements
See 5 more

Exclusion Criteria

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)
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
My life expectancy is more than 1-2 years and I have no major diseases other than COPD.
See 5 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a standard dose of albuterol delivered using each of 3 aerosol delivery devices, with treatments separated by at least 1 week each

3 weeks
3 visits (in-person)

Imaging

Participants inhale hyperpolarized Xe 129 and undergo MRI to capture lung images after each treatment

3 weeks
3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Albuterol

Trial Overview

The study tests how well lungs respond to a common COPD medication, albuterol, when delivered by three different types of inhalers: vibrating mesh nebulizer, metered dose inhaler, and jet nebulizer. The effectiveness will be measured using special MRI imaging.

How Is the Trial Designed?

3

Treatment groups

Experimental Treatment

Group I: Vibrating Mesh Nebulizer FirstExperimental Treatment4 Interventions
Group II: Metered Dose Inhaler FirstExperimental Treatment4 Interventions
Group III: Jet Nebulizer FirstExperimental Treatment4 Interventions

Albuterol is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Albuterol for:
🇪🇺
Approved in European Union as Salbutamol for:
🇨🇦
Approved in Canada as Salbutamol for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Polarean, Inc.

Lead Sponsor

Trials
3
Recruited
90+

Aerogen

Industry Sponsor

Trials
8
Recruited
500+

Citations

Efficacy of albuterol administered by nebulizer versus ...

Outcome measures included a clinical score, respiratory rate, arterial oxygen saturation, and FEV1, measured before and 10, 20, and 40 minutes after treatment.

Albuterol For Nebulizer

These studies suggest that albuterol for nebulizer is effective for treating acute asthma, with similar efficacy to metered dose inhalers and spacers, ...

Comparison of Salbutamol Delivered Via Jet Nebulizer With A ...

Nebulizers deliver only 10 % of the medication dose to the lungs (6) while inhaled medication by MDI plus spacer help the lungs to absorb around 21% of the ...

Albuterol Nebulizer - Consensus Academic Search Engine

nebulized albuterol was more effective in improving peak expiratory flow (PEF) and reducing PaCO2 levels. Additionally, nebulized albuterol had fewer side ...

ALBUTEROL SULFATE HFA

The safety data described below reflects exposure to albuterol sulfate HFA in 248 subjects treated with albuterol sulfate HFA in 3 placebo-controlled ...

MAUDE Adverse Event Report: ALBUTEROL SULFATE HFA ...

MAUDE Adverse Event Report: ALBUTEROL SULFATE HFA INHALATION AEROSOL BY TEVA PHARMACEUTICALS; NEBULIZER (DIRECT PATIENT INTERFACE) ; Not provided.

VENTOLIN HFA- albuterol sulfate aerosol, metered - DailyMed

The safety data described below reflects exposure to VENTOLIN HFA in 248 patients treated with VENTOLIN HFA in 3 placebo-controlled clinical trials of 2 to ...

Ventolin HFA Safety Data Sheet | PDF | Dangerous Goods

This safety data sheet provides information on Ventolin HFA, an inhalation aerosol used as a medicinal product for treating asthma.