Aerosol Delivery Methods for Chronic Obstructive Pulmonary Disease
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
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
Imaging
Participants inhale hyperpolarized Xe 129 and undergo MRI to capture lung images after each treatment
Follow-up
Participants are monitored for safety and effectiveness after treatment
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
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.
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.
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.
Albuterol is already approved in United States, European Union, Canada for the following indications:
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchospasm
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchospasm
- Asthma
- Chronic obstructive pulmonary disease (COPD)
- Exercise-induced bronchospasm
Find a Clinic Near You
Who Is Running the Clinical Trial?
Polarean, Inc.
Lead Sponsor
Aerogen
Industry Sponsor
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, ...
A comparison of albuterol administered by metered-dose ...
Conclusions Albuterol delivered via conventional jet nebulizer resulted in significantly greater improvement in FEV1 than albuterol ...
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.
MAY-21-2008 08:12
Eve/Face Protection: Wear chemical safety goggles and/or a face shield. Skin Protection: Wear proper protective clothing and gloves to prevent ...
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