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Bronchodilator

Metered Dose Inhaler First for Chronic Obstructive Pulmonary Disease

Phase 1

Recruiting

Led By Jaime Mata, PhD

Research Sponsored by Polarean, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥18 years at enrollment

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline and immediately postdose

Awards & highlights

Study Summary

"This trial aims to compare how well three different methods of delivering bronchodilator treatment work in patients with COPD. They will use MRI scans with a special contrast agent to see if there are

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Albuterol may cause side effects like jitteriness, headaches, rapid heartbeat, throat irritation and muscle cramps. The MRI contrast agent used might also have risks which are usually rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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My lung function improved significantly after a bronchodilator test.

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My lung function test shows COPD with FEV₁/FVC below 70%.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and immediately postdose

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline and immediately postdose

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and immediately postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ventilation Defect Percent

Secondary outcome measures

Distribution of ventilated space

Membrane uptake of Xe 129

Red blood cell Xe 129 transfer

Trial Design

3Treatment groups

Experimental Treatment

Group I: Vibrating Mesh Nebulizer FirstExperimental Treatment4 Interventions

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.

Group II: Metered Dose Inhaler FirstExperimental Treatment4 Interventions

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.

Group III: Jet Nebulizer FirstExperimental Treatment4 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Metered Dose Inhaler

2014

N/A

~980

Jet Nebulizer

2016

N/A

~260

Vibrating Mesh Nebulizer

2016

N/A

~220

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

AerogenIndustry Sponsor

5 Previous Clinical Trials

372 Total Patients Enrolled

Polarean, Inc.Lead Sponsor

2 Previous Clinical Trials

86 Total Patients Enrolled

Jaime Mata, PhDPrincipal InvestigatorUniversity of Virginia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the risk level associated with using a Vibrating Mesh Nebulizer as initial treatment for patients?

"The safety rating for the Vibrating Mesh Nebulizer First is 1 according to our team at Power, reflecting it as a Phase 1 trial with minimal data backing its safety and effectiveness."

Answered by AI

What is the current number of individuals being enrolled in this research investigation?

"Indeed, the current information on clinicaltrials.gov confirms that this investigation is actively enrolling subjects. Originally shared on February 1st, 2024, and most recently revised on February 14th of the same year, the trial aims to include 6 participants at one specific site."

Answered by AI

Are researchers currently enrolling participants for this study?

"As per clinicaltrials.gov, this investigation is actively seeking volunteers. The initial posting date was 2nd January 2024, with the latest update done on 14th February 2024."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging

2024. "Comparison of Bronchodilator Response From Three Different Aerosol Delivery Methods in Patients With COPD Using Hyperpolarized Xe 129 MRI Ventilation Imaging". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06271408.