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Medicated Aerosol Delivery Using A Jet Nebulizer Versus A Vibrating Mesh Nebulizer in COPD Exacerbation

NCT03051971 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-10-27

No results posted yet for this study

Summary

Delivery of inhaled short-acting bronchodilators (SABD) is standard of care in the emergency department (ED) for exacerbation of COPD, the goal of such being rapid reversal of airflow obstruction. However, current guidelines for the delivery of SABDs in spontaneously breathing patients make no distinction whether these medications should be delivered via metered dose inhaler (MDI) or jet nebulizer (JN), the specific medication delivery device having no significant effect on hospital admission or reversal of flow obstruction. However, advancements in nebulizer design, namely FDA-approved vibrating mesh technology, have demonstrated significant improvements relative to JNs and metered dose inhalers in efficiency and amount of drug delivered in in vivo and in vitro studies. Currently there are no clinical trials comparing the use of vibrating mesh nebulizers (VMN) to JNs and their effect on clinically important outcomes. This prospective randomized controlled pilot trial seeks to determine if there are differences in hospital admission due to COPD when a vibrating mesh nebulizer is used versus a jet nebulizer.

Conditions

Interventions

DEVICE

Vibrating Mesh Nebulizer

short-acting bronchodilator medication delivered with a vibrating mesh nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask

DEVICE

Jet Nebulizer

short-acting bronchodilator medication delivered with a jet nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask

Sponsors & Collaborators

  • Medstar Health Research Institute

    lead OTHER

Principal Investigators

  • Eric J Kriner, RRT · Medstar Health Research Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-03-31
Primary Completion
2018-03-31
Completion
2018-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03051971 on ClinicalTrials.gov