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

NCT03051971 | Withdrawn FDA Device

• 1 other identifier: 2016-281
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Hospitalization rate

  hospitalization rate among COPD exacerbation patients in the ED receiving SABD via jet nebulizer versus those receiving SABD via VMN

  through study completion (approx 1 year)

Secondary Outcomes (8)

• ICU admission

  through study completion (approx 1 year)

• Hospital length of stay

  through study completion (approx 1 year)

• NIV in escalation of respiratory support

  through study completion (approx 1 year)

• Duration of NIV support

  through study completion (approx 1 year)

• Intubation in escalation of respiratory support

  through study completion (approx 1 year)

Study Arms (2)

Jet nebulizer

ACTIVE COMPARATOR

short-acting bronchodilator (albuterol and/or ipratropium bromide) according to standard of care practices and physician discretion will be administered with a jet nebulizer

Device: Jet Nebulizer

Vibrating Mesh Nebulizer

ACTIVE COMPARATOR

short-acting bronchodilator (albuterol and/or ipratropium bromide) according to standard of care practices and physician discretion will be administered with a vibrating mesh nebulizer

Device: Vibrating Mesh Nebulizer

Interventions

Vibrating Mesh Nebulizer DEVICE

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

Also known as: Aergoen Ultra nebulizer

Vibrating Mesh Nebulizer

Jet Nebulizer DEVICE

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

Also known as: MistyFast nebulizer

Jet nebulizer

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• i. Patients ordered to receive short-acting bronchodilator therapy ii. Patients ≥ 40 years of age iii. Patients with a self-reported history of COPD and/or patients with diagnosed/suspected COPD iv. Patients whose FEV1 is ≤ 50% of predicted or are unable to perform FEV1 maneuver because of airflow-associated respiratory distress or NIV use

You may not qualify if:

• i. Patients whose indication for SABD therapy is for a clinical indication other than COPD ii. The immediate need for intubation iii. Pregnant women iv. Non-English speakers

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric J Kriner, RRT

  Medstar Health Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2017
• First Posted: February 14, 2017
• Study Start: March 1, 2017
• Primary Completion: March 1, 2018
• Study Completion: April 1, 2018
• Last Updated: October 27, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)