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

• ClinicalTrials.gov Identifier: NCT03051971
• Recruitment Status: Unknown
• First Posted: February 14, 2017
• Last Update Posted: February 14, 2017
• Sponsor: Medstar Health Research Institute
• Information provided by (Responsible Party): Eric J. Kriner, Medstar Health Research Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Chronic Obstructive Pulmonary Disease	Device: Vibrating Mesh Nebulizer; Device: Jet Nebulizer	Not Applicable

Detailed Description:

Patients ordered to receive a SABD, will be screened for presence of moderate to severe COPD exacerbation; spontaneously breathing patients as well those supported with non-invasive ventilation (NIV) will be screened for inclusion.

Upon consent, the patient will be randomized to receive the ordered SABD via a JN (MistyFast, Carefusion-BD, CA) or VMN (Aerogen Ultra, Aerogen, Galway, Ireland).

Included subjects will receive therapy with a mouthpiece interface. In the case a patient is unable to tolerate, maintain a tight seal around the mouthpiece or otherwise not perform aerosol therapy with a mouthpiece, a valved-aerosol mask (I-Guard aerosol mask, Salter Labs, Lake Forest, IL) will be utilized.

Subjects that require NIV, whether on admission to the ED or in the face of escalating therapy, will receive NIV via a non-vented, oronasal mask and the allocated nebulizer will be placed distal to the leak in the NIV circuit (between the mask and circuit). Patients will receive positive expiratory and/or inspiratory pressure at specific settings determined by the prescribing physician and clinical team.

Subjects will be re-evaluated and clinical data collected following delivery of the initial SABD treatment that includes signs of possible side effects.

The prescribing physician and clinical team will determine the need for additional SABD therapy beyond the initial therapy. Subjects indicated and ordered for additional administration of SABD will continue to receive SABD with the randomly allocated aerosol delivery device. Subjects will be re-evaluated and assessed for possible side effects after delivery of the additional SABD.

The initial order, as well as all subsequent orders for SABD medication will be at the discretion of the physician and clinical team. The type and dosage of medication and the approximate timing of medication delivery designated in the study protocol is according to and correlates with the standard practices. The process of determining need by the clinical team and administering additional SABD, followed by evaluation, will continue up to a total of four SABD treatments. If at any point following a SABD treatment, the clinical team assesses the subject and determines that no additional therapy is indicated, the subject will not receive additional SABD. Clinical data will be collected following each SABD administered (approximately every 30 minutes) and conclude at 120 min after randomization.

Subjects requiring the need for endotracheal intubation and mechanical ventilator support, immediate or in escalation of support, will be at the discretion of the attending physician. Subjects requiring endotracheal intubation as escalation of therapy following study enrollment will be included in the study analysis. Those subjects requiring the immediate need for endotracheal intubation prior to randomization will be excluded from the study.

Individualized decision regarding hospitalization or discharge to home will be according to the attending physician. Subjects admitted to the hospital for continued inpatient care will continue to receive nebulized bronchodilator therapy, as indicated and ordered, with an aerosol delivery device according to the MWHC bronchodilator protocol and standard practices.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pilot Study of Medicated Aerosol Delivery Using A Jet Nebulizer Versus A Vibrating Mesh Nebulizer in COPD Exacerbation
• Estimated Study Start Date: March 2017
• Estimated Primary Completion Date: March 2018
• Estimated Study Completion Date: April 2018

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Jet nebulizer; 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; short-acting bronchodilator medication delivered with a jet nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask; Other Name: MistyFast nebulizer
Active Comparator: Vibrating Mesh Nebulizer; 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; short-acting bronchodilator medication delivered with a vibrating mesh nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask; Other Name: Aergoen Ultra nebulizer

Outcome Measures

Primary Outcome Measures :

1. Hospitalization rate [ Time Frame: through study completion (approx 1 year) ]
   hospitalization rate among COPD exacerbation patients in the ED receiving SABD via jet nebulizer versus those receiving SABD via VMN

Secondary Outcome Measures :

1. ICU admission [ Time Frame: through study completion (approx 1 year) ]
   Percent of patients with COPD exacerbation treated with SABD via VMN versus JN admitted to an intensive care environment
2. Hospital length of stay [ Time Frame: through study completion (approx 1 year) ]
   Hospital length of stay for patients with COPD exacerbation treated with SABD via VMN versus JN
3. NIV in escalation of respiratory support [ Time Frame: through study completion (approx 1 year) ]
   Percentage of patients with COPD exacerbation treated with SABD via VMN versus JN that require NIV in escalation of respiratory support
4. Duration of NIV support [ Time Frame: through study completion (approx 1 year) ]
   Duration of NIV support in patients with COPD exacerbation treated with SABD via VMN versus JN
5. Intubation in escalation of respiratory support [ Time Frame: through study completion (approx 1 year) ]
   Percentage of patients with COPD exacerbation treated with SABD via VMN versus JN that require intubation in escalation of respiratory support
6. Percentage change in FEV1 [ Time Frame: through study completion (approx 1 year) ]
   Percentage change in FEV1 in patients with COPD exacerbation treated with SABD via VMN versus JN
7. Amount of short-acting bronchodilator medication [ Time Frame: through study completion (approx 1 year) ]
   The amount of SABD aerosol therapy administered to patients with COPD exacerbation treated with SABD via VMN versus JN
8. Hospital readmission within 30 days [ Time Frame: through study completion (approx 1 year) ]
   Percentage of patients treated with SABD via VMN versus JN that are readmitted to the hospital within thirty days of discharge

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Contacts

Contact: Eric J Kriner, RRT; 202-877-7510; eric.j.kriner@medstar.net

Locations

United States, District of Columbia

MedStar Washington Hospital Center

Washington, District of Columbia, United States, 20010

Contact: Eric J Kriner, RRT 202-877-7510 eric.j.kriner@medstar.net

Principal Investigator: Eric J Kriner, RRT

Sponsors and Collaborators

Medstar Health Research Institute

Investigators

• Principal Investigator: Eric J Kriner, RRT; Medstar Washington Hospital Center

More Information

• Responsible Party: Eric J. Kriner, Principal Investigator, Medstar Health Research Institute
• ClinicalTrials.gov Identifier: NCT03051971
• Other Study ID Numbers: 2016-281
• First Posted: February 14, 2017
• Last Update Posted: February 14, 2017
• Last Verified: February 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases; Respiratory Tract Diseases