Chronic Obstructive Pulmonary DiseaseNCT03051971
Medicated Aerosol Delivery Using A Jet Nebulizer Versus A Vibrating Mesh Nebulizer in COPD Exacerbation
A study testing Vibrating Mesh Nebulizer and Jet Nebulizer in people with Chronic Obstructive Pulmonary Disease, run by Medstar Health Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Vibrating Mesh Nebulizer and Jet Nebulizer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2017to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010
About this study
Official title: A Pilot Study of Medicated Aerosol Delivery Using A Jet Nebulizer Versus A Vibrating Mesh Nebulizer in COPD Exacerbation
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.
Read the 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Vibrating Mesh Nebulizer, Jet Nebulizer
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrating Mesh NebulizerDevice
Also called Aergoen Ultra nebulizer
short-acting bronchodilator medication delivered with a vibrating mesh nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask
Jet NebulizerDevice
Also called MistyFast nebulizer
short-acting bronchodilator medication delivered with a jet nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Vibrating Mesh Nebulizer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization rate
hospitalization rate among COPD exacerbation patients in the ED receiving SABD via jet nebulizer versus those receiving SABD via VMN
Measured: through study completion (approx 1 year)
Secondary outcomes (8)
ICU admission
Percent of patients with COPD exacerbation treated with SABD via VMN versus JN admitted to an intensive care environment
Measured: through study completion (approx 1 year)
Hospital length of stay
Hospital length of stay for patients with COPD exacerbation treated with SABD via VMN versus JN
Measured: through study completion (approx 1 year)
NIV in escalation of respiratory support
Percentage of patients with COPD exacerbation treated with SABD via VMN versus JN that require NIV in escalation of respiratory support
Measured: through study completion (approx 1 year)
Duration of NIV support
Duration of NIV support in patients with COPD exacerbation treated with SABD via VMN versus JN
Measured: through study completion (approx 1 year)
Intubation in escalation of respiratory support
Percentage of patients with COPD exacerbation treated with SABD via VMN versus JN that require intubation in escalation of respiratory support
Measured: through study completion (approx 1 year)
Percentage change in FEV1
Percentage change in FEV1 in patients with COPD exacerbation treated with SABD via VMN versus JN
Measured: through study completion (approx 1 year)
Amount of short-acting bronchodilator medication
The amount of SABD aerosol therapy administered to patients with COPD exacerbation treated with SABD via VMN versus JN
Measured: through study completion (approx 1 year)
Hospital readmission within 30 days
Percentage of patients treated with SABD via VMN versus JN that are readmitted to the hospital within thirty days of discharge
Measured: through study completion (approx 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2017
- Study startMar 2017 (estimated)
- Primary completionMar 2018 (estimated)
- Study completionApr 2018 (estimated)
Why it stopped: Study was abandoned.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medstar Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric J Kriner, RRT, Principal investigator, Medstar Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03051971
- Sponsor's protocol ID
- 2016-281
- Status last verified
- Oct 2021
- First submitted
- 30 Jan 2017
- Last updated
- 27 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Medicated Aerosol Delivery Using A Jet Nebulizer Versus A Vibrating Mesh Nebulizer in COPD Exacerbation
- ClinicalTrials.gov ID
- NCT03051971
- Acronym / sponsor ID
- 2016-281
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study was abandoned.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medstar Health Research InstituteUniversity, hospital or other
- Study start
- Mar 2017 (estimated)
- Primary completion
- Mar 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 14 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Jet nebulizer | Active comparator | Device: Jet Nebulizershort-acting bronchodilator (albuterol and/or ipratropium bromide) according to standard of care practices and physician discretion will be administered with a jet nebulizer |
| Vibrating Mesh Nebulizer | Active comparator | Device: Vibrating Mesh Nebulizershort-acting bronchodilator (albuterol and/or ipratropium bromide) according to standard of care practices and physician discretion will be administered with a vibrating mesh nebulizer |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrating Mesh NebulizerAlso: Aergoen Ultra nebulizershort-acting bronchodilator medication delivered with a vibrating mesh nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask | Device | Vibrating Mesh Nebulizer |
| Jet NebulizerAlso: MistyFast nebulizershort-acting bronchodilator medication delivered with a jet nebulizer via mouthpiece, valved facemask or non-invasive ventilation mask | Device | Jet nebulizer |
Primary outcome
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
8 secondary outcomes
ICU admission
Time frame: through study completion (approx 1 year)
Hospital length of stay
Time frame: through study completion (approx 1 year)
NIV in escalation of respiratory support
Time frame: through study completion (approx 1 year)
Duration of NIV support
Time frame: through study completion (approx 1 year)
Intubation in escalation of respiratory support
Time frame: through study completion (approx 1 year)
Percentage change in FEV1
Time frame: through study completion (approx 1 year)
Amount of short-acting bronchodilator medication
Time frame: through study completion (approx 1 year)
Hospital readmission within 30 days
Time frame: through study completion (approx 1 year)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric J Kriner, RRT principal investigator
Medstar Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrating Mesh Nebulizer and Jet Nebulizer in people with Chronic Obstructive Pulmonary Disease, run by Medstar Health Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospitalization rate (time frame: through study completion (approx 1 year)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2021.