Breath-Actuated Nebulizer Versus Conventional Continuous-Output Nebulizer in Pediatric Asthma Patients

November 23, 2020 updated by: Jerri A. Rose, University Hospitals Cleveland Medical Center

A Randomized Controlled Trial Comparing the Effectiveness of a Breath-Actuated Nebulizer Device Versus a Conventional Continuous-Output Nebulizer in Treating Pediatric Asthma Patients in the Emergency Department

A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. This study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
180

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children 1-17 years old with known history of asthma
  • children must be presenting to the emergency department for treatment of acute asthma
  • children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm

Exclusion Criteria:

  • concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia
  • no prior history of asthma
  • pregnancy
  • reported history of drug allergy to albuterol or ipratropium bromide
  • previous participation in the study within the preceding three weeks
  • vital sign instability/need for immediate emergency intervention to prevent clinical deterioration

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Breath-Actuated Nebulizer
Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer.
Device: Nebulizer (breath-actuated versus conventional continuous-output)
Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.
Active Comparator: Conventional continuous-ouput nebulizer
Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer
Device: Nebulizer (breath-actuated versus conventional continuous-output)
Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate of Admission to Hospital for Asthma Exacerbation
Time Frame: 24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)
Number (and percentage) of children in each study group requiring admission to the hospital for asthma exacerbation/status asthmaticus from the Pediatric Emergency Department (as opposed to being discharged to home)
24 hours (whether patient is admitted after presenting to emergency department for asthma or discharged home)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Length of Stay in the Emergency Department After Presenting for Asthma Exacerbation
Time Frame: only measures length of stay in emergency department on date of presentation
Length of stay in the emergency department measured in minutes; up to 400 minutes measured
only measures length of stay in emergency department on date of presentation
Patient's Satisfaction With Using Assigned Nebulizer (as Assessed by Brief Survey)
Time Frame: within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED)
Percentage of patients (or caregivers of younger children) who "agreed" or "strongly agreed" on a brief survey (using a 5-point Likert scale) that they would feel comfortable with using the same nebulizer device to take asthma treatments in the future. Likert-type scale was used, on which score of 1=strongly disagree, 2=disagree, 3=neither agree nor disagree (or unsure), 4=agree, and 5=strongly agree.
within time frame of emergency department stay (up to 400 minutes from initial presentation to pediatric ED)
Difficulty (if Any) Encountered by Patients With Using Assigned Nebulizer Device
Time Frame: number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes.
number of children who had difficulty using assigned nebulizer device during the timeframe of the ED visit during which the study nebulizer was used. Timeframe for outcome measure was length of single emergency department visit, up to 400 minutes.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospitals Cleveland Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jerri A Rose, M.D., University Hospitals Cleveland Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 8, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 25, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 23, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UH IRB # 09-08-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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