A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

August 14, 2017 updated by: Mark Snider, Le Bonheur Children's Hospital
This study is determines if metered dose inhalers are as effective as breath actuated nebulizers for the treatment of mild to moderate asthma exacerbations in pediatric patients presenting to the emergency department. Half of the participating patients received albuterol via the metered dose inhaler whereas the other half received albuterol via the breath actuated nebulizer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Albuterol administered via metered dose inhalers with spacers are more effective than small volume nebulizers in the treatment of acute pediatric asthma exacerbations. There is also supporting data that the breath actuated nebulizers are also more effective than small volume nebulizers. The effectiveness of breath actuated nebulization compared to MDI for treating asthma exacerbations is less well defined.

Metered dose inhalers with spacers are more readily available to the general population, are easily transportable and do not require a power source. Demonstrating equal effectiveness of albuterol delivery systems for treatment of acute pediatric asthma exacerbations would enable physicians to confidently utilize clinical encounters as opportunities to educate families on management of asthma exacerbations using their home appliance.

Study Type

Interventional

Enrollment (Actual)

980

Phase

  • Not Applicable

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

Ages Eligible for Study

2 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients presenting either with a first time wheeze or with an asthma exacerbation of a mild to moderate severity, both defined by a pediatric asthma score (PAS)11 of 5 to 11.

Exclusion Criteria:

  • Subjects were excluded if they had initiated therapy at an outlying medical facility or had a history of any chronic lung disease
  • Congenital heart disease, tracheostomy, or were receiving diuretic therapy.
  • Patients diagnosed by the treating physician with bronchiolitis or pneumonia were excluded along with children who were wards of the state or whose parents did not speak English.

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
Intervention / Treatment
Active Comparator: Albuterol by Metered Dose Inhaler
Albuterol administered via MDI and spacer device with weight and severity based dosing. For weight less than 20 kg: mild and moderate disease 540mcg of albuterol per dose. For weight greater than or equal to 20 kg: mild disease 540 mcg of albuterol per dose and moderate disease 1080 mcg of albuterol per dose.
Device: Metered Dose Inhaler
A metered dose inhaler (MDI) is a small hand held pressurized canister device that contains both a medication, in this case albuterol, and a propellant. Pressing the device delivers 90mcg of albuterol. The MDI is attached to a spacer device, which is a one way holding chamber which allows the medication to be delivered over a series of breaths.
Other Names:
  • Aerochamber, AWA852-02
Active Comparator: Albuterol Breath Actuated Nebulizer
Subjects randomized to BAN were evaluated for proper breath actuation technique. For subjects unable to coordinate breath actuation, the RT attached an appropriately sized mask to the device, changed the setting to continuous nebulization and returned upon completion of the treatment. Albuterol dosing was based upon the subject's weight and presenting symptom severity. Children presenting in the mild and moderate severity category weighing less than 20kg, received 2500mcg of albuterol. Children weighing more than 20kg, received 2500mcg of albuterol if their presentation met mild severity criteria, or 5000mcg if they met moderate criteria.
Device: Breath Actuated Nebulizer
The breath actuated nebulizer (BAN) device is a device that converts liquid medication, in this case albuterol, into an aerosol. It consists of a mouthpiece, a medication reservoir, and connective tubing that attaches to a compressor. This BAN device delivers medication when the patient takes a breath, but it can be attached to a mask and set to continuous nebulization for patients that are not able to coordinate their breaths.
Other Names:
  • AeroEclipse

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participant's Admitted to the Hospital for Further Treatment
Time Frame: 6 hours
Patient disposition is measured as subjects requiring further treatment and being admitted to hospital. We record the number of patients in each cohort that required admission to the hospital after being evaluated and treated in the Emergency Department.
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Emergency Department Length of Stay
Time Frame: 6 hours
Emergency department length of stay is defined as the point of time when the patient checked into the Emergency Department to the time of final disposition.
6 hours
Number of Patients With Tachycardia After Treatment
Time Frame: 6 hours
Defined as anytime after initiation of therapy when the patient's heart rate exceeded age adjusted normal sinus rhythm heart rates for their age. Not uncommonly, patient's experience tachycardia as an unintended side effect of receiving albuterol. Tachycardia can result in a patient requiring further observation in the Emergency department and therefore increasing Emergency Department length of stay. We want to determine if indeed tachycardia is unavoidable, or if its presence suggests that patients are receiving too much albuterol or if albuterol is being given by the wrong appliance.
6 hours
Number of Patients Requiring Ondansetron Dosing
Time Frame: 6 hours
Defined as a patient needing ondansetron for symptomatic relief of their nausea after initiating therapy in the Emergency Department.
6 hours
Number of Participants Requiring Repeat Visits
Time Frame: Within 7 days of initial presentation
Defined as a repeat visit to the Emergency Department for a complaint related to their wheezing, within 7 days of initial enrollment in the study.
Within 7 days of initial presentation

Collaborators and Investigators

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

Sponsor

Le Bonheur Children's Hospital

Collaborators

University of Tennessee

Investigators

  • Principal Investigator: Mark A Snider, DO, University of Tennessee

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

October 1, 2014

Primary Completion (Actual)

April 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

May 17, 2016

First Submitted That Met QC Criteria

May 18, 2016

First Posted (Estimate)

May 19, 2016

Study Record Updates

Last Update Posted (Actual)

August 15, 2017

Last Update Submitted That Met QC Criteria

August 14, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • LeBonheurCH

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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