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Completed

NCT Number: NCT02777125

A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metered Dose Inhaler

Device

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

breath actuated nebulizer

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Le Bonheur Children's Hospital

Other

Collaborators

  • University of Tennessee

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
May 19, 2016
Registry last updated
Aug 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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