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A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

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ClinicalTrials.gov Identifier: NCT02777125
Recruitment Status : Completed
First Posted : May 19, 2016
Results First Posted : August 15, 2017
Last Update Posted : August 15, 2017
Sponsor:
Collaborator:
University of Tennessee Health Science Center
Information provided by (Responsible Party):
Mark Snider, Le Bonheur Children's Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Asthma Device: Metered Dose Inhaler Device: Breath Actuated Nebulizer Not Applicable

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  (Clinical Trial)
Actual Enrollment : 980 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers
Study Start Date : October 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


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 Name: 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 Name: AeroEclipse




Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02777125


Sponsors and Collaborators
Le Bonheur Children's Hospital
University of Tennessee Health Science Center
Investigators
Principal Investigator: Mark A Snider, DO University of Tennessee Health Science Center

Publications:
Chameides L, Ralston M, American Academy of Pediatrics, American Heart Association. Pediatric Advances Life Support. Dallas, Tx: American Heart Association;2011

Responsible Party: Mark Snider, Pediatric Emergency Medicine Fellow, Le Bonheur Children's Hospital
ClinicalTrials.gov Identifier: NCT02777125     History of Changes
Other Study ID Numbers: LeBonheurCH
First Posted: May 19, 2016    Key Record Dates
Results First Posted: August 15, 2017
Last Update Posted: August 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Mark Snider, Le Bonheur Children's Hospital:
pediatrics
metered dose inhalers
breath actuated nebulizers

Additional relevant MeSH terms:
Albuterol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action