A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

NCT02777125 | Completed Results

• 1 other identifier: LeBonheurCH
• Study Type: interventional
• Target: 980
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma

Keywords

pediatrics; metered dose inhalers; breath actuated nebulizers

Outcome Measures

Primary Outcomes (1)

• Number of Participant's Admitted to the Hospital for Further Treatment

  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 Outcomes (4)

• Emergency Department Length of Stay

  6 hours

• Number of Patients With Tachycardia After Treatment

  6 hours

• Number of Patients Requiring Ondansetron Dosing

  6 hours

• Number of Participants Requiring Repeat Visits

  Within 7 days of initial presentation

Study Arms (2)

Albuterol by Metered Dose Inhaler

ACTIVE COMPARATOR

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

Albuterol Breath Actuated Nebulizer

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Aerochamber, AWA852-02

Albuterol by Metered Dose Inhaler

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.

Also known as: AeroEclipse

Albuterol Breath Actuated Nebulizer

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Le Bonheur Children's Hospital: lead
• University of Tennessee: collaborator

Related Publications (32)

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MeSH Terms

Conditions

Asthma

Interventions

Metered Dose Inhalers

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Nebulizers and Vaporizers; Equipment and Supplies

Limitations and Caveats

Unblinded study, eligible subjects may have been overlooked for fear of treatment failure. Recheck times were not standardized possibly affecting EDLOS and tachycardia. Baseline acuity differences between cohorts.

Results Point of Contact

• Title: Mark Snider DO, Principal Investigator
• Organization: University of Tennessee Health Sciences College of Medicine/Le Bonheur Children's Hospital

marksnider02@hotmail.com

9012875986

Study Officials

• Mark A Snider, DO

  University of Tennessee

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Emergency Medicine Fellow

Study Record Dates

• First Submitted: May 17, 2016
• First Posted: May 19, 2016
• Study Start: October 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: August 15, 2017
• Results First Posted: August 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share