Clinical trial NCT02777125: A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers
Official title: A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Keywords: pediatrics
metered dose inhalers
breath actuated nebulizers
Lead sponsor: Le Bonheur Children's Hospital
Sponsor class: OTHER
Collaborators: name: University of Tennessee
First posted: 2016-05-19
Enrollment: 980
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Number of Participant's Admitted to the Hospital for Further Treatment
timeFrame: 6 hours
Secondary outcomes:
measure: Emergency Department Length of Stay
timeFrame: 6 hours
measure: Number of Patients With Tachycardia After Treatment
timeFrame: 6 hours
measure: Number of Patients Requiring Ondansetron Dosing
timeFrame: 6 hours
measure: Number of Participants Requiring Repeat Visits
timeFrame: Within 7 days of initial presentation
Other outcomes:
Locations:
Study officials:
affiliation: University of Tennessee
name: Mark A Snider, DO
role: PRINCIPAL_INVESTIGATOR
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