A Randomized Trial Comparing Metered Dose Inhalers and Breath Actuated Nebulizers

Le Bonheur Children's Hospital

Status: Completed

Conditions: Asthma

Treatments: Device: Breath Actuated Nebulizer; Device: Metered Dose Inhaler

Study type: Interventional

Funder types: Other

Identifiers

NCT02777125

LeBonheurCH

Details and patient eligibility

About

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.

Full 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.

Enrollment: 980 patients

Sex: All

Ages: 2 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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980 participants in 2 patient groups

Albuterol by Metered Dose Inhaler

Active Comparator group

Description:

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.

Treatment:

Device: Metered Dose Inhaler

Albuterol Breath Actuated Nebulizer

Active Comparator group

Description:

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.

Treatment:

Device: Breath Actuated Nebulizer