Breath-Actuated Nebulizer Versus Conventional Continuous-Output Nebulizer in Pediatric Asthma Patients

University Hospitals (UH)

Status: Terminated

Conditions: Asthma

Treatments: Device: Nebulizer (breath-actuated versus conventional continuous-output)

Study type: Interventional

Funder types: Other

Identifiers

NCT01045174

UH IRB # 09-08-06

Details and patient eligibility

About

A Breath-Actuated Nebulizer is a newer type of nebulizer device that creates aerosol only when a patient is inhaling, rather than creating aerosol continuously. It is thought that breath-actuated nebulizer devices may deliver asthma rescue medications to patients' lungs more effectively and therefore lead them to recover from asthma attacks faster than conventional continuous-output nebulizer devices. This study compares outcomes including hospital admission rates, number of nebulized treatments required, and patient/family satisfaction when a breath-actuated nebulizer device versus a conventional continuous-output nebulizer is used to deliver asthma medications to pediatric asthma patients in the emergency department.

Enrollment: 180 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• children 1-17 years old with known history of asthma
• children must be presenting to the emergency department for treatment of acute asthma
• children must qualify to be treated for acute asthma according to an existing standardized asthma care algorithm

Exclusion criteria

• concomitant chronic respiratory or cardiac disease such as cystic fibrosis, congenital heart disease, or bronchopulmonary dysplasia
• no prior history of asthma
• pregnancy
• reported history of drug allergy to albuterol or ipratropium bromide
• previous participation in the study within the preceding three weeks
• vital sign instability/need for immediate emergency intervention to prevent clinical deterioration

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

180 participants in 2 patient groups

Breath-Actuated Nebulizer

Active Comparator group

Description:

Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer.

Treatment:

Device: Nebulizer (breath-actuated versus conventional continuous-output)

Conventional continuous-ouput nebulizer

Active Comparator group

Description:

Participants are randomly assigned to receive bronchodilator treatments for asthma according to the standard of care using either a breath-actuated nebulizer device or a conventional continuous-output nebulizer

Treatment:

Device: Nebulizer (breath-actuated versus conventional continuous-output)