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

NCT ID: NCT01045174

Last Updated: 2020-11-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Keywords

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Asthma Pediatric Emergency department Nebulizer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Breath-Actuated Nebulizer

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.

Group Type ACTIVE_COMPARATOR

Nebulizer (breath-actuated versus conventional continuous-output)

Intervention Type DEVICE

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. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.

Conventional continuous-ouput nebulizer

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

Group Type ACTIVE_COMPARATOR

Nebulizer (breath-actuated versus conventional continuous-output)

Intervention Type DEVICE

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. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.

Interventions

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Nebulizer (breath-actuated versus conventional continuous-output)

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. Standard unit doses of albuterol/ipratropium bromide or albuterol are used in both devices.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospitals Cleveland Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Jerri A. Rose

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jerri A Rose, M.D.

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

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Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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UH IRB # 09-08-06

Identifier Type: -

Identifier Source: org_study_id