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

This study has been terminated.
(change in availability of study investigators)
Sponsor:
Information provided by (Responsible Party):
Jerri A. Rose, University Hospitals of Cleveland
ClinicalTrials.gov Identifier:
NCT01045174
First received: January 7, 2010
Last updated: June 13, 2012
Last verified: June 2012
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Controlled Trial Comparing the Effectiveness of a Breath-Actuated Nebulizer Device Versus a Conventional Continuous-Output Nebulizer in Treating Pediatric Asthma Patients in the Emergency Department

Resource links provided by NLM:


Further study details as provided by University Hospitals of Cleveland:

Primary Outcome Measures:
  • Rate of admission to hospital for asthma exacerbation [ Time Frame: hours (whether patient is admitted after presenting to emergency department for asthma or discharged home) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Length of stay in the emergency department after presenting for asthma exacerbation [ Time Frame: only measures length of stay in emergency department on date of presentation ] [ Designated as safety issue: No ]
  • Number of aerosolized bronchodilator treatments required during emergency department course [ Time Frame: during emergency department visit on day of presentation ] [ Designated as safety issue: No ]
  • patient's satisfaction with using assigned nebulizer (as assessed by brief survey) [ Time Frame: within time frame of emergency department stay ] [ Designated as safety issue: No ]
  • difficulty (if any) encountered by patients with using assigned nebulizer device [ Time Frame: hours (during patient's emergency department course) ] [ Designated as safety issue: No ]

Enrollment: 190
Study Start Date: December 2008
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
Device: 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.
Active Comparator: 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
Device: 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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01045174

Locations
United States, Ohio
Rainbow Babies and Children's Hospital/University Hospitals of Cleveland Pediatric Emergency Department
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals of Cleveland
Investigators
Principal Investigator: Jerri A Rose, M.D. University Hospitals of Cleveland
  More Information

No publications provided

Responsible Party: Jerri A. Rose, M.D., University Hospitals of Cleveland
ClinicalTrials.gov Identifier: NCT01045174     History of Changes
Other Study ID Numbers: UH IRB # 09-08-06
Study First Received: January 7, 2010
Last Updated: June 13, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University Hospitals of Cleveland:
Asthma
Pediatric
Emergency department
Nebulizer

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on August 19, 2014