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

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ClinicalTrials.gov Identifier: NCT01045174
Recruitment Status : Terminated (change in availability of study investigators)
First Posted : January 8, 2010
Last Update Posted : June 14, 2012
Sponsor:
Information provided by (Responsible Party):
Jerri A. Rose, University Hospitals Cleveland Medical Center

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Device: Nebulizer (breath-actuated versus conventional continuous-output) Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : December 2008
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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) ]

Secondary Outcome Measures :
  1. 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 ]
  2. Number of aerosolized bronchodilator treatments required during emergency department course [ Time Frame: during emergency department visit on day of presentation ]
  3. patient's satisfaction with using assigned nebulizer (as assessed by brief survey) [ Time Frame: within time frame of emergency department stay ]
  4. difficulty (if any) encountered by patients with using assigned nebulizer device [ Time Frame: hours (during patient's emergency department course) ]


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Ages Eligible for Study:   1 Year to 17 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 Cleveland Medical Center
Investigators
Principal Investigator: Jerri A Rose, M.D. University Hospitals Cleveland Medical Center

Responsible Party: Jerri A. Rose, M.D., University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT01045174     History of Changes
Other Study ID Numbers: UH IRB # 09-08-06
First Posted: January 8, 2010    Key Record Dates
Last Update Posted: June 14, 2012
Last Verified: June 2012

Keywords provided by Jerri A. Rose, University Hospitals Cleveland Medical Center:
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
Anti-Asthmatic Agents
Respiratory System Agents