Study Stopped
study halted prematurely before enrollment of first patient
Pulmicort Respules on Relapse Rates After Treatment in the ED
Budesonide
Nebulized Budesonide After Discharge From a Pediatric Emergency Department in Preventing Asthma Relapse: A Randomized, Double-Blind, Placebo Controlled Trial.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The purpose of this study is to see if the addition of budesonide to oral corticosteroids will result in a decrease in relapse rates compared to oral corticosteroids alone in children who are discharged from the ED after an asthma exacerbation. Secondly, that there will be an improvement in lung function, a decrease in beta-2 agonist use and an improvement in health-related quality of life compared to placebo.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Oct 2007
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
December 20, 2007
CompletedFirst Posted
Study publicly available on registry
January 2, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2009
CompletedJanuary 23, 2026
September 1, 2011
1.4 years
December 20, 2007
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of unplanned ED or PCP visits for asthma in the 1 month following an ED visit for an asthma exacerbation.
28 days
Secondary Outcomes (1)
Use of rescue medications, hospitalizations and quality of life questionaires.
28 days
Study Arms (1)
Pulmicort Respules
EXPERIMENTALusing pulmicort respules
Interventions
pulmicort respules 0.5 mg twice a day for 28 days versus placebo
Eligibility Criteria
You may qualify if:
- Patient is between the ages of 2 and 8
- Has previously been diagnosed with asthma by any physician
- Has presented to the ED with an asthma exacerbation judged by a physician that is believed would not required admission to the hospital
You may not qualify if:
- Children less than 2 years (wheezing may be due to bronchiolitis)
- Children who have been on oral or inhaled corticosteroid in the last week, are pregnant, or unavailable for follow-up
- Pregnant
- Has chronic lung diseases (i.e. cystic fibrosis)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Phoenix Children's Hospital
Phoenix, Arizona, 85016, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert B Bulloch, MD
Phoenix Children's Hospital
- PRINCIPAL INVESTIGATOR
Katherine Mandeville, MD
Phoenix Children's Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 2, 2008
Study Start
October 1, 2007
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
January 23, 2026
Record last verified: 2011-09