Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
Xopenex
Comparison of Hospital Admission Rates and Plasma(s)-Albuterol Levels in Children Treated With Racemic Albuterol Versus Levalbuterol for Acute Asthma Exacerbations: A Randomized Double-Blind Clinical Trial
1 other identifier
interventional
101
1 country
1
Brief Summary
The purpose of this study is to determine in a large, double-blind, randomized, prospective pediatric clinical trial whether the use of continuous levalbuterol (Xopenex) in addition to standard emergency department treatment for acute asthma exacerbations will improve the Forced Expiratory Volume in 1 sec (FEV 1) compared to the use of continuous racemic albuterol. The secondary objective is to correlate clinical (hospitalization rates and clinical asthma scores) with plasma levels of (S)-albuterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 asthma
Started Sep 2005
Longer than P75 for phase_4 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2005
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
CompletedResults Posted
Study results publicly available
August 16, 2011
CompletedFebruary 10, 2026
September 1, 2011
3.5 years
December 20, 2007
March 17, 2011
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec
Baseline and 4 hours
Secondary Outcomes (1)
Clinical Asthma Score (CAS)
4 hours
Study Arms (1)
A
EXPERIMENTALlevalbuterol nebulization
Interventions
will receive xopenex rather than albuterol to treat acute exacerbation
Eligibility Criteria
You may qualify if:
- Patient is between the ages of 6 and 17
- Has previously been diagnosed with asthma by any physician
- Has presented to the ED with an asthma exacerbation judged by a physician to be of a moderate or severe degree
You may not qualify if:
- Requires immediate resuscitation (attending physician)
- Is pregnant and/or breast feeding
- If possibly pregnant, negative pregnancy test attached
- Has chronic lung diseases (i.e. cystic fibrosis)
- Has an uncorrected congenital heart diseaseHas a suspected foreign body aspiration
- Is allergic to albuterol and/or levalbuterol (Xopenex)
- Has an initial FEV 1\>70% predicted
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)
Results Point of Contact
- Title
- Dr Blake Bulloch
- Organization
- Phoenix Children's Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Bulloch, MD
Phoenix Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 20, 2007
First Posted
January 2, 2008
Study Start
September 1, 2005
Primary Completion
March 1, 2009
Study Completion
March 1, 2009
Last Updated
February 10, 2026
Results First Posted
August 16, 2011
Record last verified: 2011-09