Overview
Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
Status:
Completed
Completed
Trial end date:
2009-03-01
2009-03-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
Phase 4Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Phoenix Children's HospitalTreatments:
Albuterol
Criteria
Inclusion Criteria:- 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
Exclusion Criteria:
- 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