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Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)

NCT00585039

CompletedPhase 4

Sponsor: Phoenix Children's Hospital

Conditions: Asthma

Interventions: xopenex

Countries: United States

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.

Eligibility overview

Sex: ALL

Age: 6 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
Locations (1)
  • Phoenix, Arizona, United States