Phase 4
Completed N=101
Albuterol Versus Xopenex in Treatment of Acute Asthma in the Emergency Department (ED)
Source: ClinicalTrials.gov NCT00585039 ↗Enrolled (actual)
101
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcomePrimary: Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec — 19.8; 55.2 L/sec
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Forced Expiratory Volume in 1 Sec (FEV1) Measured in L/Sec |
19.8; 55.2 | — |
| SECONDARY Clinical Asthma Score (CAS) |
1.7; 3.0 | — |
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
Data sourced from ClinicalTrials.gov (NCT00585039). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.