Phase 4
N=81
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT00124176 ↗Enrolled (actual)
81
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Duration of Continuous Therapy — 18.3; 16 Hours
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Racemic albuterol (R+S albuterol) (Drug); Levalbuterol (R albuterol) (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Children's Hospital of Philadelphia
- Primary completion
- Feb 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Duration of Continuous Therapy |
18.3; 16 | — |
| SECONDARY Change in Pediatric Asthma Severity Score |
-1.0; -0.64 | — |
| SECONDARY Heart Rate |
132; 132 | — |
| SECONDARY Serum Potassium Levels |
3.6; 3.6 | — |
| SECONDARY Serum Albuterol S Isomer Levels |
5.5; 28.6 | — |
Summary
This study will use a randomized, double-blind, controlled trial design in order to assess the safety and efficacy of levalbuterol (LEV) compared to racemic albuterol (RAC) when delivered continuously in a high-dose regimen for children with severe exacerbations of asthma.
Primary hypothesis
* Children with severe asthma receiving continuous levalbuterol will have a shorter duration of continuous therapy as compared to racemic albuterol.
Secondary hypotheses
* Children receiving continuous levalbuterol will have improved lung function measured by forced expiratory volume at 1 second (FEV1) as compared to racemic albuterol.
* Children receiving continuous levalbuterol will have improved clinical asthma score as compared to racemic albuterol.
Eligibility Criteria
Inclusion Criteria
- Age 6-18 years of age
- Diagnosis of asthma with two previous visits to emergency department (ED) or primary care provider for asthma care
- Clinical decision by ED attending physician to begin continuous albuterol after standardized initial ED treatment.
Exclusion Criteria
- Clinical decision to begin continuous intravenous beta-agonist infusion (e.g. terbutaline)
- Clinical decision to admit to the Pediatric Intensive Care Unit
- Drug allergy or other contraindication to RAC or LEV
- Other concurrent disease such as sickle cell disease, cystic fibrosis, or cardiac disease
- Pregnancy
- Prior enrollment in the study
Data sourced from ClinicalTrials.gov (NCT00124176). 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.