Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Completed · Phase 4
Conditions studied: Asthma
In brief
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.
Key facts
- Study ID
- NCT00124176
- Run by
- Children's Hospital of Philadelphia
- People needed
- 81
- Starts
- 2004-04-01
- Expected to finish
- 2006-02-01
- Last updated by the study team
- 2013-03-14
Who can join
Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
Full record on ClinicalTrials.gov
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