Status:
COMPLETED
Continuous Levalbuterol for Treatment of Status Asthmaticus in Children
Lead Sponsor:
Children's Hospital of Philadelphia
Collaborating Sponsors:
Sumitomo Pharma America, Inc.
Conditions:
Asthma
Eligibility:
All Genders
6-18 years
Phase:
PHASE4
Brief 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...
Detailed Description
High-dose nebulized albuterol is standard therapy for severe asthma exacerbations at The Children's Hospital of Philadelphia (CHOP) and other tertiary care pediatric hospitals throughout the United St...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT00124176
Start Date
April 1 2004
End Date
February 1 2006
Last Update
March 14 2013
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104