Continuous Levalbuterol for Treatment of Status Asthmaticus in Children

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Children's Hospital of Philadelphia
• Collaborator: Sunovion
• Treatments: Albuterol

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