Phase 4 Completed N=81 Randomized Quadruple-blind Treatment

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children

Asthma

Source: ClinicalTrials.gov NCT00124176 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2013

Primary outcomePrimary: Duration of Continuous Therapy — 18.3; 16 Hours

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.