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Continuous Levalbuterol for Treatment of Status Asthmaticus in Children

NCT00124176 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2013-03-14

Study results available
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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.

Conditions

Interventions

DRUG

Racemic albuterol (R+S albuterol)

20mg/hr continuous racemic albuterol

DRUG

Levalbuterol (R albuterol)

10mg/hr continuous nebulized levalbuterol

Sponsors & Collaborators

Principal Investigators

  • Joseph J Zorc, MD · Children's Hospital of Philadelphia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-04-30
Primary Completion
2006-02-28
Completion
2006-02-28

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00124176 on ClinicalTrials.gov