CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 81 enrolled
Drug / intervention
Racemic albuterol (R+S albuterol) +1 moredrug
Likely dose
Racemic albuterol 20 mg/hr continuous nebulized OR Levalbuterol 10 mg/hr continuous nebulizedAI-extracted
Key inclusion· 3
  • Age 6-18 years
  • Diagnosis of asthma with at least two prior ED or primary care visits for asthma
  • ED attending physician decision to initiate continuous albuterol after standard ED treatment
Key exclusion· 6
  • Plan for continuous IV beta-agonist infusion (e.g., terbutaline)
  • Plan for PICU admission
  • Allergy or contraindication to racemic albuterol or levalbuterol
  • Concurrent disease: sickle cell, cystic fibrosis, or cardiac disease

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00124176
NCT00124176Phase 4Completed

Continuous Levalbuterol for Treatment of Status Asthmaticus in Children

Children's Hospital of Philadelphia·interventional·Posted Jul 27, 2005·Updated Mar 14, 2013

In Brief

A Phase 4 clinical trial evaluating Racemic albuterol (R+S albuterol) and Levalbuterol (R albuterol) for Asthma. Completed, enrolled 81 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited States

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 27, 2005
Enrollment StartApr 1, 2004
Primary CompletionFeb 1, 2006
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.9 years ago

Interventions

Racemic albuterol (R+S albuterol)drug

20mg/hr continuous racemic albuterol

Levalbuterol (R albuterol)drug

10mg/hr continuous nebulized levalbuterol