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Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children

NCT00189436 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2021-02-01

Study results available
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Summary

Subjects aged 1-8 years who have been discharged from the emergency department/outpatient care facility with a diagnosis of asthma/bronchospasm/wheezing after usual standard care will be enrolled into this open-label, randomized, parallel-group study to compare the efficacy of nebulized budesonide and oral corticosteroids in preventing asthma exacerbation relapse rates during the 21-day follow-up period.

Conditions

Interventions

DRUG

Nebulized Budesonide

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

DRUG

Usual care (albuterol with or without oral steroid)

Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)

Sponsors & Collaborators

  • AstraZeneca

    collaborator INDUSTRY

  • Deborah Gentile

    lead OTHER

Principal Investigators

  • David Skoner, MD · West Penn Allegheny Health System

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-03-31
Primary Completion
2009-01-31
Completion
2009-01-31

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 NCT00189436 on ClinicalTrials.gov