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

This study has been completed.

Sponsor:

Collaborator:

AstraZeneca

Information provided by (Responsible Party):

David Skoner, MD, West Penn Allegheny Health System

ClinicalTrials.gov Identifier:

NCT00189436

First received: September 12, 2005

Last updated: January 28, 2013

Last verified: January 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

January 28, 2013

Start Date ^ICMJE

March 2003

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Wheezing/Asthma/Bronchospasm relapse rate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00189436 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Urinary Cortisol [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Spirometry readings [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Pilot Study to Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Pediatric Patients Following Discharge From the Emergency Department/Outpatient Care Facility

Brief 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. Secondary outcomes include urinary cortisol-creatinine rations, symptom severity scores and peak flow rates.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Condition ^ICMJE

Asthma

Intervention ^ICMJE

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)

Study Arm (s)

Active Comparator: Treatment with Budesonide
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Intervention: Drug: Nebulized Budesonide
Active Comparator: Usual care
Subject is treated with usual care as provided by the doctor. Usual care normally consists of treatment with albuterol with or without an oral steroid.

Intervention: Drug: Usual care (albuterol with or without oral steroid)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

January 2009

Primary Completion Date

January 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Children ages 1-8 years old
Discharge from emergency department/outpatient clinic with a diagnosis of asthma exacerbation after usual standard care
Subjects must be able to show efficient use with a jet nebulizer

Exclusion Criteria:

Subjects requiring hospitalization
Subjects receiving oral steroids 1 week prior to presentation to emergency department.
Subjects with FEV1 < 50% of predicted
Subjects with co-morbid medical conditions (renal or cardiovascular disease)
Subjects with reported history of HIV
Subjects unable to follow up for study visits
Subjects who are frequently enuretic

Gender

Both

Ages

1 Year to 8 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00189436

Other Study ID Numbers ^ICMJE

BUD ER 3425, RC - 3425

Has Data Monitoring Committee

Not Provided

Responsible Party

David Skoner, MD, West Penn Allegheny Health System

Study Sponsor ^ICMJE

West Penn Allegheny Health System

Collaborators ^ICMJE

AstraZeneca

Investigators ^ICMJE

Principal Investigator:

David Skoner, MD

West Penn Allegheny Health System

Information Provided By

West Penn Allegheny Health System

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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