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

January 8, 2021 updated by: Deborah Gentile

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

61

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Bellevue, Pennsylvania, United States, 15202
        • Bellevue Pediatric Associates
      • Pittsburgh, Pennsylvania, United States, 15212
        • Allegheny General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 8 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Treatment with Budesonide
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Drug: Nebulized Budesonide
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
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.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wheezing/Asthma/Bronchospasm Relapse Rate
Time Frame: 3 weeks
This was defined as the percentage of subjects in each group (treatment with budesonide versus usual care) having an unscheduled acute visit to primary care, urgent care or an emergency department during the study period.
3 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urinary Cortisol Levels
Time Frame: 3 weeks
This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care).
3 weeks
Forced Expiratory Volume in 1 Second (FEV1)
Time Frame: 3 weeks
This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.
3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Deborah Gentile

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: David Skoner, MD, West Penn Allegheny Health System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 19, 2005

Study Record Updates

Last Update Posted (Actual)

February 1, 2021

Last Update Submitted That Met QC Criteria

January 8, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BUD ER 3425
  • RC - 3425 (Other Identifier: Institutional/Allegheny Singer Research Institute)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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