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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Nebulized Budesonide
Usual care (albuterol with or without oral steroid)
Sponsored by
Deborah Gentile
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Asthma

Eligibility Criteria

1 Year - 8 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bellevue Pediatric Associates
  • Allegheny General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Treatment with Budesonide

Usual care

Arm Description

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

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.

Outcomes

Primary Outcome Measures

Wheezing/Asthma/Bronchospasm Relapse Rate
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.

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2005
Last Updated
January 8, 2021
Sponsor
Deborah Gentile
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT00189436
Brief Title
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
Acronym
BudER
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
January 2009 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Deborah Gentile
Collaborators
AstraZeneca

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment with Budesonide
Arm Type
Active Comparator
Arm Description
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
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 Type
Drug
Intervention Name(s)
Nebulized Budesonide
Intervention Description
Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
Intervention Type
Drug
Intervention Name(s)
Usual care (albuterol with or without oral steroid)
Intervention Description
Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)
Primary Outcome Measure Information:
Title
Wheezing/Asthma/Bronchospasm Relapse Rate
Description
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.
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
Urinary Cortisol Levels
Description
This was defined as the mean +/- standard deviation of 12 hour urinary cortisol levels in each group (treatment with budesonide versus usual care).
Time Frame
3 weeks
Title
Forced Expiratory Volume in 1 Second (FEV1)
Description
This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.
Time Frame
3 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
8 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Skoner, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Pediatric Associates
City
Bellevue
State/Province
Pennsylvania
ZIP/Postal Code
15202
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States

12. IPD Sharing Statement

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

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