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

• Sponsor: Deborah Gentile (Other)
• Overall Status: Completed
• CT.gov ID: NCT00189436
• Collaborator: AstraZeneca (Industry)
• Enrollment: 61
• Locations: 2
• Arms: 2
• Duration (Months): 70.1
• Patients Per Site: 30.5
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Nebulized Budesonide; Drug: Usual care (albuterol with or without oral steroid)	Phase 4

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 61 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• 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 Start Date: Mar 1, 2003
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Jan 1, 2009

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Wheezing/Asthma/Bronchospasm Relapse Rate [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.

Secondary Outcome Measures

1. Urinary Cortisol Levels [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).

2. Forced Expiratory Volume in 1 Second (FEV1) [3 weeks]

   This was defined as the mean +/- standard deviation of FEV1 in each group (treatment with budesonide versus usual care.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 8 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bellevue Pediatric Associates	Bellevue	Pennsylvania	United States	15202
2	Allegheny General Hospital	Pittsburgh	Pennsylvania	United States	15212

Sponsors and Collaborators

• Deborah Gentile
• AstraZeneca

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Deborah Gentile, Co-Investigator, West Penn Allegheny Health System
• ClinicalTrials.gov Identifier: NCT00189436
• Other Study ID Numbers: BUD ER 3425; RC - 3425
• First Posted: Sep 19, 2005
• Last Update Posted: Feb 1, 2021
• Last Verified: Jan 1, 2021

• Keywords provided by Deborah Gentile, Co-Investigator, West Penn Allegheny Health System: Asthma
• Additional relevant MeSH terms: Respiratory Sounds; Budesonide; Albuterol

Study Results

Participant Flow

Arm/Group Title	Treatment With Budesonide	Usual Care
Arm/Group Description	Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: 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. 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)
Period Title: Overall Study
STARTED	31	30
COMPLETED	23	25
NOT COMPLETED	8	5

Baseline Characteristics

Arm/Group Title	Treatment With Budesonide	Usual Care	Total
Arm/Group Description	Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: 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. 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)	Total of all reporting groups
Overall Participants	31	30	61
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	4.8 (2.0)	5.4 (1.6)	5.1 (0.084)
Sex: Female, Male (Count of Participants)
Female	13 41.9%	10 33.3%	23 37.7%
Male	18 58.1%	20 66.7%	38 62.3%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment With Budesonide	Usual Care
Arm/Group Description	Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: 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. 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)
Measure Participants	23	25
Number [percentage of cases of asthma relapse]	8.7	4.0

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment With Budesonide	Usual Care
Arm/Group Description	Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: 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. 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)
Measure Participants	23	25
Mean (Standard Deviation) [ng cortisol/mg creatinine]	95.4 (35.3)	141.6 (42.7)

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Treatment With Budesonide	Usual Care
Arm/Group Description	Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: 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. 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)
Measure Participants	23	25
Mean (Standard Deviation) [% Predicted]	86.2 (2.5)	85.7 (3.1)

Adverse Events

Arm/Group Title	Treatment With Budesonide		Usual Care
Arm/Group Description	Subject is treated with nebulized budesonide 0.5 BID for 3 weeks Nebulized Budesonide: 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. 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)
All Cause Mortality
	Treatment With Budesonide		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Treatment With Budesonide		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)
Other (Not Including Serious) Adverse Events
	Treatment With Budesonide		Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/31 (0%)		0/30 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.