Evaluate the Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children Following Discharge From the ER/Outpatient Care Facility - Full Text View

Purpose

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.

Condition	Intervention	Phase
Asthma	Drug: Nebulized Budesonide Drug: Usual care	Phase IV

MedlinePlus related topics:

Asthma

ChemIDplus related topics:

Corticosteroids Albuterol sulfate Albuterol Levalbuterol hydrochloride Levalbuterol tartrate Budesonide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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

Further study details as provided by Allegheny General Hospital:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	132
Study Start Date:	March 2003
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Treatment with Budesonide: Active Comparator 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
Usual care: Active Comparator 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 Subject is treated with usual care as prescribed by the doctor (normally albuterol with or without oral steroid)

Eligibility

Ages Eligible for Study:	1 Year to 8 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189436

Contacts


Contact: Jennifer Koehrsen, MS, CCRC	412-359-6988	jkoehrse@wpahs.org

Locations


United States, Pennsylvania
	Allegheny General Hospital	Recruiting
	Pittsburgh, Pennsylvania, United States, 15212
	Contact: Jennifer Koehrsen, MS 412-359-6988 jkoehrse@wpahs.org
	Principal Investigator: David Skoner, MD
	Bellevue Pediatric Associates	Recruiting
	Bellevue, Pennsylvania, United States, 15202
	Contact: Timothy Kesslar 412-761-1190 tkesslar@wpahs.org
	Sub-Investigator: Gregory Hoyson, MD

Sponsors and Collaborators

Allegheny General Hospital

AstraZeneca

Investigators


Principal Investigator:	David Skoner, MD	Allegheny General Hospital

More Information

Responsible Party:	Allegheny General Hospital ( David Skoner/Principal Investigator )
Study ID Numbers:	BUD ER 3425, RC - 3425
First Received:	September 12, 2005
Last Updated:	January 25, 2008
ClinicalTrials.gov Identifier:	NCT00189436
Health Authority:	United States: Institutional Review Board

Keywords provided by Allegheny General Hospital:

Asthma

Study placed in the following topic categories:

Hypersensitivity

Lung Diseases, Obstructive

Respiratory Tract Diseases

Lung Diseases

Albuterol

Budesonide

Hypersensitivity, Immediate

Emergencies

Asthma

Respiratory Hypersensitivity

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Respiratory System Agents

Bronchial Diseases

Immune System Diseases

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Anti-Asthmatic Agents

Glucocorticoids

Hormones

Pharmacologic Actions

Autonomic Agents

Therapeutic Uses

Peripheral Nervous System Agents

Bronchodilator Agents

ClinicalTrials.gov processed this record on September 22, 2008

Sponsors and Collaborators:	Allegheny General Hospital AstraZeneca
Information provided by:	Allegheny General Hospital
ClinicalTrials.gov Identifier:	NCT00189436