Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children - Full Text View

Sponsor:	West Penn Allegheny Health System
Collaborator:	AstraZeneca
Information provided by:	West Penn Allegheny Health System
ClinicalTrials.gov Identifier:	NCT00189436

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 (albuterol with or without oral steroid)	Phase IV

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Budesonide Levalbuterol tartrate Corticosteroids

U.S. FDA Resources

Further study details as provided by West Penn Allegheny Health System:

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 ]

Enrollment:	61
Study Start Date:	March 2003
Study Completion Date:	January 2009
Primary Completion Date:	January 2009 (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 (albuterol with or without oral steroid) 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

Locations

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

Sponsors and Collaborators

West Penn Allegheny Health System

AstraZeneca

Investigators

Principal Investigator:

David Skoner, MD

West Penn Allegheny Health System

More Information

No publications provided

Responsible Party:	Allegheny General Hospital ( David Skoner/Principal Investigator )
Study ID Numbers:	BUD ER 3425, RC - 3425
Study First Received:	September 12, 2005
Last Updated:	May 28, 2009
ClinicalTrials.gov Identifier:	NCT00189436 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:

Asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Adrenergic Agents
Albuterol
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases

Tocolytic Agents
Therapeutic Uses
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on November 09, 2009