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

This study has been completed.
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
David Skoner, MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00189436
First received: September 12, 2005
Last updated: July 8, 2014
Last verified: July 2014
  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.


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


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 ]
    Asthma relapse rate was 6.5% and 4% in the nebulized budesonide and standard care groups, respectively


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
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)

Detailed Description:

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

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, Pennsylvania
Bellevue Pediatric Associates
Bellevue, Pennsylvania, United States, 15202
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
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: David Skoner, MD, Director, Allergy and Asthma Institute, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00189436     History of Changes
Other Study ID Numbers: BUD ER 3425, RC - 3425
Study First Received: September 12, 2005
Results First Received: July 8, 2014
Last Updated: July 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by West Penn Allegheny Health System:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Albuterol
Budesonide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on August 28, 2014