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: January 28, 2013
Last verified: January 2013

September 12, 2005
January 28, 2013
March 2003
January 2009   (final data collection date for primary outcome measure)
Wheezing/Asthma/Bronchospasm relapse rate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00189436 on ClinicalTrials.gov Archive Site
  • Urinary Cortisol [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
  • Spirometry readings [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Asthma
  • Drug: Nebulized Budesonide
    Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
  • 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)
  • Active Comparator: Treatment with Budesonide
    Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
    Intervention: Drug: Nebulized Budesonide
  • 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.
    Intervention: Drug: Usual care (albuterol with or without oral steroid)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
61
January 2009
January 2009   (final data collection date for primary outcome measure)

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
Both
1 Year to 8 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00189436
BUD ER 3425, RC - 3425
Not Provided
David Skoner, MD, West Penn Allegheny Health System
West Penn Allegheny Health System
AstraZeneca
Principal Investigator: David Skoner, MD West Penn Allegheny Health System
West Penn Allegheny Health System
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP