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Effect of Nebulized Budesonide and Oral Corticosteroids on Wheezing Episode Relapse in Children (BudER)
This study has been completed.
Study NCT00189436   Information provided by West Penn Allegheny Health System
First Received: September 12, 2005   Last Updated: May 28, 2009   History of Changes

September 12, 2005
May 28, 2009
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 ]
Wheezing/Asthma/Bronchospasm relapse rate [ Time Frame: 3 weeks ]
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 ]
  • Urinary Cortisol [ Time Frame: 3 weeks ]
  • Spirometry readings [ Time Frame: 3 weeks ]
 
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.

 
Phase IV
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Asthma
  • Drug: Nebulized Budesonide
  • Drug: Usual care (albuterol with or without oral steroid)
  • Active Comparator: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks
  • 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.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) 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
David Skoner/Principal Investigator, Allegheny General Hospital
BUD ER 3425, RC - 3425
West Penn Allegheny Health System
AstraZeneca
Principal Investigator: David Skoner, MD West Penn Allegheny Health System
West Penn Allegheny Health System
May 2009

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