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
Results First Received: July 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Asthma
Interventions: Drug: Nebulized Budesonide
Drug: Usual care (albuterol with or without oral steroid)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Treatment With Budesonide

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

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.

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)


Participant Flow:   Overall Study
    Treatment With Budesonide     Usual Care  
STARTED     31     30  
COMPLETED     23     25  
NOT COMPLETED     8     5  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
61 subjects were enrolled and 31 were randomized to nebulized budesonide and 30 to standard of care. 74% of subjects enrolled in the nebulized budesonide and 83% enrolled in the standard care group completed the study.

Reporting Groups
  Description
Treatment With Budesonide

Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

Nebulized Budesonide: Subject is treated with nebulized budesonide 0.5 BID for 3 weeks

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.

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)

Total Total of all reporting groups

Baseline Measures
    Treatment With Budesonide     Usual Care     Total  
Number of Participants  
[units: participants]
  31     30     61  
Age  
[units: years]
Mean ± Standard Deviation
  4.8  ± 2.0     5.4  ± 1.6     5.1  ± 0.084  
Gender  
[units: participants]
     
Female     13     10     23  
Male     18     20     38  



  Outcome Measures

1.  Primary:   Wheezing/Asthma/Bronchospasm Relapse Rate   [ Time Frame: 3 weeks ]

2.  Secondary:   Urinary Cortisol   [ Time Frame: 3 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Spirometry Readings   [ Time Frame: 3 weeks ]
Results not yet posted.   Anticipated Posting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: David Skoner, MD
Organization: Allegheny Singer Research Institute, WPAHS
phone: 412-359-4099
e-mail: dskoner@wpahs.org


No publications provided


Responsible Party: David Skoner, MD, 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