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Study of Budesonide as an Addition to Standard Therapy in Adult Asthmatics in the Emergency Room.

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Jacobi Medical Center
Nassau University Medical Center
Information provided by (Responsible Party):
Robert A Silverman, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT00588406
First received: December 21, 2007
Last updated: December 15, 2015
Last verified: December 2015
Results First Received: October 12, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Budesonide
Drug: albuterol
Drug: Ipratropium bromide
Drug: Prednisone

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Budesonide

Budesonide, 2mg, 4 doses, plus standard care

Budesonide: 2mg/dose by nebulizer, four doses over 3 hours

albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours

Ipratropium bromide: 2.5 mg, one dose

Prednisone: 60mg PO

Placob

Placebo plus standard care

albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours

Ipratropium bromide: 2.5 mg, one dose

Prednisone: 60mg PO


Participant Flow:   Overall Study
    Budesonide     Placob  
STARTED     46     49  
COMPLETED     46     49  
NOT COMPLETED     0     0  



  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.
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Reporting Groups
  Description
Budesonide

Budesonide, 2mg, 4 doses, plus standard care

Budesonide: 2mg/dose by nebulizer, four doses over 3 hours

albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours

Ipratropium bromide: 2.5 mg, one dose

Prednisone: 60mg PO

Placebo

Placebo plus standard care

albuterol: 2.5mg/dose by nebulizer, 7 doses over 6 hours

Ipratropium bromide: 2.5 mg, one dose

Prednisone: 60mg PO

Total Total of all reporting groups

Baseline Measures
    Budesonide     Placebo     Total  
Number of Participants  
[units: participants]
  46     49     95  
Age  
[units: years]
Mean (Standard Deviation)
  37.2  (11.4)     42.6  (11.4)     40  (11.7)  
Gender  
[units: participants]
     
Female     29     22     51  
Male     17     27     44  
Race/Ethnicity, Customized  
[units: participants]
     
White     2     3     5  
Black     28     18     46  
Hispanic     12     20     32  
Other     2     6     8  
Unknown     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     46     49     95  
Forced expiratory volume at one second (FEV1) % predicted  
[units: percent predicted of FEV1]
Mean (Standard Deviation)
  29.5  (9.5)     29  (8.1)     29.2  (8.7)  



  Outcome Measures
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1.  Primary:   FEV1 Percent Predicted   [ Time Frame: 4 hours post-randomization ]

2.  Secondary:   Hospitalization   [ Time Frame: 6 hours ]


  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:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Robert Silverman
Organization: North Shore Long Island Jewish Health System
phone: 718-470-7501
e-mail: rsilverman@nshs.edu



Responsible Party: Robert A Silverman, North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT00588406     History of Changes
Other Study ID Numbers: 07.02.019
Study First Received: December 21, 2007
Results First Received: October 12, 2015
Last Updated: December 15, 2015
Health Authority: United States: Institutional Review Board