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Budesonide Inhalation Suspension for Acute Asthma in Children
This study has been completed.
Study NCT00393367   Information provided by Children's Hospital of Philadelphia

First Received on October 25, 2006.   Last Updated on June 24, 2011   History of Changes
Results First Received: April 9, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Asthma
Acute Asthma
Reactive Airway Exacerbation
Interventions: Drug: Budesonide inhalation suspension (0.5 mg/2mL) 2mg, albuterol (5mg/mL) 7.5 or 10mg
Drug: Prednisolone, prednisone, or methylprednisolone
Drug: Albuterol, ipratropium bromide
Drug: Ipratropium bromide

  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
No text entered.

Reporting Groups
  Description
Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
Placebo (Saline) standardized treatment with nebulized saline

Participant Flow:   Overall Study
    Budesonide Inhalation Suspension (BIS)     Placebo (Saline)  
STARTED     91     88  
COMPLETED     89     81  
NOT COMPLETED     2     7  
Protocol Violation                 2                 5  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
Placebo (Saline) standardized treatment with nebulized saline

Baseline Measures
    Budesonide Inhalation Suspension (BIS)     Placebo (Saline)     Total  
Number of Participants  
[units: participants]
 		  91     88     179  
Age  
[units: participants]
 		     
<=18 years     91     88     179  
Between 18 and 65 years     0     0     0  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation 		  6.2  ± 3.9     6.3  ± 4.0     6.2  ± 4.0  
Gender  
[units: participants]
 		     
Female     27     34     61  
Male     64     54     118  
Region of Enrollment  
[units: participants]
 		     
United States     91     88     179  



  Outcome Measures
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1.  Primary:   Median Change in Asthma Score 2 Hours After Intervention   [ Time Frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator ]
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2.  Primary:   Mean Change in Asthma Score at 2 Hours   [ Time Frame: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator ]
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3.  Secondary:   Number of Patients Hospitalized   [ Time Frame: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo ]
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4.  Secondary:   Change in Mean Heart Rate   [ Time Frame: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator ]
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5.  Secondary:   Mean or Change in Respiratory Rate.   [ Time Frame: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator ]
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6.  Secondary:   Oxygen Saturation.   [ Time Frame: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator ]
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7.  Secondary:   Number of Subjects Remaining in the Severe Asthma Category   [ Time Frame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator ]
  Show Outcome Measure 7

8.  Secondary:   Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category   [ Time Frame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator ]
  Show Outcome Measure 8

9.  Secondary:   Number of Subjects Moving From the Severe Asthma to Mild Asthma Category   [ Time Frame: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator ]
  Show Outcome Measure 9

10.  Secondary:   Relapse / Readmission Numbers.   [ Time Frame: within 5 days of ED visit ]
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11.  Secondary:   Adverse Events (Non-serious).   [ Time Frame: within 30 days of the ED visit ]
  Show Outcome Measure 11

12.  Secondary:   Serious Adverse Events   [ Time Frame: 0-5 days ]
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  Serious Adverse Events
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  Other Adverse Events
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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.


Limitations and Caveats
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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Results Point of Contact:  
Name/Title: Cynthia J. Mollen
Organization: The Children's Hospital of Philadelphia
phone: 215-590-4410
e-mail: mollenc@email.chop.edu


Publications:
Edmonds ML, Camargo CA Jr, Pollack CV Jr, Rowe BH. Early use of inhaled corticosteroids in the emergency department treatment of acute asthma. Cochrane Database Syst Rev. 2003;(3):CD002308. Review.
Qureshi F, Pestian J, Davis P, Zaritsky A. Effect of nebulized ipratropium on the hospitalization rates of children with asthma. N Engl J Med. 1998 Oct 8;339(15):1030-5.
Sung L, Osmond MH, Klassen TP. Randomized, controlled trial of inhaled budesonide as an adjunct to oral prednisone in acute asthma. Acad Emerg Med. 1998 Mar;5(3):209-13.
Devidayal, Singhi S, Kumar L, Jayshree M. Efficacy of nebulized budesonide compared to oral prednisolone in acute bronchial asthma. Acta Paediatr. 1999 Aug;88(8):835-40.
Scarfone RJ, Loiselle JM, Wiley JF 2nd, Decker JM, Henretig FM, Joffe MD. Nebulized dexamethasone versus oral prednisone in the emergency treatment of asthmatic children. Ann Emerg Med. 1995 Oct;26(4):480-6.
Nuhoglu Y, Atas E, Nuhoglu C, Iscan M, Ozcay S. Acute effect of nebulized budesonide in asthmatic children. J Investig Allergol Clin Immunol. 2005;15(3):197-200.
Schuh S, Reisman J, Alshehri M, Dupuis A, Corey M, Arseneault R, Alothman G, Tennis O, Canny G. A comparison of inhaled fluticasone and oral prednisone for children with severe acute asthma. N Engl J Med. 2000 Sep 7;343(10):689-94.


Responsible Party: Cynthia J. Mollen, MD, Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00393367     History of Changes
Other Study ID Numbers: 2006-8-4875
Study First Received: October 25, 2006
Results First Received: April 9, 2010
Last Updated: June 24, 2011
Health Authority: United States: Institutional Review Board





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