Text Size

Budesonide Inhalation Suspension for Acute Asthma in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier:
NCT00393367
First received: October 25, 2006
Last updated: August 6, 2012
Last verified: August 2012
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
  Hide Participant Flow

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
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
  Hide Baseline Characteristics

Reporting Groups
  Description
Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
Placebo (Saline) standardized treatment with nebulized saline
Total Total of all reporting groups

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
  Show All Outcome Measures

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 ]
  Show Outcome Measure 1

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 ]
  Show Outcome Measure 2

3.  Secondary:   Number of Patients Hospitalized   [ Time Frame: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo ]
  Show Outcome Measure 3

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 ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change in Respiratory Rate.   [ Time Frame: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator ]
  Show Outcome Measure 5

6.  Secondary:   Oxygen Saturation.   [ Time Frame: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator ]
  Show Outcome Measure 6

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 ]
  Hide Outcome Measure 7

Measure Type Secondary
Measure Title Number of Subjects Remaining in the Severe Asthma Category
Measure Description Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who remained in this category 2 hours after the budesonide/albuterol intervention or saline/albuterol comparator.
Time Frame From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator  
Safety Issue No  

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.
Number of patients who presented in the severe asthma category (Asthma Score 12-15) who remained in that category 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.

Reporting Groups
  Description
Budesonide Inhalation Suspension (BIS) No text entered.
Placebo (Normal Saline) No text entered.

Measured Values
    Budesonide Inhalation Suspension (BIS)     Placebo (Normal Saline)  
Number of Participants Analyzed  
[units: participants]
 		  35     27  
Number of Subjects Remaining in the Severe Asthma Category  
[units: Participants]
 		  4     4  


Statistical Analysis 1 for Number of Subjects Remaining in the Severe Asthma Category
Groups [1] All groups
Method [2] Chi-squared
P Value [3] 0.69
Risk Difference (RD) [4] -0.03
95% Confidence Interval ( -0.20 to 0.14 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  No text entered.
[2] Other relevant information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.
[4] Other relevant estimation information:
  No text entered.



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 ]
  Show Outcome Measure 10

11.  Secondary:   Number of Participants With 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 ]
  Show Outcome Measure 12


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide More Information

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
No text entered.  


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:


Responsible Party: 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: August 6, 2012
Health Authority: United States: Institutional Review Board