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Budesonide Inhalation Suspension for Acute Asthma in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00393367
Recruitment Status : Completed
First Posted : October 27, 2006
Results First Posted : July 25, 2011
Last Update Posted : August 10, 2012
Sponsor:
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, 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
Enrollment 179
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Saline)
Hide Arm/Group Description standardized treatment with nebulized Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized saline
Period Title: Overall Study
Started 91 88
Completed 89 81
Not Completed 2 7
Reason Not Completed
Protocol Violation             2             5
Withdrawal by Subject             0             2
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Saline) Total
Hide Arm/Group Description standardized treatment with nebulized Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized saline Total of all reporting groups
Overall Number of Baseline Participants 91 88 179
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 88 participants 179 participants
<=18 years
91
 100.0%
88
 100.0%
179
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants 88 participants 179 participants
6.2  (3.9) 6.3  (4.0) 6.2  (4.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants 88 participants 179 participants
Female
27
  29.7%
34
  38.6%
61
  34.1%
Male
64
  70.3%
54
  61.4%
118
  65.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 91 participants 88 participants 179 participants
91 88 179
1.Primary Outcome
Title Median Change in Asthma Score 2 Hours After Intervention
Hide Description The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.
Time Frame Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
Hide Outcome Measure Data
Hide Analysis Population Description
88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 88 81
Median (Full Range)
Unit of Measure: Units on a scale
-3
(-8 to 2)
-3
(-8 to 3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Normal Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.44
Comments The difference in median improvement between treatment groups was expected to be greater than 2.
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Primary Outcome
Title Mean Change in Asthma Score at 2 Hours
Hide Description The scale used is the Asthma Score published by Qureshi et al. The Asthma Score ranges from a low of 5 to maximum of 15 points. One to 3 points are given for each of 5 categories: age-based respiratory rate, oxygen saturation, wheeze, retractions, and dyspnea. For category detalails, please see the Qureshi reference. Scores of 5-7 are considered mild, 8-11 moderate, and 12-15 severe. Asthma Scores are recorded prior to any intervention and at 2 hours after budesonide inhalation suspension/albuterol intervention or saline placebo/albuterol comparator.
Time Frame Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
Hide Outcome Measure Data
Hide Analysis Population Description
88 of the 91 patients randomized to budesonide were evaluable for the primary outcome (1 was discharged home, 1 had no 2 hour score, and 1 did not have a valid initial score). 81 of the 89 patients randomized to placebo were evaluable (1 inadvertently received standard therapy, 2 withdrew, and 5 were admitted before a 2 hour score evaluation).
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 88 81
Mean (95% Confidence Interval)
Unit of Measure: Units on a scale
-2.9
(-3.4 to -2.4)
-3.0
(-3.5 to -2.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Normal Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.1
Confidence Interval (2-Sided) 95%
-0.6 to 0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.36
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Number of Patients Hospitalized
Hide Description The number of patients requiring hospital admission 4 hours after budesonide/albuterol intervention or saline/albuterol comparator. All hospitalization decisions are made at the discretion of the attending physician.
Time Frame within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Saline)
Hide Arm/Group Description:
standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
standardized treatment with nebulized saline
Overall Number of Participants Analyzed 91 89
Measure Type: Number
Unit of Measure: Participants
56 55
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-0.14 to 0.14
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Change in Mean Heart Rate
Hide Description Mean of heart rate in beats per minute before treatment minus mean of heart rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol
Time Frame From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 82 72
Mean (95% Confidence Interval)
Unit of Measure: Beats per minute
12
(7 to 17)
13
(9 to 17)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Normal Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1
Confidence Interval (2-Sided) 95%
-7 to 6
Parameter Dispersion
Type: Standard Error of the mean
Value: 3
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Mean Change in Respiratory Rate.
Hide Description Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.
Time Frame Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 83 71
Mean (95% Confidence Interval)
Unit of Measure: Breaths per minute
-6
(-8 to -3)
-6
(-8 to -4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Normal Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-3 to 3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.6
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Oxygen Saturation.
Hide Description Mean oxygen saturation (non-invasive pulse-oximetry, % hemoglobin saturation) 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator minus mean oxygen saturation before treatment.
Time Frame 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 72 64
Mean (95% Confidence Interval)
Unit of Measure: Percent Hemoglobin Saturation
1.0
(0.3 to 1.6)
1.0
(0.2 to 1.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Normal Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0
Confidence Interval (2-Sided) 95%
-1 to 1
Parameter Dispersion
Type: Standard Error of the mean
Value: .49
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Number of Subjects Remaining in the Severe Asthma Category
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 27
Measure Type: Number
Unit of Measure: Participants
4 4
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Normal Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.03
Confidence Interval 95%
-0.20 to 0.14
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category
Hide Description Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the moderate category (Asthma Severity score 8-11) 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 27
Measure Type: Number
Unit of Measure: Participants
22 11
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Normal Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.08
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value 0.22
Confidence Interval (2-Sided) 95%
-0.02 to 0.47
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Number of Subjects Moving From the Severe Asthma to Mild Asthma Category
Hide Description Of the patients who presented in the severe asthma category (Asthma Severity score of 12-15), those who moved to the mild category (Asthma Severity score 5-7) 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
Hide Outcome Measure Data
Hide Analysis Population Description
Number of patients who presented in the severe asthma category (Asthma Score 12-15) who moved to the moderate asthma category (Asthma Score 8-11) 2 hours after either the intervention with budesonide/albuterol or saline/albuterol comparator.
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 35 27
Measure Type: Number
Unit of Measure: Participants
8 10
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Budesonide Inhalation Suspension (BIS), Placebo (Normal Saline)
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.22
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Method of Estimation Estimation Parameter Risk Difference (RD)
Estimated Value -0.14
Confidence Interval (2-Sided) 95%
-0.37 to 0.08
Estimation Comments [Not Specified]
10.Secondary Outcome
Title Relapse / Readmission Numbers.
Hide Description Participants admitted to the hospital within 5 days of the ED visit
Time Frame within 5 days of ED visit
Hide Outcome Measure Data
Hide Analysis Population Description
89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 89 85
Measure Type: Number
Unit of Measure: Participants
2 2
11.Secondary Outcome
Title Number of Participants With Adverse Events (Non-serious).
Hide Description [Not Specified]
Time Frame within 30 days of the ED visit
Hide Outcome Measure Data
Hide Analysis Population Description
Of the 180 patients randomized, 91 were to BIS, 89 were to placebo. Two patients were lost to follow-up in the BIS group and 4 in the placebo group.
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Normal Saline)
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 89 85
Measure Type: Number
Unit of Measure: Participants
Rhinorrhea 6 11
Headache 5 9
Diarrhea 3 7
Sore throat 4 3
Cough 2 3
Hyperglycemia 2 0
12.Secondary Outcome
Title Serious Adverse Events
Hide Description Serious Adverse Events
Time Frame 0-5 days
Hide Outcome Measure Data
Hide Analysis Population Description
89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Saline)
Hide Arm/Group Description:
standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)
standardized treatment with nebulized saline
Overall Number of Participants Analyzed 89 85
Measure Type: Number
Unit of Measure: participants
Return within 5 days with hosptial admission 2 2
Increased level of care 1 0
Time Frame 30 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Budesonide Inhalation Suspension (BIS) Placebo (Saline)
Hide Arm/Group Description standardized treatment with nebulized Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized saline
All-Cause Mortality
Budesonide Inhalation Suspension (BIS) Placebo (Saline)
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Budesonide Inhalation Suspension (BIS) Placebo (Saline)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/91 (3.30%)      2/88 (2.27%)    
Respiratory, thoracic and mediastinal disorders     
Hospitalization within 5 days of Emergency Department discharge home *  2/91 (2.20%)  2 2/88 (2.27%)  2
Increased level of care *  1/91 (1.10%)  1 0/88 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Budesonide Inhalation Suspension (BIS) Placebo (Saline)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   30/91 (32.97%)      27/91 (29.67%)    
Blood and lymphatic system disorders     
epistaxis *  3/91 (3.30%)  3 1/91 (1.10%)  1
Gastrointestinal disorders     
diarrhea *  3/91 (3.30%)  3 7/91 (7.69%)  7
emesis *  4/91 (4.40%)  4 6/91 (6.59%)  6
stomach ache *  1/91 (1.10%)  1 3/91 (3.30%)  3
Infections and infestations     
sore throat *  4/91 (4.40%)  4 3/91 (3.30%)  3
fever *  3/91 (3.30%)  3 3/91 (3.30%)  3
ear infection *  0/91 (0.00%)  0 3/91 (3.30%)  3
respiratory infection *  4/91 (4.40%)  4 1/91 (1.10%)  1
Metabolism and nutrition disorders     
hyperglycemia *  2/91 (2.20%)  2 0/91 (0.00%)  0
Musculoskeletal and connective tissue disorders     
leg pain *  1/91 (1.10%)  1 2/91 (2.20%)  2
Nervous system disorders     
headache *  5/91 (5.49%)  5 9/91 (9.89%)  9
Respiratory, thoracic and mediastinal disorders     
rhinorrhea *  6/91 (6.59%)  6 11/91 (12.09%)  11
cough *  2/91 (2.20%)  2 3/91 (3.30%)  3
chest pain *  2/91 (2.20%)  2 2/91 (2.20%)  2
*
Indicates events were collected by non-systematic assessment
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
Layout table for Results Point of Contact information
Name/Title: Cynthia J. Mollen
Organization: The Children's Hospital of Philadelphia
Phone: 215-590-4410
EMail: mollenc@email.chop.edu
Layout table for additonal information
Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT00393367    
Other Study ID Numbers: 2006-8-4875
First Submitted: October 25, 2006
First Posted: October 27, 2006
Results First Submitted: April 9, 2010
Results First Posted: July 25, 2011
Last Update Posted: August 10, 2012