Trial Outcomes & Findings for Budesonide Inhalation Suspension for Acute Asthma in Children (NCT NCT00393367)

NCT ID: NCT00393367

Last Updated: 2012-08-10

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 179 participants
• Primary outcome timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator
• Results posted on: 2012-08-10

Participant Flow

Participant milestones

Measure	Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)	Placebo (Saline) standardized treatment with nebulized saline
Overall Study STARTED	91	88
Overall Study COMPLETED	89	81
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Measure	Budesonide Inhalation Suspension (BIS) standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)	Placebo (Saline) standardized treatment with nebulized saline
Overall Study Protocol Violation	2	5
Overall Study Withdrawal by Subject	0	2

Baseline Characteristics

Budesonide Inhalation Suspension for Acute Asthma in Children

Baseline characteristics by cohort

Measure	Budesonide Inhalation Suspension (BIS) n=91 Participants standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)	Placebo (Saline) n=88 Participants standardized treatment with nebulized saline	Total n=179 Participants Total of all reporting groups
Age, Categorical <=18 years	91 Participants n=5 Participants	88 Participants n=7 Participants	179 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age Continuous	6.2 years STANDARD_DEVIATION 3.9 • n=5 Participants	6.3 years STANDARD_DEVIATION 4.0 • n=7 Participants	6.2 years STANDARD_DEVIATION 4.0 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	34 Participants n=7 Participants	61 Participants n=5 Participants
Sex: Female, Male Male	64 Participants n=5 Participants	54 Participants n=7 Participants	118 Participants n=5 Participants
Region of Enrollment United States	91 participants n=5 Participants	88 participants n=7 Participants	179 participants n=5 Participants

PRIMARY outcome

Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

Population: 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).

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.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=88 Participants	Placebo (Normal Saline) n=81 Participants
Median Change in Asthma Score 2 Hours After Intervention	-3 Units on a scale Interval -8.0 to 2.0	-3 Units on a scale Interval -8.0 to 3.0

PRIMARY outcome

Timeframe: Initial asthma score minus score 2 hours after budesonide/albuterol intervention or saline placebo/albuterol comparator

Population: 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).

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.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=88 Participants	Placebo (Normal Saline) n=81 Participants
Mean Change in Asthma Score at 2 Hours	-2.9 Units on a scale Interval -3.4 to -2.4	-3.0 Units on a scale Interval -3.5 to -2.5

SECONDARY outcome

Timeframe: within 4 hours after the budesonide/albuterol intervention or saline/albuterol placebo

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.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=91 Participants	Placebo (Normal Saline) n=89 Participants
Number of Patients Hospitalized	56 Participants	55 Participants

SECONDARY outcome

Timeframe: From the initial heart rate to heart rate 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

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

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=82 Participants	Placebo (Normal Saline) n=72 Participants
Change in Mean Heart Rate	12 Beats per minute Interval 7.0 to 17.0	13 Beats per minute Interval 9.0 to 17.0

SECONDARY outcome

Timeframe: Initial rate, minus rate taken 2 hours after budesonide/albuterol intervention or saline/albuterol comparator

Mean respiratory rate in breaths per minute before treatment minus respiratory rate 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=83 Participants	Placebo (Normal Saline) n=71 Participants
Mean Change in Respiratory Rate.	-6 Breaths per minute Interval -8.0 to -3.0	-6 Breaths per minute Interval -8.0 to -4.0

SECONDARY outcome

Timeframe: 2 hours after treatment with either budesonide/albuterol or saline/albuterol comparator

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.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=72 Participants	Placebo (Normal Saline) n=64 Participants
Oxygen Saturation.	1.0 Percent Hemoglobin Saturation Interval 0.3 to 1.6	1.0 Percent Hemoglobin Saturation Interval 0.2 to 1.7

SECONDARY outcome

Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

Population: 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.

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.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=35 Participants	Placebo (Normal Saline) n=27 Participants
Number of Subjects Remaining in the Severe Asthma Category	4 Participants	4 Participants

SECONDARY outcome

Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

Population: 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.

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.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=35 Participants	Placebo (Normal Saline) n=27 Participants
Number of Subjects Moving From the Severe Asthma to Moderate Asthma Category	22 Participants	11 Participants

SECONDARY outcome

Timeframe: From the initial score to 2 hours after intervention with budesonide/albuterol or saline/albuterol comparator

Population: 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.

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.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=35 Participants	Placebo (Normal Saline) n=27 Participants
Number of Subjects Moving From the Severe Asthma to Mild Asthma Category	8 Participants	10 Participants

SECONDARY outcome

Timeframe: within 5 days of ED visit

Population: 89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.

Participants admitted to the hospital within 5 days of the ED visit

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=89 Participants	Placebo (Normal Saline) n=85 Participants
Relapse / Readmission Numbers.	2 Participants	2 Participants

SECONDARY outcome

Timeframe: within 30 days of the ED visit

Population: 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.

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=89 Participants	Placebo (Normal Saline) n=85 Participants
Number of Participants With Adverse Events (Non-serious). Rhinorrhea	6 Participants	11 Participants
Number of Participants With Adverse Events (Non-serious). Headache	5 Participants	9 Participants
Number of Participants With Adverse Events (Non-serious). Diarrhea	3 Participants	7 Participants
Number of Participants With Adverse Events (Non-serious). Sore throat	4 Participants	3 Participants
Number of Participants With Adverse Events (Non-serious). Cough	2 Participants	3 Participants
Number of Participants With Adverse Events (Non-serious). Hyperglycemia	2 Participants	0 Participants

SECONDARY outcome

Timeframe: 0-5 days

Population: 89 of the 91 patients randomized to BIS were available for follow-up. 85 of the 89 patients randomized to placebo were available.

Serious Adverse Events

Outcome measures

Measure	Budesonide Inhalation Suspension (BIS) n=89 Participants	Placebo (Normal Saline) n=85 Participants
Serious Adverse Events Return within 5 days with hosptial admission	2 participants	2 participants
Serious Adverse Events Increased level of care	1 participants	0 participants

Adverse Events

Budesonide Inhalation Suspension (BIS)

Serious events: 3 serious events

Other events: 30 other events

Deaths: 0 deaths

Placebo (Saline)

Serious events: 2 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Measure	Budesonide Inhalation Suspension (BIS) n=91 participants at risk standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)	Placebo (Saline) n=91 participants at risk；n=88 participants at risk standardized treatment with nebulized saline
Respiratory, thoracic and mediastinal disorders Hospitalization within 5 days of Emergency Department discharge home	2.2% 2/91 • Number of events 2 • 30 days	2.3% 2/88 • Number of events 2 • 30 days
Respiratory, thoracic and mediastinal disorders Increased level of care	1.1% 1/91 • Number of events 1 • 30 days	0.00% 0/88 • 30 days

Other adverse events

Measure	Budesonide Inhalation Suspension (BIS) n=91 participants at risk standardized treatment with nebulized Budesonide Inhalation Suspension (BIS)	Placebo (Saline) n=91 participants at risk；n=88 participants at risk standardized treatment with nebulized saline
Respiratory, thoracic and mediastinal disorders rhinorrhea	6.6% 6/91 • Number of events 6 • 30 days	12.1% 11/91 • Number of events 11 • 30 days
Nervous system disorders headache	5.5% 5/91 • Number of events 5 • 30 days	9.9% 9/91 • Number of events 9 • 30 days
Gastrointestinal disorders diarrhea	3.3% 3/91 • Number of events 3 • 30 days	7.7% 7/91 • Number of events 7 • 30 days
Infections and infestations sore throat	4.4% 4/91 • Number of events 4 • 30 days	3.3% 3/91 • Number of events 3 • 30 days
Respiratory, thoracic and mediastinal disorders cough	2.2% 2/91 • Number of events 2 • 30 days	3.3% 3/91 • Number of events 3 • 30 days
Metabolism and nutrition disorders hyperglycemia	2.2% 2/91 • Number of events 2 • 30 days	0.00% 0/91 • 30 days
Gastrointestinal disorders emesis	4.4% 4/91 • Number of events 4 • 30 days	6.6% 6/91 • Number of events 6 • 30 days
Infections and infestations fever	3.3% 3/91 • Number of events 3 • 30 days	3.3% 3/91 • Number of events 3 • 30 days
Blood and lymphatic system disorders epistaxis	3.3% 3/91 • Number of events 3 • 30 days	1.1% 1/91 • Number of events 1 • 30 days
Infections and infestations ear infection	0.00% 0/91 • 30 days	3.3% 3/91 • Number of events 3 • 30 days
Infections and infestations respiratory infection	4.4% 4/91 • Number of events 4 • 30 days	1.1% 1/91 • Number of events 1 • 30 days
Gastrointestinal disorders stomach ache	1.1% 1/91 • Number of events 1 • 30 days	3.3% 3/91 • Number of events 3 • 30 days
Respiratory, thoracic and mediastinal disorders chest pain	2.2% 2/91 • Number of events 2 • 30 days	2.2% 2/91 • Number of events 2 • 30 days
Musculoskeletal and connective tissue disorders leg pain	1.1% 1/91 • Number of events 1 • 30 days	2.2% 2/91 • Number of events 2 • 30 days

Additional Information

Cynthia J. Mollen

The Children's Hospital of Philadelphia

Phone: 215-590-4410

Email: mollenc@email.chop.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place