Trial Outcomes & Findings for The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room (NCT NCT01524198)

NCT ID: NCT01524198

Last Updated: 2014-03-13

Results Overview

The number of patients hospitalized over the study period (17 months).

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 945 participants
• Primary outcome timeframe: 17 months
• Results posted on: 2014-03-13

Participant Flow

Participant milestones

Measure	Normal Saline, Albuterol, Ipratropium Bromide Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if \< 20 kg or 5 mg if \>= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back	Budesonide, Albuterol, Ipratropium Bromide Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if \< 20 kg body weight or 5 mg if \>= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
Overall Study STARTED	471	474
Overall Study COMPLETED	448	458
Overall Study NOT COMPLETED	23	16

Reasons for withdrawal

Measure	Normal Saline, Albuterol, Ipratropium Bromide Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if \< 20 kg or 5 mg if \>= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back	Budesonide, Albuterol, Ipratropium Bromide Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if \< 20 kg body weight or 5 mg if \>= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
Overall Study Protocol Violation	8	6
Overall Study Withdrawal by Subject	15	10

Baseline Characteristics

The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room

Baseline characteristics by cohort

Measure	Normal Saline, Albuterol, Ipratropium Bromide n=448 Participants Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if \< 20 kg or 5 mg if \>= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back	Budesonide, Albuterol, Ipratropium Bromide n=458 Participants Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if \< 20 kg body weight or 5 mg if \>= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back	Total n=906 Participants Total of all reporting groups
Age, Categorical <=18 years	448 Participants n=93 Participants	458 Participants n=4 Participants	906 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Sex: Female, Male Female	161 Participants n=93 Participants	156 Participants n=4 Participants	317 Participants n=27 Participants
Sex: Female, Male Male	287 Participants n=93 Participants	302 Participants n=4 Participants	589 Participants n=27 Participants
Region of Enrollment Saudi Arabia	448 participants n=93 Participants	458 participants n=4 Participants	906 participants n=27 Participants

PRIMARY outcome

Timeframe: 17 months

The number of patients hospitalized over the study period (17 months).

Outcome measures

Measure	Normal Saline, Albuterol, Ipratropium Bromide n=448 Participants Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if \< 20 kg or 5 mg if \>= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back	Budesonide, Albuterol, Ipratropium Bromide n=458 Participants Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if \< 20 kg body weight or 5 mg if \>= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
Patients Hospitalization Rate	82 participants	75 participants

SECONDARY outcome

Timeframe: 2, 3, or 4 hours from baseline

A negative change of asthma score from baseline measurement to measurement at disposition, which could be at 2, 3, or 4 hours time points would indicate a decrese in asthma severity. The asthma score ranged between 5 and 15 points as in the protocol, where 5 is the mildest and 15 is the most severe.

Outcome measures

Measure	Normal Saline, Albuterol, Ipratropium Bromide n=448 Participants Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if \< 20 kg or 5 mg if \>= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back	Budesonide, Albuterol, Ipratropium Bromide n=458 Participants Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if \< 20 kg body weight or 5 mg if \>= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
Change in Asthma Score From Baseline as Compared to the Score at Disposition	-4.58 units on asthma score Standard Deviation 2.33	-4.77 units on asthma score Standard Deviation 2.31

Adverse Events

Normal Saline, Albuterol, Ipratropium Bromide

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Budesonide, Albuterol, Ipratropium Bromide

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Normal Saline, Albuterol, Ipratropium Bromide n=448 participants at risk Subjects who are receiving normal saline in addition to Albuterol 2.5 mg if \< 20 kg or 5 mg if \>= 20 kg body weight and ipratropium bromide (IB) 250 mcg; 3 nebulizations back to back	Budesonide, Albuterol, Ipratropium Bromide n=458 participants at risk Subjects with acute asthma exacerbation who receive Budesonide 500 mcg, in addition to Albuterol 2.5 mg if \< 20 kg body weight or 5 mg if \>= 20 kg body weight and Ipratropium Bromine (IB) 250 mcg; 3 nebulization doses back to back
Nervous system disorders Fine tremor	2.2% 10/448 • Number of events 10	1.5% 7/458 • Number of events 7
Cardiac disorders Palpitation	1.1% 5/448 • Number of events 5	1.3% 6/458 • Number of events 6

Additional Information

Dr. Abdullah Alangari

King Saud University

Phone: 966506287276

Email: alangari100@gmail.com

Results disclosure agreements

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