The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room
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|ClinicalTrials.gov Identifier: NCT01524198|
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : February 13, 2014
Last Update Posted : March 13, 2014
Asthma is the most common chronic illness of childhood. About 10% of children are affected. Not surprisingly, acute asthma exacerbations are one of the common reasons to visit pediatric emergency rooms (ER). About 5.7% of all pediatric emergency room visits are due to acute asthma exacerbation. Around 8% of those get admitted to the hospital. This constitutes huge financial and administrative burden on the health care system.
Inhaled corticosteroids (ICS) is the gold standard prophylactic therapy for patients with persistent asthma. In the setting of acute asthma exacerbation systemic steroids given early in the course of treatment help decrease the rate of admission and return to the ER. However, the anti-inflammatory action of corticosteroids, through which this effect is caused, takes 4 hours to start working. This is because it is mediated through genomic pathways where the transcription of several inflammatory cytokines is suppressed. It was also shown that corticosteroids can cause vasoconstriction through non-genomic pathways. The onset of this action is as quick as 30-60 minutes. It is proposed that this action is mediated by blocking the extraneuronal uptake (metabolism) of norepinephrine in vascular smooth muscle cells, hence, making it available for re-use by the sympathetic neuronal cells.
Our objective is to compare the efficacy of adding repetitive sequential doses of budesonide versus placebo (normal saline (NS)) to β2-agonist and ipratropium bromide (IB) combination (standard treatment) in the management of acute asthma in children in the ER. We hypothesize that the addition of budesonide to β2-agonist and IB in the management of moderate to severe acute asthma in the ER is superior to the addition of placebo.
|Condition or disease||Intervention/treatment||Phase|
|Status Asthmaticus||Drug: Budesonide Drug: Normal saline||Phase 2 Phase 3|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||945 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room|
|Study Start Date :||November 2010|
|Actual Primary Completion Date :||April 2012|
|Actual Study Completion Date :||April 2012|
Placebo Comparator: Normal Saline
Subjects who are receiving normal saline (NS) 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
Drug: Normal saline
0.5 ml to 1.5 ml normal saline (to complete 3 mls total volume), plus albuterol plus ipratropium bromide nebulizations 3 doses back to back
Active Comparator: Budesonide
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
500 mcg budesonide plus Albuterol plus ipratropium bromide (IB) nebulization, 3 doses back to back
Other Name: Pulmicort
- Patients Hospitalization Rate [ Time Frame: 17 months ]The number of patients hospitalized over the study period (17 months).
- Change in Asthma Score From Baseline as Compared to the Score at Disposition [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01524198
|King Fahad Medical City|
|Riyadh, Saudi Arabia, 11525|
|Principal Investigator:||Abdullah A Alangari, MBBS||King Saud University|