CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 945 enrolled
Drug / intervention
Budesonide +1 moredrug
Likely dose
Budesonide 500 mcgfrom record
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Search/NCT01524198
NCT01524198Phase 3Completed

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

King Saud University·interventional·Posted Feb 1, 2012·Updated Mar 13, 2014

In Brief

A Phase 3 clinical trial evaluating Budesonide and Normal saline for Status Asthmaticus. Completed, enrolled 945 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia

Timeline

Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 1, 2012
Enrollment StartNov 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 14.4 years ago

Interventions

Budesonidedrug

500 mcg budesonide plus Albuterol plus ipratropium bromide (IB) nebulization, 3 doses back to back

Normal salinedrug

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