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

• Status: Completed
• Trial end date: 2012-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: King Saud University
• Collaborator: King Fahad Medical City
• Treatments: Albuterol; Bromides; Budesonide; Ipratropium

Criteria

Inclusion Criteria:

• Children 2-12 years of age with physician diagnosed asthma or a previous episode of SOB that responded well to β2-agonists who present to the ER with moderate or severe asthma exacerbation

Exclusion Criteria:

• Children with mild asthma exacerbation.

• Children with severe asthma exacerbation who are in critical condition or need immediate intervention.

• Children who have heart disease or chronic lung disease other than asthma.

• Systemic steroids administered within the past 7 days.