The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Status Asthmaticus |
Drug: budesonide, albuterol, IB Drug: Normal saline, albuterol, IB |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | The Use of Inhaled Corticosteroids in the Treatment of Asthma is Children in the Emergency Room |
- Patients hospitalization rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Change in symptom score at the time of disposition [ Time Frame: 18 months ] [ Designated as safety issue: No ]
| Enrollment: | 723 |
| Study Start Date: | November 2010 |
| Study Completion Date: | April 2012 |
| Primary Completion Date: | April 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Normal saline, Albuterol, IB
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
|
Drug: Normal saline, albuterol, IB
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
Other Name: Normal saline
|
|
Active Comparator: Budesonide, Albuterol, IB
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
|
Drug: budesonide, albuterol, IB
500 mcg budesonide plus Albuterol plus ipratropium bromide (IB) nebulization, 3 doses back to back
Other Name: Pulmicort
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 2 Years to 12 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations| Saudi Arabia | |
| King Fahad Medical City | |
| Riyadh, Saudi Arabia, 11525 | |
| Principal Investigator: | Abdullah A Alangari, MBBS | King Saud University |
More Information
No publications provided
| Responsible Party: | AAlangari, Associate Professor of Pediatrics, King Saud University |
| ClinicalTrials.gov Identifier: | NCT01524198 History of Changes |
| Other Study ID Numbers: | 08-MED520-02 |
| Study First Received: | January 30, 2012 |
| Last Updated: | February 3, 2013 |
| Health Authority: | Saudi Arabia: Ministry for Higher Education |
Additional relevant MeSH terms:
|
Emergencies Status Asthmaticus Disease Attributes Pathologic Processes Asthma Bronchial Diseases Respiratory Tract Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Albuterol Ipratropium Budesonide Tocolytic Agents |
Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents |
ClinicalTrials.gov processed this record on May 16, 2013