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

This study has been completed.
Sponsor:
Collaborator:
King Fahad Medical City
Information provided by (Responsible Party):
AAlangari, King Saud University
ClinicalTrials.gov Identifier:
NCT01524198
First received: January 30, 2012
Last updated: February 12, 2014
Last verified: February 2014
  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
Drug: Normal saline
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

Resource links provided by NLM:


Further study details as provided by King Saud University:

Primary Outcome Measures:
  • Patients Hospitalization Rate [ Time Frame: 17 months ] [ Designated as safety issue: No ]
    The number of patients hospitalized over the study period (17 months).


Secondary Outcome Measures:
  • Change in Asthma Score From Baseline as Compared to the Score at Disposition [ Time Frame: 2, 3, or 4 hours from baseline ] [ Designated as safety issue: No ]
    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.


Enrollment: 945
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
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
Other Name: Normal saline
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
Drug: Budesonide
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
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01524198

Locations
Saudi Arabia
King Fahad Medical City
Riyadh, Saudi Arabia, 11525
Sponsors and Collaborators
King Saud University
King Fahad Medical City
Investigators
Principal Investigator: Abdullah A Alangari, MBBS King Saud University
  More Information

No publications provided by King Saud University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
Results First Received: November 2, 2013
Last Updated: February 12, 2014
Health Authority: Saudi Arabia: Ministry for Higher Education

Additional relevant MeSH terms:
Status Asthmaticus
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Ipratropium
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 22, 2014