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Trial record 94 of 150 for:    Ipratropium OR atrovent

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01524198
Recruitment Status : Completed
First Posted : February 1, 2012
Results First Posted : February 13, 2014
Last Update Posted : March 13, 2014
King Fahad Medical City
Information provided by (Responsible Party):
AAlangari, King Saud University

Brief 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.

Condition or disease Intervention/treatment Phase
Status Asthmaticus Drug: Budesonide Drug: Normal saline Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 945 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids
Drug Information available for: Budesonide

Arm Intervention/treatment
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
Drug: Budesonide
500 mcg budesonide plus Albuterol plus ipratropium bromide (IB) nebulization, 3 doses back to back
Other Name: Pulmicort

Primary Outcome Measures :
  1. Patients Hospitalization Rate [ Time Frame: 17 months ]
    The number of patients hospitalized over the study period (17 months).

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01524198

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

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AAlangari, Associate Professor of Pediatrics, King Saud University Identifier: NCT01524198     History of Changes
Other Study ID Numbers: 08-MED520-02
First Posted: February 1, 2012    Key Record Dates
Results First Posted: February 13, 2014
Last Update Posted: March 13, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Status Asthmaticus
Disease Attributes
Pathologic Processes
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists