Comparison of Oral Dexamethasone Doses in Asthma Exacerbation

July 17, 2009 updated by: Rady Children's Hospital, San Diego

Comparison of Single Dose Versus Two Doses of Oral Dexamethasone in the Management of Acute Asthma Exacerbations in the Pediatric Emergency Department.

Hypothesis: A 2-day course of oral dexamethasone is the superior option for the resolution of symptoms and prevention of relapse in the emergency department (ED) management of mild-moderate asthma exacerbations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Asthma has become a major public health problem of increasing concern in the US as it is the most prevalent chronic disease of childhood with over 6 million children under the age of 17 affected 7. Low-income populations, minorities, and children living in inner cities experience disproportionately higher morbidity and mortality due to asthma. Children who suffer from asthma often present to the ED or outpatient center for management of their symptoms and exacerbations. Asthma related ED visits in 2004 were estimated at 1.8 million, with children younger than 17 accounting for almost half with 754,000 visits 7 Recent clinical trials have shown the efficacy of dexamethasone in the ED management of asthma. In Quereshi et al, a randomized study of 533 patients showed that two doses of DEX taken on days 1 and 2 were equally efficacious as 5 days of prednisolone2. However, patients treated with DEX demonstrated improved compliance with less vomiting, fewer missed days of school and fewer missed parental workdays. A more recent study by Altamimi et al compared single dose DEX to 5-day prednisolone1. This double blinded, randomized prospective study of 134 children concluded that single dose DEX is no worse than 5 days of prednisolone as well.dexamethasone in the acute management of asthma exacerbation. However, practices vary as to the use of single dose, two-day dosing and when to administer the second dose. The purpose of this study is to compare various dosing regimes of dexamethasone in its efficacy in the treatment of asthma exacerbations. Given the longer duration of action of DEX (36-72 hours), we hypothesize that 2 doses of DEX given on days 1 & 3 are superior to single dose DEX in improving symptoms and preventing relapse in the ED management of mild to moderate asthma exacerbations.

These previous studies show similar efficacy of dexamethasone when compared to the standard 5-day prednisone/prednisolone treatment. . Within the institution, the investigators have incorporated the use of dexamethasone in the management of acute asthma exacerbations. However, practices vary as to the use of a single dose, two-day dosing and the timing of the second dose for those patients receiving two doses of dexamethasone.

The purpose of this study was to determine if single dose oral dexamethasone is as effective as a 2 dose course of oral dexamethasone in preventing relapse within 7 days for pediatric asthma patients managed in the ED. Given the long half life of dexamethasone, the investigators hypothesized that 2 doses given on days 1 and 3 are superior to single dose in improving symptoms and preventing relapse in the ED management of mild to moderate asthma exacerbations.

Study Type

Interventional

Enrollment (Actual)

125

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92123
        • Rady Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 17 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • children 2-17 years old

  • with a history of wheezing (> 1 episode requiring ß-2 agonist therapy) who present to the ED with mild to moderate asthma exacerbations

    *mild-moderate exacerbations are defined as a RSS < 11

  • patients whose symptoms do not resolve after the first albuterol/atrovent treatment (given in the ED, or at home or via EMS within 1 hour prior to arrival to the ED) are eligible for enrollment

Exclusion Criteria:

  • age < 2 years due to overlap with bronchiolitis
  • use of steroids within 3 weeks
  • recent exposure to TB, varicella, or herpes
  • active varicella/herpes infections
  • concomitant stridor, vomited 2 doses in ED
  • severe asthma as defined by RSS > 12
  • requirement for or pre-existing IV access
  • need for immediate airway protection
  • history of intubations for asthma or comorbidities (Chronic Lung Disease (CLD), Congenital Heart Defects (CHD), or neurologic disorders)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Single dose dexamethasone
Single dose dexamethasone 0.6 mg/kg, rounded to nearest 2 mg, max 16 mg administered in ED
Drug: Dexamethasone
Single loading dose in ED 0.6 mg/kg, rounded to nearest 2 mg,use 4 mg tabs max dose 16 mg.
Other Names:
  • Decadron
Drug: Dexamethasone
Firstdose in ED 0.6 mg/kg, rounded to nearest 2 mg, use 4 mg tabs max dose 16 mg; a prescription for second dose as above to be taken on day 3 after discharge
Other Names:
  • Decadron
ACTIVE_COMPARATOR: Two dose dexamethasone
First dose in ED, a prescription for second dose to be administered on Day 3 after discharge
Drug: Dexamethasone
Single loading dose in ED 0.6 mg/kg, rounded to nearest 2 mg,use 4 mg tabs max dose 16 mg.
Other Names:
  • Decadron
Drug: Dexamethasone
Firstdose in ED 0.6 mg/kg, rounded to nearest 2 mg, use 4 mg tabs max dose 16 mg; a prescription for second dose as above to be taken on day 3 after discharge
Other Names:
  • Decadron

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary outcome measures are the rate of relapse (including admission to hospital after ED discharge, or unscheduled PCP or ED visits, or new oral corticosteroid prescribed) and time (days) to resolution of symptoms.
Time Frame: Phone follow up on day 7-10 after discharge, day of discharge = day 1. Total duration of study is 10 months.
Phone follow up on day 7-10 after discharge, day of discharge = day 1. Total duration of study is 10 months.

Secondary Outcome Measures

Outcome Measure
Time Frame
The secondary outcome measures include compliance, patient/parent satisfaction and rate of hospitalization from the ED.
Time Frame: Phone follow up on day 7-10 after discharge, day of discharge = day 1. Total duration of study is 10 months.
Phone follow up on day 7-10 after discharge, day of discharge = day 1. Total duration of study is 10 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rady Children's Hospital, San Diego

Investigators

  • Principal Investigator: Ghazala Sharieff, MD, Rady Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (ACTUAL)

May 1, 2009

Study Completion (ACTUAL)

May 1, 2009

Study Registration Dates

First Submitted

June 8, 2009

First Submitted That Met QC Criteria

July 17, 2009

First Posted (ESTIMATE)

July 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

July 20, 2009

Last Update Submitted That Met QC Criteria

July 17, 2009

Last Verified

July 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 080453

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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