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Comparison of Oral Dexamethasone Doses in Asthma Exacerbation

Primary Purpose

Asthma, Reactive Airway Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexamethasone
Dexamethasone
Sponsored by
Rady Children's Hospital, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Dexamethasone, Emergency Department

Eligibility Criteria

2 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Rady Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Single dose dexamethasone

Two dose dexamethasone

Arm Description

Single dose dexamethasone 0.6 mg/kg, rounded to nearest 2 mg, max 16 mg administered in ED

First dose in ED, a prescription for second dose to be administered on Day 3 after discharge

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The secondary outcome measures include compliance, patient/parent satisfaction and rate of hospitalization from the ED.

Full Information

First Posted
June 8, 2009
Last Updated
July 17, 2009
Sponsor
Rady Children's Hospital, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT00942201
Brief Title
Comparison of Oral Dexamethasone Doses in Asthma Exacerbation
Official Title
Comparison of Single Dose Versus Two Doses of Oral Dexamethasone in the Management of Acute Asthma Exacerbations in the Pediatric Emergency Department.
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Rady Children's Hospital, San Diego

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Reactive Airway Disease
Keywords
Asthma, Dexamethasone, Emergency Department

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single dose dexamethasone
Arm Type
Active Comparator
Arm Description
Single dose dexamethasone 0.6 mg/kg, rounded to nearest 2 mg, max 16 mg administered in ED
Arm Title
Two dose dexamethasone
Arm Type
Active Comparator
Arm Description
First dose in ED, a prescription for second dose to be administered on Day 3 after discharge
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
Single loading dose in ED 0.6 mg/kg, rounded to nearest 2 mg,use 4 mg tabs max dose 16 mg.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Decadron
Intervention Description
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
Primary Outcome Measure Information:
Title
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.
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ghazala Sharieff, MD
Organizational Affiliation
Rady Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rady Children's Hospital
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17198210
Citation
Altamimi S, Robertson G, Jastaniah W, Davey A, Dehghani N, Chen R, Leung K, Colbourne M. Single-dose oral dexamethasone in the emergency management of children with exacerbations of mild to moderate asthma. Pediatr Emerg Care. 2006 Dec;22(12):786-93. doi: 10.1097/01.pec.0000248683.09895.08.
Results Reference
result
PubMed Identifier
11445789
Citation
Qureshi F, Zaritsky A, Poirier MP. Comparative efficacy of oral dexamethasone versus oral prednisone in acute pediatric asthma. J Pediatr. 2001 Jul;139(1):20-6. doi: 10.1067/mpd.2001.115021.
Results Reference
result
PubMed Identifier
10700684
Citation
Gries DM, Moffitt DR, Pulos E, Carter ER. A single dose of intramuscularly administered dexamethasone acetate is as effective as oral prednisone to treat asthma exacerbations in young children. J Pediatr. 2000 Mar;136(3):298-303. doi: 10.1067/mpd.2000.103353.
Results Reference
result
PubMed Identifier
18467673
Citation
Greenberg RA, Kerby G, Roosevelt GE. A comparison of oral dexamethasone with oral prednisone in pediatric asthma exacerbations treated in the emergency department. Clin Pediatr (Phila). 2008 Oct;47(8):817-23. doi: 10.1177/0009922808316988. Epub 2008 May 8.
Results Reference
result

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Comparison of Oral Dexamethasone Doses in Asthma Exacerbation

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