Comparison of Oral Dexamethasone Doses in Asthma Exacerbation

Sponsor

Rady Children's Hospital, San Diego (Other)

Overall Status

Completed

CT.gov ID

NCT00942201

Collaborator

(none)

125

Enrollment

Location

Arms

Duration (Months)

13.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Reactive Airway Disease	Drug: Dexamethasone Drug: Dexamethasone	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

125 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Aug 1, 2008

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

May 1, 2009

Arms and Interventions

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
Active Comparator: Two dose dexamethasone First dose in ED, a prescription for second dose to be administered on Day 3 after discharge	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

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

Active Comparator: Two dose dexamethasone

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

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

Outcome Measures

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. [Phone follow up on day 7-10 after discharge, day of discharge = day 1. Total duration of study is 10 months.]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)