Comparison of Oral Dexamethasone Doses in Asthma Exacerbation

NCT00942201 | Completed

• 1 other identifier: 080453
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Reactive Airway Disease

Keywords

Asthma; Dexamethasone; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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.

Study Arms (2)

Single dose dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Two dose dexamethasone

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

Single loading dose in ED 0.6 mg/kg, rounded to nearest 2 mg,use 4 mg tabs max dose 16 mg.

Also known as: Decadron

Single dose dexamethasone

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rady Children's Hospital, San Diego: lead

Study Sites (1)

Rady Children's Hospital

San Diego, California, 92123, United States

Location

Related Publications (4)

• 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.

  PMID: 17198210 RESULT

• 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.

  PMID: 11445789 RESULT

• 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.

  PMID: 10700684 RESULT

• 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.

  PMID: 18467673 RESULT

MeSH Terms

Conditions

Asthma; Pulmonary Disease, Chronic Obstructive; Emergencies

Interventions

Dexamethasone; Calcium Dobesilate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds

Study Officials

• Ghazala Sharieff, MD

  Rady Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 8, 2009
• First Posted: July 20, 2009
• Study Start: August 1, 2008
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: July 20, 2009

Record last verified: 2009-07

Locations

US (1)