Comparison of Oral Dexamethasone Doses in Asthma Exacerbation

This study has been completed.
Sponsor:
Information provided by:
Rady Children's Hospital, San Diego
ClinicalTrials.gov Identifier:
NCT00942201
First received: June 8, 2009
Last updated: July 17, 2009
Last verified: July 2009
  Purpose

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 Intervention
Asthma
Reactive Airway Disease
Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Rady Children's Hospital, San Diego:

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. [ Time Frame: Phone follow up on day 7-10 after discharge, day of discharge = day 1. Total duration of study is 10 months. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: August 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Decadron

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.

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00942201

Locations
United States, California
Rady Children's Hospital
San Diego, California, United States, 92123
Sponsors and Collaborators
Rady Children's Hospital, San Diego
Investigators
Principal Investigator: Ghazala Sharieff, MD Rady Children's Hospital
  More Information

Publications:
Responsible Party: Nazli Ghafouri, MD, UC San DIego/Rady Children's Pediatric Emergency Medicine Fellowship
ClinicalTrials.gov Identifier: NCT00942201     History of Changes
Other Study ID Numbers: 080453
Study First Received: June 8, 2009
Last Updated: July 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Rady Children's Hospital, San Diego:
Asthma
Dexamethasone
Emergency Department

Additional relevant MeSH terms:
Asthma
Pulmonary Disease, Chronic Obstructive
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone acetate
Dexamethasone
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on October 01, 2014