Trial of One Versus Two Doses of Dexamethasone for Pediatric Asthma Exacerbation

Phase 3

Completed

• Conditions: Asthma
• Interventions: Drug: Dexamethasone; Drug: placebo

• Registration Number: NCT02725008
• Lead Sponsor: Geoffrey W Jara-Almonte

Brief Summary

Comparing one versus two doses of oral dexamethasone for the treatment of asthma in the pediatric emergency department.

Detailed Description

A randomized double blinded placebo controlled trial comparing one dose of dexamethasone administered in the Emergency Department with two doses, the first given in the emergency department and the second 24 hours after the index ED visit.

Study Timeline

• Study Start: 2015-11
• Study First Submitted: 2016-03-18
• Study First Submitted QC: 2016-03-24
• Study First Posted: 2016-03-31
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Results First Submitted: 2018-11-30
• Status Verified: 2019-02
• Results First Submitted QC: 2019-02-25
• Last Update Submitted: 2019-02-25
• Results First Posted: 2019-02-27
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

Inclusion Criteria

• History of asthma defined as at least two (2) prior episodes of respiratory illness characterized by wheezing treated with inhaled beta agonists

Exclusion Criteria

• pregnancy
• severe chronic cardiac, respiratory, neurological or neuromuscular disease
• complete resolution of symptoms after one treatment of beta agonists
• severe asthma symptoms as defined by a Pulmonary Index Score of 12 or greater

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Investigational	placebo	Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit
Control	Dexamethasone	Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and a second dose of 0.6 milligrams per kilogram up to 16 milligrams to take 24 hours after ED visit
Investigational	Dexamethasone	Patients are given one dose of oral dexamethasone 0.6 milligrams per kilogram up to 16 milligrams in the ED and placebo to be taken 24 hours after ED visit

Primary Outcome Measures

Name	Time	Method
Treatment Failure	5 days	number of patients who experience any of the following outcomes - unplanned hospital admission for asthma symptoms, unplanned ED visit for asthma symptoms, unplanned urgent care visit for asthma symptoms, unplanned primary care physician visit for asthma symptoms, or prescription of a course of steroids

Secondary Outcome Measures

Name	Time	Method
Change in Symptom Severity From Day 1 to Day 5	5 days	Severity of asthma symptoms as reported by the Patient Self Assessment Score. Patients assessed severity of asthma symptoms in 4 categories (wheezing, coughing, activity and sleep) once per day during the 5 days between study enrollment and follow-up. Score range is 0 - 12 with 0 being mildest symptoms and 12 being most severe symptoms. Reported as change in score between enrollment (day 1) and follow-up (day 5).

Trial Locations

Locations (1)

New York Methodist Hospital; 🇺🇸 Brooklyn, New York, United States