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

Asthma Clinical Trial

— R2D2  

Official title:

A Randomized Double Blinded Placebo Controlled Trial of One Versus Two Doses of Oral Dexamethasone for the Treatment of Acute Asthma Exacerbation in the Pediatric Emergency Department (ED)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725008
• Other study ID #: 714220-1
• Status: Completed
• Phase: Phase 3
• Start date: November 2015
• Est. completion date: November 2017

Study information

• Verified date: February 2019
• Source: New York Methodist Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: November 2017
• Est. primary completion date: November 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 20 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Dexamethasone

• placebo
to be given to the experimental group on the day after discharge from the ED in lieu of the second dose of dexamethasone

Locations

Country	Name	City	State
United States	New York Methodist Hospital	Brooklyn	New York

Sponsors (1)

Lead Sponsor	Collaborator
Geoffrey W Jara-Almonte

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment Failure	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	5 days
Secondary	Change in Symptom Severity From Day 1 to Day 5	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).	5 days