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Completed

NCT Number: NCT02725008

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

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

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Key information

Conditions

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

Age range

18 month–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

New York Methodist Hospital

Brooklyn, New York, 11215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexamethasone

Drug

Other names: decadron

Placebo

Drug

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

Primary outcomes

  1. Treatment Failure

    Time frame: 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 outcomes

  1. Change in Symptom Severity From Day 1 to Day 5

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Geoffrey W Jara-Almonte

Other

Registry information

Official study 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)

Acronym: R2D2

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Mar 31, 2016
Registry last updated
Feb 27, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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