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

NCT02725008 | Completed Phase 3 Results DMC

• 1 other identifier: 714220-1
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Asthma

Keywords

Asthma; Pediatric; Emergency Department; Dexamethasone; Steroid

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Symptom Severity From Day 1 to Day 5

  5 days

Study Arms (2)

Control

ACTIVE COMPARATOR

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

Drug: Dexamethasone

Investigational

EXPERIMENTAL

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

Drug: Dexamethasone; Drug: placebo

Interventions

Dexamethasone DRUG

Also known as: decadron

Control; Investigational

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

Investigational

Eligibility Criteria

• Age: 18 Months - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Geoffrey W Jara-Almonte: lead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

MeSH Terms

Conditions

Asthma; 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; 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

Limitations and Caveats

Target enrollment was not reached.

Results Point of Contact

• Title: Christopher P Kelly
• Organization: New York Presbyterian - Brooklyn Methodist Hospital

chk9064@nyp.org

718.780.5040

Study Officials

• Christopher Kelly, MD

  New York Presbyterian Brooklyn Methodist Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Sub-Investigator

Study Record Dates

• First Submitted: March 18, 2016
• First Posted: March 31, 2016
• Study Start: November 1, 2015
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: February 27, 2019
• Results First Posted: February 27, 2019

Record last verified: 2019-02

Locations

US (1)