Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

August 25, 2015 updated by: IWK Health Centre
The purpose of this study is to assess whether smaller volumes of oral dexamethasone result in better tolerability, specifically less vomiting, in pediatric patients during an acute asthma exacerbation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

430

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3K 6R8
        • IWK Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • acute asthma exacerbation
  • requiring oral systemic corticosteroids for management

Exclusion Criteria:

  • preference for pills over liquid formulation
  • history of Nissen fundoplication surgery
  • needed immediate airway intervention
  • require oral medications to be given via a G or J tube
  • if patient care would be compromised
  • enrolled in the study on a previous visit.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 10 mg/mL Unsweetened Formulation
no prior vomiting
Drug: Dexamethasone
Experimental: 1 mg/mL Ora Sweet Formulation
no prior vomiting
Drug: Dexamethasone
Drug: Ora Sweet
A pharmaceutical suspending vehicle and flavouring agent added to the dexamethasone. All arms received the same amount of dexamethasone based on the child's weight, only in different volumes.
Active Comparator: 10 mg/mL Unsweetened with prior vomiting
with prior vomiting
Drug: Dexamethasone
Experimental: 1 mg/mL Ora Sweet with prior vomiting
with prior vomiting
Drug: Dexamethasone
Drug: Ora Sweet
A pharmaceutical suspending vehicle and flavouring agent added to the dexamethasone. All arms received the same amount of dexamethasone based on the child's weight, only in different volumes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The primary objective of this study was to assess whether smaller volumes of oral dexamethasone resulted in better tolerability, specifically less vomiting, in pediatric patients with an acute exacerbation of asthma.
Time Frame: During Emergency Department visit
During Emergency Department visit

Secondary Outcome Measures

Outcome Measure
Time Frame
To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.
Time Frame: 7-14 days following emergency dept visit
7-14 days following emergency dept visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IWK Health Centre

Collaborators

IWK Foundation

Investigators

  • Principal Investigator: Lyn K Sonnenberg, MD, IWK Health Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2004

Primary Completion (Actual)

April 1, 2006

Study Completion (Actual)

May 1, 2006

Study Registration Dates

First Submitted

September 8, 2009

First Submitted That Met QC Criteria

September 8, 2009

First Posted (Estimate)

September 9, 2009

Study Record Updates

Last Update Posted (Estimate)

August 26, 2015

Last Update Submitted That Met QC Criteria

August 25, 2015

Last Verified

September 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2967

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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