Back to resultsDexamethasone Tolerability in the Treatment of Acute Asthma in Children
Primary Purpose
Asthma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ora Sweet
Dexamethasone
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring pediatric, dexamethasone, management, corticosteroids, asthma
Eligibility Criteria
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.
Sites / Locations
- IWK Health Centre
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Placebo Comparator
Experimental
Active Comparator
Experimental
Arm Label
10 mg/mL Unsweetened Formulation
1 mg/mL Ora Sweet Formulation
10 mg/mL Unsweetened with prior vomiting
1 mg/mL Ora Sweet with prior vomiting
Arm Description
no prior vomiting
no prior vomiting
with prior vomiting
with prior vomiting
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.
Full Information
NCT ID
NCT00973687
First Posted
September 8, 2009
Last Updated
August 25, 2015
Sponsor
IWK Health Centre
Collaborators
IWK Foundation
1. Study Identification
Unique Protocol Identification Number
NCT00973687
Brief Title
Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
Official Title
Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
Study Type
Interventional
2. Study Status
Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
April 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
IWK Health Centre
Collaborators
IWK Foundation
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
pediatric, dexamethasone, management, corticosteroids, asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
430 (Actual)
8. Arms, Groups, and Interventions
Arm Title
10 mg/mL Unsweetened Formulation
Arm Type
Placebo Comparator
Arm Description
no prior vomiting
Arm Title
1 mg/mL Ora Sweet Formulation
Arm Type
Experimental
Arm Description
no prior vomiting
Arm Title
10 mg/mL Unsweetened with prior vomiting
Arm Type
Active Comparator
Arm Description
with prior vomiting
Arm Title
1 mg/mL Ora Sweet with prior vomiting
Arm Type
Experimental
Arm Description
with prior vomiting
Intervention Type
Drug
Intervention Name(s)
Ora Sweet
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.
Time Frame
7-14 days following emergency dept visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lyn K Sonnenberg, MD
Organizational Affiliation
IWK Health Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Dexamethasone Tolerability in the Treatment of Acute Asthma in Children
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