Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

Asthma Clinical Trial

Official title:

Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00973687
• Other study ID #: 2967
• Status: Completed
• Phase: N/A
• First received: September 8, 2009
• Last updated: August 25, 2015
• Start date: September 2004
• Est. completion date: May 2006

Study information

• Verified date: September 2009
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: May 2006
• Est. primary completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 2 Years to 14 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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.
• Dexamethasone

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (2)

Lead Sponsor	Collaborator
IWK Health Centre	IWK Foundation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		During Emergency Department visit	No
Secondary	To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.		7-14 days following emergency dept visit	No