Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

NCT ID: NCT00973687

Last Updated: 2015-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

430 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2006-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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10 mg/mL Unsweetened Formulation

no prior vomiting

Group Type PLACEBO_COMPARATOR

Dexamethasone

Intervention Type DRUG

1 mg/mL Ora Sweet Formulation

no prior vomiting

Group Type EXPERIMENTAL

Ora Sweet

Intervention Type DRUG

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

Intervention Type DRUG

10 mg/mL Unsweetened with prior vomiting

with prior vomiting

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

1 mg/mL Ora Sweet with prior vomiting

with prior vomiting

Group Type EXPERIMENTAL

Ora Sweet

Intervention Type DRUG

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

Intervention Type DRUG

Interventions

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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.

Intervention Type DRUG

Dexamethasone

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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IWK Foundation

UNKNOWN

Sponsor Role collaborator

IWK Health Centre

OTHER

Sponsor Role lead

Responsible Party

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IWK Health Centre

Principal Investigators

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Lyn K Sonnenberg, MD

Role: PRINCIPAL_INVESTIGATOR

IWK Health Centre

Locations

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IWK Health Centre

Halifax, Nova Scotia, Canada

Site Status

Countries

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Canada

Other Identifiers

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2967

Identifier Type: -

Identifier Source: org_study_id

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