Trial | NCT00973687  Report issue

Official Title

Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    urea ...

  • Study Participants

    430
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 Started
Sep 30
2004
Primary Completion
Apr 30
2006
Study Completion
May 31
2006
Last Update
Aug 26
2015
Estimate

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.

Drug Dexamethasone

10 mg/mL Unsweetened Formulation Placebo Comparator

no prior vomiting

1 mg/mL Ora Sweet Formulation Experimental

no prior vomiting

10 mg/mL Unsweetened with prior vomiting Active Comparator

with prior vomiting

1 mg/mL Ora Sweet with prior vomiting Experimental

with prior vomiting

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.
No Results Posted