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Completed

NCT Number: NCT00973687

Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

2 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ora Sweet

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

Drug

Primary outcomes

  1. 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 outcomes

  1. To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation.

    Time frame: 7-14 days following emergency dept visit

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • IWK Foundation

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 9, 2009
Registry last updated
Aug 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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