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Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00973687
First Posted: September 9, 2009
Last Update Posted: August 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
IWK Foundation
Information provided by:
IWK Health Centre
  Purpose
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.

Condition Intervention
Asthma Drug: Ora Sweet Drug: Dexamethasone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

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. [ Time Frame: During Emergency Department visit ]

Secondary Outcome Measures:
  • To evaluate asthma symptom control post emergency room visit for acute asthma exacerbation. [ Time Frame: 7-14 days following emergency dept visit ]

Enrollment: 430
Study Start Date: September 2004
Study Completion Date: May 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 10 mg/mL Unsweetened Formulation
no prior vomiting
Drug: Dexamethasone
Experimental: 1 mg/mL Ora Sweet Formulation
no prior vomiting
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
Active Comparator: 10 mg/mL Unsweetened with prior vomiting
with prior vomiting
Drug: Dexamethasone
Experimental: 1 mg/mL Ora Sweet with prior vomiting
with prior vomiting
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973687


Locations
Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
IWK Foundation
Investigators
Principal Investigator: Lyn K Sonnenberg, MD IWK Health Centre
  More Information

Responsible Party: Dr. Lyn Sonnenberg, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00973687     History of Changes
Other Study ID Numbers: 2967
First Submitted: September 8, 2009
First Posted: September 9, 2009
Last Update Posted: August 26, 2015
Last Verified: September 2009

Keywords provided by IWK Health Centre:
pediatric
dexamethasone
management
corticosteroids
asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone acetate
Dexamethasone
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action