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Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

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ClinicalTrials.gov Identifier: NCT00973687
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : August 26, 2015
Sponsor:
Collaborator:
IWK Foundation
Information provided by:
IWK Health Centre

Brief 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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Ora Sweet Drug: Dexamethasone Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 430 participants
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
Study Start Date : September 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : May 2006

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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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.

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

Responsible Party: Dr. Lyn Sonnenberg, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00973687     History of Changes
Other Study ID Numbers: 2967
First Posted: September 9, 2009    Key Record Dates
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