Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

This study has been completed.
Sponsor:
Collaborator:
IWK Foundation
Information provided by:
IWK Health Centre
ClinicalTrials.gov Identifier:
NCT00973687
First received: September 8, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  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 Blind (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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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
No Intervention: 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
No Intervention: 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

Ages Eligible for Study:   2 Years to 14 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Dr. Lyn Sonnenberg, IWK Health Centre
ClinicalTrials.gov Identifier: NCT00973687     History of Changes
Other Study ID Numbers: 2967
Study First Received: September 8, 2009
Last Updated: September 8, 2009
Health Authority: Canada: Ethics Review Committee

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
Dexamethasone 21-phosphate
BB 1101
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on July 24, 2014