Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

NCT00973687 | Completed

• 1 other identifier: 2967
• Study Type: interventional
• Target: 430
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

pediatric; dexamethasone; management; corticosteroids; asthma

Outcome Measures

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.

  During Emergency Department visit

Secondary Outcomes (1)

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

  7-14 days following emergency dept visit

Study Arms (4)

10 mg/mL Unsweetened Formulation

PLACEBO COMPARATOR

no prior vomiting

Drug: Dexamethasone

1 mg/mL Ora Sweet Formulation

EXPERIMENTAL

no prior vomiting

Drug: Ora Sweet; Drug: Dexamethasone

10 mg/mL Unsweetened with prior vomiting

ACTIVE COMPARATOR

with prior vomiting

Drug: Dexamethasone

1 mg/mL Ora Sweet with prior vomiting

EXPERIMENTAL

with prior vomiting

Drug: Ora Sweet; Drug: Dexamethasone

Interventions

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.

1 mg/mL Ora Sweet Formulation; 1 mg/mL Ora Sweet with prior vomiting

Dexamethasone DRUG

1 mg/mL Ora Sweet Formulation; 1 mg/mL Ora Sweet with prior vomiting; 10 mg/mL Unsweetened Formulation; 10 mg/mL Unsweetened with prior vomiting

Eligibility Criteria

• Age: 2 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• acute asthma exacerbation
• requiring oral systemic corticosteroids for management

You may not qualify if:

• 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.

Sponsors & Collaborators

• IWK Health Centre: lead
• IWK Foundation: collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

Location

MeSH Terms

Conditions

Asthma

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Lyn K Sonnenberg, MD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 8, 2009
• First Posted: September 9, 2009
• Study Start: September 1, 2004
• Primary Completion: April 1, 2006
• Study Completion: May 1, 2006
• Last Updated: August 26, 2015

Record last verified: 2009-09

Locations

CA (1)