Dexamethasone Tolerability in the Treatment of Acute Asthma in Children

IWK Health Centre

Status: Completed

Conditions: Asthma

Treatments: Drug: Dexamethasone; Drug: Ora Sweet

Study type: Interventional

Funder types: Other

Identifiers

NCT00973687

2967

Details and patient eligibility

About

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.

Enrollment: 430 patients

Sex: All

Ages: 2 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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430 participants in 4 patient groups, including a placebo group

10 mg/mL Unsweetened Formulation

Placebo Comparator group

Description:

no prior vomiting

Treatment:

Drug: Dexamethasone

1 mg/mL Ora Sweet Formulation

Experimental group

Description:

no prior vomiting

Treatment:

Drug: Ora Sweet

Drug: Dexamethasone

10 mg/mL Unsweetened with prior vomiting

Active Comparator group

Description:

with prior vomiting

Treatment:

Drug: Dexamethasone

1 mg/mL Ora Sweet with prior vomiting

Experimental group

Description:

with prior vomiting

Treatment:

Drug: Ora Sweet

Drug: Dexamethasone