Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study

NCT03133897 | Terminated Phase 3 DMC

• 1 other identifier: CHEO
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Current corticosteroid regimens for children hospitalized with asthma typically include a 5-day course of prednisone or prednisolone. However, these medications taste poorly and are associated with vomiting and poor compliance. Outpatient evidence suggests that a 2-day course of dexamethasone is as effective as a longer course of prednisone and prednisolone, and better tolerated. Studies in hospitalized patients are lacking. The investigators' primary objective is to determine the feasibility of a non-inferiority trial, comparing 2 days of dexamethasone to 4 days of inpatient prednisone/prednisolone for inpatient asthma treatment. The investigators also wish to determine the feasibility of 1) enrolling patients upon admission to hospital, 2) asking patients and/or caregivers to complete a symptom weekly for 4 weeks, 3) reassessing patients post hospital discharge, 4) successfully completing phone follow up 4 weeks post hospital discharge, and 5) collecting health utilization data post hospital discharge. This study will inform a future multi-site trial comparing prednisone/prednisolone to dexamethasone in inpatient asthma treatment. It has the potential of improving the delivery of care in asthma, by improving compliance with a mainstay of treatment. It will also enhance collaboration within Ontario pediatric hospitals, facilitating knowledge translation and standardization of care across institutions.

Conditions

Asthma

Keywords

dexamethasone; prednisone; inpatient; paediatrics

Outcome Measures

Primary Outcomes (1)

• Health Utilization

  Readmission to hospital, repeat ED visit within 4 weeks for asthma, or unplanned visits to primary health care providers for asthma symptoms.

  4 weeks

Secondary Outcomes (4)

• Allocation success

  4 weeks

• recruitment success

  1 year

• compliance with symptom reporting

  4 weeks after discharge

• Retention rate

  4 weeks

Study Arms (2)

Prednisone

ACTIVE COMPARATOR

Prednisone group: Children will receive four doses (days) of prednisone 1 mg/kg/dose once daily (maximum dose 50 mg) following the initial dose of corticosteroid received in the ED under the Nursing Medical Directive or Pre-Printed Order form.

Drug: Prednisone

Dexamethasone

EXPERIMENTAL

Dexamethasone group: Children will receive the approximate pharmacologic equivalent of two doses (days) of dexamethasone 0.6 mg/kg/dose (maximum dose 16 mg per dose) once daily as follows. The standard dose of prednisone/prednisolone provided in the emergency department is 2 mg/kg/dose (maximum dose 50 mg), which is approximately equivalent to 0.3 mg/kg/dose of dexamethasone. Therefore, patients who received prednisone/prednisolone in emergency department as per the current Nursing Medical Directive and Pre-Printed Order form will receive a "top-up" These patients will then receive a dose of dexamethasone 0.6 mg/kg (maximum dose 16 mg) 24 hours after the initial corticosteroid dose received in the Emergency Department of dexamethasone 0.3 mg/kg (maximum dose 8 mg) upon enrollment.

Drug: Dexamethasone

Interventions

Dexamethasone DRUG

experimental group will receive 2 day treatment

Dexamethasone

Prednisone DRUG

control group will receive 4 day treatment

Prednisone

Eligibility Criteria

• Age: 18 Months - 17 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children admitted during the study period with a diagnosis of asthma exacerbation,
• Children aged 18 months to 17 years of age
• Children who received oral Corticosteroids in the Emergency Department prior to admission under our hospital Emergency Department Nursing Medical Directive and/or Pre-Printed Order Form

You may not qualify if:

• Children who received IV Corticosteroid (CS) in the Emergency Department (ED)
• Children who received oral CS in the ED prescribed in any other way than through the Children's Hospital of Eastern Ontario ED Nursing Medical Directive and/or Pre-Printed Order Form as doses may not be standardized
• Children who have received more than one dose of oral CS prior to enrolment
• Children who have received their first dose of oral CS greater than 12 hours prior to enrolment
• Children who received oral or IV CS in the previous 4 weeks
• Children with any of the following: unrepaired congenital heart disease, chronic lung diseases other than asthma, severe neurological impairment and other significant co-morbid disorders as they are not typically treated on our hospital's asthma pathway
• Children whose caregivers do not understand English or French

Sponsors & Collaborators

• Children's Hospital of Eastern Ontario: lead

Study Sites (1)

Children's Hospital of Eastern Ontario

Ottawa, Ontario, K1H 8L1, Canada

Location

Related Publications (1)

• Pound CM, McDonald J, Tang K, Seidman G, Jetty R, Zaidi S, Plint AC. Dexamethasone versus prednisone for children receiving asthma treatment in the paediatric inpatient population: protocol for a feasibility randomised controlled trial. BMJ Open. 2018 Dec 14;8(12):e025630. doi: 10.1136/bmjopen-2018-025630.

  PMID: 30552284 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Dexamethasone; Prednisone

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; Pregnadienediols

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consulting Paediatrician

Study Record Dates

• First Submitted: April 21, 2017
• First Posted: April 28, 2017
• Study Start: March 5, 2018
• Primary Completion: August 2, 2019
• Study Completion: March 11, 2020
• Last Updated: September 7, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)