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

NCT03133897 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-09-07

No results posted yet for this study

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

Interventions

DRUG

Dexamethasone

experimental group will receive 2 day treatment

DRUG

Prednisone

control group will receive 4 day treatment

Sponsors & Collaborators

  • Children's Hospital of Eastern Ontario

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-03-05
Primary Completion
2019-08-02
Completion
2020-03-11

Countries

  • Canada

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03133897 on ClinicalTrials.gov