drugset / Trial / NCT03133897

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

NCT03133897 ↗

Phase 3 Terminated 20 enrolled Children's Hospital of Eastern Ontario
RandomizedParallel-groupDouble-blindOther

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.

Timeline

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

Outcome

Outcome not reported

Stopped: “it was felt by the sponsoring institution that the current standard of oversight expected by the Health Canada regulations, would not be possible to achieve”

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 0.6 mg/kg Oral
Comparator Prednisone Other / unclassified 1 mg/kg Oral

Indications