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NCT03133897

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

Terminated Phase 3 Last updated 7 September 2020
What this trial tests

Phase 3 trial testing Dexamethasone in Asthma in 20 participants. Terminated before completion.

Timeline
5 March 2018
Primary endpoint
2 August 2019
11 March 2020

Quick facts

Lead sponsorChildren's Hospital of Eastern Ontario
PhasePhase 3
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposeother
Enrollment20
Start date5 March 2018
Primary completion2 August 2019
Estimated completion11 March 2020
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital of Eastern Ontario

Who can join

Adults 18 Months to 17, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Dexamethasone versus prednisone for children receiving asthma treatment in the paediatric inpatient population: protocol for a feasibility randomised controlled trial.
    Pound CM, McDonald J, Tang K, Seidman G, et al · · 2018 · cited 4× · PMID 30552284 · DOI 10.1136/bmjopen-2018-025630

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Other trials of Dexamethasone

Trials testing the same drug.

Other recruiting trials for Asthma

Currently open trials in the same condition.

Other Children's Hospital of Eastern Ontario trials

Trials by the same sponsor.

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