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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03133897
Recruitment Status : Terminated (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)
First Posted : April 28, 2017
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Catherine Pound, Children's Hospital of Eastern Ontario

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.


Condition or disease Intervention/treatment Phase
Asthma Drug: Dexamethasone Drug: Prednisone Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: Dexamethasone Versus Prednisone for Asthma Treatment in the Pediatric Inpatient Population; a Feasibility Study
Actual Study Start Date : March 5, 2018
Actual Primary Completion Date : August 2, 2019
Actual Study Completion Date : March 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

Arm Intervention/treatment
Active Comparator: Prednisone
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
control group will receive 4 day treatment

Experimental: Dexamethasone
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
experimental group will receive 2 day treatment




Primary Outcome Measures :
  1. Health Utilization [ Time Frame: 4 weeks ]
    Readmission to hospital, repeat ED visit within 4 weeks for asthma, or unplanned visits to primary health care providers for asthma symptoms.


Secondary Outcome Measures :
  1. Allocation success [ Time Frame: 4 weeks ]

    proportion receiving assigned CS as per randomization group

    (1) proportion receiving assigned CS as per randomization group proportion receiving assigned corticosteroid as per randomization group


  2. recruitment success [ Time Frame: 1 year ]
    number screened, number eligible, number enrolled

  3. compliance with symptom reporting [ Time Frame: 4 weeks after discharge ]
    Compliance with reporting symptoms in diary

  4. Retention rate [ Time Frame: 4 weeks ]
    Proportion of patients coming back for follow-up visits and Proportion of patients reached at 4-week follow-up



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Months to 17 Years   (Child)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Children admitted during the study period with a diagnosis of asthma exacerbation,
  2. Children aged 18 months to 17 years of age
  3. 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

Exclusion Criteria:

  1. Children who received IV Corticosteroid (CS) in the Emergency Department (ED)
  2. 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
  3. Children who have received more than one dose of oral CS prior to enrolment
  4. Children who have received their first dose of oral CS greater than 12 hours prior to enrolment
  5. Children who received oral or IV CS in the previous 4 weeks
  6. 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
  7. Children whose caregivers do not understand English or French

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133897


Locations
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Canada, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
Sponsors and Collaborators
Children's Hospital of Eastern Ontario
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Catherine Pound, Consulting Paediatrician, Children's Hospital of Eastern Ontario
ClinicalTrials.gov Identifier: NCT03133897    
Other Study ID Numbers: CHEO
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: September 7, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Catherine Pound, Children's Hospital of Eastern Ontario:
dexamethasone
prednisone
inpatient
paediatrics
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Dexamethasone
Prednisone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents