Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia

NCT ID: NCT01326494

Last Updated: 2021-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

92 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2021-05-31

Brief Summary

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The purpose of this study is to investigate the benefits of giving filled prescription of a medication to be used upon early onset of symptoms of URTI induced asthma. The hope is to reduce the need to present to Health Care centres for treatment.

Detailed Description

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In Canada, asthma affects more the 12% of children. Exacerbation are a common feature of asthma. In children, upper respiratory tract infection (URTI's) are responsible for over 80% of asthma exacerbation.

Experts in asthma care acknowledge this critical problem and have developed guidelines to reduce asthma exacerbation.

The criteria for participation in this study to have 2 or more presentations to a Health Service centre in the past 12 months for URTI induced asthma. These patients will be followed and interviewed monthly over a 12 month period to investigate whether the use of Oral cortico-steroids upon early onset of URTI induced asthma prevents the need for presentation to hospital

Conditions

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Upper Respiratory Tract Infection Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Arm 1 Oral Cortico Steroid

A filled prescription will be given to be used upon early onset of symptoms.

Group Type ACTIVE_COMPARATOR

Arm 1 Oral Cortico Steroids

Intervention Type DRUG

Prednisolone: 1 mg / kg per day course of dose for 5 days up to child's weight of 20 kgs.

Dexamethasone: 0.3mg/kg per dose for 3 days (minimum weight 20 kgs )

Usual care for Asthma treatment

monitor the readmission of URTI induced asthma in children over a 12 month period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Arm 1 Oral Cortico Steroids

Prednisolone: 1 mg / kg per day course of dose for 5 days up to child's weight of 20 kgs.

Dexamethasone: 0.3mg/kg per dose for 3 days (minimum weight 20 kgs )

Intervention Type DRUG

Other Intervention Names

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Prednisone

Eligibility Criteria

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Inclusion Criteria

* 2 or more presentations to Emergency department in a 12 month period

Exclusion Criteria

* less then 2 presentations to Emergency department in a 12 month period
Minimum Eligible Age

12 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Bruce Carleton

Principle Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruce Carleton, B.Pharm, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

The University of British Columbia

Locations

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BC Children's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H10-00184

Identifier Type: -

Identifier Source: org_study_id

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