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

May 13, 2021 updated by: Bruce Carleton, University of British Columbia
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

92

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • BC Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Arm 1 Oral Cortico Steroid
A filled prescription will be given to be used upon early onset of symptoms.
Drug: 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 )

Other Names:
  • Prednisone
NO_INTERVENTION: Usual care for Asthma treatment
monitor the readmission of URTI induced asthma in children over a 12 month period

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of representation to Health Services for Exacerbation of URTI induced asthma
Time Frame: One year
To review the effect of medication given at early onset of symptoms have on reducing the presentation to Health Services and Emergency Departments.
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: Bruce Carleton, B.Pharm, Pharm.D., The University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (ACTUAL)

May 1, 2012

Study Completion (ACTUAL)

May 1, 2021

Study Registration Dates

First Submitted

March 29, 2011

First Submitted That Met QC Criteria

March 29, 2011

First Posted (ESTIMATE)

March 31, 2011

Study Record Updates

Last Update Posted (ACTUAL)

May 14, 2021

Last Update Submitted That Met QC Criteria

May 13, 2021

Last Verified

May 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H10-00184

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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