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

Primary Purpose

Upper Respiratory Tract Infection, Asthma

Status

Completed

Phase

Phase 4

Locations

Canada

Study Type

Interventional

Intervention

Arm 1 Oral Cortico Steroids

About this trial

This is an interventional prevention trial for Upper Respiratory Tract Infection focused on measuring Upper Respiratory Tract Infection, Asthma, URTI induced exacerbation of Asthma

Eligibility Criteria

12 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

BC Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Arm 1 Oral Cortico Steroid

Usual care for Asthma treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Reduction of representation to Health Services for Exacerbation of URTI induced asthma

To review the effect of medication given at early onset of symptoms have on reducing the presentation to Health Services and Emergency Departments.

Secondary Outcome Measures

Full Information

NCT ID

NCT01326494

First Posted

March 29, 2011

Last Updated

May 13, 2021

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT01326494

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2021

Overall Recruitment Status

Completed

Study Start Date

April 2011 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Respiratory Tract Infection, Asthma

Keywords

Upper Respiratory Tract Infection, Asthma, URTI induced exacerbation of Asthma

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

92 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm 1 Oral Cortico Steroid

Arm Type

Active Comparator

Arm Description

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

Arm Title

Usual care for Asthma treatment

Arm Type

No Intervention

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Arm 1 Oral Cortico Steroids

Other Intervention Name(s)

Prednisone

Intervention Description

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 )

Primary Outcome Measure Information:

Title

Reduction of representation to Health Services for Exacerbation of URTI induced asthma

Description

To review the effect of medication given at early onset of symptoms have on reducing the presentation to Health Services and Emergency Departments.

Time Frame

One year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Bruce Carleton, B.Pharm, Pharm.D.

Organizational Affiliation

The University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

BC Children's Hospital

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V6H 3V4

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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