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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT01326494
First received: March 29, 2011
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Upper Respiratory Tract Infection
Asthma
Drug: Arm 1 Oral Cortico Steroids
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Reduction of representation to Health Services for Exacerbation of URTI induced asthma [ Time Frame: One year ] [ Designated as safety issue: No ]
    To review the effect of medication given at early onset of symptoms have on reducing the presentation to Health Services and Emergency Departments.


Enrollment: 92
Study Start Date: April 2011
Estimated Study Completion Date: December 2015
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Prednisone
No Intervention: Usual care for Asthma treatment
monitor the readmission of URTI induced asthma in children over a 12 month period

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

  Eligibility

Ages Eligible for Study:   12 Months to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01326494

Locations
Canada, British Columbia
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3V4
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: Bruce Carleton, B.Pharm, Pharm.D. The University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT01326494     History of Changes
Other Study ID Numbers: H10-00184
Study First Received: March 29, 2011
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Upper Respiratory Tract Infection
Asthma
URTI induced exacerbation of Asthma

Additional relevant MeSH terms:
Asthma
Infection
Respiratory Tract Infections
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 23, 2014