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

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ClinicalTrials.gov Identifier: NCT01326494

Recruitment Status : Active, not recruiting

First Posted : March 31, 2011

Last Update Posted : November 6, 2017

Sponsor:

Information provided by (Responsible Party):

Bruce Carleton, University of British Columbia

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.

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

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 Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	92 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Reducing the Acute Care Burden of Childhood Asthma on Health Services in British Columbia
Study Start Date :	April 2011
Actual Primary Completion Date :	May 2012
Estimated Study Completion Date :	December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma Steroids

U.S. FDA Resources

Arms and Interventions

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 Name: Prednisone
No Intervention: Usual care for Asthma treatment monitor the readmission of URTI induced asthma in children over a 12 month period

Outcome Measures

Primary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	12 Months to 18 Years (Child, Adult)
Sexes Eligible for Study:	All
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

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): 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


Responsible Party:	Bruce Carleton, Principle Investigator, University of British Columbia
ClinicalTrials.gov Identifier:	NCT01326494 History of Changes
Other Study ID Numbers:	H10-00184
First Posted:	March 31, 2011 Key Record Dates
Last Update Posted:	November 6, 2017
Last Verified:	November 2017

Keywords provided by Bruce Carleton, University of British Columbia:


Upper Respiratory Tract Infection Asthma URTI induced exacerbation of Asthma

Additional relevant MeSH terms:


Asthma Respiratory Tract Infections Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases	Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Infection

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