NCT01326494

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
92

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2011

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 29, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 31, 2011

Completed
1 day until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2021

Completed
Last Updated

May 14, 2021

Status Verified

May 1, 2021

Enrollment Period

1.1 years

First QC Date

March 29, 2011

Last Update Submit

May 13, 2021

Conditions

Upper Respiratory Tract InfectionAsthma

Keywords

Upper Respiratory Tract InfectionAsthmaURTI induced exacerbation of Asthma

Outcome Measures

Primary Outcomes (1)

  • 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.

    One year

Study Arms (2)

Arm 1 Oral Cortico Steroid

ACTIVE COMPARATOR

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

Drug: Arm 1 Oral Cortico Steroids

Usual care for Asthma treatment

NO INTERVENTION

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

Interventions

Arm 1 Oral Cortico SteroidsDRUG

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 )

Also known as: Prednisone
Arm 1 Oral Cortico Steroid

Eligibility Criteria

Age12 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • or more presentations to Emergency department in a 12 month period

You may not qualify if:

  • less then 2 presentations to Emergency department in a 12 month period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3V4, Canada

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsAsthma

Interventions

Prednisone

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Bruce Carleton, B.Pharm, Pharm.D.

    The University of British Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

March 29, 2011

First Posted

March 31, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2012

Study Completion

May 1, 2021

Last Updated

May 14, 2021

Record last verified: 2021-05

Locations

CA(1)