NCT03243110

Brief Summary

The study will consist of three phases: Phase A: General population survey for estimation of the prevalence of asthma, and prospective collection of resource utilization and quality-of-life data for 12 months, Phase B: comparison of healthcare resource usage collected prospectively to the data collected using administrative data in the population recruited in Phase A, and Phase C: Economic modeling of asthma to extrapolate the findings across Canada and into the future years.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
613

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2010

Longer than P75 for all trials

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

Study Start

First participant enrolled

December 1, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
3.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 8, 2017

Completed
Last Updated

November 13, 2017

Status Verified

August 1, 2017

Enrollment Period

2.8 years

First QC Date

August 3, 2017

Last Update Submit

November 8, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Costs of asthma in BC and Canada per patient

    Costs per patients will be calculated by multiplying the amount of healthcare resources used by the corresponding unit costs. The investigators will adjust all unit costs to 2010 Canadian dollar according to the medical care component of the Consumer Price Index(42). The lowest price for available (generic drugs if exists) versions of medications will be used based on province-specific data.

    September 2013

Secondary Outcomes (2)

  • Calculating quality of life of participants with asthma using the Asthma Quality of Life Questionnaire

    January 2017

  • Calculating quality of life of participants with asthma using the EuroQol's EQ-5D Questionnaire

    February 2017

Study Arms (1)

Asthmatics requiring breathing test

Participants must have had a diagnosis of asthma by a physician. The participant must have had a self-reported health care interaction related to asthma (physician visit, ED visit, hospitalization) in the past 5 years. Participants must be 1 to 85 years old.

Diagnostic Test: breathing test

Interventions

breathing testDIAGNOSTIC_TEST

Spirometry is a non-invasive means of measuring lung function: The participant is asked to take a deep breath and then exhale into the sensor as hard and as long as possible. Soft nose clips may be used to prevent air escaping through the nose. If the participant does not show a definitive diagnosis of asthma, a methacholine challenge test will be performed to elicit bronchoconstriction in participants. In methacholine challenge test, the participant breaths in standardized dose of nebulized methacholine again. Methacholine challenge test is widely accepted and standardized method for assisting the diagnosis of asthma and there will be no experimental altercation in the method methacholine challenge is performed.

Asthmatics requiring breathing test

Eligibility Criteria

Age1 Year - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Phase A of the study will be based on the survey of the general population (1-85 y/o) of two well-defined target areas and recruitment of those with a self-reported physician diagnosis of asthma. Phase B of the study is the retrospective elicitation of the health record of participants. In Phase C of the study builds upon the data of Phase A and B and other published studies to extrapolate the results to the Canadian population for the next 10 years, as such it does not involve direct population sampling.

You may qualify if:

  • Patient must state that they have had a diagnosis of asthma by a physician. In addition, the patient must have had a self-reported health care interaction related to asthma (physician visit, ED visit, hospitalization) in the past 5 years.
  • Patient must be 1 to 85 years old.

You may not qualify if:

  • Patients unable to provide informed consent due to language difficulties or cognitive impairment.
  • Patients who have a greater than 10 pack-year smoking history (this will exclude patients with possible COPD).
  • Patients who know that they will be moving out of the province within 12 months of study entry.
  • Patients in whom metacholine challenge test is contraindicated due to non-asthma-related reasons (e.g. patients with cerebral aneurysm, pregnant and breastfeeding participants).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

Breath Tests

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mohsen Sadatsafavi, MD,Ph.D

    University of British Columbia

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 3, 2017

First Posted

August 8, 2017

Study Start

December 1, 2010

Primary Completion

September 1, 2013

Study Completion

June 1, 2017

Last Updated

November 13, 2017

Record last verified: 2017-08