NCT01525381

Brief Summary

Our study will enroll 644 randomly-selected Canadians who have been diagnosed with asthma by a physician within the previous five years. It will be determined what diagnostic tests were initially performed to make this diagnosis. Participants will undergo lung function testing over 6-8 weeks to determine their respiratory status and to confirm they have asthma. Participants may be followed up to one year depending on their test results.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
701

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Longer than P75 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 31, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 2, 2012

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

3.4 years

First QC Date

January 31, 2012

Last Update Submit

March 29, 2016

Conditions

Asthma

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Canadians diagnosed with Asthma and 18 years of age and older.

You may qualify if:

  • Patient must have a recent diagnosis of asthma by a physician. Diagnosis of asthma must have occurred within 5 years prior to entry into the study.
  • Patient must be at least 18 years old.

You may not qualify if:

  • Patients in whom methacholine challenge is contraindicated
  • Patients using chronic oral prednisone.
  • Patients with heart attack or stroke within three previous months, and those with known aortic or cerebral aneurysms.
  • Pregnant patients (unknown effect of methacholine on the fetus) and breastfeeding patients (unknown whether methacholine is excreted in breast milk).
  • Patients unable to provide informed consent.
  • Patients not able to perform spirometry and/or methacholine challenge testing.
  • Patients who have a greater than 10 pack-year smoking history (this will exclude patients with possible COPD).
  • Patients who currently have active pulmonary Tuberculosis
  • Patients who have had eye surgery in the past 3 months or who have a detached retina
  • Patients involved in another interventional asthma study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ottawa Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shawn Aaron, MD

    Ottawa Hosptial Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2012

First Posted

February 2, 2012

Study Start

November 1, 2011

Primary Completion

April 1, 2015

Study Completion

March 1, 2016

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

CA(1)