International Severe Asthma Registry: Canadian Cohort (ISAR)

April 27, 2026 updated by: Celine Bergeron, University of British Columbia
The International Severe Asthma Registry is a global initiative looking to ensure that the care of people with severe asthma will continue to improve by collecting detailed information about the health and treatment of as many people with the disease as possible. The study will gather anonymized longitudinal real-life data for participants with severe asthma for five years. The purpose of the registry is to track the progress of participants and determine how well they are responding to treatment. Medical research using data from the registry will give the investigators a better understanding of severe asthma and help the investigators develop and improve the care and treatment for severe asthma participants. The Canadian cohort of the registry will collect information from Canadian participants with severe asthma across seven different sites.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Study staff will collect medical information through reviewing participant medical charts and interviewing participants about their health/asthma. The information collected includes birth date, gender, ethnicity, height/weight, body mass index, medical history (smoking history and exacerbation history), current and past asthma related medications, and any recent test results available pertaining to blood work, lung function, allergen skin prick, and imaging. This information will be collected at the baseline visit, and then once a year at a follow up visit, for five years (total of five visits).

Participants will be assigned a unique study number to protect the confidentiality of their personal health care information. All study data will be de-identified and then stored in a secure information management system, hosted at the study sponsor, Optimum Patient Care Global Limited in Cambridge, United Kingdom. Participant identities will always be kept confidential and will not be included in any research that is published. Data collected across the Canadian sites will be used to find ways to improve asthma treatments in Canada, to report on current patterns of managing severe asthma in Canada, to identify different sub-groups of severe asthma, and to carry out various medical research to understand asthma better and develop new treatments.

Research records and health or other source records may be inspected in the presence of the Principal Investigator or by representatives of the University of British Columbia's Clinical Research Ethics Board for the purpose of monitoring the research. No information or records that disclose participants' identities will be published without subject consent, nor will any information or records that disclose participants' identities be removed or released without subject consent unless required by law.

Study Type

Observational

Enrollment (Estimated)

714

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2G3
        • Recruiting
        • University of Alberta
        • Contact:
        • Principal Investigator:
          • Mohit Bhutani
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z1M9
        • Recruiting
        • University of British Columbia
        • Contact:
        • Principal Investigator:
          • Celine Bergeron
        • Sub-Investigator:
          • Gordon Kirkpatrick
      • Vancouver, British Columbia, Canada, V6Z1Y6
        • Recruiting
        • University of British Columbia
        • Principal Investigator:
          • Delbert Dorscheid
        • Contact:
    • Ontario
      • Kingston, Ontario, Canada
      • London, Ontario, Canada
        • Not yet recruiting
        • University of Western Ontario
        • Contact:
        • Sub-Investigator:
          • Hana Serajeddini
      • Ottawa, Ontario, Canada
        • Recruiting
        • The Ottawa Hospital
        • Contact:
        • Principal Investigator:
          • Shawn Aaron
      • Toronto, Ontario, Canada, M5T3A9
        • Recruiting
        • Inspiration Research Limited
        • Principal Investigator:
          • Kenneth Chapman
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • Not yet recruiting
        • McGill University
        • Contact:
        • Principal Investigator:
          • Ron Olivenstein
      • Sherbrooke, Quebec, Canada
    • Quebéc
      • Quebéc City, Quebéc, Canada, G1V4G5
        • Recruiting
        • Université Laval
        • Principal Investigator:
          • Andreanne Cote
        • Contact:
        • Sub-Investigator:
          • Louis-Philippe Boulet
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
        • Active, not recruiting
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population will be selected from respirology/pulmonary clinics across Canada. Participants will be identified and recruited by the study investigators and study staff based on their clinical presentation.

Description

Inclusion Criteria:

  • Participants 18 years or older
  • Participants receiving treatment according to GINA Step 5 or uncontrolled in GINA Step 4 (uncontrolled is defined as having severe asthma symptoms or frequent exacerbations)

Exclusion Criteria:

-Participants with mild to moderate asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Severe Asthma Participants
Participants with severe asthma classified at GINA Step 4 and uncontrolled in terms of their symptoms and exacerbations or GINA Step 5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood eosinophil counts
Time Frame: Past 12 months
10^9/L
Past 12 months
Blood Immunoglobulin E (IgE) counts
Time Frame: Past 12 months
kilo unit/L
Past 12 months
Fractional exhaled nitric oxide level
Time Frame: Past 12 months
parts per billion
Past 12 months
Start and end dates of oral corticosteroid medication
Time Frame: Prior to baseline visit
Day/Month/Year for start and end dates if available
Prior to baseline visit
Asthma Control
Time Frame: Past 4 weeks
Assessed through the Global Initiative for Asthma (GINA) Questionnaire
Past 4 weeks
Start and end dates of biologic medications such as anti-interleukin-5, anti-immunoglobulin E, or anti-interleukin-4 treatments (if relevant)
Time Frame: Prior to baseline visit
Day/Month/Year for start and end dates if available
Prior to baseline visit
Reason for switching biologic medication (if relevant)
Time Frame: Past 12 months
Options include: lack of clinical efficacy, side effects, biologic access restriction, and patient preference
Past 12 months
Start and end dates of all asthma related inhaled medications
Time Frame: Prior to baseline visit
Day/Month/Year for start and end dates if available
Prior to baseline visit
Number of asthma exacerbations requiring rescue steroids
Time Frame: Past 12 months
Severe asthma exacerbations are defined as events that require urgent action (rescue steroids) by the participant and physician to prevent a serious outcome
Past 12 months
Number of emergency room visits for asthma
Time Frame: Past 12 months
Total number of visits
Past 12 months
Number of hospital admissions for asthma
Time Frame: Past 12 months
Total number of admissions
Past 12 months
Spirometry test results for Forced Vital Capacity (FVC)
Time Frame: Past 12 months
Pre- and post-bronchodilator FVC results in litres
Past 12 months
Spirometry test results for Forced Expiratory Volume in One Second (FEV1)
Time Frame: Past 12 months
Pre- and post-bronchodilator FEV1 results in litres
Past 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

McGill University
Université de Sherbrooke
University of Alberta
University of Toronto
The Ottawa Hospital
Western University, Canada
University of Saskatchewan
Laval University
Kingston Health Sciences Centre

Investigators

  • Principal Investigator: Celine Bergeron, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2018

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

July 31, 2019

First Submitted That Met QC Criteria

August 2, 2019

First Posted (Actual)

August 5, 2019

Study Record Updates

Last Update Posted (Actual)

May 1, 2026

Last Update Submitted That Met QC Criteria

April 27, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H17 - 03052

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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