International Severe Asthma Registry: Canadian Cohort

NCT04045587 | Recruiting

• 1 other identifier: H17 - 03052
• Study Type: observational
• Target: 714
• Locations: 1 country
• Sites: 12

Brief Summary

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.

Conditions

Severe Asthma

Outcome Measures

Primary Outcomes (13)

• Blood eosinophil counts

  10\^9/L

  Past 12 months

• Blood Immunoglobulin E (IgE) counts

  kilo unit/L

  Past 12 months

• Fractional exhaled nitric oxide level

  parts per billion

  Past 12 months

• Start and end dates of oral corticosteroid medication

  Day/Month/Year for start and end dates if available

  Prior to baseline visit

• Asthma Control

  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)

  Day/Month/Year for start and end dates if available

  Prior to baseline visit

• Reason for switching biologic medication (if relevant)

  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

  Day/Month/Year for start and end dates if available

  Prior to baseline visit

• Number of asthma exacerbations requiring rescue steroids

  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

  Total number of visits

  Past 12 months

• Number of hospital admissions for asthma

  Total number of admissions

  Past 12 months

• Spirometry test results for Forced Vital Capacity (FVC)

  Pre- and post-bronchodilator FVC results in litres

  Past 12 months

• Spirometry test results for Forced Expiratory Volume in One Second (FEV1)

  Pre- and post-bronchodilator FEV1 results in litres

  Past 12 months

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Participants with mild to moderate asthma

Sponsors & Collaborators

• University of Alberta: collaborator
• Laval University: collaborator
• Western University, Canada: collaborator
• University of British Columbia: lead
• University of Toronto: collaborator
• McGill University: collaborator
• Université de Sherbrooke: collaborator
• The Ottawa Hospital: collaborator
• Kingston Health Sciences Centre: collaborator
• University of Saskatchewan: collaborator

Study Sites (12)

University of Alberta

Edmonton, Alberta, T6G2G3, Canada

RECRUITING

Synergy MD Specialty Group

Edmonton, Alberta, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V5Z1M9, Canada

RECRUITING

University of British Columbia

Vancouver, British Columbia, V6Z1Y6, Canada

RECRUITING

Kingston General Hospital

Kingston, Ontario, Canada

RECRUITING

University of Western Ontario

London, Ontario, Canada

NOT YET RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

Inspiration Research Limited

Toronto, Ontario, M5T3A9, Canada

RECRUITING

McGill University

Montreal, Quebec, H4A3J1, Canada

NOT YET RECRUITING

Université de Sherbrooke

Sherbrooke, Quebec, Canada

RECRUITING

Université Laval

Quebéc City, Quebéc, G1V4G5, Canada

RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Celine Bergeron

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shelley Abercromby

CONTACT

(604) 875-4111; Shelley.Abercromby@vch.ca

Maria Naval

CONTACT

604-875-5697; Maria.Naval@vch.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 31, 2019
• First Posted: August 5, 2019
• Study Start: November 6, 2018
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (12)