International Severe Asthma Registry: Canadian Cohort

NCT ID: NCT04045587

Last Updated: 2024-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

714 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-11-06

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Severe Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

University of Toronto

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role collaborator

McGill University

OTHER

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role collaborator

The Ottawa Hospital

OTHER

Sponsor Role collaborator

Queen's University

OTHER

Sponsor Role collaborator

University of Saskatchewan

OTHER

Sponsor Role collaborator

Western University, Canada

OTHER

Sponsor Role collaborator

University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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Celine Bergeron

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Celine Bergeron

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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University of Alberta

Edmonton, Alberta, Canada

Site Status RECRUITING

Synergy MD Specialty Group

Edmonton, Alberta, Canada

Site Status RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

University of British Columbia

Vancouver, British Columbia, Canada

Site Status RECRUITING

Kingston General Hospital

Kingston, Ontario, Canada

Site Status RECRUITING

University of Western Ontario

London, Ontario, Canada

Site Status NOT_YET_RECRUITING

The Ottawa Hospital

Ottawa, Ontario, Canada

Site Status RECRUITING

Inspiration Research Limited

Toronto, Ontario, Canada

Site Status RECRUITING

McGill University

Montreal, Quebec, Canada

Site Status NOT_YET_RECRUITING

Université de Sherbrooke

Sherbrooke, Quebec, Canada

Site Status RECRUITING

Université Laval

Quebéc City, Quebéc, Canada

Site Status RECRUITING

University of Saskatchewan

Saskatoon, Saskatchewan, Canada

Site Status ACTIVE_NOT_RECRUITING

Countries

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Canada

Central Contacts

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Shelley Abercromby

Role: CONTACT

Phone: (604) 875-4111

Email: [email protected]

Maria Naval

Role: CONTACT

Phone: 604-875-5697

Email: [email protected]

Facility Contacts

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Amy Haarsma

Role: primary

Carrie McPhee

Role: primary

Shelley Abercromby

Role: primary

Leiana Hoshyari

Role: primary

Alison Morra

Role: primary

Hana Serajeddini

Role: primary

Kathy Vandemheen

Role: primary

Kayla Cardoso

Role: primary

Cathy Fugere

Role: primary

Martine Duval

Role: primary

Marie-Eve Boulay

Role: primary

Other Identifiers

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H17 - 03052

Identifier Type: -

Identifier Source: org_study_id