International Severe Asthma Registry: Canadian Cohort

Recruiting

• Conditions: Severe Asthma

• Registration Number: NCT04045587
• Lead Sponsor: University of British Columbia

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-11-06
• Study First Submitted: 2019-07-31
• Study First Submitted QC: 2019-08-02
• Study First Posted: 2019-08-05
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05
• Primary Completion: 2027-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 714

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)

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Exclusion Criteria

-Participants with mild to moderate asthma

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Trial Locations

Locations (11)

University of Western Ontario; 🇨🇦 London, Ontario, Canada

Université de Sherbrooke; 🇨🇦 Sherbrooke, Quebec, Canada

University of Saskatchewan; 🇨🇦 Saskatoon, Saskatchewan, Canada

University of Alberta; 🇨🇦 Edmonton, Alberta, Canada

Synergy MD Specialty Group; 🇨🇦 Edmonton, Alberta, Canada

University of British Columbia; 🇨🇦 Vancouver, British Columbia, Canada

Kingston General Hospital; 🇨🇦 Kingston, Ontario, Canada

The Ottawa Hospital; 🇨🇦 Ottawa, Ontario, Canada

Inspiration Research Limited; 🇨🇦 Toronto, Ontario, Canada

McGill University; 🇨🇦 Montréal, Quebec, Canada

Université Laval; 🇨🇦 Quebéc City, Quebec, Canada