International Severe Asthma Registry: Canadian Cohort

Study Overview
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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.

Official Title
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International Severe Asthma Registry: Canadian Cohort

Conditions
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Severe Asthma

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe Asthma Participants<br>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?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |