International Severe Asthma Registry: Canadian Cohort

Severe Asthma Clinical Trial

— ISAR  

Official title:

International Severe Asthma Registry: Canadian Cohort

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04045587
• Other study ID #: H17 - 03052
• Status: Recruiting
• Start date: November 6, 2018
• Est. completion date: December 2023

Study information

• Verified date: June 2022
• Source: University of British Columbia
• Contact: Shelley Abercromby
• Phone: (604) 875-4111
• Email: Shelley.Abercromby[@]vch.ca
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 714
• Est. completion date: December 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Severe Asthma

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	Synergy MD Specialty Group	Edmonton	Alberta
Canada	University of Alberta	Edmonton	Alberta
Canada	Kingston General Hospital	Kingston	Ontario
Canada	McGill University	Montréal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	Université Laval	Quebéc City	Quebec
Canada	Inspiration Research Limited	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Canada	University of British Columbia	Vancouver	British Columbia

Sponsors (6)

Lead Sponsor	Collaborator
University of British Columbia	Laval University, McGill University, University of Alberta, University of Calgary, University of Toronto

Country where clinical trial is conducted

Canada, 

Outcome

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