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NCT Number: NCT04045587

International Severe Asthma Registry: Canadian Cohort

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.

Recruiting

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Key information

Conditions

Severe Asthma Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Synergy MD Specialty Group, Edmonton, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Blood eosinophil counts

    Time frame: Past 12 months

    10^9/L

  2. Blood Immunoglobulin E (IgE) counts

    Time frame: Past 12 months

    kilo unit/L

  3. Fractional exhaled nitric oxide level

    Time frame: Past 12 months

    parts per billion

  4. Start and end dates of oral corticosteroid medication

    Time frame: Prior to baseline visit

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

  5. Asthma Control

    Time frame: Past 4 weeks

    Assessed through the Global Initiative for Asthma (GINA) Questionnaire

  6. Start and end dates of biologic medications such as anti-interleukin-5, anti-immunoglobulin E, or anti-interleukin-4 treatments (if relevant)

    Time frame: Prior to baseline visit

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

  7. Reason for switching biologic medication (if relevant)

    Time frame: Past 12 months

    Options include: lack of clinical efficacy, side effects, biologic access restriction, and patient preference

  8. Start and end dates of all asthma related inhaled medications

    Time frame: Prior to baseline visit

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

  9. Number of asthma exacerbations requiring rescue steroids

    Time frame: 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

  10. Number of emergency room visits for asthma

    Time frame: Past 12 months

    Total number of visits

  11. Number of hospital admissions for asthma

    Time frame: Past 12 months

    Total number of admissions

  12. Spirometry test results for Forced Vital Capacity (FVC)

    Time frame: Past 12 months

    Pre- and post-bronchodilator FVC results in litres

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

    Time frame: Past 12 months

    Pre- and post-bronchodilator FEV1 results in litres

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Naval

CONTACT

[email protected]

604-875-5697

Shelley Abercromby

CONTACT

[email protected]

(604) 875-4111 ext. 62500

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

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

Registry information

Acronym: ISAR

Important dates

Study start
2018
Primary completion
2027
Study completion
2028
First posted
Aug 5, 2019
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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