Severe AsthmaISARNCT04045587
International Severe Asthma Registry: Canadian Cohort
An observational study of Severe Asthma, run by University of British Columbia at 12 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Asthma
- How many people
- 714 participants
- Where
- 12 sitesCanada
- Study dates
- 6 Nov 2018to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will be selected from respirology/pulmonary clinics across Canada. Participants will be identified and recruited by the study investigators and study staff based on their clinical presentation.
Who may be able to join
- 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)
Who cannot join
- -Participants with mild to moderate asthma
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Canada12 sites, 11 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G2G3
Amy Haarsma, (780) 492-3741, haarsma@ualberta.ca
Mohit Bhutani
- Recruiting
Synergy MD Specialty Group
Edmonton, Alberta
Carrie McPhee, cmcphee@yegresearchgroup.com
Dina Fathy
- Recruiting
Kingston General Hospital
Kingston, Ontario
Alison Morra, alison.morra@kingstonhsc.ca
Diane Lougheed
- Not yet recruiting
University of Western Ontario
London, Ontario
Hana Serajeddini, hserajed@uwo.ca
Hana Serajeddini
- Not yet recruiting
McGill University
Montreal, Quebec, H4A3J1
Cathy Fugere, (514) 934-1934 ext. 38936, cathy.fugere@mail.mcgill.ca
Ron Olivenstein
- Recruiting
The Ottawa Hospital
Ottawa, Ontario
Kathy Vandemheen, (613) 737-8259, kvandemheen@ohri.ca
Shawn Aaron
- Recruiting
Université Laval
Quebéc City, Quebéc, G1V4G5
Marie-Eve Boulay, (418) 656-8711 ext. 2617, Marie-Eve.Boulay@criucpq.ulaval.ca
Andréanne Côté
- Active, not recruiting
University of Saskatchewan
Saskatoon, Saskatchewan
- Recruiting
Université de Sherbrooke
Sherbrooke, Quebec
Martine Duval, Martine.Duval@USherbrooke.ca
Simon Couillard
- Recruiting
Inspiration Research Limited
Toronto, Ontario, M5T3A9
Kayla Cardoso, (416) 944-9602, kcardoso@inspirationresearch.ca
Kenneth Chapman
- Recruiting
University of British Columbia
Vancouver, British Columbia, V5Z1M9
Shelley Abercromby, (604) 875-4111 ext. 62500, Shelley.Abercromby@ubc.ca
Celine Bergeron
- Recruiting
University of British Columbia
Vancouver, British Columbia, V6Z1Y6
Leiana Hoshyari, (604) 682-2344 ext. 62492, LHoshyari@advancinghealth.ubc.ca
Delbert Dorscheid
About this study
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.
Read the 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.
- Conditions
- Severe Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood eosinophil counts
10^9/L
Measured: Past 12 months
Blood Immunoglobulin E (IgE) counts
kilo unit/L
Measured: Past 12 months
Fractional exhaled nitric oxide level
parts per billion
Measured: Past 12 months
Start and end dates of oral corticosteroid medication
Day/Month/Year for start and end dates if available
Measured: Prior to baseline visit
Asthma Control
Assessed through the Global Initiative for Asthma (GINA) Questionnaire
Measured: 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
Measured: 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
Measured: Past 12 months
Start and end dates of all asthma related inhaled medications
Day/Month/Year for start and end dates if available
Measured: 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
Measured: Past 12 months
Number of emergency room visits for asthma
Total number of visits
Measured: Past 12 months
Number of hospital admissions for asthma
Total number of admissions
Measured: Past 12 months
Spirometry test results for Forced Vital Capacity (FVC)
Pre- and post-bronchodilator FVC results in litres
Measured: Past 12 months
Spirometry test results for Forced Expiratory Volume in One Second (FEV1)
Pre- and post-bronchodilator FEV1 results in litres
Measured: Past 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2019
- Study start6 Nov 2018
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 714 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- University of Alberta, University of Toronto, Laval University, McGill University, Université de Sherbrooke, The Ottawa Hospital, Kingston Health Sciences Centre, University of Saskatchewan, Western University, Canada
- Responsible party
- Principal investigator, Celine Bergeron, University of British Columbia
- Investigators
- Celine Bergeron, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04045587
- Sponsor's protocol ID
- H17 - 03052
- Acronym
- ISAR
- Status last verified
- Apr 2026
- First submitted
- 31 Jul 2019
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Severe Asthma Registry: Canadian Cohort
- ClinicalTrials.gov ID
- NCT04045587
- Acronym / sponsor ID
- ISAR / H17 - 03052
- Conditions
- Severe Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 714 participants (estimated)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- University of Alberta, University of Toronto, Laval University, McGill University, Université de Sherbrooke, The Ottawa Hospital, Kingston Health Sciences Centre, University of Saskatchewan, Western University, Canada
- Study start
- 6 Nov 2018 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will be selected from respirology/pulmonary clinics across Canada. Participants will be identified and recruited by the study investigators and study staff based on their clinical presentation.
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- -Participants with mild to moderate asthma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Blood eosinophil counts
Time frame: Past 12 months
10^9/L
Blood Immunoglobulin E (IgE) counts
Time frame: Past 12 months
kilo unit/L
Fractional exhaled nitric oxide level
Time frame: Past 12 months
parts per billion
Start and end dates of oral corticosteroid medication
Time frame: Prior to baseline visit
Day/Month/Year for start and end dates if available
Asthma Control
Time frame: Past 4 weeks
Assessed through the Global Initiative for Asthma (GINA) Questionnaire
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
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
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
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
Number of emergency room visits for asthma
Time frame: Past 12 months
Total number of visits
Number of hospital admissions for asthma
Time frame: Past 12 months
Total number of admissions
Spirometry test results for Forced Vital Capacity (FVC)
Time frame: Past 12 months
Pre- and post-bronchodilator FVC results in litres
Spirometry test results for Forced Expiratory Volume in One Second (FEV1)
Time frame: Past 12 months
Pre- and post-bronchodilator FEV1 results in litres
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Celine Bergeron principal investigator
University of British Columbia
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Asthma, run by University of British Columbia at 12 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shelley Abercromby ((604) 875-4111 ext. 62500, Shelley.Abercromby@vch.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood eosinophil counts (time frame: Past 12 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.