Recruiting

Observational Study

Sponsor:

University of British Columbia

Code:

NCT04045587

Conditions

Severe Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Severe Asthma

Study ID

NCT04045587

Start date

Nov 6, 2018

Status verified date

Apr, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

714 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Blood eosinophil counts [ Time Frame: Past 12 months ]
  • Blood Immunoglobulin E (IgE) counts [ Time Frame: Past 12 months ]
  • Fractional exhaled nitric oxide level [ Time Frame: Past 12 months ]
  • Start and end dates of oral corticosteroid medication [ Time Frame: Prior to baseline visit ]
  • Asthma Control [ Time Frame: 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) [ Time Frame: Prior to baseline visit ]
  • Reason for switching biologic medication (if relevant) [ Time Frame: Past 12 months ]
  • Start and end dates of all asthma related inhaled medications [ Time Frame: Prior to baseline visit ]
  • Number of asthma exacerbations requiring rescue steroids [ Time Frame: Past 12 months ]
  • Number of emergency room visits for asthma [ Time Frame: Past 12 months ]
  • Number of hospital admissions for asthma [ Time Frame: Past 12 months ]
  • Spirometry test results for Forced Vital Capacity (FVC) [ Time Frame: Past 12 months ]
  • Spirometry test results for Forced Expiratory Volume in One Second (FEV1) [ Time Frame: Past 12 months ]

Central Contacts and Locations

Central contacts

Shelley Abercromby

(604) 875-4111Shelley.Abercromby@vch.ca

Maria Naval

604-875-5697Maria.Naval@vch.ca

Locations

University of Alberta

Recruiting

Edmonton, Alberta, Canada, T6G2G3

Contacts

Amy Haarsma

(780) 492-3741haarsma@ualberta.ca

Principal Investigator:

Mohit Bhutani

Synergy MD Specialty Group

Recruiting

Edmonton, Alberta, Canada

Contacts

Carrie McPhee

cmcphee@yegresearchgroup.com

Principal Investigator:

Dina Fathy

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V5Z1M9

Contacts

Shelley Abercromby

(604) 875-4111Shelley.Abercromby@ubc.ca

Principal Investigator:

Celine Bergeron

University of British Columbia

Recruiting

Vancouver, British Columbia, Canada, V6Z1Y6

Contacts

Leiana Hoshyari

(604) 682-2344LHoshyari@advancinghealth.ubc.ca

Principal Investigator:

Delbert Dorscheid

Kingston General Hospital

Recruiting

Kingston, Ontario, Canada

Contacts

Alison Morra

alison.morra@kingstonhsc.ca

Principal Investigator:

Diane Lougheed

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

Contacts

Kathy Vandemheen

(613) 737-8259kvandemheen@ohri.ca

Principal Investigator:

Shawn Aaron

Inspiration Research Limited

Recruiting

Toronto, Ontario, Canada, M5T3A9

Contacts

Kayla Cardoso

(416) 944-9602kcardoso@inspirationresearch.ca

Principal Investigator:

Kenneth Chapman

Université de Sherbrooke

Recruiting

Sherbrooke, Quebec, Canada

Contacts

Martine Duval

Martine.Duval@USherbrooke.ca

Université Laval

Recruiting

Quebéc City, Quebéc, Canada, G1V4G5

Contacts

Marie-Eve Boulay

(418) 656-8711Marie-Eve.Boulay@criucpq.ulaval.ca

Principal Investigator:

Andréanne Côté

More Information

Sponsor

University of British Columbia

Last update posted

May 1, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2026-05-01.