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Research Study for Uncontrolled Eosinophilic Asthma

Enrolling at: Windsor
Phase 3Study phase
12–75Age range
1 siteResearch locations

About this study

Do you suffer from uncontrolled Eosinophilic Asthma?

This clinical research study is looking at the safety and effectiveness of a medication for people with severe asthma. Asthma is a condition in which your airways narrow and swell and may produce extra mucus. This can make breathing difficult and trigger coughing, a whistling sound (wheezing) when you breathe out, and shortness of breath.

This is a randomized, active-controlled study designed to investigate the efficacy and safety of adding fixed-dose benralizumab (30 mg), administered subcutaneously (SC) every 4 weeks for the first 3 doses and then every 8 weeks for participants with a history of eosinophilic asthma, who remain uncontrolled on medium-dose Inhaled corticosteroid-Long-acting β2-agonists (ICS-LABA) with or without other asthma controller(s) (with the exception of oral corticosteroids), compared to the conventional treatment step of escalation of inhaled therapy to high-dose ICS-LABA plus placebo (benralizumab).

Would you like to contribute to medical research?

As a volunteer in a research study, you’ll receive study-related medical care from the study doctor and regular follow-up of your asthma to monitor the effectiveness of the care you’ll receive. The results of this research will be used to find out if the investigational medication being studied will be of benefit to others with asthma, and whether it will be made widely available to all Canadians with asthma. Study volunteers are an important part of moving medical care forward.

Who may qualify

You may qualify if
  • Provide written informed consent
  • Are 12 to 75 years of age
  • Have a documented history of physician-diagnosed asthma requiring treatment with at least medium-dose ICS (> 250 μg fluticasone dry powder formulation equivalents total daily dose) and a LABA, for at least 12 months prior to Visit (V) 1.
  • Have documented treatment with medium-dose ICS and LABA for at least 3 months prior to Visit 1 with or without additional asthma controllers (excluding oral corticosteroids).
  • Have a weight of ≥ 35 kg.
  • Have pre-Bronchodilator (BD) Forced expiratory volume in 1 second (FEV1) of ≤ 90% predicted
  • Have documented at least 2 asthma exacerbations in the 12 months prior to the date of informed consent.
  • Have a ACQ-6 score ≥ 1.5 at Visit 1, plus at least once in the run-in period (from V2 to V3) and at V3.
  • Have evidence of asthma as documented by excessive variability in lung function, as defined in the protocol.
  • Have peripheral blood eosinophil count of ≥ 150 cells/μL, as defined in the protocol.
  • Have at least 70% compliance with usual asthma controller ICS-LABA during run-in period (from Visit 2 to Visit 3) based on asthma daily diary
This study may not be a fit if
  • Have any important pulmonary disease other than asthma at the discretion of the investigator, or ever been diagnosed with pulmonary or systemic disease, other than asthma, which are associated with elevated peripheral eosinophil counts.
  • Have had an asthma exacerbation requiring use of Systemic corticosteroids (SCS), or acute upper/lower respiratory infection that requires antibiotics or antiviral medication within 30 days prior to the date informed consent is obtained or during the screening/run-in period
  • Have any unstable disorder that in the opinion of the investigator could affect the study according to the study protocol.
  • Have clinically significant chronic or ongoing active infections requiring systemic treatment (at investigator’s discretion)
  • Have a history of alcohol or drug abuse within 12 months prior to the date informed consent is obtained.
  • Are a current smoker or former smoker with a smoking history ≥ 10 pack-years. Former smokers must have stopped for at least 6 months prior to Visit 1 to be eligible.
Every study has additional criteria the research site will review with you.

What participation may involve

  • Regular visits with the study team at no cost
  • Study assessments and health monitoring throughout
  • Check-ins between visits
  • Informed consent before anything begins — questions welcome

What participants may receive

  • Study-related care from a physician-led team
  • Study assessments at no cost
  • Reimbursement for reasonable travel, where applicable
Specifics vary by study and site, and are never a guarantee of benefit. Being in a study is not a substitute for regular medical care.

Learn more

About the condition

Asthma

Asthma is a long-term condition of the airways, the tubes that carry air in and out of your lungs. In asthma those tubes can swell, tighten and fill…

Learn about this condition →
About the condition

Chronic Obstructive Pulmonary Disease (COPD)

Chronic obstructive pulmonary disease, or COPD, is a long-term lung condition in which the airways are narrowed and the small air sacs deep in the lungs are damaged.…

Learn about this condition →

Common questions

Do I have to decide now?
No. Answering the questions is not a commitment — it simply lets the research team see whether this study may be appropriate and contact you to talk it through.
Will it cost me anything?
No. Study visits and study assessments are provided at no cost, and reasonable travel may be reimbursed where applicable.
What happens after I submit the form?
A member of the research team reviews your answers and contacts you — usually within two business days — to answer questions and review the next steps.
Could I receive a placebo?
Some studies compare a treatment with a placebo. Whether this study does is explained clearly during informed consent, before you decide anything.
Can I leave the study after it starts?
Yes. Participation is always voluntary. You can withdraw at any time without giving a reason and without it affecting your regular medical care.
Request contact

Ask the research site to contact you

Your answers go only to the research site, help the team prepare before they call — and completing the form doesn’t obligate you to take part.
JAS Study Interest (Stream A)

See if you may qualify

A few quick questions — about a minute. Your answers help the research team prepare before they contact you.

For anyone under 18, a parent or legal guardian should complete this form and would need to consent on their behalf.

See if you may qualify →

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