Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA) (NCT06705764) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)
Canada100 participantsStarted 2026-05-11
Plain-language summary
Adults with severe asthma may have sudden worsening shortness of breath that results in their going to Emergency Department for urgent care. Emergency Room visits for asthma management across Alberta have been reviewed and it has been found that adults frequently need to return for repeated worsening. This is a large drain on health care resources as well as being very distressing for individuals with asthma. Occasionally this results in admission to hospital and rarely may lead to death. People are often treated with steroids to try to prevent the need for Emergency Room visits even though steroid medications have many long term bad side effects.
A new medication for patients considered to have severe asthma has been recently approved by Health Canada. This medication, Tezepelumab, is a monthly injection and it helps control asthma in adults regardless of the underlying cause. The study will examine if starting Tezepelumab, compared with a placebo, in the Emergency Room will help settle symptoms of asthma and prevent future worsening requiring repeated Emergency Room visits or the need for courses of outpatient steroid medications.
Who can participate
Age range18 Years – 55 Years
SexALL
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Inclusion criteria
✓. Provision of informed consent prior to any study specific procedures
✓. Female and/or male aged 18 to 55 years
✓. History of physician-diagnosed asthma
✓. All subjects will have been prescribed high dose inhaled corticosteroid (\> 500 ug fluticasone propionate dry powder formulation equivalents total daily dose. See Appendix C) plus at least one second controller (LABA, LAMA or LTRA) for at least 3 months prior to enrolment.
✓. Documented history of at least one moderate or severe asthma exacerbation in the past 12 months
✓. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
✓. Female subjects must be 1 year post-menopausal, surgically sterile, or using an acceptable method of contraception (an acceptable method of contraception is defined as a barrier method in conjunction with a spermicide) for the duration of the study (from the time they sign consent) and for 3 months after the last dose of study drug/matching placebo to prevent pregnancy. In addition, oral contraceptives, approved contraceptive implant, long-term injectable contraception, intrauterine device, or tubal ligation are allowed. Oral contraception alone is not acceptable; additional barrier methods in conjunction with spermicide must be used.
What they're measuring
1
Proportion of patients who have moderate and severe exacerbations of asthma
. Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug.
Exclusion criteria
✕. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
✕. Previous enrolment in the present study
✕. Participation in another clinical study with an investigational product during the last 6 months
✕. Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product.
✕. Patients who are admitted to hospital at screening.
✕. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.
✕. Known to have tested positive for human immunodeficiency virus
✕. Current smokers with a smoking history of \> 10 pack-years. Current smokers with a smoking history of \< 10 pack-years are permitted . Ex-smokers should not have a smoking history \> 10 pack-years at screening. Participants who use e-cigarettes will also be excluded from the study.