NCT06705764RecruitingPhase 4

Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)

Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA): A Phase 4 Double-Blinded, Parallel-Group, Randomized Control Trial With an Open Label Extension

Source: ClinicalTrials.gov · Last updated 17 Jul 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Phase (registry): Phase 4
Study type: Interventional
Enrollment: 100 (estimated)
First submitted: 18 Oct 2024
Start date: 11 May 2026
Primary completion date: Nov 2026
Lead sponsor: University of Alberta
Diseases: Asthma
NCT number: NCT06705764

What you commit to

Study type: Interventional · Phase 4
Planned participants: 100
From 11 May 2026 to the primary completion date, Nov 2026
2 sites in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Previous enrolment in the present study
Participation in another clinical study with an investigational product during the last 6 months
Any concomitant medications that are known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).

Other illness

Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product.
Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.
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.
Known history of drug or alcohol abuse within 1 year of screening
History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Subjects with atrial fibrillation controlled by medication are permitted.

Lab values

History of QT prolongation associated with other medications that required discontinuation of that medication.
Congenital long QT syndrome.
Creatinine clearance \<50 ml/min (calculated by Cockcroft-Gault formula, reference Appendix G).

Other

Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
Patients who are admitted to hospital at screening.
Known to have tested positive for human immunodeficiency virus
For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.

Who the study is looking for

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.
Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug.
Subject willing and able to comply with study procedures

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
University of Alberta Coordinator of this site? Confirm its status	Edmonton	Canada	Recruiting
Sturgeon Community Hospital Coordinator of this site? Confirm its status	St. Albert	Canada	Not yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.