Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)
NCT06705764 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100
Last updated 2026-05-06
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.
Conditions
Interventions
- DRUG
-
Tezepelumab
Tezepelumab 210 mg (1.91 ml) subcutaneous every 4 weeks. Randomized Control Trial 90 days with Tezepelumab/ Matching Placebo dosing on Day 0, Day 30 and Day 60. Open-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90
- DRUG
-
Placebo 1.91 ml subcutaneous every 4 weeks. Randomized Control Trial 90 days with Tezepelumab/ Matching Placebo dosing on Day 0, Day 30 and Day 60.
Sponsors & Collaborators
- collaborator INDUSTRY
-
University of Alberta
lead OTHER
Principal Investigators
-
Irvin Mayers, MD · University of Alberta
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 55 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-05-11
- Primary Completion
- 2026-11-30
- Completion
- 2026-11-30
- FDA Drug
- Yes
Countries
- Canada
Study Locations
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