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

May 5, 2026 updated by: University of Alberta

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

All patients with a physician-diagnosed history of asthma and a history of a moderate or severe exacerbation of asthma presenting to the Emergency Department (ED) with an acute exacerbation of asthma will be reviewed by a study coordinator. From this population, subjects with at least 3-month history of prescription for a high dose inhaled corticosteroid (ICS) plus a reliever medication such as a long-acting beta2 agonist (LABA), long-acting muscarinic antagonist (LAMA) or a leukotriene receptor antagonist (LRTA) will be approached for study enrolment while still within the ED. Following informed consent, subject will be randomized in a 1:1 ratio to either Tezepelumab 210 mg S/Q Q4W or to a marching placebo. The proportion of subjects returning to ED for an exacerbation of asthma by Day-90 will serve as the primary study outcome. After Day-90 subjects will be entered into an open-label study with all receiving Tezepelumab 210 mg S/Q Q4W. A key secondary outcome will be the proportion of subjects returning to ED for an exacerbation of asthma by Day-180. Other secondary outcomes will include Alarmin expression, ACQ-5, FEV1 as well as study drug safety and tolerability

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • Alberta
    • Ca-ab
      • Edmonton, Ca-ab, Canada, T6G 2G3
        • University of Alberta
        • Contact:
        • Contact:
        • Principal Investigator:
          • Irvin Mayers, MD
        • Sub-Investigator:
          • Paige Lacy, PhD
        • Sub-Investigator:
          • Mohit Bhutani, MD
        • Sub-Investigator:
          • Adil Adatia, MD
        • Sub-Investigator:
          • Carol Chung, MD
        • Sub-Investigator:
          • Bo Zheng, MD
        • Sub-Investigator:
          • Subhabrata Moitra, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Provision of informed consent prior to any study specific procedures
  2. Female and/or male aged 18 to 55 years
  3. History of physician-diagnosed asthma
  4. 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.
  5. Documented history of at least one moderate or severe asthma exacerbation in the past 12 months
  6. Negative pregnancy test (urine or serum) for female subjects of childbearing potential.
  7. 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.
  8. Subjects who are blood donors should not donate blood during the study and for 3 months following their last dose of study drug.
  9. Subject willing and able to comply with study procedures

Exclusion Criteria:

  1. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)
  2. Previous enrolment in the present study
  3. Participation in another clinical study with an investigational product during the last 6 months
  4. Patients with a known hypersensitivity to Tezepelumab or any of the excipients of the product.
  5. Patients who are admitted to hospital at screening.
  6. Positive hepatitis C antibody hepatitis B virus surface antigen or hepatitis B virus core antibody, at screening.
  7. Known to have tested positive for human immunodeficiency virus
  8. 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.
  9. Known history of drug or alcohol abuse within 1 year of screening
  10. Any concomitant medications that are known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).
  11. History of QT prolongation associated with other medications that required discontinuation of that medication.
  12. Congenital long QT syndrome.
  13. Creatinine clearance <50 ml/min (calculated by Cockcroft-Gault formula, reference Appendix G).
  14. For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
  15. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Tezepelumab
Tezepelumab 210 mg S/Q Q4W
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
Placebo Comparator: Placebo
Matching Placebo S/Q Q4W
Drug: Placebo
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.
Other: Tezepelumab Open Label
Open-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of patients who have moderate and severe exacerbations of asthma
Time Frame: 90 Days post-treatment
Numbers of moderate and severe exacerbations at Day 90 post-treatment in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo
90 Days post-treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numbers of subjects returning to ED
Time Frame: 90 Days post-treatment
Numbers of subjects returning to ED by Day-90 in those treated with standard care and S/Q Tezepelumab or treated with standard care and placebo.
90 Days post-treatment
Proportion of subjects returning to ED
Time Frame: 60 Days post-treatment
Proportion of subjects returning to ED by Day-30 and Day-60 in those treated with standard care and S/Q Tezepelumab or treated with standard care and placebo.
60 Days post-treatment
Asthma control Questionnaire (ACQ-5)
Time Frame: 90 Days post-treatment

ACQ-5 at Day-90 in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo ACQ-5 greater than 1.5 units in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo ACQ-5 less than 0.75 units in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo

ACQ (Asthma Control Questionnaire). Each question is scored on a scale of 0 to 6, with 0 representing excellent control and 6 representing extremely poor control. The final score is the mean of the five responses.
90 Days post-treatment
TSLP levels
Time Frame: Day 1
TSLP levels at the time of ED presentation
Day 1
IL-25 levels
Time Frame: Day 1
IL-25 levels at the time of ED presentation
Day 1
Il-33 levels
Time Frame: Day 1
IL-33 levels at the time of ED presentation
Day 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with treatment-related adverse events as assessed by an intensity rating scale
Time Frame: Through study completion, an average of 180 days
To evaluate the safety and tolerability of Tezepelumab in relation to Placebo the results from laboratory tests and vital signs will be assessed to determine treatment-related adverse events.
Through study completion, an average of 180 days
Nasal brushing expressions of TSLP(Exploratory Outcome)
Time Frame: Day-30, 90 and 180 post ED visit
Nasal brushing expressions of TSLP
Day-30, 90 and 180 post ED visit
Measure ACQ-5 at selected time-points (Exploratory Outcome)
Time Frame: Day-30, 90 and 180 post ED visit

Compare time course of ACQ-5 following discharge from ED in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at Day-30, 90 and 180 post ED visit.

  1. Compare frequency of uncontrolled subjects (ACQ-5 greater than 1.5 units) in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at Day-30 and 180.
  2. Compare frequency of well-controlled subjects (ACQ-5 less than 0.75 units) in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at Day-30 and 180.

ACQ (Asthma Control Questionnaire). Each question is scored on a scale of 0 to 6, with 0 representing excellent control and 6 representing extremely poor control. The final score is the mean of the five responses.
Day-30, 90 and 180 post ED visit
Measure pre-bronchodilator FEV1 at selected time points (exploratory outcome)
Time Frame: Day 30, 90 and 180 days post ED visit
Compare time course of lung function, assessed as in-laboratory FEV1, following discharge from ED in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at 30, 90 and 180 days post ED visit.
Day 30, 90 and 180 days post ED visit
Measure TSLP expression at various time points Peripheral blood eosinophil counts FeNO Serum IgE (Exploratory Outcome)
Time Frame: Day 1

Correlate acute asthma severity with TSLP expression during ED visit

  1. Compare TSLP expression during ED visit in subjects with Type 2 asthma and non-Type 2 asthma
  2. Measure cell and plasma expression of TSLP, IL-25 and IL-33 in subjects presenting to ED following an acute asthma exacerbation obtained from nasopharyngeal and plasma samples.
Day 1
FeNO will be tested at selected time-points (Exploratory Outcome)
Time Frame: Day 30, 90 and 180 post ED visit
Compare time course of FeNO following discharge from ED in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at Day-30, 90 and 180 post ED visit.
Day 30, 90 and 180 post ED visit
Nasal brushing expressions of IL-33 (Exploratory Outcome)
Time Frame: Day-30, 90 and 180 post ED visit
Nasal brushing expressions of IL-33
Day-30, 90 and 180 post ED visit
Nasal brushing expressions of IL-25 (Exploratory Outcome)
Time Frame: Day-30, 90 and 180 post ED visit
Nasal brushing expressions of IL-25
Day-30, 90 and 180 post ED visit
Measure pre-bronchodilator PEF at selected time points (exploratory outcome)
Time Frame: Day-30, 90 and 180 post ED visit
Compare time course of lung function, assessed as at home PEF, following discharge from ED in subjects treated with standard care and S/Q Tezepelumab or treated with standard care and placebo at 30, 90 and 180 days post ED visit.
Day-30, 90 and 180 post ED visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Irvin Mayers, MD, University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 11, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

October 18, 2024

First Submitted That Met QC Criteria

November 22, 2024

First Posted (Actual)

November 26, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2026

Last Update Submitted That Met QC Criteria

May 5, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESR-22-22102

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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