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

NCT06705764 | Not Yet Recruiting Phase 4 FDA Drug

• 1 other identifier: ESR-22-22102
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

Brief 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

Severe Asthma

Keywords

Asthma; Severe Asthma; Asthma Exacerbation; Tezepelumab; Emergency deparment visits for asthma

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who have moderate and severe exacerbations of asthma

  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 Outcomes (6)

• Numbers of subjects returning to ED

  90 Days post-treatment

• Proportion of subjects returning to ED

  60 Days post-treatment

• Asthma control Questionnaire (ACQ-5)

  90 Days post-treatment

• TSLP levels

  Day 1

• IL-25 levels

  Day 1

Other Outcomes (9)

• Number of participants with treatment-related adverse events as assessed by an intensity rating scale

  Through study completion, an average of 180 days

• Nasal brushing expressions of TSLP(Exploratory Outcome)

  Day-30, 90 and 180 post ED visit

• Measure ACQ-5 at selected time-points (Exploratory Outcome)

  Day-30, 90 and 180 post ED visit

Study Arms (3)

Tezepelumab

ACTIVE COMPARATOR

Tezepelumab 210 mg S/Q Q4W

Drug: Tezepelumab

Placebo

PLACEBO COMPARATOR

Matching Placebo S/Q Q4W

Drug: Placebo

Tezepelumab Open Label

OTHER

Open-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90

Drug: Tezepelumab

Interventions

Tezepelumab DRUG

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

Tezepelumab; Tezepelumab Open Label

Placebo 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.

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Known history of drug or alcohol abuse within 1 year of screening
• Any concomitant medications that are known to be associated with Torsades de Pointes or potent inducers of cytochrome P450 3A4 (CYP3A4).
• 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).
• For women only - currently pregnant (confirmed with positive pregnancy test) or breast feeding.
• 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.

Sponsors & Collaborators

• University of Alberta: lead
• AstraZeneca: collaborator

Study Sites (2)

Sturgeon Community Hospital

St. Albert, Alberta, T8N6C4, Canada

Location

University of Alberta

Edmonton, Ca-ab, T6G 2G3, Canada

Location

Related Publications (12)

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Related Links

• Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA). Updated 2024

MeSH Terms

Conditions

Asthma

Interventions

tezepelumab

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Irvin Mayers, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hannah Anstruther, RRT

CONTACT

7804923741; hannahanstruther@ualberta.ca

Angela C Johnson, RRT

CONTACT

7804923741; ahillaby@ualberta.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2024
• First Posted: November 26, 2024
• Study Start (Estimated): May 11, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)