Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)
NCT ID: NCT06705764
Last Updated: 2026-01-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE4
100 participants
INTERVENTIONAL
2026-02-02
2026-11-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Tezepelumab
Tezepelumab 210 mg S/Q Q4W
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
Matching Placebo S/Q Q4W
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.
Tezepelumab Open Label
Open-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90
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
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
55 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
University of Alberta
OTHER
Responsible Party
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Principal Investigators
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Irvin Mayers, MD
Role: PRINCIPAL_INVESTIGATOR
University of Alberta
Locations
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Sturgeon Community Hospital
St. Albert, Alberta, Canada
University of Alberta
Edmonton, Ca-ab, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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Zhao W, Weng Y. Block urn design - a new randomization algorithm for sequential trials with two or more treatments and balanced or unbalanced allocation. Contemp Clin Trials. 2011 Nov;32(6):953-61. doi: 10.1016/j.cct.2011.08.004. Epub 2011 Aug 22.
Wang W, Li Y, Lv Z, Chen Y, Li Y, Huang K, Corrigan CJ, Ying S. Bronchial Allergen Challenge of Patients with Atopic Asthma Triggers an Alarmin (IL-33, TSLP, and IL-25) Response in the Airways Epithelium and Submucosa. J Immunol. 2018 Oct 15;201(8):2221-2231. doi: 10.4049/jimmunol.1800709. Epub 2018 Sep 5.
Osborne NJ, Alcock I, Wheeler BW, Hajat S, Sarran C, Clewlow Y, McInnes RN, Hemming D, White M, Vardoulakis S, Fleming LE. Pollen exposure and hospitalization due to asthma exacerbations: daily time series in a European city. Int J Biometeorol. 2017 Oct;61(10):1837-1848. doi: 10.1007/s00484-017-1369-2. Epub 2017 May 12.
Mayers I, Randhawa A, Qian C, Talukdar M, Soliman M, Jayasingh P, Johnston K, Bhutani M. Asthma-related emergency admissions and associated healthcare resource use in Alberta, Canada. BMJ Open Respir Res. 2023 Oct;10(1):e001934. doi: 10.1136/bmjresp-2023-001934.
Khatri SB, Iaccarino JM, Barochia A, Soghier I, Akuthota P, Brady A, Covar RA, Debley JS, Diamant Z, Fitzpatrick AM, Kaminsky DA, Kenyon NJ, Khurana S, Lipworth BJ, McCarthy K, Peters M, Que LG, Ross KR, Schneider-Futschik EK, Sorkness CA, Hallstrand TS; American Thoracic Society Assembly on Allergy, Immunology, and Inflammation. Use of Fractional Exhaled Nitric Oxide to Guide the Treatment of Asthma: An Official American Thoracic Society Clinical Practice Guideline. Am J Respir Crit Care Med. 2021 Nov 15;204(10):e97-e109. doi: 10.1164/rccm.202109-2093ST.
Juniper EF, Bousquet J, Abetz L, Bateman ED; GOAL Committee. Identifying 'well-controlled' and 'not well-controlled' asthma using the Asthma Control Questionnaire. Respir Med. 2006 Apr;100(4):616-21. doi: 10.1016/j.rmed.2005.08.012. Epub 2005 Oct 13.
Juniper EF, Svensson K, Mork AC, Stahl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005 May;99(5):553-8. doi: 10.1016/j.rmed.2004.10.008. Epub 2004 Nov 26.
Hsu SC, Chang JH, Lee CL, Huang WC, Hsu YP, Liu CT, Jean SS, Huang SK, Hsu CW. Differential time-lag effects of ambient PM2.5 and PM2.5-bound PAHs on asthma emergency department visits. Environ Sci Pollut Res Int. 2020 Dec;27(34):43117-43124. doi: 10.1007/s11356-020-10243-y. Epub 2020 Jul 29.
Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.
EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
Berger VW, Bejleri K, Agnor R. Comparing MTI randomization procedures to blocked randomization. Stat Med. 2016 Feb 28;35(5):685-94. doi: 10.1002/sim.6637. Epub 2015 Sep 3.
Baren JM, Boudreaux ED, Brenner BE, Cydulka RK, Rowe BH, Clark S, Camargo CA Jr. Randomized controlled trial of emergency department interventions to improve primary care follow-up for patients with acute asthma. Chest. 2006 Feb;129(2):257-265. doi: 10.1378/chest.129.2.257.
Related Links
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Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA). Updated 2024
Other Identifiers
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ESR-22-22102
Identifier Type: -
Identifier Source: org_study_id
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