Severe AsthmaPhase 4TERAANCT06705764
Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)
A Phase 4 study testing Tezepelumab in people with Severe Asthma, run by University of Alberta at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Severe Asthma
- What is being tested?
- Tezepelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesCanada
- Study dates
- 11 May 2026to Nov 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada2 sites, 2 recruiting
- Recruiting
University of Alberta
Edmonton, Alberta, T6G 2G3
Amy May, RRT, 7804923741, amy.may@ualberta.ca
Hannah Anstruther, RRT, 7804923741, hannahanstruther@ualberta.ca
- Not yet recruiting
Sturgeon Community Hospital
St. Albert, Alberta, T8N6C4
Amy May, 7804923741, amy.may@ualberta.ca
Hannah Anstruther, RRT, 7804923741, hannahanstruther@ualberta.ca
About this study
Official title: 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.
Read the 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
- Conditions
- Severe Asthma
- Being tested
- Tezepelumab, Placebo
- Keywords
- Asthma, Severe Asthma, Asthma Exacerbation, Tezepelumab, Emergency deparment visits for asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabDrug
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
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Tezepelumab | Active comparator | Tezepelumab 210 mg S/Q Q4W Receives: Drug: Tezepelumab |
| Placebo | Placebo comparator | Matching Placebo S/Q Q4W Receives: Drug: Placebo |
| Tezepelumab Open Label | Other | Open-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90 Receives: Drug: Tezepelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 Days post-treatment
Secondary outcomes (6)
Numbers of subjects returning to ED
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.
Measured: 90 Days post-treatment
Proportion of subjects returning to ED
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.
Measured: 60 Days post-treatment
Asthma control Questionnaire (ACQ-5)
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.
Measured: 90 Days post-treatment
TSLP levels
TSLP levels at the time of ED presentation
Measured: Day 1
IL-25 levels
IL-25 levels at the time of ED presentation
Measured: Day 1
Il-33 levels
IL-33 levels at the time of ED presentation
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start11 May 2026
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Severe AsthmaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Irvin Mayers, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06705764
- Sponsor's protocol ID
- ESR-22-22102
- Acronym
- TERAA
- Status last verified
- Jul 2026
- First submitted
- 18 Oct 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21893215Wang 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.
PubMed 30185520Osborne 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.
PubMed 28500390Mayers 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.
PubMed 37914234Khatri 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.
PubMed 34779751Juniper 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.
PubMed 16226443Juniper 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.
PubMed 15823451Hsu 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.
PubMed 32729038Graham 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.
PubMed 31613151EuroQol 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.
PubMed 10109801Berger 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.
PubMed 26337607Baren 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.
PubMed 16478839
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06705764
- Acronym / sponsor ID
- TERAA / ESR-22-22102
- Conditions
- Severe Asthma
- Keywords
- Asthma, Severe Asthma, Asthma Exacerbation, Tezepelumab, Emergency deparment visits for asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- 11 May 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tezepelumab | Active comparator | Drug: TezepelumabTezepelumab 210 mg S/Q Q4W |
| Placebo | Placebo comparator | Drug: PlaceboMatching Placebo S/Q Q4W |
| Tezepelumab Open Label | Other | Drug: TezepelumabOpen-label extension study from Day 90 to Day 180 with Tezepelumab dosing at Day 90 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezepelumabTezepelumab 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 | Tezepelumab, Tezepelumab Open Label |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
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
6 secondary outcomes
Numbers of subjects returning to ED
Time frame: 90 Days post-treatment
Proportion of subjects returning to ED
Time frame: 60 Days post-treatment
Asthma control Questionnaire (ACQ-5)
Time frame: 90 Days post-treatment
TSLP levels
Time frame: Day 1
IL-25 levels
Time frame: Day 1
Il-33 levels
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Results publication: PubMed 21893215Zhao 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.
- Results publication: PubMed 30185520Wang 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.
- Results publication: PubMed 28500390Osborne 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.
- Results publication: PubMed 37914234Mayers 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.
- Results publication: PubMed 34779751Khatri 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.
- Results publication: PubMed 16226443Juniper 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.
- Results publication: PubMed 15823451Juniper 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.
- Results publication: PubMed 32729038Hsu 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.
- Results publication: PubMed 31613151Graham 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.
- Results publication: PubMed 10109801EuroQol 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.
- Results publication: PubMed 26337607Berger 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.
- Results publication: PubMed 16478839Baren 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.
- Global Strategy for Asthma Management and Prevention, Global Initiative for Asthma (GINA). Updated 2024Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Irvin Mayers, MD principal investigator
University of Alberta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tezepelumab in people with Severe Asthma, run by University of Alberta at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hannah Anstruther, RRT (7804923741, hannahanstruther@ualberta.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who have moderate and severe exacerbations of asthma (time frame: 90 Days post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06705764, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.