New monthly shot could keep severe asthma patients out of the ER
NCT ID NCT06705764
First seen Jun 25, 2026 · Last updated Jul 17, 2026 · Updated 2 times
Summary
This study tests whether a monthly injection called Tezepelumab can help adults with severe asthma avoid repeated emergency room visits and asthma attacks. One hundred participants will receive either the drug or a placebo for 90 days, followed by an open-label extension. The goal is to see if starting this medication in the ER can reduce the need for steroids and hospital stays.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Tezepelumab (a monthly injection)
- What this could lead to
- If it works, this could offer a new way to prevent severe asthma attacks and reduce emergency room visits for adults with hard-to-control asthma.
- What could go wrong
- This is a relatively small, early-phase trial (100 participants) and results may not apply to all asthma patients. The drug is already approved, but its effectiveness in an emergency setting is unproven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Nov 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Sturgeon Community Hospital
NOT_YET_RECRUITINGSt. Albert, Alberta, T8N6C4, Canada
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University of Alberta
RECRUITINGEdmonton, Alberta, T6G 2G3, Canada
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- Scientists probe why tezepelumab doesn't stop all asthma attacks
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