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New monthly shot could keep severe asthma patients out of the ER

NCT ID NCT06705764

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

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

18 to 55 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Sturgeon Community Hospital

    NOT_YET_RECRUITING

    St. Albert, Alberta, T8N6C4, Canada

  • University of Alberta

    RECRUITING

    Edmonton, Alberta, T6G 2G3, Canada

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