Tezepelumab for adults with severe asthma presenting to the emergency department

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In adults with severe asthma who come to the emergency department for an acute flare, the trial compares tezepelumab 210 mg subcutaneous every 4 weeks to placebo started in the ED. Participants are randomized 1:1 and followed to Day 90 for the primary outcome of ED visits due to asthma exacerbations, with Day 180 as a key secondary outcome. All participants who complete Day 90 enter an open-label phase where everyone receives tezepelumab. Secondary outcomes include biomarkers (alarmins), ACQ-5 scores, FEV1, and safety/tolerability. Eligible participants have a history of asthma, frequent high-dose inhaled corticosteroid use with a second controller, and recent exacerbations; the study is conducted at the University of Alberta and affiliated sites.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alberta
  Edmonton, Alberta, Canada Recruiting
• Sturgeon Community Hospital
  St. Albert, Alberta, Canada Not yet recruiting

Study contacts

• Principal investigator: Irvin Mayers, MD — University of Alberta
• Study coordinator: Hannah Anstruther, RRT
• Email: hannahanstruther@ualberta.ca
• Phone: 7804923741

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Structured physical activity program added to tezepelumab for adults with severe asthma

  A 12-week program to help adults with severe asthma who start tezepelumab see if adding guided physical activity improves activity levels and chances of remission.

  Recruiting University of Leeds · Leeds · NCT07735494

• Tezepelumab to reduce maintenance medication in people with severe asthma

  This will test whether people aged 12–80 with severe asthma in China who start tezepelumab can safely reduce their regular maintenance medicines while keeping asthma controlled.

  Recruiting at 59 sites Phase 3 AstraZeneca · Beijing and 74 other locations · NCT07363642

• Exercise program for adults with severe asthma starting biologics

  A tailored exercise program is being tested to see if it helps adults with severe asthma who are starting biologic therapy feel better and breathe better.

  Recruiting Helsinki University Central Hospital · Helsinki · NCT07655037

• Tezepelumab in real-world CRSwNP: a real-world look at patient outcomes

  This study tests tezepelumab in adults with chronic rhinosinusitis with nasal polyps to see how their symptoms and daily life change in routine care over about two years.

  Recruiting at 19 sites AstraZeneca · Berlin and 18 other locations · NCT07633158

• Frevecitinib (KN-002) for severe asthma: a 12-week dose-ranging study

  This study tests three doses of frevecitinib vs placebo to see if it helps people with severe asthma not controlled by standard inhaled steroids and LABA therapy.

  Recruiting at 9 sites Phase 2 Kinaset Therapeutics Inc · Lancaster, California and 13 other locations · NCT07532265

• Benralizumab treatment for adults with ABPA and severe asthma

  This will test whether benralizumab helps adults (18–75) who have severe asthma with allergic bronchopulmonary aspergillosis (ABPA).

  Recruiting at 2 sites Qianfoshan Hospital · Jinan, Shandong and 1 other locations · NCT07530770

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.