Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)

Launched by UNIVERSITY OF ALBERTA · Nov 22, 2024

Keywords

ClinConnect Summary

The TERA trial is studying a new medication called Tezepelumab, which is designed to help adults with severe asthma who often experience sudden and serious breathing problems that require emergency room visits. This trial aims to find out if giving Tezepelumab as a monthly injection in the emergency room can improve asthma symptoms and reduce the need for repeat visits or the use of steroid medications, which can have long-term side effects.

To participate in this trial, you need to be between 18 and 55 years old, have a history of asthma that hasn't been well controlled with high-dose inhalers, and have experienced at least one serious asthma flare-up in the past year. Participants will receive either the Tezepelumab injection or a placebo (a treatment that looks the same but has no active ingredients) during their emergency room visit. The study is not yet recruiting participants, but it aims to involve adults of all genders who meet the eligibility criteria. If you or a loved one are interested, you can expect close monitoring and support throughout the study.

Gender

ALL

Eligibility criteria

• 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.