Severe Asthma study: Tezepelumab
Official title Tezepelumab in the Treatment of Emergency Room Asthma in Adults (TERAA)
ClinicalTrials.gov ID: NCT06705764
What this study is testing
What is Tezepelumab?
an investigational subcutaneous injectable medicine being studied for severe asthma is designed to block thymic stromal lymphopoietin (TSLP), a protein that triggers airway inflammation
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see whether giving Tezepelumab in the emergency room helps control asthma symptoms and stops the need for more ER visits or steroid courses.
- Who it's for
- Adults who have severe asthma and have recently gone to the emergency department for an asthma flare.
- What's involved
- Participants will receive either Tezepelumab or a placebo injection in the ER, then follow up with regular visits and tests to monitor asthma control.
- Time commitment
- The study lasts about a year, with several clinic visits and routine tests to track asthma symptoms and medication use.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55
You may be able to join if
- 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 people will have been prescribed high dose inhaled corticosteroid (\> 500 ug fluticasone propionate dry powder formulation equivalents total...
- Documented history of at least one moderate or severe asthma exacerbation in the past 12 months
You likely can't join if
- 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.
See the full eligibility criteria
- 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 people will have been prescribed high dose inhaled corticosteroid (\> 500 ug fluticasone propionate dry powder formulation equivalents total daily dose.
- Documented history of at least one moderate or severe asthma exacerbation in the past 12 months
- Negative pregnancy test (urine or serum) for female people of childbearing potential.
- Female people 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)...
- people 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
- 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.
- 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 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...
The study team makes the final eligibility decision.
Where it is enrolling
- Edmonton, Alberta, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Edmonton, Alberta, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.