United States, Denmark, France16,640 participantsStarted 2025-09-15
Plain-language summary
The aim of this study is to evaluate the risk of serious adverse cardiovascular events in adolescent and adult patients with severe asthma taking tezepelumab compared to a population receiving standard of care treatment for severe asthma.
Who can participate
Age range
12 Years – 130 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.
Exclusion Criteria for both exposed and unexposed groups include:
* \<12 months of data availability prior to index date,
* age \<12 years at index date,
* history of congenital heart disease or heart transplant outcome-specific exclusion criterion applied for each objective will include the presence of non-fatal myocardial infarction or stroke and the specific outcome of interest in the 180 days prior to index date
* for comparative analysis, an additional exclusion criterion will be considered, i.e. exposure to non-tezepelumab biologics on index date or within the 5-half-life clearance period of the biologic
* matching criteria (including, among other variables, the type and duration of SOC exposure in the 12 months before index date and propensity score \[PS\] matching) will be applied to ensure exposed and unexposed patients' comparability
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is described as a PASS — a post-authorization safety study — which means it's designed to monitor real-world safety rather than test a new treatment; can you explain what that means for me and whether participating would change anything about how I receive Tezspire?
2Since the primary outcome being tracked is MACE — major adverse cardiovascular events — does my personal cardiac history or current heart health make it especially important, or risky, for me to be part of this kind of safety surveillance study?
3Because this is a safety monitoring study rather than a traditional phase 1, 2, or 3 trial, what kind of data will be collected about me, how long would I be followed, and what does my participation actually involve day-to-day?
4Given that MACE is what's being watched for, should I be discussing my existing cardiovascular risk factors with a cardiologist before deciding whether to take part in this study?
5If I'm already on Tezspire or being considered for it, is there a meaningful difference between participating in this safety study versus just receiving the treatment outside of it — and would standard care outside the study be a better path given my specific situation?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
composite outcome MACE
Timeframe: five years from tezepelumab market launch