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Tezspire Cardiac Events PASS

An Observational Multi-Country Post-Authorisation Safety Study to Evaluate the Risk of Serious Adverse Cardiovascular Events in Adolescent and Adult Patients With Severe Asthma Taking Tezepelumab

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
12 Years to 130 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at the risk of serious heart and blood vessel problems in teens and adults with severe asthma. It compares people taking tezepelumab (Tezspire) with people getting standard treatment for severe asthma.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have been diagnosed with asthma.
  • Receive tezepelumab or high-intensity standard treatment for severe asthma during the study’s enrollment period.

Who can't join

  • Have less than 12 months of health data before the study start date used for you.
  • Are younger than 12 on that date.
  • Have a history of a heart problem present at birth or a heart transplant.
  • For each study question, had a heart attack or stroke that was not fatal, or the specific health event being studied, within 180 days before that date.
  • For the treatment comparison, use a biologic medicine other than tezepelumab on that date or recently enough that it is still in the drug’s clearance period. Biologics are medicines made from living sources.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

DE