Heart-event monitoring for people with severe asthma taking Tezepelumab (Tezspire)

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

This is a non-interventional, longitudinal, population-based cohort analysis using secondary data from multiple national and commercial data sources in Denmark, France, Germany, and the USA. The study will describe rates of major adverse cardiovascular events (MACE: non-fatal myocardial infarction, non-fatal stroke, and cardiovascular death) in patients exposed and unexposed to tezepelumab and will use a prevalent new-user design for comparative analyses. Comparative analyses will apply propensity score matching and matching on treatment type and duration, and will exclude patients with recent outcome events or recent exposure to other biologics as specified. The primary aim is to quantify and compare long-term risks of serious cardiovascular events to meet post-authorization safety requirements.

Why it matters

Who can join: the full rules

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

Where it's running

• Healthcare Integrated Research Database (HIRD)
  Wilmington, Delaware, United States Recruiting
• Danish registries (access/analysis)
  Copenhagen, Denmark Recruiting
• French National Health Data System (SNDS)
  Paris, France Recruiting
• Team Gesundheit GKV Claims data (SHI)
  Berlin, Germany Recruiting

Study contacts

• Principal investigator: Peter Egger — IQVIA Pty Ltd
• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

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

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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.