RecruitingNCT06951867

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


Sponsor

AstraZeneca

Enrollment

16,640 participants

Start Date

Sep 15, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 130 Years

Plain Language Summary

Simplified for easier understanding

This post-approval safety study is monitoring for potential heart-related events in patients with severe asthma who are being treated with tezepelumab (Tezspire) compared to those on other intensive standard asthma therapies. Researchers are collecting real-world data to ensure the long-term safety profile of this medication. **You may be eligible if...** - You are 12 years or older - You have a diagnosis of severe asthma - You are currently receiving tezepelumab (Tezspire) or another intensive standard-of-care treatment for severe asthma **You may NOT be eligible if...** - You have less than 12 months of medical records available before your treatment start date - You have a history of congenital heart disease or heart transplant - You have had a heart attack or stroke in the 180 days before starting treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGTezepelumab

The exposure of primary interest is tezepelumab for severe asthma. Exposure will be assessed based on prescriptions or administrations depending on the data source. A comparable cohort of unexposed patients treated with high-intensity SOC will be identified based on the presence of a trigger exposure (i.e., augmentation or change of the non-biologic high-intensity treatment that does not represent treatment de-escalation) to mirror tezepelumab start in the exposed cohort. Due to the limited knowledge of the cardiovascular profile of biologics, SOC for comparative analyses will only include non-biologic high-intensity treatment.


Locations(4)

Healthcare Integrated Research Database (HIRD)

Wilmington, Delaware, United States

Danish registries (access/analysis)

Copenhagen, Denmark

French National Health Data System (SNDS)

Paris, France

Team Gesundheit GKV Claims data (SHI)

Berlin, Germany

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NCT06951867


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