Tezspire Cardiac Events PASS

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12-130
SponsorAstraZeneca

About this trial

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 criteria

Qualifiers

patients with a diagnosis of asthma receiving tezepelumab or high-intensity SOC treatment for severe asthma at any point during the study inclusion period.

Disqualifiers

<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

Trial design

Treatments tested in this trial

  • Tezepelumab

Treatment groups

16,640 Participants
are divided into 2 treatment groups

Locations

4
Denmark
Danish registries (access/analysis) Copenhagen Denmark
France
French National Health Data System (SNDS) Paris France
Germany
Team Gesundheit GKV Claims data (SHI) Berlin Germany
United States
Healthcare Integrated Research Database (HIRD)19801, WilmingtonDelaware, United States

Sponsors and collaborators

AstraZeneca

Lead sponsor

IQVIA Pvt. Ltd

Collaborator