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 groupsSponsors and collaborators
AstraZeneca
Lead sponsor
IQVIA Pvt. Ltd
Collaborator
Source ClinicalTrials.gov