Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea

AstraZeneca

Status: Begins enrollment in 9 months

Conditions: Severe Asthma

Study type: Observational

Funder types: Industry

Identifiers

NCT06998095

D5180R00020

Details and patient eligibility

About

The objectives of this study are to describe the occurrence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma in South Korea.

Full description

Primary objective(s):

• To estimate the incidence proportion of adverse events (AEs), adverse drug reactions (ADR1s), serious adverse events (SAEs), serious adverse drug reaction (SADRs), unexpected2 adverse events, unexpected adverse drug reactions and expected adverse drug reactions, separately among patients receiving tezepelumab for severe asthma in routine clinical practice.
• To describe the nature (type), severity, and causality of adverse events (AEs)/adverse drug reactions (ADRs) and actions taken to address AEs among patients receiving tezepelumab for severe asthma in routine clinical practice.

Secondary objective(s) :

• To estimate the proportion of patients with improved asthma control from baseline to week 24 after tezepelumab initiation or the last known routine visit [i.e., end of treatment (EoT)]
• To estimate the incidence rate of adverse events (AEs) , adverse drug reactions (ADRs), serious adverse events (SAEs), serious adverse drug reaction (SADRs), unexpected adverse events, unexpected adverse drug reactions and expected adverse drug reactions per unit time, separately among patients receiving tezepelumab for severe asthma in routine clinical practice.

Exploratory Objective(s):

• To estimate the incidence proportion of AEs by demographic and clinical characteristics
• To estimate the proportion of patients with improved asthma control from baseline to week 24 after tezepelumab initiation or the last known routine visit by demographic and clinical characteristics

This is a prospective, single-arm, multicenter, observational study to evaluate the safety and effectiveness of tezepelumab from treatment initiation up to 24 weeks in patients who are prescribed tezepelumab according to its approved indication for severe asthma in South Korea.

The asthma control effectiveness assessment will be an evaluation of change from treatment initiation up to 24 weeks after treatment initiation. This study design will reflect the actual management of these subjects in routine clinical practice. The treating physician will determine the treatment plan, as well as the frequency of laboratory and clinical assessment, if necessary, based on routine practice.

Enrollment: 150 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients who are treated with at least one dose of tezepelumab according to the indication in the locally approved prescribing information
2. Patients with evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study

Exclusion criteria

1. Other off-label indications according to the locally approved prescribing information
2. Current participation in any interventional trial