Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- AstraZeneca
- Enrollment
- 210
- Primary Endpoint
- Safety (adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs/SADRs)
Study Overview
Brief Summary
The objectives of this study are to describe the incidence of adverse events and the effectiveness of tezepelumab in patients receiving tezepelumab as indicated for severe asthma or CRSwNP in South Korea.
Detailed Description
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 in South Korea.
The effectiveness assessment will estimate the proportion of patients with improved asthma control or a clinically meaningful improvement in SNOT-22 scores, from treatment initiation up to 24 weeks after the initiation of tezepelumab.
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.
All patients will be evaluated for safety during tezepelumab use (24 weeks) or within 30 days after the last administration of tezepelumab if the patients discontinued tezepelumab before 24 weeks.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 12 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients who are treated with at least one dose of tezepelumab according to the indication in the locally approved prescribing information
- •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
- •Other off-label indications according to the locally approved prescribing information
- •Current participation in any interventional trial
Outcomes
Primary Outcomes
Safety (adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs/SADRs)
Time Frame: up to 24 weeks
To estimate the incidence proportion 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, 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 Outcomes
- A measure of asthma control at week 24 or at the last known routine visit as assessed by study investigator according to GINA guidelines(up to 24 weeks)
- Safety (adverse events (AEs), adverse drug reactions (ADRs), serious AEs (SAEs), serious ADRs (SADRs), unexpected AEs/ADRs, unexpected SAEs/SADRs)(up tp 24 weeks)