Tezepelumab (Tezspire) Regulatory Postmarketing Surveillance in Korea
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Other off-label indications according to the locally approved prescribing information
Current participation in any interventional trial
Trial population
Study Population: The study population will consist of adolescent and adult patients with a diagnosis of severe asthma or CRSwNP who are receiving tezepelumab according to its approved indication by MFDS. Eligible patients will be enrolled by a continuous registration method.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Incidence proportion of AEs, ADRs, SAEs, SADRs, unexpected AEs/ADRs and unexpected SAEs/SADRs
Time frame
Baseline to Week 24 or 30 days after last dose if discontinued earlier.2
Characterization of AEs/ADRs (nature, maximum severity, causality to tezepelumab, actions taken, and outcomes)
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 approved indications in routine clinical practice.
Time frame
Baseline to Week 24 or 30 days after last dose if discontinued earlier.Secondary outcomes
1
Proportion of patients with severe asthma who show improvement in asthma control
A patient whose GINA assessment changed from "Uncontrolled" at baseline to "Partly controlled" or "Well Controlled" at end of study or from "Partly controlled" at baseline to "Well Controlled" at end of study is defined as "Improved".
Time frame
Baseline to Week 24 or 30 days after last dose if discontinued earlier.2
Proportion of CRSwNP patients achieving clinically meaningful improvement in SNOT-22
Changes from baseline in SNOT-22 total scores, including the minimal clinically important difference(MCID) of 8.9 points, will be assessed to determine clinically meaningful improvement.
Time frame
Baseline to Week 24 or 30 days after last dose if discontinued earlier.3
Incidence rate of AEs, ADRs, SAEs, SADRs,unexpected AEs/ADRs, unexpected SAEs/SADRs
Time frame
Baseline to Week 24 or 30 days after last dose if discontinued earlier.Other outcomes
1
Incidence proportion of AEs by demographic and clinical characteristics
Time frame
Baseline to Week 24 or 30 days after last dose if discontinued earlier.2
Proportion of patients with improved asthma control by demographic and clinical characteristics
Proportion achieving "improved" GINA control (as defined above) summarized within prespecified subgroups (demographics, baseline clinical characteristics), with exact 95% CIs.
Time frame
Baseline to Week 24 or 30 days after last dose if discontinued earlier.3
Proportion of patients with clinically meaningful improvement in SNOT-22 scores by demographic and clinical characteristics
Proportion of SNOT-22 responders (≥8.9-point reduction) summarized within prespecified subgroups (demographics, baseline clinical characteristics), with exact 95% CIs.
Time frame
Baseline to Week 24 or 30 days after last dose if discontinued earlier.Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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