Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 2:15 PM
Ignite Modification Date:
2025-12-24 @ 2:15 PM
NCT ID:
NCT06998095
Brief Summary:
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.
Detailed 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.
Study:
NCT06998095
Study Brief:
Protocol Section:
NCT06998095