Chronic Rhinosinusitis With Nasal Polyps(CRSwNP), Severe Asthma
Conditions
Keywords
severe asthma, Chronic Rhinosinusitis with Nasal Polyps(CRSwNP)
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.
Interventions
None listed
Sponsors
AstraZeneca
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence proportion of AEs, ADRs, SAEs, SADRs, unexpected AEs/ADRs and unexpected SAEs/SADRs | Baseline to Week 24 or 30 days after last dose if discontinued earlier. | — |
| Characterization of AEs/ADRs (nature, maximum severity, causality to tezepelumab, actions taken, and outcomes) | Baseline to Week 24 or 30 days after last dose if discontinued earlier. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with severe asthma who show improvement in asthma control | Baseline to Week 24 or 30 days after last dose if discontinued earlier. | 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". |
| Proportion of CRSwNP patients achieving clinically meaningful improvement in SNOT-22 | Baseline to Week 24 or 30 days after last dose if discontinued earlier. | 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. |
| Incidence rate of AEs, ADRs, SAEs, SADRs,unexpected AEs/ADRs, unexpected SAEs/SADRs | Baseline to Week 24 or 30 days after last dose if discontinued earlier. | — |
Contacts
CONTACTAstraZeneca Clinical Study Information Center
Outcome results
None listed