Chronic Rhinosinusitis With Nasal Polyps
Conditions
Keywords
Chronic Rhinosinusitis with Nasal Polyps, CRSwNP, Korea, NIS, Xolair
Brief summary
This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.
Detailed description
This is a 24-week, prospective, open-label, multi-center, single-arm, observational, post-marketing surveillance study under routine clinical practice and does not impose a therapy, visit, or assessment. The study design was approved by the Korean health authority. The purpose of this study is not to answer scientific hypotheses, but to describe the incidences of all potential adverse events (AEs), serious adverse events (SAEs), and unexpected AEs not listed in the local label information occurring in Korean patients under routine clinical practice following the approved local label information.
Interventions
OTHERXolair
There is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
1. Adults aged ≥18 years 2. Patients with CRSwNP who are not adequately controlled with conventional therapy (INCS) 3. Patients prescribed with Xolair® as per the locally approved label information. 4. Patients who provide written informed consent to participate in the study
Exclusion criteria
1. Patients who do not provide consent to participate in the study 2. Patients participating in other clinical trial 3. Contraindications listed in the locally approved label information of Xolair® * Hypersensitivity to the active ingredient or any other ingredient of Xolair® * Patients with myocardial infarction or history of myocardial infarction (pre-filled syringes only)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidences of adverse events/adverse drug reactions (AEs/ADRs) | Up to 24 weeks | Incidences of adverse events/adverse drug reactions (AEs/ADRs), serious AEs/ADRs (SAEs/SADRs), unexpected AEs/ADRs (UAEs/UADRs), serious unexpected AEs/ADRs (SUAEs/SUADRs) will be collected |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in SNOT-22 | Baseline, Week 12 and Week 24 | Sino-Nasal Outcome Test-22 (SNOT-22) is a validated questionnaire that is used to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life. |
| Incidences of AEs by subject characteristics | Up to 24 weeks | The incidences of AEs by subject characteristics (demographic and other baseline information, Xolair® administration status, concomitant medication and therapy, etc.). The significance of the difference in the incidence of adverse events between categories within each characteristic will be tested using the Chi-square test or Fisher's exact test. |
| Subject characteristics that affect the occurrence of adverse events | Up to 24 weeks | Logistic regression analysis will be performed to analyze subject characteristics that affect the occurrence of adverse events. |
| change from baseline in SNOT-22 according to subject characteristics | Week 12 and Week 24 | Change from baseline in SNOT-22 according to subject characteristics (demographic and other baseline information, Xolair® administration status, concomitant medication and therapy, etc.). The statistical significance of the difference in the change between the groups will be tested by two-sample t-test, Wilcoxon rank sum test, ANOVA, or Kruskal-Wallis test. |
| Subject characteristics that affect the change from baseline in SNOT-22 | Week 12 and Week 24 | Multivariate linear regression analysis will be performed to evaluate the subject characteristics (demographic and other baseline information, Xolair® administration status, concomitant medication and therapy, etc.) that affect the change from baseline in SNOT-22 |
Countries
South Korea
Outcome results
None listed