Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps

Sponsor

Novartis Pharmaceuticals (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05626257

Collaborator

(none)

112

Enrollment

Location

24.6

Anticipated Duration (Months)

4.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Rhinosinusitis With Nasal Polyps	Other: Xolair

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

112 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Regulatory Post-Marketing Surveillance (rPMS) of Xolair® (Xolair® 150mg Powder for Solution for Injection, Xolair® 150mg/1ml Liquid in Pre-filled Syringe, Xolair® 75mg/0.5ml Liquid in Pre-filled Syringe) for Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Actual Study Start Date :

Jan 12, 2023

Anticipated Primary Completion Date :

Jan 31, 2025

Anticipated Study Completion Date :

Jan 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Xolair patients who prescribed with Xolair according to the current label information in Korea.	Other: Xolair There is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled.

Arm

Intervention/Treatment

Xolair

patients who prescribed with Xolair according to the current label information in Korea.

Other: Xolair

There is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Adults aged ≥18 years
Patients with CRSwNP who are not adequately controlled with conventional therapy (INCS)
Patients prescribed with Xolair® as per the locally approved label information.
Patients who provide written informed consent to participate in the study

Exclusion Criteria:

Patients who do not provide consent to participate in the study
Patients participating in other clinical trial
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)