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

Active, not recruiting

• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Interventions: Other: Xolair

• Registration Number: NCT05626257
• Lead Sponsor: Novartis Pharmaceuticals

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.

Study Timeline

• Study First Submitted: 2022-11-15
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-23
• Study Start: 2023-01-12
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-17
• Last Update Posted: 2025-03-18
• Primary Completion: 2025-04-15
• Study Completion: 2025-04-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 135

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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 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

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Suwon, Korea, Republic of