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

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)

This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.

Study Overview

• Status: Completed
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 135

Contacts and Locations

Study Locations

• South Korea
  • Daegu, South Korea, 705 718
    • Novartis Investigative Site
  • Gyeonggi-do, South Korea, 14353
    • Novartis Investigative Site
  • Seoul, South Korea, 03722
    • Novartis Investigative Site
  • Seoul, South Korea, 06351
    • Novartis Investigative Site
  • Seoul, South Korea, 07804
    • Novartis Investigative Site
  • Seoul, South Korea, 2447
    • Novartis Investigative Site
  • Suwon, South Korea, 16247
    • Novartis Investigative Site
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, South Korea, 14068
      • Novartis Investigative Site
    • Bundang Gu, Gyeonggi-do, South Korea, 13620
      • Novartis Investigative Site
    • Uijeongbu-si, Gyeonggi-do, South Korea, 11759
      • Novartis Investigative Site
  • Korea
    • Incheon, Korea, South Korea, 405 760
      • Novartis Investigative Site
    • Seoul, Korea, South Korea, 08308
      • Novartis Investigative Site
    • Seoul, Korea, South Korea, 03312
      • Novartis Investigative Site
    • Seoul, Korea, South Korea, 03080
      • Novartis Investigative Site
    • Seoul, Korea, South Korea, 07061
      • Novartis Investigative Site
  • Yangcheon gu
    • Seoul, Yangcheon gu, South Korea, 07985
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

this study will involve patients who received at least one dose of Xolair® for the treatment of Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) according to the current label information in Korea.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidences of adverse events/adverse drug reactions (AEs/ADRs)	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	Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in SNOT-22	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.	Baseline, Week 12 and Week 24
Incidences of AEs by subject characteristics	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.	Up to 24 weeks
Subject characteristics that affect the occurrence of adverse events	Logistic regression analysis will be performed to analyze subject characteristics that affect the occurrence of adverse events.	Up to 24 weeks
change from baseline in SNOT-22 according to subject characteristics	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.	Week 12 and Week 24
Subject characteristics that affect the change from baseline in SNOT-22	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	Week 12 and Week 24

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

• Link to study results

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2023
• Primary Completion (Actual): April 15, 2025
• Study Completion (Actual): April 15, 2025

Study Registration Dates

• First Submitted: November 15, 2022
• First Submitted That Met QC Criteria: November 15, 2022
• First Posted (Actual): November 23, 2022

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: NIS; Xolair; Korea; CRSwNP; Chronic Rhinosinusitis with Nasal Polyps
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Paranasal Sinus Diseases; Rhinosinusitis; Polyps; Nasal Polyps; Sinusitis; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Antibodies, Anti-Idiotypic; Omalizumab
• Other Study ID Numbers: CIGE025EKR04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO