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

NCT ID: NCT05626257

Last Updated: 2025-11-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 135 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-01-12
• Study Completion Date: 2025-04-15

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Xolair

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

Xolair

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Anyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Novartis Investigative Site

Uijeongbu-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Incheon, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Korea, South Korea

Novartis Investigative Site

Seoul, Yangcheon gu, South Korea

Novartis Investigative Site

Daegu, , South Korea

Novartis Investigative Site

Gyeonggi-do, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Seoul, , South Korea

Novartis Investigative Site

Suwon, , South Korea

Countries

South Korea

Other Identifiers

CIGE025EKR04

Identifier Type: -

Identifier Source: org_study_id