Last Update: Jan 25, 2024
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) Identifier:
Novartis Reference Number:CIGE025EKR04
All compounds are either investigational or being studied for (a) new use(s). Efficacy and safety have not been established. There is no guarantee that they will become commercially available for the use(s) under investigation.

Study Description

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

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.

Chronic Rhinosinusitis With Nasal Polyps
Jan 12, 2023
Jan 31, 2025
18 Years - 100 Years (Adult, Older Adult)




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

Eligibility Criteria

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)

Study Location

Novartis Investigative Site


Bundang Gu,Gyeonggi Do,13620,Korea, Republic of

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