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)

ClinicalTrials.gov Identifier: NCT05626257

Novartis Reference Number: CIGE025EKR04

Last Update: Jan 20, 2023

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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.

Condition 
Chronic Rhinosinusitis With Nasal Polyps
Phase 
Not Given
Overall status 
Recruiting
Start date 
Jan 12, 2023
Completion date 
Jan 31, 2025
Gender 
All
Age(s)
18 Years - 100 Years (Adult, Older Adult)

Interventions

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.

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 Locations

Korea, Republic of
Novartis Investigative Site
Recruiting
Bundang Gu, 13620
Gyeonggi Do
Korea, Republic of

Contacts

Name: 
Novartis Pharmaceuticals
Phone: 

Have a question?

Call 1-888-669-6682 or email [email protected]