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

Novartis

Status: Completed

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Other: Xolair

Study type: Observational

Funder types: Industry

Identifiers

NCT05626257

CIGE025EKR04

Details and patient eligibility

About

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

Full 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.

Enrollment: 135 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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)

Trial design

135 participants in 1 patient group

Xolair

Description:

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

Treatment:

Other: Xolair