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

NCT05626257 | Completed

• 1 other identifier: CIGE025EKR04
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 16

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Keywords

Chronic Rhinosinusitis with Nasal Polyps; CRSwNP; Korea; NIS; Xolair

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change from baseline in SNOT-22

  Baseline, Week 12 and Week 24

• Incidences of AEs by subject characteristics

  Up to 24 weeks

• Subject characteristics that affect the occurrence of adverse events

  Up to 24 weeks

• change from baseline in SNOT-22 according to subject characteristics

  Week 12 and Week 24

• Subject characteristics that affect the change from baseline in SNOT-22

  Week 12 and Week 24

Study Arms (1)

Xolair

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

Other: Xolair

Interventions

Xolair 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.

Xolair

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (16)

Novartis Investigative Site

Anyang-si, Gyeonggi-do, 14068, South Korea

Location

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, 13620, South Korea

Location

Novartis Investigative Site

Uijeongbu-si, Gyeonggi-do, 11759, South Korea

Location

Novartis Investigative Site

Incheon, Korea, 405 760, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 03080, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 03312, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 07061, South Korea

Location

Novartis Investigative Site

Seoul, Korea, 08308, South Korea

Location

Novartis Investigative Site

Seoul, Yangcheon gu, 07985, South Korea

Location

Novartis Investigative Site

Daegu, 705 718, South Korea

Location

Novartis Investigative Site

Gyeonggi-do, 14353, South Korea

Location

Novartis Investigative Site

Seoul, 03722, South Korea

Location

Novartis Investigative Site

Seoul, 06351, South Korea

Location

Novartis Investigative Site

Seoul, 07804, South Korea

Location

Novartis Investigative Site

Seoul, 2447, South Korea

Location

Novartis Investigative Site

Suwon, 16247, South Korea

Location

MeSH Terms

Interventions

Omalizumab

Intervention Hierarchy (Ancestors)

Antibodies, Anti-Idiotypic; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Serum Globulins; Globulins

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: November 23, 2022
• Study Start: January 12, 2023
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

KR (16)