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Completed

NCT Number: NCT05626257

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

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

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Anyang-si, Gyeonggi-do, South Korea

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. Incidences of adverse events/adverse drug reactions (AEs/ADRs)

    Time frame: Up to 24 weeks

    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

Secondary outcomes

  1. Change from baseline in SNOT-22

    Time frame: Baseline, Week 12 and Week 24

    Sino-Nasal Outcome Test-22 (SNOT-22) is a validated questionnaire that is used to assess the impact of chronic rhinosinusitis on health-related quality of life (HRQoL). It is a 22 item questionnaire with each item assigned a score ranging from 0 (no problem) to 5 (problem as bad as it can be). The total score may range from 0 (no disease) to 110 (worst disease), lower scores representing better health related quality of life.

  2. Incidences of AEs by subject characteristics

    Time frame: Up to 24 weeks

    The incidences of AEs by subject characteristics (demographic and other baseline information, Xolair® administration status, concomitant medication and therapy, etc.). The significance of the difference in the incidence of adverse events between categories within each characteristic will be tested using the Chi-square test or Fisher's exact test.

  3. Subject characteristics that affect the occurrence of adverse events

    Time frame: Up to 24 weeks

    Logistic regression analysis will be performed to analyze subject characteristics that affect the occurrence of adverse events.

  4. change from baseline in SNOT-22 according to subject characteristics

    Time frame: Week 12 and Week 24

    Change from baseline in SNOT-22 according to subject characteristics (demographic and other baseline information, Xolair® administration status, concomitant medication and therapy, etc.). The statistical significance of the difference in the change between the groups will be tested by two-sample t-test, Wilcoxon rank sum test, ANOVA, or Kruskal-Wallis test.

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

    Time frame: Week 12 and Week 24

    Multivariate linear regression analysis will be performed to evaluate the subject characteristics (demographic and other baseline information, Xolair® administration status, concomitant medication and therapy, etc.) that affect the change from baseline in SNOT-22

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Nov 23, 2022
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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