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

Novartis Pharmaceuticals135 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

135

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Interventions

XolairOTHER

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

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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)

Locations (16)

Novartis Investigative Site

Anyang-si, Gyeonggi-do, South Korea

Novartis Investigative Site

Bundang Gu, Gyeonggi-do, South Korea

Novartis Investigative Site

Outcomes

Primary Outcomes

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

Time frame: Up to 24 weeks

Secondary Outcomes

Change from baseline in SNOT-22

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.

Time frame: Baseline, Week 12 and Week 24

Incidences of AEs by subject characteristics

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.

Time frame: Up to 24 weeks

Subject characteristics that affect the occurrence of adverse events

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

Time frame: Up to 24 weeks

change from baseline in SNOT-22 according to subject characteristics

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.

Data from ClinicalTrials.gov

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