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

Chronic Rhinosinusitis With Nasal Polyps Clinical Trial

Official 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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05626257
• Other study ID #: CIGE025EKR04
• Status: Recruiting
• Start date: January 12, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: January 2024
• Source: Novartis
• Contact: Novartis Pharmaceuticals
• Phone: +41613241111
• Email: novartis.email[@]novartis.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Rhinosinusitis With Nasal Polyps
• Nasal Polyps
• Polyps
• Sinusitis

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Novartis Investigative Site	Bundang Gu	Gyeonggi Do

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, Week 12 and Week 24
Secondary	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.	Up to 24 weeks
Secondary	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.	Up to 24 weeks
Secondary	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.	Week 12 and Week 24
Secondary	Subject characteristics that affect the change from baseline in SNOT-22	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	Week 12 and Week 24