Clinical trial NCT05626257: Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps
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)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Keywords: Chronic Rhinosinusitis with Nasal Polyps
CRSwNP
Korea
NIS
Xolair
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2022-11-23
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Incidences of adverse events/adverse drug reactions (AEs/ADRs)
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Change from baseline in SNOT-22
timeFrame: Baseline, Week 12 and Week 24
measure: Incidences of AEs by subject characteristics
timeFrame: Up to 24 weeks
measure: Subject characteristics that affect the occurrence of adverse events
timeFrame: Up to 24 weeks
measure: change from baseline in SNOT-22 according to subject characteristics
timeFrame: Week 12 and Week 24
measure: Subject characteristics that affect the change from baseline in SNOT-22
timeFrame: Week 12 and Week 24
Other outcomes:
Locations:
city: Anyang Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Bundang Gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Uijeongbu si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Daegu
country: Korea, Republic of
facility: Novartis Investigative Site
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Suwon
country: Korea, Republic of
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: