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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 135
- Locations
- 17
- Primary Endpoint
- Incidences of adverse events/adverse drug reactions (AEs/ADRs)
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Outcomes
Primary Outcomes
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
- 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)
- 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 change from baseline in SNOT-22(Week 12 and Week 24)