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

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ClinicalTrials.gov Identifier: NCT05626257
Recruitment Status : Recruiting
First Posted : November 23, 2022
Last Update Posted : January 20, 2023
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Study Description
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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.

Condition or disease Intervention/treatment
Chronic Rhinosinusitis With Nasal Polyps Other: Xolair

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
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Study Type : Observational
Estimated Enrollment : 112 participants
Observational Model: Cohort
Time Perspective: Prospective
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)
Actual Study Start Date : January 12, 2023
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Omalizumab

Groups and Cohorts
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Group/Cohort Intervention/treatment
Xolair
patients who prescribed with Xolair according to the current label information in Korea.
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05626257


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals

Locations
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Korea, Republic of
Novartis Investigative Site Recruiting
Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
More Information
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT05626257    
Other Study ID Numbers: CIGE025EKR04
First Posted: November 23, 2022    Key Record Dates
Last Update Posted: January 20, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Chronic Rhinosinusitis with Nasal Polyps
CRSwNP
Korea
NIS
Xolair
Additional relevant MeSH terms:
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Sinusitis
Nasal Polyps
Polyps
Pathological Conditions, Anatomical
Respiratory Tract Infections
Infections
Paranasal Sinus Diseases
 Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Omalizumab
Anti-Allergic Agents
Anti-Asthmatic Agents
Respiratory System Agents