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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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 )

Tracking Information
First Submitted Date November 15, 2022
First Posted Date November 23, 2022
Last Update Posted Date January 20, 2023
Actual Study Start Date January 12, 2023
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 15, 2022)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 15, 2022)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Chronic Rhinosinusitis With Nasal Polyps
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.
Study Groups/Cohorts Xolair
patients who prescribed with Xolair according to the current label information in Korea.
Intervention: Other: Xolair
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 15, 2022)		 112
Original Estimated Enrollment Same as current
Estimated Study Completion Date January 31, 2025
Estimated Primary Completion Date January 31, 2025   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Novartis Pharmaceuticals +41613241111 novartis.email@novartis.com
Contact: Novartis Pharmaceuticals
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT05626257
Other Study ID Numbers CIGE025EKR04
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Novartis ( Novartis Pharmaceuticals )
Original Responsible Party Same as current
Current Study Sponsor Novartis Pharmaceuticals
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
PRS Account Novartis
Verification Date January 2023