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
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|Condition or disease||Intervention/treatment|
|Chronic Rhinosinusitis With Nasal Polyps||Other: Xolair|
|Study Type :||Observational|
|Estimated Enrollment :||112 participants|
|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|
patients who prescribed with Xolair according to the current label information in Korea.
There is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled.
- 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
- 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
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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|
- 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
- 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)
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
|Contact: Novartis Pharmaceuticalsfirstname.lastname@example.org|
|Contact: Novartis Pharmaceuticals|
|Korea, Republic of|
|Novartis Investigative Site||Recruiting|
|Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620|
|Study Director:||Novartis Pharmaceuticals||Novartis Pharmaceuticals|
|Responsible Party:||Novartis Pharmaceuticals|
|Other Study ID Numbers:||
|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|
Chronic Rhinosinusitis with Nasal Polyps
Pathological Conditions, Anatomical
Respiratory Tract Infections
Paranasal Sinus Diseases
Respiratory Tract Diseases
Respiratory System Agents