Chronic Rhinosinusitis With Nasal PolypsNCT05626257
Regulatory Post-Marketing Surveillance of Xolair® for Chronic Rhinosinusitis With Nasal Polyps
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by Novartis Pharmaceuticals at 16 sites in South Korea.
Trial summary
This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Xolair
- How many people
- 135 participants
- Where
- 16 sitesSouth Korea
- Study dates
- 12 Jan 2023to 15 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
South Korea16 sites
Novartis Investigative Site
Anyang-si, Gyeonggi-do, 14068
Novartis Investigative Site
Bundang Gu, Gyeonggi-do, 13620
Novartis Investigative Site
Daegu, 705 718
Novartis Investigative Site
Gyeonggi-do, 14353
Novartis Investigative Site
Incheon, Korea, 405 760
Novartis Investigative Site
Seoul, Korea, 03080
Novartis Investigative Site
Seoul, Korea, 03312
Novartis Investigative Site
Seoul, Korea, 07061
Novartis Investigative Site
Seoul, Korea, 08308
Novartis Investigative Site
Seoul, Yangcheon gu, 07985
Novartis Investigative Site
Seoul, 03722
Novartis Investigative Site
Seoul, 06351
Novartis Investigative Site
Seoul, 07804
Novartis Investigative Site
Seoul, 2447
Novartis Investigative Site
Suwon, 16247
Novartis Investigative Site
Uijeongbu-si, Gyeonggi-do, 11759
About this study
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)
This study aims to evaluate the safety and effectiveness of Xolair® in patients with chronic rhinosinusitis with nasal polyps in routine clinical practice.
Read the 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.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Xolair
- Keywords
- Chronic Rhinosinusitis with Nasal Polyps, CRSwNP, Korea, NIS, Xolair
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XolairOther
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 group | Role | What they receive |
|---|---|---|
| Xolair | patients who prescribed with Xolair according to the current label information in Korea. Receives: Other: Xolair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidences of adverse events/adverse drug reactions (AEs/ADRs)
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
Measured: Up to 24 weeks
Secondary outcomes (5)
Change from baseline in SNOT-22
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.
Measured: Baseline, Week 12 and Week 24
Incidences of AEs by subject characteristics
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.
Measured: Up to 24 weeks
Subject characteristics that affect the occurrence of adverse events
Logistic regression analysis will be performed to analyze subject characteristics that affect the occurrence of adverse events.
Measured: Up to 24 weeks
change from baseline in SNOT-22 according to subject characteristics
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.
Measured: Week 12 and Week 24
Subject characteristics that affect the change from baseline in SNOT-22
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
Measured: Week 12 and Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2022
- Study start12 Jan 2023
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626257
- Sponsor's protocol ID
- CIGE025EKR04
- Status last verified
- Nov 2025
- First submitted
- 15 Nov 2022
- Last updated
- 29 May 2026
- Results posted
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05626257
- Acronym / sponsor ID
- CIGE025EKR04
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- Chronic Rhinosinusitis with Nasal Polyps, CRSwNP, Korea, NIS, Xolair
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 12 Jan 2023 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 23 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Xolair | – | Other: Xolairpatients who prescribed with Xolair according to the current label information in Korea. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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®
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XolairThere is no treatment allocation. Patients administered Xolair by prescription that have started before inclusion of the patient into the study will be enrolled. | Other | Xolair |
Primary outcome
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
5 secondary outcomes
Change from baseline in SNOT-22
Time frame: Baseline, Week 12 and Week 24
Incidences of AEs by subject characteristics
Time frame: Up to 24 weeks
Subject characteristics that affect the occurrence of adverse events
Time frame: Up to 24 weeks
change from baseline in SNOT-22 according to subject characteristics
Time frame: Week 12 and Week 24
Subject characteristics that affect the change from baseline in SNOT-22
Time frame: Week 12 and Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Link to study resultsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by Novartis Pharmaceuticals at 16 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidences of adverse events/adverse drug reactions (AEs/ADRs) (time frame: Up to 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.