Chronic rhinosinusitis with nasal polyps (CRSwNP) is a long-lasting inflammatory disease of the nose and sinuses that can cause nasal blockage, loss of smell, nasal discharge, facial discomfort, sleep problems, and reduced quality of life. POLARIS is a prospective, multicenter, real-world, non-interventional registry study. It will enroll approximately 1,000 adolescents and adults aged 12 years or older with bilateral CRSwNP at about 33 centers in China and follow them for 36 months. All treatment decisions will be made by the treating physicians according to routine clinical practice. The study will not assign participants to any treatment. The study aims to describe the disease burden, underlying inflammatory characteristics, real-world treatment patterns, effectiveness of current treatments, and long-term outcomes of Chinese patients with CRSwNP. Key assessments will include changes in nasal symptoms measured by the Total Nasal Symptom Score, changes in disease-related quality of life measured by the 22-item Sino-Nasal Outcome Test, and the proportions of patients classified as cured, controlled, or uncontrolled at months 12, 24, and 36. The study will also examine treatment escalation, surgery, systemic corticosteroid and biologic use, health care and economic burden, safety events, and clinical characteristics and biomarkers associated with persistent high disease burden or frequent treatment escalation.
This is a prospective, multicenter, real-world, non-interventional longitudinal registry study conducted at approximately 33 centers in China. Approximately 1,000 participants aged 12 years or older with bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) will be followed for 36 months. Eligible participants must meet the protocol-defined diagnostic, nasal polyp score, and symptom criteria. Participants will receive standard medical care as determined by their treating physicians. No treatment will be assigned by the study, and participation will not restrict or otherwise determine the use of medical therapy, systemic corticosteroids, biologic therapy, endoscopic sinus surgery, or other clinically indicated treatment. The study uses a combination of scheduled and event-driven in-person visits and telephone follow-up. Scheduled in-person visits are planned at Months 3, 6, 9, 12, 18, 24, 30, and 36, and telephone visits are planned at Months 15, 21, 27, and 33. During follow-up, participants with worsening symptoms, defined as persistent NCS of at least 2, LoS of at least 2, or SNOT-22 of at least 30 during the previous week, will have an additional in-person visit within a window of ±2 weeks to determine whether treatment escalation is needed. Participants undergoing endoscopic sinus surgery will have an additional in-person visit approximately 2 weeks after surgery. Participants receiving a protocol-defined oral corticosteroid course of at least 7 days at a daily dose of at least 30 mg prednisone equivalent will have an additional in-person visit approximately 2 weeks after corticosteroid discontinuation. Each post-treatment visit has a window of ±2 weeks. If a participant receives two or more qualifying escalation treatments, the earliest applicable post-treatment time point will be used. Biologic initiation or switching does not trigger this additional 2-week visit. Collected information will include demographic and clinical characteristics, medical and surgical history, comorbidities, treatment patterns, symptom scores, disease-related quality of life, nasal polyp assessments, treatment outcomes, treatment escalation events, health care resource use, economic and humanistic burden, and safety events. Laboratory results and biological specimens, including blood, nasal polyp tissue, nasal cells, and nasal secretions, may be collected as specified in the protocol and when applicable. The primary assessments describe changes from baseline in the Total Nasal Symptom Score and the 22-item Sino-Nasal Outcome Test, and the proportions of participants classified as cured, controlled, or uncontrolled at months 12, 24, and 36. Secondary and exploratory analyses will describe treatment escalation, surgery, systemic corticosteroid and biologic use, clinical and biomarker changes, and factors associated with persistent high disease burden or frequent treatment escalation. The primary analyses will be descriptive; exploratory statistical models may be used to evaluate associations between participant characteristics, biomarkers, treatment patterns, and outcomes. Study personnel will receive standardized protocol and data collection training. Data will be entered into an electronic data capture system with role-based access, predefined range and consistency checks, an audit trail, and investigator confirmation. Data queries, periodic monitoring, and data quality reviews will be used to address missing, inconsistent, or implausible information and to support adherence to the protocol and protection of participant privacy.
Study Type
OBSERVATIONAL
Enrollment
1,000
Participants may receive any clinically indicated treatment for CRSwNP according to routine clinical practice, including intranasal corticosteroids, systemic corticosteroids, endoscopic sinus surgery, biologic therapies, and other appropriate management. Treatment selection, initiation, switching, discontinuation, and escalation are determined by the treating physicians. The study does not provide or assign any treatment; it observes real-world treatment patterns and associated clinical outcomes over 36 months.
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Change From Baseline in 22-Item Sino-Nasal Outcome Test (SNOT-22) Total Score
The SNOT-22 is a 22-item patient-reported questionnaire assessing disease-related quality of life. Each item is scored from 0 to 5, giving a total score from 0 to 110, with higher scores indicating greater impairment. Change in the total score from baseline will be summarized at each specified time point.
Time frame: Baseline and Months 12, 24, and 36
Change From Baseline in Total Nasal Symptom Score (TNSS)
TNSS is recorded daily by participants using a paper symptom diary. The visit-level TNSS total score and component scores will generally be derived from diary entries completed during the 14 consecutive days before each visit. Change from baseline will be summarized at each specified time point.
Time frame: Baseline and Months 12, 24, and 36
Percentage of Participants in Each CRSwNP Treatment Outcome Category
At each time point, participants will be classified as cured, controlled, or uncontrolled according to protocol-defined criteria. Cured is defined as having no rhinosinusitis-related symptoms and no mucosal edema, nasal polyps, or abnormal secretions on nasal endoscopy for 6 months without treatment intervention. Controlled is defined as having no rhinosinusitis-related symptoms for 6 months while receiving treatment intervention, with a Nasal Polyp Score (NPS) of \<=1 on each side. Uncontrolled disease is defined as the persistence of rhinosinusitis-related symptoms despite treatment, indicated by a weekly mean Nasal Congestion Score (NCS) of at least 2 or a weekly mean Loss of Smell Score (LoS) of at least 2, or a Nasal Polyp Score (NPS) greater than 1 on either side. The percentage of participants in each category will be summarized.
Time frame: Months 12, 24, and 36
Annualized Rate of Treatment Escalation Events
The annualized rate of treatment escalation events will be calculated as the total number of events divided by the observed participant-years. Treatment escalation includes endoscopic sinus surgery or revision surgery, initiation or switching of biologic therapy for CRSwNP, and a systemic corticosteroid course of at least 7 days at a daily dose of at least 30 mg prednisone equivalent.
Time frame: From baseline through Month 36
Percentage of Participants With at Least One Treatment Escalation Event
The cumulative number and percentage of participants experiencing at least one treatment escalation event will be summarized. Treatment escalation includes endoscopic sinus surgery or revision surgery, initiation or switching of biologic therapy for CRSwNP, and protocol-defined systemic corticosteroid treatment.
Time frame: Months 12, 24, and 36
Time to First Treatment Escalation Event
Time from enrollment to the first treatment escalation event will be assessed. Treatment escalation includes endoscopic sinus surgery or revision surgery, initiation or switching of biologic therapy for CRSwNP, and protocol-defined systemic corticosteroid treatment.
Time frame: From baseline to the first treatment escalation event, assessed through Month 36
Percentage of Participants With Controlled Disease Using Each Treatment Modality
Among participants classified as having controlled disease, the percentage using each routine-care treatment modality will be summarized. Treatment modalities include intranasal corticosteroids, oral corticosteroids, biologic therapy, and endoscopic sinus surgery.
Time frame: Months 12, 24, and 36
Percentage of Participants Undergoing Endoscopic Sinus Surgery or Revision Surgery
The percentage of participants who undergo at least one endoscopic sinus surgery or revision surgery during registry follow-up will be summarized.
Time frame: From baseline through Month 36
Time From Baseline to First Endoscopic Sinus Surgery or Revision Surgery
The interval from enrollment to the first endoscopic sinus surgery or revision surgery occurring during registry follow-up will be assessed.
Time frame: From baseline to the first surgery, assessed through Month 36
Percentage of Participants Using Oral Corticosteroids
The percentage of participants who receive oral corticosteroid treatment at least once during registry follow-up will be summarized.
Time frame: From baseline through Month 36
Annualized Number of Systemic Corticosteroid Courses per Participant-Year
The number of systemic corticosteroid courses will be divided by the observed participant-years to calculate the annualized number of courses per participant-year.
Time frame: From baseline through Month 36
Cumulative Systemic Corticosteroid Dose in Prednisone Equivalents
The cumulative systemic corticosteroid dose received during registry follow-up will be calculated and expressed in milligrams of prednisone equivalent.
Time frame: From baseline through Month 36
Percentage of Participants With at Least Two Systemic Corticosteroid Courses per Year
The percentage of participants receiving at least two systemic corticosteroid courses within each year of follow-up will be summarized.
Time frame: Year 1, Year 2, and Year 3
Percentage of Participants Using Biologic Therapy for CRSwNP
The percentage of participants who receive at least one biologic therapy for CRSwNP during registry follow-up will be summarized.
Time frame: From baseline through Month 36
Time From Enrollment to First Use of Biologic Therapy for CRSwNP
The interval from enrollment to the first use of a biologic therapy for CRSwNP will be assessed among participants initiating biologic therapy during registry follow-up.
Time frame: From baseline to first biologic use, assessed through Month 36
Duration of Biologic Therapy for CRSwNP
The duration of each biologic treatment episode for CRSwNP will be summarized during registry follow-up.
Time frame: From baseline through Month 36
Biologic Therapy Switching Patterns
Switching between biologic therapies for CRSwNP will be characterized, including the number and sequence of biologic therapy switches recorded during registry follow-up.
Time frame: From baseline through Month 36
Biologic Therapy Discontinuation and Reasons for Discontinuation
Biologic therapy discontinuations will be summarized, including the percentage of participants discontinuing biologic therapy and the documented reasons for discontinuation.
Time frame: From baseline through Month 36
Cumulative CRSwNP-Related Healthcare Resource Utilization
The cumulative numbers of CRSwNP-related outpatient visits, emergency department visits, and hospitalizations will be summarized through Months 12, 24, and 36. Healthcare resource utilization occurring both at and outside participating sites may be captured from available medical records or participant report, with the data source and verifiability recorded.
Time frame: From enrollment through Months 12, 24, and 36
Cumulative CRSwNP-Related Direct Medical Costs
Cumulative available and traceable direct medical costs related to CRSwNP management, including outpatient, emergency department, and hospitalization costs, will be summarized through Months 12, 24, and 36. Costs that cannot be verified or clearly attributed to CRSwNP management will not be imputed.
Time frame: From enrollment through Months 12, 24, and 36
Work Productivity and Activity Impairment Outcomes
Changes from baseline in Work Productivity and Activity Impairment Questionnaire scores, including absenteeism, presenteeism, overall work impairment, and activity impairment, will be assessed at Months 12, 24, and 36. The cumulative number of work or school days missed because of CRSwNP will also be summarized through each time point.
Time frame: Baseline and Months 12, 24, and 36
Number and Percentage of Participants With Serious Adverse Events
All serious adverse events occurring during registry follow-up will be collected through continuous passive collection, irrespective of treatment or intervention type, and summarized descriptively.
Time frame: From baseline through Month 36
Number and Percentage of Participants With Patient-Reported Biologic-Related Adverse Drug Reactions
Patient-reported adverse drug reactions related to biologic therapy that are documented during routine clinical care will be collected, when applicable, and summarized descriptively.
Time frame: From baseline through Month 36
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