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NCT Number: NCT07795658

China CRSwNP Registry Study

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.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Nasal Polyps Nose Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Polyps Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 12 years or older at the time of signing the informed consent or assent form.
  • Confirmed diagnosis of chronic rhinosinusitis with bilateral nasal polyps (CRSwNP) according to the Chinese Guideline for Diagnosis and Treatment of Chronic Rhinosinusitis (2024).
  • Baseline Nasal Polyp Score (NPS) of at least 4 on a scale of 0 to 8, with a score of at least 1 in each nasal cavity.
  • At baseline, a self-reported Nasal Congestion Score (NCS) of at least 2 and/or Loss of Smell Score (LoS) of at least 2, each assessed on a scale of 0 to 3 based on symptoms during the previous 2 weeks.
  • Able and willing to comply with long-term clinical follow-up and study assessments.
  • Voluntary written informed consent. For minors, written informed consent from a parent or legal guardian and participant assent will be obtained as required by applicable regulations and ethics committee requirements.

Exclusion criteria

  • Presence of another poorly controlled serious disease, recurrent chronic disease, or infectious disease.
  • Pregnancy or breastfeeding.
  • History of excessive alcohol consumption, defined as more than 14 units of alcohol per week (1 unit equals 360 mL of beer, 45 mL of spirits containing 40% alcohol, or 150 mL of wine), or a history of drug abuse.
  • Other concomitant conditions that may interfere with the study, including but not limited to fungal sinusitis except allergic fungal rhinosinusitis, odontogenic sinusitis, antrochoanal polyps, eosinophilic granulomatosis with polyangiitis (EGPA/Churg-Strauss syndrome), cystic fibrosis, granulomatosis with polyangiitis, Young syndrome, Kartagener syndrome, or other ciliary dyskinesia syndromes.
  • Any medical, social, psychological, or personal condition that, in the investigator's judgment, may interfere with participation or reasonably be expected to prevent completion of scheduled follow-up visits and assessments, such as limited life expectancy, substance abuse, or severe cognitive impairment.

Treatment and study plan

Routine Clinical Care for CRSwNP

Other

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.

Primary outcomes

  1. Change From Baseline in 22-Item Sino-Nasal Outcome Test (SNOT-22) Total Score

    Time frame: Baseline and Months 12, 24, and 36

    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.

  2. Change From Baseline in Total Nasal Symptom Score (TNSS)

    Time frame: Baseline and Months 12, 24, and 36

    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.

  3. Percentage of Participants in Each CRSwNP Treatment Outcome Category

    Time frame: Months 12, 24, and 36

    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.

Secondary outcomes

  1. Annualized Rate of Treatment Escalation Events

    Time frame: From baseline through Month 36

    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.

  2. Percentage of Participants With at Least One Treatment Escalation Event

    Time frame: Months 12, 24, and 36

    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.

  3. Time to First Treatment Escalation Event

    Time frame: From baseline to the first treatment escalation event, assessed through Month 36

    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.

  4. Percentage of Participants With Controlled Disease Using Each Treatment Modality

    Time frame: Months 12, 24, and 36

    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.

  5. Percentage of Participants Undergoing Endoscopic Sinus Surgery or Revision Surgery

    Time frame: From baseline through Month 36

    The percentage of participants who undergo at least one endoscopic sinus surgery or revision surgery during registry follow-up will be summarized.

  6. Time From Baseline to First Endoscopic Sinus Surgery or Revision Surgery

    Time frame: From baseline to the first surgery, assessed through Month 36

    The interval from enrollment to the first endoscopic sinus surgery or revision surgery occurring during registry follow-up will be assessed.

  7. Percentage of Participants Using Oral Corticosteroids

    Time frame: From baseline through Month 36

    The percentage of participants who receive oral corticosteroid treatment at least once during registry follow-up will be summarized.

  8. Annualized Number of Systemic Corticosteroid Courses per Participant-Year

    Time frame: From baseline through Month 36

    The number of systemic corticosteroid courses will be divided by the observed participant-years to calculate the annualized number of courses per participant-year.

  9. Cumulative Systemic Corticosteroid Dose in Prednisone Equivalents

    Time frame: From baseline through Month 36

    The cumulative systemic corticosteroid dose received during registry follow-up will be calculated and expressed in milligrams of prednisone equivalent.

  10. Percentage of Participants With at Least Two Systemic Corticosteroid Courses per Year

    Time frame: Year 1, Year 2, and Year 3

    The percentage of participants receiving at least two systemic corticosteroid courses within each year of follow-up will be summarized.

  11. Percentage of Participants Using Biologic Therapy for CRSwNP

    Time frame: From baseline through Month 36

    The percentage of participants who receive at least one biologic therapy for CRSwNP during registry follow-up will be summarized.

  12. Time From Enrollment to First Use of Biologic Therapy for CRSwNP

    Time frame: From baseline to first biologic use, assessed through Month 36

    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.

  13. Duration of Biologic Therapy for CRSwNP

    Time frame: From baseline through Month 36

    The duration of each biologic treatment episode for CRSwNP will be summarized during registry follow-up.

  14. Biologic Therapy Switching Patterns

    Time frame: From baseline through Month 36

    Switching between biologic therapies for CRSwNP will be characterized, including the number and sequence of biologic therapy switches recorded during registry follow-up.

  15. Biologic Therapy Discontinuation and Reasons for Discontinuation

    Time frame: From baseline through Month 36

    Biologic therapy discontinuations will be summarized, including the percentage of participants discontinuing biologic therapy and the documented reasons for discontinuation.

  16. Cumulative CRSwNP-Related Healthcare Resource Utilization

    Time frame: From enrollment through Months 12, 24, and 36

    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.

  17. Cumulative CRSwNP-Related Direct Medical Costs

    Time frame: From enrollment through Months 12, 24, and 36

    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.

  18. Work Productivity and Activity Impairment Outcomes

    Time frame: Baseline and Months 12, 24, and 36

    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.

  19. Number and Percentage of Participants With Serious Adverse Events

    Time frame: From baseline through Month 36

    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.

  20. Number and Percentage of Participants With Patient-Reported Biologic-Related Adverse Drug Reactions

    Time frame: From baseline through Month 36

    Patient-reported adverse drug reactions related to biologic therapy that are documented during routine clinical care will be collected, when applicable, and summarized descriptively.

Other outcomes

  1. Change in Nasal Polyp Score Before and After a Major CRSwNP Clinical Intervention

    Time frame: From the pre-intervention assessment to 6 and 12 months after a major CRSwNP clinical intervention, within the 36-month follow-up period

    Nasal Polyp Score (NPS) will be assessed by nasal endoscopy. Changes between the corresponding assessments before and after a major CRSwNP clinical intervention will be summarized. Major interventions include endoscopic sinus surgery or revision surgery, initiation or switching of biologic therapy, and protocol-defined systemic corticosteroid treatment.

  2. Change in Total Nasal Symptom Score Before and After a Major CRSwNP Clinical Intervention

    Time frame: From the pre-intervention assessment to 6 and 12 months after a major CRSwNP clinical intervention, within the 36-month follow-up period

    Total Nasal Symptom Score (TNSS) is recorded daily using a paper symptom diary. Visit-level scores will generally be derived from diary entries completed during the preceding 14 consecutive days. Changes between assessments before and after a major CRSwNP clinical intervention will be summarized.

  3. Change in Nasal Congestion Score Before and After a Major CRSwNP Clinical Intervention

    Time frame: From the pre-intervention assessment to 6 and 12 months after a major CRSwNP clinical intervention, within the 36-month follow-up period

    Nasal Congestion Score (NCS) will be used to assess participant-reported nasal congestion severity. Changes between assessments before and after a major CRSwNP clinical intervention will be summarized.

  4. Change in Loss of Smell Score Before and After a Major CRSwNP Clinical Intervention

    Time frame: From the pre-intervention assessment to 6 and 12 months after a major CRSwNP clinical intervention, within the 36-month follow-up period

    Loss of Smell Score (LoS) will be used to assess participant-reported impairment in sense of smell. Changes between assessments before and after a major CRSwNP clinical intervention will be summarized.

  5. Change in SNOT-22 Total Score Before and After a Major CRSwNP Clinical Intervention

    Time frame: From the pre-intervention assessment to 6 and 12 months after a major CRSwNP clinical intervention, within the 36-month follow-up period

    The 22-item Sino-Nasal Outcome Test (SNOT-22) total score ranges from 0 to 110, with higher scores indicating greater disease-related impairment. Changes between assessments before and after a major CRSwNP clinical intervention will be summarized.

  6. Change in Lund-Mackay Computed Tomography Score Before and After a Major CRSwNP Clinical Intervention

    Time frame: From the pre-intervention assessment to 6 and 12 months after a major CRSwNP clinical intervention, within the 36-month follow-up period

    When clinically available, sinus computed tomography findings will be assessed using the Lund-Mackay score. Changes between assessments before and after a major CRSwNP clinical intervention will be summarized, when available in routine clinical practice

  7. Change in Asthma Control Questionnaire-6 Score Before and After a Major CRSwNP Clinical Intervention

    Time frame: From the pre-intervention assessment to 6 and 12 months after a major CRSwNP clinical intervention, within the 36-month follow-up period

    Among participants with comorbid asthma, asthma control will be assessed using the Asthma Control Questionnaire-6 (ACQ-6). Changes between assessments before and after a major CRSwNP clinical intervention will be summarized.

  8. Change in Forced Expiratory Volume in 1 Second Before and After a Major CRSwNP Clinical Intervention

    Time frame: From the pre-intervention assessment to 6 and 12 months after a major CRSwNP clinical intervention, within the 36-month follow-up period

    Among participants with comorbid asthma, forced expiratory volume in 1 second (FEV1) obtained during routine clinical care will be evaluated. Changes between assessments before and after a major CRSwNP clinical intervention will be summarized, when available in routine clinical practice.

  9. Change in Protocol-Specified Biomarkers During Follow-up

    Time frame: Baseline and protocol-specified follow-up assessments through Month 36

    Changes in available protocol-specified biomarkers will be characterized descriptively. These may include peripheral blood cell counts, serum total immunoglobulin E, nasal polyp tissue inflammatory cell counts, and biomarkers derived from the nasal microbiome, nasal exfoliated cells, and nasal secretions, when available.

  10. Association Between Baseline Clinical Characteristics and Persistent High Disease Burden

    Time frame: Baseline characteristics and 6-month follow-up periods assessed through Month 36

    Associations between baseline clinical characteristics and persistent high disease burden will be explored. Persistent high disease burden is defined as sustained Nasal Polyp Score (NPS) >=4, Nasal Congestion Score (NCS) >=2, Loss of Smell Score (LoS) >=2, or 22-item Sino-Nasal Outcome Test (SNOT-22) score >=30 during a 6-month follow-up period.

  11. Association Between Baseline Clinical Characteristics and Frequent Treatment Escalation

    Time frame: Baseline characteristics and treatment escalation events assessed through Month 36

    Associations between baseline clinical characteristics and frequent treatment escalation during follow-up will be explored. Frequent treatment escalation is defined as an annualized treatment escalation event rate greater than 1 event per year.

  12. Association Between Duration of Biologic Therapy and Time to Subsequent Treatment Escalation After Discontinuation

    Time frame: From initiation of biologic therapy through subsequent treatment escalation after discontinuation, assessed through Month 36

    Among participants who discontinue biologic therapy, the association between the duration of biologic treatment and post-discontinuation clinical outcomes, including time to subsequent treatment escalation, will be explored.

Study contacts

Contact information is provided by the study sponsor or research team.

Mu Xian, MD

CONTACT

[email protected]

+86 136 7113 8761

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

POLARIS: A Prospective, Multicenter Real-World Study to Investigate the Treatment Pattern and Prognostic Outcome in Chinese Severe Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Patients

Acronym: POLARIS

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
Aug 31, 2026
Registry last updated
Aug 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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