China CRSwNP Registry Study

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

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.

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.