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China CRSwNP Registry Study

Not Yet RecruitingN/A

Sponsor: Beijing Tongren Hospital

Conditions: Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Interventions: Routine Clinical Care for CRSwNP

Countries: China

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.

Eligibility overview

Sex: ALL

Age: 12 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Beijing, Beijing Municipality, China