China CRSwNP Registry Study

NCT07795658 | Not Yet Recruiting

• 1 other identifier: POLARIS
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Keywords

CRSwNP; Severe CRSwNP; Chronic Rhinosinusitis; Nasal Polyps; Prospective Registry; Real-World Study; Treatment Patterns; Disease Burden; Treatment Escalation; Endotype; Biomarkers; Long-Term Outcomes

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Months 12, 24, and 36

Secondary Outcomes (20)

• Annualized Rate of Treatment Escalation Events

  From baseline through Month 36

• Percentage of Participants With at Least One Treatment Escalation Event

  Months 12, 24, and 36

• Time to First Treatment Escalation Event

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

• Percentage of Participants With Controlled Disease Using Each Treatment Modality

  Months 12, 24, and 36

• Percentage of Participants Undergoing Endoscopic Sinus Surgery or Revision Surgery

  From baseline through Month 36

Other Outcomes (12)

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

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

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

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

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

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

Study Arms (1)

CRSwNP Registry Cohort

Approximately 1,000 adolescents and adults aged 12 years or older with bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) who meet the protocol-defined nasal polyp and symptom criteria will be enrolled at approximately 33 centers in China and followed prospectively for 36 months. Participants will receive treatment selected by their treating physicians according to routine clinical practice. No treatment is assigned by the study.

Other: Routine Clinical Care for CRSwNP

Interventions

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.

CRSwNP Registry Cohort

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will comprise adolescents and adults aged 12 years or older with bilateral chronic rhinosinusitis with nasal polyps (CRSwNP) receiving routine clinical care at participating otolaryngology centers in China. Eligible participants will be enrolled prospectively and followed for 36 months. All treatment decisions, including medical therapy, endoscopic sinus surgery, and biologic therapy, will be made by treating physicians according to routine clinical practice and will not be assigned by the study.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing Tongren Hospital: lead
• AstraZeneca: collaborator

Study Sites (1)

Beijing Tongren Hospital, Capital Medical University

Beijing, Beijing Municipality, 100730, China

Location

Related Publications (15)

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• Han JK, Silver J, Dhangar I, Veeranki P, Deb A. Quantifying corticosteroid burden in chronic rhinosinusitis with nasal polyps: A retrospective US database study. Ann Allergy Asthma Immunol. 2025 Jun;134(6):685-693.e5. doi: 10.1016/j.anai.2024.10.015. Epub 2024 Oct 19.

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• Zhang J, Sima Y, Shao S, Zheng M, Zhao Y, Gao F, Wang X, Zhang L. Cost-utility and clinical outcome analysis of surgery or oral corticosteroids treatment in patients with chronic rhinosinusitis with nasal polyps. Asia Pac Allergy. 2024 Dec;14(4):174-182. doi: 10.5415/apallergy.0000000000000160. Epub 2024 Oct 28.

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• DeConde AS, Mace JC, Levy JM, Rudmik L, Alt JA, Smith TL. Prevalence of polyp recurrence after endoscopic sinus surgery for chronic rhinosinusitis with nasal polyposis. Laryngoscope. 2017 Mar;127(3):550-555. doi: 10.1002/lary.26391. Epub 2016 Nov 12.

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• Bachert C, Bhattacharyya N, Desrosiers M, Khan AH. Burden of Disease in Chronic Rhinosinusitis with Nasal Polyps. J Asthma Allergy. 2021 Feb 11;14:127-134. doi: 10.2147/JAA.S290424. eCollection 2021.

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• Lou H, Meng Y, Piao Y, Wang C, Zhang L, Bachert C. Predictive significance of tissue eosinophilia for nasal polyp recurrence in the Chinese population. Am J Rhinol Allergy. 2015 Sep-Oct;29(5):350-6. doi: 10.2500/ajra.2015.29.4231. Epub 2015 Jul 27.

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• Guo CL, Lu RY, Wang CS, Zhao JF, Pan L, Liu HC, Liao B, Liu Z. Identification of Inflammatory Endotypes by Clinical Characteristics and Nasal Secretion Biomarkers in Chronic Rhinosinusitis with Nasal Polyps. Int Arch Allergy Immunol. 2023;184(10):955-965. doi: 10.1159/000530193. Epub 2023 May 30.

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• Ma L, Deng Y, Wang K, Shi J, Sun Y. Relationship between Eosinophilic and Neutrophilic Inflammation in Chinese Chronic Rhinosinusitis with Nasal Polyps. Int Arch Allergy Immunol. 2023;184(6):576-586. doi: 10.1159/000528946. Epub 2023 Feb 6.

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• Yu J, Xian M, Piao Y, Zhang L, Wang C. Changes in Clinical and Histological Characteristics of Nasal Polyps in Northern China over the Past 2-3 Decades. Int Arch Allergy Immunol. 2021;182(7):615-624. doi: 10.1159/000513312. Epub 2021 Feb 17.

  PMID: 33596581 BACKGROUND

• Shi JB, Fu QL, Zhang H, Cheng L, Wang YJ, Zhu DD, Lv W, Liu SX, Li PZ, Ou CQ, Xu G. Epidemiology of chronic rhinosinusitis: results from a cross-sectional survey in seven Chinese cities. Allergy. 2015 May;70(5):533-9. doi: 10.1111/all.12577. Epub 2015 Mar 4.

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• Bachert C, Han JK, Wagenmann M, Hosemann W, Lee SE, Backer V, Mullol J, Gevaert P, Klimek L, Prokopakis E, Knill A, Cavaliere C, Hopkins C, Hellings P. EUFOREA expert board meeting on uncontrolled severe chronic rhinosinusitis with nasal polyps (CRSwNP) and biologics: Definitions and management. J Allergy Clin Immunol. 2021 Jan;147(1):29-36. doi: 10.1016/j.jaci.2020.11.013. Epub 2020 Nov 20.

  PMID: 33227318 BACKGROUND

• Xian M, Yan B, Song X, Chen J, Tang J, Jiang Y, Wan L, Liu W, Xue J, Cao Z, Yu Y, Yang X, Shi L, Wang G, Xu Y, Yang Y, Ye J, Jiang L, Quan F, Tan G, Liu F, Xu Z, Zhang X, Li J, Su L, Yang Y, Fan J, He G, Zhu L, Wang X, Wang M, Shen S, Li J, Li H, Wei X, Yu H, Liu Z, Ma R, Liu H, Liu J, Lv W, Yang Q, Zhu D, Cheng L, Wang C, Zhang L. Chinese Position Paper on Biologic Therapy for Chronic Rhinosinusitis With Nasal Polyps. Allergy. 2025 May;80(5):1208-1225. doi: 10.1111/all.16519. Epub 2025 Mar 5.

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• Zhu DD, Yu HM, Xian M, Song XC, Chen JJ, Tang J, Jiang Y, Wan LJ, Liu W, Xue JM, Cao ZW, Yu YF, Yang XL, Shi L, Wang GK, Xu Y, Yang YC, Ye J, Jiang LY, Quan F, Tan GL, Liu F, Xu ZD, Zhang XW, Li JP, Su LZ, Yang Y, Fan JG, He G, Zhu L, Guo R, Wang XD, Yan B, Wang M, Shen S, Yang G, Li J, Li HB, Wei X, Liu Z, Ma RX, Liu HH, Liu JF, Lyu W, Yang QT, Cheng L, Wang CS, Zhang L. [Expert consensus on the treatment of chronic rhinosinusitis with nasal polyps with biologics (2025)]. Zhonghua Er Bi Yan Hou Tou Jing Wai Ke Za Zhi. 2025 Nov 7;60(11):1389-1398. doi: 10.3760/cma.j.cn115330-20250527-00295. Chinese.

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• Subspecialty Group of Rhinology, Editorial Board of Chinese Journal of Otorhinolaryngology Head and Neck Surgery; Subspecialty Group of Rhinology, Society of Otorhinolaryngology Head and Neck Surgery, Chinese Medical Association. Chinese Guidelines for Diagnosis and Treatment of Chronic Rhinosinusitis (2024). World J Otorhinolaryngol Head Neck Surg. 2025 Aug 14;12(1):25-55. doi: 10.1002/wjo2.70031. eCollection 2026 Feb.

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  PMID: 32077450 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Blood and serum samples, nasal polyp tissue, nasal epithelial cells, nasal secretions, and other protocol-specified specimens may be collected and retained for analyses of inflammatory cells, immunologic markers, biomarkers, and the nasal microbiome. Some retained tissue and cell-containing specimens may contain extractable DNA. No protocol-mandated germline genetic testing is planned. Specimen collection, testing, storage, use, and disposal will be conducted in China in accordance with the approved protocol, ethics requirements, and applicable human genetic resources regulations.

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Chengshuo Wang, MD, PhD

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

• Luo Zhang, MD, PhD

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mu Xian, MD

CONTACT

+86 136 7113 8761; mu_xian@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: August 31, 2026
• Study Start (Estimated): October 31, 2026
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)