China CRSwNP Registry Study

This is a prospective, multicenter, real‐world, non‐interventional longitudinal registrystudy conducted at approximately 33 centers in China. Approximately 1,000 participantsaged 12 years or older with bilateral chronic rhinosinusitis with nasal polyps (CRSwNP)will be followed for 36 months. Eligible participants must meet the protocol‐defineddiagnostic, nasal polyp score, and symptom criteria.Participants will receive standard medical care as determined by their treatingphysicians. No treatment will be assigned by the study, and participation will notrestrict 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 telephonefollow‐up. Scheduled in‐person visits are planned at Months 3, 6, 9, 12, 18, 24, 30, and36, and telephone visits are planned at Months 15, 21, 27, and 33.During follow‐up, participants with worsening symptoms, defined as persistent NCS of atleast 2, LoS of at least 2, or SNOT‐22 of at least 30 during the previous week, will havean additional in‐person visit within a window of ±2 weeks to determine whether treatmentescalation is needed.Participants undergoing endoscopic sinus surgery will have an additional in‐person visitapproximately 2 weeks after surgery. Participants receiving a protocol‐defined oralcorticosteroid course of at least 7 days at a daily dose of at least 30 mg prednisoneequivalent will have an additional in‐person visit approximately 2 weeks aftercorticosteroid discontinuation. Each post‐treatment visit has a window of ±2 weeks. If aparticipant receives two or more qualifying escalation treatments, the earliestapplicable post‐treatment time point will be used. Biologic initiation or switching doesnot trigger this additional 2‐week visit.Collected information will include demographic and clinical characteristics, medical andsurgical history, comorbidities, treatment patterns, symptom scores, disease‐relatedquality of life, nasal polyp assessments, treatment outcomes, treatment escalationevents, health care resource use, economic and humanistic burden, and safety events.Laboratory results and biological specimens, including blood, nasal polyp tissue, nasalcells, and nasal secretions, may be collected as specified in the protocol and whenapplicable.The primary assessments describe changes from baseline in the Total Nasal Symptom Scoreand the 22‐item Sino‐Nasal Outcome Test, and the proportions of participants classifiedas cured, controlled, or uncontrolled at months 12, 24, and 36. Secondary and exploratoryanalyses will describe treatment escalation, surgery, systemic corticosteroid andbiologic use, clinical and biomarker changes, and factors associated with persistent highdisease burden or frequent treatment escalation. The primary analyses will bedescriptive; exploratory statistical models may be used to evaluate associations betweenparticipant characteristics, biomarkers, treatment patterns, and outcomes.Study personnel will receive standardized protocol and data collection training. Datawill be entered into an electronic data capture system with role‐based access, predefinedrange and consistency checks, an audit trail, and investigator confirmation. Dataqueries, periodic monitoring, and data quality reviews will be used to address missing,inconsistent, or implausible information and to support adherence to the protocol andprotection of participant privacy.