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Clinical Trials in China / NCT07446738
Active, not recruiting Observational

A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients

NCT07446738 · tracked via the Priya Life Science China tracker
Sponsor
AstraZeneca
Phase
Observational
Started
2026-03-19
Last updated
2026-09-25

Condition(s) studied

Chronic Rhinosinusitis With Nasal Polyps

Investigational drug(s) / intervention(s)

Other: Routine Clinical Care for CRSwNP

Other: Routine Clinical Care for CRSwNP: Patients will receive standard medical care as determined by the treating physician according to routine clinical practice at each site. No treatment assignment will be made as part of the study.

Study summary

This is a prospective, multicenter real-world observational study designed to describe post-operative outcomes, quality of life, disease control, recurrence-related characteristics, economic burden and post-operative treatment patterns in Chinese patients with CRSwNP undergoing endoscopic sinus surgery (ESS).

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Participant must be 16 years of age or older, at the time of signing the informed consent. 2. Participants with a documented diagnosis of bilateral CRSwNP. 3. ESS is performed during the screening period. 4. Voluntarily participate and sign the ICF. 5. No history or current psychiatric disorders, with normal cognitive functions including understanding, expression, and orientation. Exclusion Criteria: 1. Any significant disease or disorder that the investigator believes may place the patient at risk or may affect the study results or the patient's ability to participate in the study. 2. Use of biologic therapy for CRSwNP within 3 months prior to surgery. 3. Currently participating in an interventional study. 4. Patients who are unable to independently complete questionnaires due to language barriers or mental status.

Primary outcome measure(s)

  • The observed value and change from baseline in SNOT-22 total score at week-52 — baseline-week52
    To describe the Sino-Nasal Outcome Test (SNOT)-22 total score at 52 weeks post- operatively. \[SNOT-22: score 0-5 each item, 5 means worse outcome, 22 items totally\]
  • The observed value and change from baseline in MLK score at week-52 — baseline-week52
    To describe the Modified Lund-Kennedy (MLK) score at 52 weeks post-operatively. \[MLK score: score 0-24, 24 means worse outcome\]

Trial sites (21)

FacilityCityRegionStatus
The Seventh Affiliated Hospital Sun Yat-sen University Guangzhou Guangdong
Shengjing Hospital of China Medical University Shenyang Liaoning
QiLu Hospital of Shandong University Jinan Shandong
Research Site Changchun China
Research Site Changsha China
Research Site Chengdu China
Research Site Guangzhou China
Research Site Guangzhou China
Research Site Guangzhou China
Research Site Haikou China
Research Site Kunming China
Research Site Nanchang China
Research Site Nanjing China
Research Site Nanning China
Research Site Qingdao China
Research Site Shanghai China
Research Site Shenzhen China
Research Site Ürümqi China
Research Site Wuhan China
Research Site Wuhan China
Research Site Xiamen China

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Other trials for the same condition

An Extension Study to Investigate the Long-term Safety and Tolerability of Itepekimab in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps Active, not recruiting
A Phase 3 Study to Assess the Efficacy, Safety, and Tolerability of Itepekimab (Anti-IL-33 mAb) in Participants With Inadequately-controlled Chronic Rhinosinusitis With Nasal Polyps Active, not recruiting
A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab Recruiting
Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07446738 on ClinicalTrials.gov ↗ ← All trials in China