Postoperative outcomes and quality of life after endoscopic sinus surgery in Chinese CRSwNP patients
PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese CRSwNP Patients
We will follow Chinese patients with chronic rhinosinusitis with nasal polyps who have endoscopic sinus surgery to see how their symptoms, quality of life, disease control, treatments, and costs change after surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | AstraZeneca Industry-sponsored |
| Locations | 16 sites (Changchun and 15 other locations) |
| Trial ID | NCT07446738 on ClinicalTrials.gov |
What this trial studies
This is a prospective, multicenter real-world observational project enrolling about 200 patients with CRSwNP who undergo endoscopic sinus surgery across roughly 20 centers in China. Participants will receive standard medical care decided by their treating physicians and attend scheduled clinical assessments and questionnaires. The study will collect data on symptom scores, disease control, recurrence, postoperative treatment patterns, quality of life, and economic burden. These collected outcomes will characterize real-world postoperative recovery and resource use in this population.
Who should consider this trial
Good fit: Adults aged 16 or older in China with a documented diagnosis of CRSwNP who undergo endoscopic nasal polypectomy and can provide informed consent and complete study questionnaires.
Not a fit: Patients who do not undergo surgery, who have significant comorbidities or psychiatric/cognitive impairment, who cannot complete questionnaires, or who are enrolled in other interventional trials are unlikely to benefit directly from this study's findings.
Why it matters
Potential benefit: If successful, the findings could help clinicians tailor postoperative follow-up and treatment to reduce recurrence, improve quality of life, and lower costs for patients with CRSwNP in China.
How similar studies have performed: Prior observational and interventional research has shown that endoscopic sinus surgery often improves symptoms and quality of life, but multicenter real-world data specifically describing recurrence patterns and economic burden in Chinese CRSwNP populations are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 CRSwNP. 3. Endoscopic nasal polypectomy is performed during the screening period. 4. Voluntarily participate and sign the informed consent form as described in A 3. 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. Currently participating in an interventional study. 3. Patients who are unable to independently complete questionnaires due to language barriers or mental status.
Where this trial is running
Changchun and 15 other locations
- Research Site — Changchun, China (Recruiting)
- Research Site — Chengdu, China (Recruiting)
- Research Site — Guangzhou, China (Recruiting)
- Research Site — Guangzhou, China (Not_yet_recruiting)
- Research Site — Guangzhou, China (Recruiting)
- Research Site — Haikou, China (Not_yet_recruiting)
- Research Site — Nanchang, China (Recruiting)
- Research Site — Nanjing, China (Not_yet_recruiting)
- Research Site — Nanning, China (Recruiting)
- Research Site — Qingdao, China (Withdrawn)
- Research Site — Shanghai, China (Recruiting)
- Research Site — Shenzhen, China (Not_yet_recruiting)
- Research Site — Ürümqi, China (Recruiting)
- Research Site — Wuhan, China (Recruiting)
- Research Site — Wuhan, China (Recruiting)
- Research Site — Xiamen, China (Recruiting)
Study contacts
- Principal investigator: Weiping Wen, Professor — First Affiliated Hospital, Sun Yat-Sen University
- Study coordinator: AstraZeneca Clinical Study Information Center
- Email: information.center@astrazeneca.com
- Phone: 1-877-240-9479
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.