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

PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese CRSwNP Patients

This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP recurrence.

Study Overview

• Status: Recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Procedure: Endoscopic Sinus Surgery (ESS)

Detailed Description

This is a prospective, multicenter real-world study to describe the postoperative outcomes and quality of life, disease control and characteristics of patients who underwent surgery, as well as economic burden and post-operative treatment patterns in Chinese patients with CRSwNP. Patients will receive standard medical care as determined by the treating physician at each site and undergo scheduled clinical assessments.

Approximately 200 patients diagnosed with CRSwNP by physicians and scheduled for surgical treatment will be enrolled across 20 centres in different regions of China.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Changchun, China, 130033
    • Recruiting
    • Research Site
  • Chengdu, China, 610078
    • Recruiting
    • Research Site
  • Guangzhou, China
    • Recruiting
    • Research Site
  • Guangzhou, China, 510062
    • Recruiting
    • Research Site
  • Guangzhou, China, 514700
    • Not yet recruiting
    • Research Site
  • Haikou, China, 570311
    • Not yet recruiting
    • Research Site
  • Nanchang, China
    • Recruiting
    • Research Site
  • Nanjing, China
    • Not yet recruiting
    • Research Site
  • Nanning, China, 530021
    • Recruiting
    • Research Site
  • Qingdao, China
    • Withdrawn
    • Research Site
  • Shanghai, China, 200031
    • Recruiting
    • Research Site
  • Shenzhen, China
    • Not yet recruiting
    • Research Site
  • Wuhan, China, 430000
    • Recruiting
    • Research Site
  • Wuhan, China
    • Recruiting
    • Research Site
  • Xiamen, China, 361003
    • Recruiting
    • Research Site
  • Ürümqi, China, 830054
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Chinese CRSwNP Patients

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Standard of Care Endoscopic Sinus Surgery (ESS); Although this study is non-interventional and observational in nature regarding treatment decisions, it is registered as an interventional study focusing on the Standard-of-Care (SoC) Functional Endoscopic Sinus Surgery (FESS) as the index procedure. The "intervention" serves as the baseline event for the prospective evaluation of real-world outcomes. The study aims to assess the clinical trajectory (including SNOT-22, Nasal Polyp Score, and CT findings) following this standard clinical procedure over a 52-week period. The surgery is performed strictly according to clinical routine, local guidelines, and the investigator's professional discretion.

Procedure: Endoscopic Sinus Surgery (ESS); This is a standard of care surgical procedure performed according to clinical routine. No experimental treatment or investigational drug is administered as part of this study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• The observed and change from baseline of Sino-Nasal Outcome Test (SNOT)-22 score at week-52	Assess the Change in Sinonasal outcome test-22(SNOT-22) at 52 weeks post-operatively [SNOT-22: score 0-5 each item, 5 means worse outcome, 22 items totally]	week0-52
• The observed and change from baseline of Modified Lund-Kennedy (MLK) score at week-52	Assess the opacification of the paranasal sinuses by using Modified Lund-Kennedy (MLK) score at week 52. [MLK score: score 0-24, 24 means worse outcome]	week0-52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes from baseline at each collection point: • VAS - Total sinus symptoms item	Assess the changes in post-operative symptom by Visual Analogue Scale(VAS) total sinus symptoms . [VAS: score 0-10, 10 indicates worse outcome]	week0-52
Changes in NPS from baseline at each collection point	Assess the changes in post-operative by Nasal Polyp Score (NPS). [NPS: score 0-4, 4 indicates worse outcome]	week0-52
Changes from baseline at each collection point: • VAS - Nasal blockage item	Assess the changes in post-operative symptom by Visual Analogue Scale(VAS) Nasal blockage item . [VAS: score 0-10, 10 indicates worse outcome]	week0-52
Changes from baseline at each collection point: • SNOT-22 Smell/taste Item Score	Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Smell/taste Item Score. [SNOT-22: score 0-5 for each item, 5 means worse outcome]	week0-52
Changes from baseline at each collection point: • SNOT-22 Nasal Congestion Item Score	Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Nasal Congestion Item Score. [SNOT-22: score 0-5 for each item, 5 means worse outcome]	week0-52
Changes from baseline at each collection point: • Nasal Congestion Score (NCS)	Assess the changes in post-operative symptom by Nasal Congestion Score(NCS). [NCS: score 0-3, 3 indicates worse outcome]	week0-52
Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) Loss of Smell	Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Loss of Smell Item Score. [SNOT-22: score 0-5 for each item, 5 means worse outcome]	week0-52
Changes from baseline at each collection point: • Nasal Airway Resistance (NAR)	Assess the changes in post-operative symptom by Nasal Airway Resistance(NAR).	week0-52
Pre-operative, 24-week post-operatively, and 52-week Lund-Mackay CT Scores	Assess the changes in post-operative Lund-Mackay CT Scores	week0-52
Changes from baseline at each collection point: • SF-36((Short Form Health Survey)	Assess the changes in post-operative Quality of Life by SF-36((Short Form Health Survey), which is a widely used questionnaire to measure health-related quality of life.	week0-52
Changes from baseline at each collection point: • The Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score	Assess the changes in post-operative Quality of Life by Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score. [SNOT-22: score 0-5 for each item, 5 means worse outcome]	week0-52
Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) sleep domain	Assess the changes in post-operative Sleep Quality by Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score. [SNOT-22: score 0-5 for each item, 5 means worse outcome]	week0-52
The proportion of patients using Intranasal corticosteroids (INCS)	Assess the post-operative medication use and participants requiring surgery within one year post-operatively by the proportion of patients using Intranasal corticosteroids (INCS).	week0-52
Systemic glucocorticoids use for CRSwNP and asthma	Assess the post-operative medication use and participants requiring surgery within one year post-operatively by： Proportion of patients who used at least once.; The daily dosage (convert according to the equivalent dose of prednisone.); And the number of use days.	week0-52
Antibiotics use for CRSwNP and asthma	Assess the post-operative medication use and participants requiring surgery within one year post-operatively by: Proportion of patients who used at least once.; The number of use days.	week0-52
Biologics use for CRSwNP and asthma	Assess the post-operative medication use and participants requiring surgery within one year post-operatively by: Proportion of patients who used at least once.; The frequency of use.	week0-52
ICS/LABA or ICS/LABA/LAMA use for asthma	Assess the post-operative medication use and participants requiring surgery within one year post-operatively by; Proportion of patients who used at least once.; The number of use days.	week0-52
Proportion of other related medications used.	Assess the post-operative medication use and participants requiring surgery within one year post-operatively.	week0-52
The proportion of participants requiring surgery within one year and the number of surgery	Assess the post-operative medication use and participants requiring surgery within one year post-operatively	week0-52
Time to first recurrence	Assess the time to first recurrence in patients post-operatively	week0-52
Proportion of Recurrence	Assess the time to first recurrence in patients post-operatively	week0-52
Week-52 and week-4 proportion of clinically meaningful improvement patients based on: Nasal Congestion Score (NCS) (MCID relative to pre-operative of -1.0)	Assess the proportion of clinically meaningful improvement patients post-operatively at Week-52 and Week-4	week0-52
Assess the proportion of clinically meaningful improvement patients post-operatively	Assess the proportion of clinically meaningful improvement patients post-operatively based on: Sinonasal outcome test-22(SNOT-22) total score, with a Minimum Clinically Important Difference (MCID) relative to pre-operative of -8.9 at Week-52 and Week-4. [SNOT-22: score 0-5 for each item, 5 means worse outcome]	week0-52
Week-52 and week-4 proportion of clinically meaningful improvement patients	Assess the proportion of clinically meaningful improvement patients post-operatively at Week-52 and Week-4 by Visual Analogue Scale(VAS) for nasal blockage item (MCID relative to pre-operative of -3). [VAS scale: 0-10,10 means worse outcome]	week0-52
Post-operative complications	Post-operative complications by; The proportion of patients with complications.; The types of post-operative complications.; And the number of complication occurrences.	week0-52
Changes from baseline at each collection point: Spirometry (pre-BD FEV1)	Assess asthma (for asthma participants only)	week0-52
Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5)	Assess asthma (for asthma participants only) by ACQ-5. [ACQ-5: score 0-6 for each item, 6 means worse outcome]	week0-52
Pre-operative, 24-week post-operatively, and 52-week ethmoid/maxillary sinuses (E/M) ratio	Assess the changes in post-operative ethmoid/maxillary sinuses (E/M) ratio.	week0-52
Pre-operative, 24-week post-operatively, and 52-week Olfactory Cleft Scores(NCS)	Assess the changes in post-operative Olfactory Cleft Scores(NCS). [NCS: score 0-3, 3 means worse outcome]	week0-52
The number of days of use intranasal corticosteroids (INCS).	Assess the post-operative medication use and participants requiring surgery within one year post-operatively by the number of days of use intranasal corticosteroids (INCS).	week0-52

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Weiping Wen, Professor, First Affiliated Hospital, Sun Yat-Sen University; Principal Investigator: Dongdong Zhu, Professor, China-Japan Union Hospital, Jilin University

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2026
• Primary Completion (Estimated): August 30, 2027
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: January 26, 2026
• First Submitted That Met QC Criteria: February 27, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): May 12, 2026
• Last Update Submitted That Met QC Criteria: May 11, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)
• Other Study ID Numbers: D5242R00005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No