Chronic Rhinosinusitis With Nasal PolypsPREDICTNCT07446738
A Study to Investigate the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by AstraZeneca at 21 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Rhinosinusitis With Nasal Polyps
- What is being tested?
- Other: Routine Clinical Care for CRSwNP
- How many people
- 146 participants
- Where
- 21 sitesChina
- Study dates
- 19 Mar 2026to 21 Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chinese CRSwNP Patients
Who may be able to join
- Participant must be 16 years of age or older, at the time of signing the informed consent.
- Participants with a documented diagnosis of bilateral CRSwNP.
- ESS is performed during the screening period.
- Voluntarily participate and sign the ICF.
- No history or current psychiatric disorders, with normal cognitive functions including understanding, expression, and orientation.
Who cannot join
- 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.
- Use of biologic therapy for CRSwNP within 3 months prior to surgery.
- Currently participating in an interventional study.
- Patients who are unable to independently complete questionnaires due to language barriers or mental status.
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
Research Site
Changchun, 130033
Research Site
Changsha
Research Site
Chengdu, 610078
The Seventh Affiliated Hospital Sun Yat-sen University
Guangzhou, Guangdong, 518106
Research Site
Guangzhou, 510062
Research Site
Guangzhou, 514700
Research Site
Guangzhou
Research Site
Haikou, 570311
QiLu Hospital of Shandong University
Jinan, Shandong, 250012
Research Site
Kunming
Research Site
Nanchang
Research Site
Nanjing
Research Site
Nanning, 530021
Research Site
Qingdao
Research Site
Shanghai, 200031
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110002
Research Site
Shenzhen
Research Site
Ürümqi, 830054
Research Site
Wuhan, 430000
Research Site
Wuhan
Research Site
Xiamen, 361003
About this study
Official title: PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients
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).
Read the detailed description
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). Patients will receive standard medical care as determined by the treating physician at each site and, where possible, undergo scheduled study assessments that coincide with routine follow-up.
Approximately 200 patients diagnosed with CRSwNP by physicians and scheduled for surgical treatment will be enrolled from ~20 sites across different regions of China.
Potential participants will be identified during a screening period of up to 4 weeks before surgery. Participants who meet the eligibility criteria, provide informed consent, and undergo ESS during the screening period will be enrolled.
After enrolment, participants will undergo 52 weeks of post-operative follow-up. Planned follow-up timepoints are week 4 (Visit 2), week 12 (Visit 3), week 24 (Visit 4), week 36 (Visit 5), and week 52 (Visit 6). Follow-up data will be obtained from medical records, routine clinical assessments, and participant-reported questionnaires.
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Being tested
- Other: Routine Clinical Care for CRSwNP
- Keywords
- CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Other: Routine Clinical Care for CRSwNPOther
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 group | Role | What they receive |
|---|---|---|
| CRSwNP Registry Cohort | This is a prospective, multicenter real-world observational study .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. Receives: Other: Other: Routine Clinical Care for CRSwNP |
What is being measured
The primary outcome is the main question the study is designed to answer.
The observed value and change from baseline in SNOT-22 total score at week-52
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]
Measured: baseline-week52
The observed value and change from baseline in MLK score at week-52
To describe the Modified Lund-Kennedy (MLK) score at 52 weeks post-operatively. [MLK score: score 0-24, 24 means worse outcome]
Measured: baseline-week52
Secondary outcomes (46)
The observed values and changes from baseline at each collection point: VAS - Total sinus symptoms item
To describe the changes in post-operative symptom by Visual Analogue Scale(VAS) total sinus symptoms .
[VAS: score 0-10, 10 indicates worse outcome]
Measured: baseline-week52
The observed values and changes from baseline in NPS at each collection point
To describe the changes in post-operative by Nasal Polyp Score (NPS). [NPS: score 0-4, 4 indicates worse outcome]
Measured: baseline-week52
The observed values and changes from baseline at each collection point: VAS - Nasal blockage item
To describe the changes in post-operative symptom by Visual Analogue Scale(VAS) Nasal blockage item .
[VAS: score 0-10, 10 indicates worse outcome]
Measured: baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 Smell/taste Item Score
To describe 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]
Measured: baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 Nasal Congestion Item Score
To describe 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]
Measured: baseline-week52
The observed values and changes from baseline at each collection point: Nasal Congestion Score (NCS)
To describe the changes in post-operative symptom by Nasal Congestion Score(NCS).
[NCS: score 0-3, 3 indicates worse outcome]
Measured: baseline-week52
The observed values and changes from baseline at each collection point: Loss of Smell
To describe the changes in post-operative symptom by Loss of Smell Item Score. [ Loss of Smell : score 0-3 for each item, 3 means worse outcome]
Measured: baseline-week52
The observed values and changes from baseline at each collection point: Nasal Airway Resistance (NAR)
To describe the changes in post-operative symptom by Nasal Airway Resistance(NAR).
Measured: baseline-week52
Pre-operative, 24-week post-operatively, and 52- week post-operative Lund-Mackay CT Scores.
To describe the changes in post-operative CT Scores
Measured: week0-52
The observed values and cChanges from baseline at each collection point: SF-36((Short Form Health Survey)
To describe 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.
Measured: baseline-week52
The observed values and changes from baseline at each collection point: The SNOT-22 top five items' frequency counts and average score
To describe 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]
Measured: baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 sleep domain
To describe the changes in post-operative Sleep Quality [SNOT-22: score 0-5 for each item, 5 means worse outcome]
Measured: baseline-week52
Intranasal corticosteroids (INCS): the proportion of participants using INCS.
To describe the post-operative medication use and need for surgery within one year post-operatively by the proportion of participants using Intranasal corticosteroids (INCS).
Measured: week0-52
The daily dosage of participants used Systemic glucocorticoids (SCSs) for CRSwNP
To describe the post-operative medication use and need for surgery within one year post-operatively by：
- The daily dosage (convert according to the equivalent dose of prednisone.) of participants used Systemic glucocorticoids (SCSs) for CRSwNP
Measured: week0-52
Proportion of participants who used Antibiotics for CRSwNP at least once
To describe the post-operative medication use and need for surgery within one year post-operatively by:
- Proportion of participants who used Antibiotics for CRSwNP at least once.
Measured: week0-52
Proportion of participants who used biologics for CRSwNP at least once
To describe the post-operative medication use and need for surgery within one year post-operatively by:
- Proportion of participants who used at least once.
Measured: week0-52
Proportion of participants who used ICS/LABA for asthma at least once.
To describe the post-operative medication use and need for surgery within one year post-operatively by
- Proportion of participants who used at least once.
Measured: week0-52
Proportion of other related medications used.
To describe the post-operative medication use and need for surgery within one year post-operatively.
Measured: week0-52
The proportion of participants requiring surgery within one year and the number of surgery
To describe the post-operative medication use and need for surgery within one year post-operatively.
Measured: week0-52
Time to first recurrence
To describe the time to first recurrence and proportion of participants with recurrence
Measured: week0-52
Proportion of participants with recurrence
To describe the time to first recurrence and proportion of participants with recurrence
Measured: week0-52
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: -NCS (MCID relative to pre-operative of -1.0)
To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4
Measured: week0-52
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: - SNOT-22 total score (with a Minimum Clinically Important Difference (MCID) relative to pre-operative of -8.9)
To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4 [SNOT-22: score 0-5 for each item, 5 means worse outcome]
Measured: week0-52
Proportion of participants demonstrating clinically meaningful improvement at Week 52 and Week 4 postoperatively based on: - VAS for nasal blockage item (MCID relative to pre-operative of -3)
To describe the proportion of post-operative participants demonstrating clinically meaningful improvement at Week-52 and Week-4 [VAS scale: 0-10,10 means worse outcome]
Measured: week0-52
The proportion of participants with post-operative complications
Post-operative complications by
•The proportion of participants with complications.
Measured: week0-52
Changes from baseline at each collection point: Spirometry (pre-BD FEV1)
To describe asthma-related outcomes (for asthma participants only)
Measured: baseline-week52
Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5)
To describe asthma-related outcomes (for asthma participants only) [ACQ-5: score 0-6 for each item, 6 means worse outcome]
Measured: baseline-week52
Pre-operative, 24-week post-operatively, and 52-week ethmoid/maxillary sinuses (E/M) ratio
To describe the changes in post-operative ethmoid/maxillary sinuses (E/M) ratio.
Measured: week0-52
Pre-operative, 24-week post-operatively, and 52-week Olfactory Cleft Scores(NCS)
To describe the changes in post-operative Olfactory Cleft Scores(NCS). [NCS: score 0-3, 3 means worse outcome]
Measured: week0-52
The number of days of use intranasal corticosteroids (INCS).
To describe the post-operative medication use and need for surgery within one year post-operatively by the number of days of use intranasal corticosteroids (INCS).
Measured: week0-52
The proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP
To describe the post-operative medication use and need for surgery within one year post-operatively by：
- Proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP at least once.
Measured: week0-52
Number of days of treatment with Systemic glucocorticoids (SCSs) for CRSwNP.
To describe the post-operative medication use and need for surgery within one year post-operatively by：
- The number of use days that participants used Systemic glucocorticoids (SCSs) for CRSwNP.
Measured: week0-52
The proportion of participants who used Systemic glucocorticoids (SCSs) for asthma
To describe the post-operative medication use and need for surgery within one year post-operatively by：
- Proportion of participants who used Systemic glucocorticoids (SCSs) for asthma at least once.
Measured: week0-52
The daily dosage of participants used Systemic glucocorticoids (SCSs) for asthma
To describe the post-operative medication use and need for surgery within one year post-operatively by：
- The daily dosage (convert according to the equivalent dose of prednisone.) of participants used Systemic glucocorticoids (SCSs) for asthma
Measured: week0-52
Number of days of treatment with Systemic glucocorticoids (SCSs) for asthma.
To describe the post-operative medication use and need for surgery within one year post-operatively by：
- The number of use days that participants used Systemic glucocorticoids (SCSs) for asthma.
Measured: week0-52
Number of days of treatment with Antibiotics for CRSwNP
To describe the post-operative medication use and need for surgery within one year post-operatively by:
- The number of use days.
Measured: week0-52
Proportion of participants who used Antibiotics for asthma at least once
To describe the post-operative medication use and need for surgery within one year post-operatively by:
- Proportion of participants who used Antibiotics for asthma at least once.
Measured: week0-52
Number of days of treatment with Antibiotics for asthma
To describe the post-operative medication use and need for surgery within one year post-operatively by:
- The number of use days.
Measured: week0-52
Number of days of treatment with ICS/LABA for asthma
To describe the post-operative medication use and need for surgery within one year post-operatively by
- The number of use days.
Measured: week0-52
Proportion of participants who used ICS/LABA/LAMA for asthma at least once.
To describe the post-operative medication use and need for surgery within one year post-operatively by
- Proportion of participants who used at least once.
Measured: week0-52
Number of days of treatment with ICS/LABA/LAMA for asthma
To describe the post-operative medication use and need for surgery within one year post-operatively by
- The number of use days.
Measured: week0-52
The types of post-operative complications
Post-operative complications by
•The types of post-operative complications.
Measured: week0-52
The number of post-operative complications occurrences.
Post-operative complications by
•The number of complication occurrences.
Measured: week0-52
Proportion of participants who used biologics for asthma
To describe the post-operative medication use and need for surgery within one year post-operatively by:
- Proportion of participants who used at least once.
Measured: week0-52
The frequency of use biologics for CRSwNP
To describe the post-operative medication use and need for surgery within one year post-operatively by:
- The frequency of use.
Measured: week0-52
The frequency of use biologics for asthma
To describe the post-operative medication use and need for surgery within one year post-operatively by:
- The frequency of use.
Measured: week0-52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start19 Mar 2026
- Primary completion21 Oct 2027 (estimated)
- Study completion21 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Rhinosinusitis With Nasal PolypsStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Weiping Wen, Professor, Principal investigator, First Affiliated Hospital, Sun Yat-Sen UniversityDongdong Zhu, Professor, Principal investigator, China-Japan Union Hospital, Jilin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07446738
- Sponsor's protocol ID
- D5242R00005
- Acronym
- PREDICT
- Status last verified
- Sep 2026
- First submitted
- 26 Jan 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.