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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients
- ClinicalTrials.gov ID
- NCT07446738
- Acronym / sponsor ID
- PREDICT / D5242R00005
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Keywords
- CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 146 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 19 Mar 2026 (actual)
- Primary completion
- 21 Oct 2027 (estimated)
- Study completion
- 21 Oct 2027 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CRSwNP Registry Cohort | – | Other: Other: Routine Clinical Care for CRSwNPThis 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chinese CRSwNP Patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Other: Routine Clinical Care for CRSwNPPatients 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. | Other | CRSwNP Registry Cohort |
Primary outcome
The observed value and change from baseline in SNOT-22 total score at week-52
Time frame: 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
Time frame: baseline-week52
To describe the Modified Lund-Kennedy (MLK) score at 52 weeks post-operatively. [MLK score: score 0-24, 24 means worse outcome]
46 secondary outcomes
The observed values and changes from baseline at each collection point: VAS - Total sinus symptoms item
Time frame: baseline-week52
The observed values and changes from baseline in NPS at each collection point
Time frame: baseline-week52
The observed values and changes from baseline at each collection point: VAS - Nasal blockage item
Time frame: baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 Smell/taste Item Score
Time frame: baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 Nasal Congestion Item Score
Time frame: baseline-week52
The observed values and changes from baseline at each collection point: Nasal Congestion Score (NCS)
Time frame: baseline-week52
The observed values and changes from baseline at each collection point: Loss of Smell
Time frame: baseline-week52
The observed values and changes from baseline at each collection point: Nasal Airway Resistance (NAR)
Time frame: baseline-week52
Pre-operative, 24-week post-operatively, and 52- week post-operative Lund-Mackay CT Scores.
Time frame: week0-52
The observed values and cChanges from baseline at each collection point: SF-36((Short Form Health Survey)
Time frame: baseline-week52
The observed values and changes from baseline at each collection point: The SNOT-22 top five items' frequency counts and average score
Time frame: baseline-week52
The observed values and changes from baseline at each collection point: SNOT-22 sleep domain
Time frame: baseline-week52
Intranasal corticosteroids (INCS): the proportion of participants using INCS.
Time frame: week0-52
The daily dosage of participants used Systemic glucocorticoids (SCSs) for CRSwNP
Time frame: week0-52
Proportion of participants who used Antibiotics for CRSwNP at least once
Time frame: week0-52
Proportion of participants who used biologics for CRSwNP at least once
Time frame: week0-52
Proportion of participants who used ICS/LABA for asthma at least once.
Time frame: week0-52
Proportion of other related medications used.
Time frame: week0-52
The proportion of participants requiring surgery within one year and the number of surgery
Time frame: week0-52
Time to first recurrence
Time frame: week0-52
Proportion of participants with recurrence
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: week0-52
The proportion of participants with post-operative complications
Time frame: week0-52
Changes from baseline at each collection point: Spirometry (pre-BD FEV1)
Time frame: baseline-week52
Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5)
Time frame: baseline-week52
Pre-operative, 24-week post-operatively, and 52-week ethmoid/maxillary sinuses (E/M) ratio
Time frame: week0-52
Pre-operative, 24-week post-operatively, and 52-week Olfactory Cleft Scores(NCS)
Time frame: week0-52
The number of days of use intranasal corticosteroids (INCS).
Time frame: week0-52
The proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP
Time frame: week0-52
Number of days of treatment with Systemic glucocorticoids (SCSs) for CRSwNP.
Time frame: week0-52
The proportion of participants who used Systemic glucocorticoids (SCSs) for asthma
Time frame: week0-52
The daily dosage of participants used Systemic glucocorticoids (SCSs) for asthma
Time frame: week0-52
Number of days of treatment with Systemic glucocorticoids (SCSs) for asthma.
Time frame: week0-52
Number of days of treatment with Antibiotics for CRSwNP
Time frame: week0-52
Proportion of participants who used Antibiotics for asthma at least once
Time frame: week0-52
Number of days of treatment with Antibiotics for asthma
Time frame: week0-52
Number of days of treatment with ICS/LABA for asthma
Time frame: week0-52
Proportion of participants who used ICS/LABA/LAMA for asthma at least once.
Time frame: week0-52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiping Wen, Professor principal investigator
First Affiliated Hospital, Sun Yat-Sen University
Dongdong Zhu, Professor principal investigator
China-Japan Union Hospital, Jilin University
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Rhinosinusitis With Nasal Polyps, run by AstraZeneca at 21 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The observed value and change from baseline in SNOT-22 total score at week-52 (time frame: baseline-week52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.