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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Sinus Surgery (ESS) | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Chinese CRSwNP Patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| AstraZeneca Clinical Study Information Center | Contact | 1-877-240-9479 | information.center@astrazeneca.com |
| Name | Affiliation | Role |
|---|---|---|
| Weiping Wen, Professor | First Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Dongdong Zhu, Professor | China-Japan Union Hospital, Jilin University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Recruiting | Changchun | 130033 | China | ||
| Research Site |
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.
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.
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
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No Retention of biospecimen.
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：
| week0-52 |
| Antibiotics use for CRSwNP and asthma | Assess the post-operative medication use and participants requiring surgery within one year post-operatively by:
| week0-52 |
| Biologics use for CRSwNP and asthma | Assess the post-operative medication use and participants requiring surgery within one year post-operatively by:
| 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
| 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
| 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 |
| Not yet recruiting |
| Changsha |
| China |
| Research Site | Recruiting | Chengdu | 610078 | China |
| Research Site | Recruiting | Guangzhou | 510062 | China |
| Research Site | Recruiting | Guangzhou | 514700 | China |
| Research Site | Recruiting | Guangzhou | China |
| Research Site | Recruiting | Haikou | 570311 | China |
| Research Site | Recruiting | Kunming | China |
| Research Site | Recruiting | Nanchang | China |
| Research Site | Recruiting | Nanjing | China |
| Research Site | Recruiting | Nanning | 530021 | China |
| Research Site | Withdrawn | Qingdao | China |
| Research Site | Recruiting | Shanghai | 200031 | China |
| Research Site | Recruiting | Shenzhen | China |
| Research Site | Recruiting | Ürümqi | 830054 | China |
| Research Site | Recruiting | Wuhan | 430000 | China |
| Research Site | Recruiting | Wuhan | China |
| Research Site | Recruiting | Xiamen | 361003 | China |