Chronic Rhinosinusitis With Nasal Polyps
Conditions
Keywords
CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)
Brief summary
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.
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.
Interventions
PROCEDUREEndoscopic 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.
Sponsors
AstraZeneca
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| • The observed and change from baseline of Sino-Nasal Outcome Test (SNOT)-22 score at week-52 | week0-52 | Assess the Change in Sinonasal outcome test-22(SNOT-22) at 52 weeks post-operatively \[SNOT-22: score 0-5 each item, 5 means worse outcome, 22 items totally\] |
| • The observed and change from baseline of Modified Lund-Kennedy (MLK) score at week-52 | week0-52 | Assess the opacification of the paranasal sinuses by using Modified Lund-Kennedy (MLK) score at week 52. \[MLK score: score 0-24, 24 means worse outcome\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes from baseline at each collection point: • VAS - Total sinus symptoms item | week0-52 | Assess the changes in post-operative symptom by Visual Analogue Scale(VAS) total sinus symptoms . \[VAS: score 0-10, 10 indicates worse outcome\] |
| Changes in NPS from baseline at each collection point | week0-52 | Assess the changes in post-operative by Nasal Polyp Score (NPS). \[NPS: score 0-4, 4 indicates worse outcome\] |
| Changes from baseline at each collection point: • VAS - Nasal blockage item | week0-52 | Assess the changes in post-operative symptom by Visual Analogue Scale(VAS) Nasal blockage item . \[VAS: score 0-10, 10 indicates worse outcome\] |
| Changes from baseline at each collection point: • SNOT-22 Smell/taste Item Score | week0-52 | Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Smell/taste Item Score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\] |
| Changes from baseline at each collection point: • SNOT-22 Nasal Congestion Item Score | week0-52 | Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Nasal Congestion Item Score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\] |
| Changes from baseline at each collection point: • Nasal Congestion Score (NCS) | week0-52 | Assess the changes in post-operative symptom by Nasal Congestion Score(NCS). \[NCS: score 0-3, 3 indicates worse outcome\] |
| Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) Loss of Smell | week0-52 | Assess the changes in post-operative symptom by Sinonasal outcome test-22(SNOT-22) Loss of Smell Item Score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\] |
| Changes from baseline at each collection point: • Nasal Airway Resistance (NAR) | week0-52 | Assess the changes in post-operative symptom by Nasal Airway Resistance(NAR). |
| Pre-operative, 24-week post-operatively, and 52-week Lund-Mackay CT Scores | week0-52 | Assess the changes in post-operative Lund-Mackay CT Scores |
| Changes from baseline at each collection point: • SF-36((Short Form Health Survey) | week0-52 | 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. |
| Changes from baseline at each collection point: • The Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score | week0-52 | Assess the changes in post-operative Quality of Life by Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\] |
| Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) sleep domain | week0-52 | Assess the changes in post-operative Sleep Quality by Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\] |
| The proportion of patients using Intranasal corticosteroids (INCS) | week0-52 | Assess the post-operative medication use and participants requiring surgery within one year post-operatively by the proportion of patients using Intranasal corticosteroids (INCS). |
| Systemic glucocorticoids use for CRSwNP and asthma | week0-52 | 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. |
| Antibiotics use for CRSwNP and asthma | week0-52 | 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. |
| Biologics use for CRSwNP and asthma | week0-52 | 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. |
| ICS/LABA or ICS/LABA/LAMA use for asthma | week0-52 | 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. |
| Proportion of other related medications used. | week0-52 | Assess the post-operative medication use and participants requiring surgery within one year post-operatively. |
| The proportion of participants requiring surgery within one year and the number of surgery | week0-52 | Assess the post-operative medication use and participants requiring surgery within one year post-operatively |
| Time to first recurrence | week0-52 | Assess the time to first recurrence in patients post-operatively |
| Proportion of Recurrence | week0-52 | Assess the time to first recurrence in patients post-operatively |
| 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) | week0-52 | Assess the proportion of clinically meaningful improvement patients post-operatively at Week-52 and Week-4 |
| Assess the proportion of clinically meaningful improvement patients post-operatively | week0-52 | 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. \[SNOT-22: score 0-5 for each item, 5 means worse outcome\] |
| Week-52 and week-4 proportion of clinically meaningful improvement patients | week0-52 | 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). \[VAS scale: 0-10,10 means worse outcome\] |
| Post-operative complications | week0-52 | Post-operative complications by * The proportion of patients with complications. * The types of post-operative complications. * And the number of complication occurrences. |
| Changes from baseline at each collection point: Spirometry (pre-BD FEV1) | week0-52 | Assess asthma (for asthma participants only) |
| Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5) | week0-52 | Assess asthma (for asthma participants only) by ACQ-5. \[ACQ-5: score 0-6 for each item, 6 means worse outcome\] |
| Pre-operative, 24-week post-operatively, and 52-week ethmoid/maxillary sinuses (E/M) ratio | week0-52 | Assess the changes in post-operative ethmoid/maxillary sinuses (E/M) ratio. |
| Pre-operative, 24-week post-operatively, and 52-week Olfactory Cleft Scores(NCS) | week0-52 | Assess the changes in post-operative Olfactory Cleft Scores(NCS). \[NCS: score 0-3, 3 means worse outcome\] |
| The number of days of use intranasal corticosteroids (INCS). | week0-52 | 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). |
Countries
China
Contacts
CONTACTAstraZeneca Clinical Study Information Center
PRINCIPAL_INVESTIGATORWeiping Wen, Professor
First Affiliated Hospital, Sun Yat-Sen University
PRINCIPAL_INVESTIGATORDongdong Zhu, Professor
China-Japan Union Hospital, Jilin University
Outcome results
None listed