PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese Post-operative CRSwNP Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- AstraZeneca
- 入组人数
- 146
- 试验地点
- 39
- 主要终点
- The observed value and change from baseline in SNOT-22 total score at week-52
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Other: Routine Clinical Care for CRSwNP (Other)
结局指标
主要结局
The observed value and change from baseline in SNOT-22 total score at week-52
时间窗: 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
时间窗: baseline-week52
To describe the Modified Lund-Kennedy (MLK) score at 52 weeks post-operatively. \[MLK score: score 0-24, 24 means worse outcome\]
• The observed and change from baseline of Sino-Nasal Outcome Test (SNOT)-22 score at week-52
时间窗: 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
时间窗: week0-52
Assess the opacification of the paranasal sinuses by using Modified Lund-Kennedy (MLK) score at week 52. \[MLK score: score 0-24, 24 means worse outcome\]
次要结局
- Proportion of other related medications used.(week0-52)
- The proportion of participants requiring surgery within one year and the number of surgery(week0-52)
- Time to first recurrence(week0-52)
- Pre-operative, 24-week post-operatively, and 52-week ethmoid/maxillary sinuses (E/M) ratio(week0-52)
- Pre-operative, 24-week post-operatively, and 52-week Olfactory Cleft Scores(NCS)(week0-52)
- The number of days of use intranasal corticosteroids (INCS).(week0-52)
- The observed values and changes from baseline at each collection point: VAS - Total sinus symptoms item(baseline-week52)
- The observed values and changes from baseline in NPS at each collection point(baseline-week52)
- The observed values and changes from baseline at each collection point: VAS - Nasal blockage item(baseline-week52)
- The observed values and changes from baseline at each collection point: SNOT-22 Smell/taste Item Score(baseline-week52)
- The observed values and changes from baseline at each collection point: SNOT-22 Nasal Congestion Item Score(baseline-week52)
- The observed values and changes from baseline at each collection point: Nasal Congestion Score (NCS)(baseline-week52)
- The observed values and changes from baseline at each collection point: Loss of Smell(baseline-week52)
- The observed values and changes from baseline at each collection point: Nasal Airway Resistance (NAR)(baseline-week52)
- Pre-operative, 24-week post-operatively, and 52- week post-operative Lund-Mackay CT Scores.(week0-52)
- The observed values and cChanges from baseline at each collection point: SF-36((Short Form Health Survey)(baseline-week52)
- The observed values and changes from baseline at each collection point: The SNOT-22 top five items' frequency counts and average score(baseline-week52)
- The observed values and changes from baseline at each collection point: SNOT-22 sleep domain(baseline-week52)
- Intranasal corticosteroids (INCS): the proportion of participants using INCS.(week0-52)
- The daily dosage of participants used Systemic glucocorticoids (SCSs) for CRSwNP(week0-52)
- Proportion of participants who used Antibiotics for CRSwNP at least once(week0-52)
- Proportion of participants who used biologics for CRSwNP at least once(week0-52)
- Proportion of participants who used ICS/LABA for asthma at least once.(week0-52)
- Proportion of participants with recurrence(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)(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)(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)(week0-52)
- The proportion of participants with post-operative complications(week0-52)
- Changes from baseline at each collection point: Spirometry (pre-BD FEV1)(baseline-week52)
- Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5)(baseline-week52)
- The proportion of participants who used Systemic glucocorticoids (SCSs) for CRSwNP(week0-52)
- Number of days of treatment with Systemic glucocorticoids (SCSs) for CRSwNP.(week0-52)
- The proportion of participants who used Systemic glucocorticoids (SCSs) for asthma(week0-52)
- The daily dosage of participants used Systemic glucocorticoids (SCSs) for asthma(week0-52)
- Number of days of treatment with Systemic glucocorticoids (SCSs) for asthma.(week0-52)
- Number of days of treatment with Antibiotics for CRSwNP(week0-52)
- Proportion of participants who used Antibiotics for asthma at least once(week0-52)
- Number of days of treatment with Antibiotics for asthma(week0-52)
- Number of days of treatment with ICS/LABA for asthma(week0-52)
- Proportion of participants who used ICS/LABA/LAMA for asthma at least once.(week0-52)
- Number of days of treatment with ICS/LABA/LAMA for asthma(week0-52)
- The types of post-operative complications(week0-52)
- The number of post-operative complications occurrences.(week0-52)
- Proportion of participants who used biologics for asthma(week0-52)
- The frequency of use biologics for CRSwNP(week0-52)
- The frequency of use biologics for asthma(week0-52)
- Changes from baseline at each collection point: • VAS - Total sinus symptoms item(week0-52)
- Changes in NPS from baseline at each collection point(week0-52)
- Changes from baseline at each collection point: • VAS - Nasal blockage item(week0-52)
- Changes from baseline at each collection point: • SNOT-22 Smell/taste Item Score(week0-52)
- Changes from baseline at each collection point: • SNOT-22 Nasal Congestion Item Score(week0-52)
- Changes from baseline at each collection point: • Nasal Congestion Score (NCS)(week0-52)
- Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) Loss of Smell(week0-52)
- Changes from baseline at each collection point: • Nasal Airway Resistance (NAR)(week0-52)
- Pre-operative, 24-week post-operatively, and 52-week Lund-Mackay CT Scores(week0-52)
- Changes from baseline at each collection point: • SF-36((Short Form Health Survey)(week0-52)
- Changes from baseline at each collection point: • The Sinonasal outcome test-22(SNOT-22) top five items' frequency counts and average score(week0-52)
- Changes from baseline at each collection point: • Sinonasal outcome test-22(SNOT-22) sleep domain(week0-52)
- The proportion of patients using Intranasal corticosteroids (INCS)(week0-52)
- Systemic glucocorticoids use for CRSwNP and asthma(week0-52)
- Antibiotics use for CRSwNP and asthma(week0-52)
- Biologics use for CRSwNP and asthma(week0-52)
- ICS/LABA or ICS/LABA/LAMA use for asthma(week0-52)
- Proportion of Recurrence(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)(week0-52)
- Assess the proportion of clinically meaningful improvement patients post-operatively(week0-52)
- Week-52 and week-4 proportion of clinically meaningful improvement patients(week0-52)
- Post-operative complications(week0-52)
- Changes from baseline at each collection point: Spirometry (pre-BD FEV1)(week0-52)
- Changes from baseline at each collection point: Asthma Control Questionnaire-5(ACQ-5)(week0-52)