PREDICT: A Prospective, Multicenter Real-World Study to Describe the Clinical Outcome and Quality of Life in Chinese CRSwNP Patients
概览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AstraZeneca
- 入组人数
- 200
- 试验地点
- 29
- 主要终点
- • The observed and change from baseline of Sino-Nasal Outcome Test (SNOT)-22 score at week-52
概览
简要总结
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.
详细描述
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.
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 CRSwNP.
- •Endoscopic nasal polypectomy is performed during the screening period.
- •Voluntarily participate and sign the informed consent form as described in A
- •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.
- •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
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.
干预措施: Endoscopic Sinus Surgery (ESS) (Procedure)
结局指标
主要结局
• 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
- 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 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)
- 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)
- 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)