NCT05649813已完成不适用
Prospective Registry on Chronic RhinoSinusitis With Nasal Polyps In the Greater Gulf Region
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- The mean baseline nasal polyps score (NPS)
研究概览
简要总结
Primary Objective:
- To describe the clinical characteristics of participants with chronic rhinosinusitis with nasal polyps (CRSwNP) in terms of disease severity, Type 2 inflammation-related comorbidities (such as asthma and allergic rhinitis), other associated comorbidities, and treatments used in a real-world setting
Secondary Objectives:
- Describe the progression in treatment outcomes at different visits (baseline, 3 months, 6 months, and 12 months).
- To assess the healthcare resource utilization of participants with CRSwNP in countries of the Gulf region (number of visits, emergency room (ER), surgery, etc).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participants.
- •Participants diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP) for at least one year prior to study start.
- •Participants diagnosed with CRSwNP according to criteria of American Academy of Otolaryngology-Head and Neck Surgery (i.e. the diagnosis is confirmed in medical records by clinical symptoms and objective evidence of nasal polyps by using anterior rhinoscopy and nasal endoscopy when available and/or computed tomography (CT) scan).
- •Participants should be at least 18 years old.
- •Participants must have signed an informed consent.
排除标准
- •Participants with chronic rhinosinusitis without nasal polyps (CRSsNP)
- •Pregnant/breastfeeding participants or participants planning for a pregnancy.
- •Participants participating in other interventional clinical trials involving any investigational drug.
- •Participants with granulomatous diseases such as vasculitis or sarcoidosis. The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
结局指标
主要结局
The mean baseline nasal polyps score (NPS)
时间窗: Day 0
Percentage of participants with Type 2 inflammation-related comorbidities including bronchial asthma, allergic rhinitis, atopic dermatitis, chronic spontaneous urticaria, eosinophilic esophagitis (EoE), and food allergy
时间窗: Day 0
Percentage of participants with other associated comorbidities including chronic obstructive pulmonary disease (COPD), ulcerative colitis, eosinophilic gastritis, or other comorbidities (if relevant)
时间窗: Day 0
Percentage of participants with mild, moderate or severe disease (measured by visual analogue scale [VAS] score)
时间窗: Day 0 (baseline) to Month 12
The mean baseline Sinonasal Outcome Test (SNOT-22) scores
时间窗: Day 0
Percentage of different medications used by participants with CRSwNP during the follow-up period as per decision of the treating physician
时间窗: Day 0 to Month 12
次要结局
- The proportion of CRSwNP patients with hospitalization(Day 0 to Month 12)
- The proportion of surgical procedures performed during the hospital visit including nasal polypectomy with additional sinus dissection, isolated nasal polypectomy, or functional endoscopic sinus surgery [FESS])(Day 0 to Month 12)
- The mean change in the baseline Sinonasal Outcome Test (SNOT-22) scores(Day 0 (baseline), Month 3, Month 6, and Month 12)
- The mean change in the baseline nasal polyps score (NPS)(Day 0, Month 3, Month 6, and Month 12)
- Mean change in the baseline total symptoms score (TSS)(Day 0, Month 6, and Month 12)
- Total number of surgeries(Day 0 to Month 12)
- The mean number of participants with CRSwNP who need surgical treatment(Day 0 to Month 12)
- The mean number of days/visits to ER, office, or general practitioner(Day 0 to Month 12)
- The mean number of days of sick leaves(Day 0 to Month 12)
- The proportion of CRSwNP patients with emergency room (ER), office, or general practitioner visits(Day 0 to Month 12)
研究者
研究点 (1)
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