jRCT1031210642进行中（未招募）不适用
ASSESSING LONG-TERM OUTCOMES OF DUPIXENT TREATMENT IN PATIENTS WITH CHRONIC RHINOSINUSITIS WITH NASAL POLYPOSIS (AROMA)
Regeneron pharmaceutical0 个研究点目标入组 50 人开始时间: 待定最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 50
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Patients in or over 18 years at initiation
- •All patients who are newly initiated on DUPIXENT for the treatment of CRSwNP according to the respective prescribing information (Product Label or SmPC)
- •Willing and able to comply with clinic visits and study-related procedures as per protocol
- •Provide informed consent signed by study patient or legally acceptable representative
- •Able to understand and complete study-related questionnaires as per protocol
排除标准
- •Patients who have a contraindication to DUPIXENT according to the country-specific prescribing information
- •Any previous treatment with DUPIXENT for any condition
- •Any condition that, in the opinion of the investigator, may interfere with the patient s ability to participate in the study per protocol
- •Participation in an ongoing interventional or observational study that might, in the treating physician s opinion, influence the assessments for the current study
结局指标
主要结局
-
- Baseline Patient Characteristics - Baseline Disease Characteristics
次要结局
- Incidence and severity of adverse events (AEs)
- Total symptom score (TSS)
- Change in University of Pennsylvania Smell Identification Test (UPSIT) score
- CT-Lund-Mackay Score
- Nasal Peak Inspiratory Flow (PNIF)
- Forced Expiratory Volume in 1 second (FEV1)
- Fractional exhaled Nitric Oxide (FeNO)
- Asthma Control Questionnaire, 6-item (ACQ-6)
- Mini Asthma Quality of Life Questionnaire (MiniAQLQ)
- Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)
- Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)
- Sino-Nasal Outcome Test (SNOT-22)
- Patient Oriented Eczema Measure (POEM)
- Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)
- Changes of Healthcare Utilization
- Short Form 12
- European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)
- Global Impression for Disease Severity (Global Physician Assessment)
- Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)
研究者
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