NCT04959448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)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 717
- 试验地点
- 144
- 主要终点
- Baseline Patient Characteristics
研究概览
简要总结
The primary objectives of the study are:
- To longitudinally characterize the long-term effectiveness of DUPIXENT® through assessment of patient-reported symptoms, Health-Related Quality of Life (HRQoL) related to Chronic rhinosinusitis with nasal polyposis (CRSwNP) and other type 2 comorbidities, and their change over-time.
- To characterize patients who receive DUPIXENT® for CRSwNP in a real-world setting with respect to their medical history, demographic and disease characteristics, and type 2 comorbidities
The secondary objectives of the study are:
- To characterize real-world utilization of DUPIXENT® for patients with CRSwNP
- To collect patient and physician global assessment of disease severity and treatment satisfaction for patients receiving DUPIXENT® for CRSwNP
- To collect long-term safety data for patients receiving DUPIXENT® for CRSwNP
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
- •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 per protocol
结局指标
主要结局
Baseline Patient Characteristics
时间窗: Baseline up to 3 years
Demographics includes but is not limited to gender, age, ethnicity, height, weight, BMI, education, current employment status, physician information.
Baseline Disease Characteristics
时间窗: Baseline up to 3 years
Medical History includes but is not limited to history of CRSwNP, comorbid conditions, age at CRSwNP diagnosis, and baseline measurements of effectiveness variables.
次要结局
- DUPIXENT® Treatment Characteristics(Baseline up to 3 years)
- CRSwNP Treatment Characteristics(Baseline up to 3 years)
- Incidence and severity of adverse events (AEs)(Baseline up to 3 years)
- Participant Assessment: Mini Rhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ)(Baseline up to 3 Years)
- Participant Assessment: Total symptom score (TSS), including sub-scores (nasal congestion [NC] and loss of smell [LOS])(Baseline up to 3 years)
- Physician Assessment: Change in University of Pennsylvania Smell Identification Test (UPSIT) score(Baseline up to 3 years)
- Physician Assessment: CT-Lund-Mackay Score(Baseline up to 3 years)
- Physician Assessment: Nasal Peak Inspiratory Flow (PNIF)(Baseline up to 3 years)
- Physician Assessment: - Forced Expiratory Volume in 1 second (FEV1)(Baseline up to 3 years)
- Physician Assessment: Fractional exhaled Nitric Oxide (FeNO)(Baseline up to 3 Years)
- Participant Assessment: Asthma Control Questionnaire, 6-item (ACQ-6)(Baseline up to 3 Years)
- Participant Assessment: Mini Asthma Quality of Life Questionnaire (MiniAQLQ)(Baseline up to 3 Years)
- Participant Assessment: Allergic Rhinitis (AR) using AR Visual Analog Scale (VAS)(Baseline up to 3 Years)
- Participant Assessment: Sino-Nasal Outcome Test (SNOT-22)(Baseline up to 3 Years)
- Participant Assessment: Patient Oriented Eczema Measure (POEM)(Baseline up to 3 Years)
- Participant Assessment: Work Productivity and Activity Impairment Questionnaire for asthma (WPAI-CRSwNP)(Baseline up to 3 Years)
- Physician Assessment: Changes of Healthcare Utilization(Baseline up to 3 years)
- Participant Assessment: Short Form 12(Baseline up to 3 years)
- Participant Assessment: European Quality of Life 5-Dimensions, 5-Level Questionnaire (EQ-5D-5L)(Baseline up to 3 years)
- Participant Assessment: Global Impression for Symptom Severity, Treatment Satisfaction (Global Patient Assessment)(Baseline up to 3 years)
- Physician Assessment: Global Impression for Disease Severity (Global Physician Assessment)(Baseline up to 3 years)
研究者
研究点 (144)
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