NCT07052396招募中不适用
A Prospective, Non-interventional, Multicenter Observational Study to Evaluate Long-term Effectiveness and Safety, Patient Characteristics and Subjective Patient-reported Outcomes of Dupilumab in Patients With COPD Under Real-world Conditions
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 350
- 试验地点
- 18
- 主要终点
- Change from Baseline in COPD Assessment Test (CAT) Score
研究概览
简要总结
Study to evaluate the change of health-related quality of life, patient characteristics, efficacy and safety in Chronic Obstructive Pulmonary Disease (COPD) patients with Dupilumab therapy in a real-world setting over 24 months.
详细描述
Non-interventional Study. Patients receive Dupilumab in accordance with the summary of product characteristics in a real-world setting. The Dupilumab initiation must be independent of the study recruitment and patient data is documented based on clinical routine.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Participants willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study.
- •Adult participants.
- •Participants with uncontrolled Chronic Obstructive Pulmonary Disease (COPD) despite long-acting muscarinic antagonist (LAMA)/ long-acting beta2-agonist (LABA)/ Inhaled Corticosteroid (ICS) (or LAMA/LABA if ICS are not appropriate) therapy and elevated blood eosinophils
- •Participants newly initiated on dupilumab treatment as indicated in the dupilumab Summary of Product Characteristics (SmPC) in the specified label for COPD, determined by the treating physician, and independent of participation in the non-interventional study (NIS).
排除标准
- •Participants not eligible for dupilumab treatment according to SmPC.
- •Participation in an ongoing interventional or observational study or participation in an interventional or observational study up to 12 months before enrolment that might, in the treating physician's opinion, influence the assessments for the current study.
- •Any acute or chronic condition that, in the treating physician´s opinion, would limit the participants´s ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
- •Participants hospitalized due to an exacerbation of their COPD within the last 4 weeks prior to enrolment.
结局指标
主要结局
Change from Baseline in COPD Assessment Test (CAT) Score
时间窗: Baseline up to 12 months
The COPD Assessment Test (CAT) is a questionnaire to assess the health status and quality of life of people with COPD. The questionnaire consists of eight simple statements, which participants answer using a numerical scale. The CAT score ranges from 0 to 40, with lower scores indicating a better health status.
次要结局
- Change from Baseline in CAT Score(Baseline to up to 6 months and 24 months)
- Analysis of Socio-demographics, Medical Disease and Treatment History(Baseline)
- Analysis of Clinical Disease Characteristics including Exacerbations(Baseline)
- Analysis of Clinical Disease Characteristics including Lung Function Parameters(Baseline)
- Analysis of Clinical Disease Characteristics including Eosinophils [EOS] Levels(Baseline)
- Analysis of Clinical Disease Characteristics including Fractional Exhaled Nitric Oxide [FeNO] Levels(Baseline)
- Analysis of Clinical Disease Characteristics including Immunoglobulin E [IgE] Levels(Baseline)
- Analysis of Clinical Disease Characteristics including Comorbidities(Baseline)
- Analysis of Clinical Disease Characteristics including Date of COPD Diagnosis and GOLD Grade/Group at COPD Diagnosis(Baseline)
- Annualized Rate of Moderate and Severe COPD Exacerbations(Baseline to up to 12 and 24 months)
- Change in Rate of Moderate and Severe Exacerbations(Baseline to up to 6, 12 and 24 months)
- Change Over Time in Pre- and Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)(Baseline to up to 6, 12 and 24 months)
- Analysis of Clinical Disease Characteristics including Current Global Initiative for Chronic Obstructive Lung Disease (GOLD) Grade and Group(Baseline)
- Analysis of Clinical Disease Characteristics including Smoking Status and Pack Years(Baseline)
- Time to First Moderate or Severe Exacerbation Since Study Start(Baseline to up to 6, 12 and 24 months)
- Cumulative Moderate and Severe Exacerbations Over Time(Baseline to up to 6, 12 and 24 months)
- Change Over Time in Bronchodilator FEV1/Forced Vital Capacity (FVC)(Baseline to up to 6, 12 and 24 months)
- Change Over Time in Modified Medical Research Council (mMRC)(Baseline to up to 6, 12 and 24 months)
- Number of Missed Workdays due to COPD(Baseline to up to 6, 12 and 24 months)
- Number of Hospitalization After Dupilumab Treatment(Baseline to up to 6, 12 and 24 months)
- Reason(s) for Initiation of Dupilumab Treatment(Baseline)
- Occurrence of Product Technical Complaints (PTCs)(Baseline to up to 6, 12 and 24 months)
- Type of AEs(Baseline to up to 24 months)
- Frequency of Adverse Events (AEs) During the Observation Period(Baseline to up to 24 months)
- Frequency of Possible Dupilumab-Related Treatment Emergent AEs (TEAEs)(Baseline to up to 24 months)
- Type of Possible Dupilumab-Related TEAEs(Baseline to up to 24 months)
研究者
研究点 (18)
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