Prospective and Retrospective Observational Real-world Study to Characterize Patients With COPD on Dupilumab Long-term Treatment, and Assess Safety and Patient Reported Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Sanofi
- 入组人数
- 500
- 试验地点
- 22
- 主要终点
- Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels)
研究概览
简要总结
The OBS19236 is a retrospective and prospective, non-interventional observational study in COPD patients treated with dupilumab as part of routine clinical care. It will follow-up about 350 to 500 participants over 36 months in up to 50 sites in France.
详细描述
Study duration per participant is expected to be approximately 36 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Patients willing and able to sign informed consent for use of their pseudonymized clinical data within the present non-intervention study.
- •Adult patients.
- •Patients 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 (a blood eosinophil count ≥ 300 cells/microL).
- •Patients 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
- •Patient not eligible for dupilumab treatment according to SmPC.
- •Participation in an ongoing interventional study or participation in an interventional 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 patient's ability to complete questionnaires or to participate in this study or impact the interpretation of the results.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Treated cohort
Dupilumab
结局指标
主要结局
Descriptive statistical analysis of clinical disease characteristics (fractional exhaled nitric oxide [FeNO] levels)
时间窗: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (immunoglobulin E [IgE] levels)
时间窗: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (Global Initiative for Chronic Obstructive Lung Disease (GOLD) grade and group)
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (smoking status and pack years (tobacco and cannabis))
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (treated asthma in childhood and concomitant asthma according to the investigator opinion)
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (Cardiovascular (CV) comorbidities)
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (Otorhinolaryngology (ORL) comorbidities)
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (date of Chronic Obstructive Pulmonary Disease (COPD) diagnosis)
时间窗: Baseline
Date of COPD diagnosis and GOLD grade/group at COPD diagnosis
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (BODE and/or BODEx scores-index for COPD survival)
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (history of pulmonary rehabilitation)
时间窗: Baseline
Descriptive statistical analysis of socio-demographics
时间窗: Baseline
Descriptive statistical analysis of medical disease
时间窗: Baseline
Descriptive statistical analysis of treatment history
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (symptoms)
时间窗: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (exacerbations)
时间窗: In the 2 years prior to Dupilumab initiation
Descriptive statistical analysis of clinical disease characteristics (lung function parameters)
时间窗: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of Vaccine status.
时间窗: Baseline
Descriptive statistical analysis of clinical disease characteristics (max eosinophils [EOS])
时间窗: In the 1 year prior to Dupilumab initiation
Descriptive statistical analysis of Hospital Anxiety and Depression scale (HADS).
时间窗: Baseline
Score range 0-42, higher values indicating a worse outcome
Descriptive statistical analysis of Emphysema assessment according to treating physician, based on CT scan
时间窗: In the last 3 years prior to treatment initiation
次要结局
- Change over time in pre- and post-bronchodilator forced expiratory volume in 1 second (FEV1)(From treatment start to month 6, 12, 24 and 36.)
- Change over time in pre- and post-bronchodilator Forced Vital Capacity (FVC)(From treatment start to month 6, 12, 24 and 36)
- Change over time in pre- and post- bronchodilator forced expiratory volume in 1 second (FEV1)/ Forced vital capacity (FVC)(From treatment start to month 6, 12, 24 and 36)
- Annualized rate of Chronic Obstructive Pulmonary Disease (COPD) exacerbations(After 12, 24 and 36 months compared to the year before baseline.)
- Change in exacerbation rate(From treatment start to month 6, 12, 24 and 36.)
- Time to first exacerbation(Since Dupilumab initiation and during the study period (3 years))
- Cumulative moderate and severe exacerbations(Since Dupilumab initiation and during the study period (3 years))
- Change over time in COPD Assessment Test (CAT) Score(From treatment start to month 6, 12, 24 and 36.)
- Change over time in modified Medical Research Council (mMRC) score(From treatment start to month 6, 12, 24 and 36.)
- Number of hospitalizations during dupilumab treatment vs. the year before dupilumab initiation(After 6, 12, 24 and 36 months of dupilumab treatment vs. the year before dupilumab initiation)
- Reason(s) for discontinuation of dupilumab treatment(Month 6, 12, 24, and 36)
- Frequency and type of Adverse events (AEs)(During the study period (3 years))
- Frequency and type of possible dupilumab-related treatment-emergent adverse events (TEAEs)(During the study period (3 years))