An Observational, Prospective, Real-world Data Registry in Chronic Obstructive Pulmonary Disease (COPD) Patients Suffering From Frequent Exacerbations (AIREIC)
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 3,000
- 主要终点
- Disease course of participants enrolled in COPD registry
研究概览
简要总结
This registry will collect data on COPD, including the course of disease, treatment patterns, and potential new therapies. The registry will also track the experience of participants and caregivers in clinical practice.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of COPD for at least 12 months
- •On stable, standard of care (SoC) COPD maintenance therapy
- •Have experienced at least 2 exacerbations (moderate or severe) in the last 12 months, with one of them occurring while on SoC therapy
排除标准
- •In palliative treatment
- •Participating in any interventional drug trials
研究组 & 干预措施
COPD Arm
Participants with COPD with frequent exacerbations will be followed from the date of enrollment until death, loss to follow up, withdrawal of consent, or the end of the follow-up period, for up to 3 years.
结局指标
主要结局
Disease course of participants enrolled in COPD registry
时间窗: Up to 3 years
Treatment patterns of participants enrolled in COPD registry
时间窗: Up to 3 years
Treatment patterns of participants enrolled in COPD registry would be monitored through medical records and the changes in the standard of care and potentially moving to other treatments such as biologics.
QoL of participants enrolled in COPD registry as measured by the EQ-5D Five Levels plus respiratory dimension (EQ-5D-5L+R) questionnaire
时间窗: Up to 3 years
Number of novel therapies for participants enrolled in COPD registry
时间窗: Up to 3 years
Through medical records, the number and type of novel therapies would be assessed for participants enrolled in COPD registry.
Health care utilization (HCU) by participants enrolled in COPD registry as measured by number of medical visits
时间窗: Up to 3 years
Quality of life (QoL) of participants enrolled in COPD registry as measured by the Chronic Airways Assessment Test (CAAT)
时间窗: Up to 3 years
HCU by participants enrolled in COPD registry as measured by types of medical care institutions visited
时间窗: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the Work Productivity and Impairment (WPAI)-COPD
时间窗: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the COPD treatment satisfaction questionnaire
时间窗: Up to 3 years
QoL of participants enrolled in COPD registry as measured by the exacerbation experience questionnaire
时间窗: Up to 3 years
Caregiver burden as measured by the Work Productivity and Impairment (WPAI) questionnaire
时间窗: Up to 3 years
Caregiver burden as measured by the Zarit Burden Interview 12-item (ZBI-12)
时间窗: Up to 3 years
次要结局
未报告次要终点