Chronicling the COPD Patient Journey and Change in Impact of a Single Inhaler Combination Therapy on COPD Symptoms, Quality of Life and Exacerbations Following Initiation of Budenoside/Glycopyrronium/Formoterol [BGF](CHRONICLES COPD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 152
- 试验地点
- 1
- 主要终点
- Mean change from baseline in the COPD Assessment Test (CAT) score
研究概览
简要总结
The CHRONICLES study will investigate the change in clinical and patient reported outcomes after six-months of treatment with Budenoside/Glycopyrronium/Formoterol [BGF] in a real-world setting.
详细描述
This is a prospective, open label, non-interventional, single network of clinical practice centers study that will be conducted in routine clinical care in the pulmonary/ primary care practitioner (PCP) care setting in Ontario, Canada. Eligible patients will be enrolled into the study only following the treating physician's decision and patient agreement to initiate treatment with BGF. Patients will be observed for up to 6 months post-treatment initiation with BGF.
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
- 35 Years 至 130 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Physician diagnosis of COPD
- •COPD patients in the Best Care Network who have a CAT score >=10
- •Age >=35 at time of enrolment
- •Minimum 12-month recorded prior medical history for patients
- •Physician decision and patient agreement to initiate treatment with Breztri based on routine care (and in accordance with label and reimbursement criteria)
- •Ability to read English and to provide consent to inclusion in the study
排除标准
- •Diagnosis of asthma
- •Dementia or other health issues related to memory
- •Inability to use inhalers
- •COPD due to documented α-1 antitrypsin deficiency
- •Previous treatment with triple fixed-dose combination therapy in 12 months prior to screening visit
- •Hospitalisation due to COPD exacerbation within the last 30 days prior to enrolment
- •Pregnancy or lactation period
- •Participation in an ongoing clinical interventional or observational trial for another COPD medication (or completed another trial within last 30 days of initiating BGF)
- •Patient self-reporting or a physician record with an active COVID-19 infection at time of enrolment or hospitalized due to COVID-19 infection in the last 60 days
- •Previous enrolment in this study
研究组 & 干预措施
Budenoside/Glycopyrronium/Formoterol
Patients with COPD who initiate BGF as prescribed by physician per the approved country-specific label and reimbursement criteria
干预措施: Budenoside/Glycopyrronium/Formoterol (Drug)
结局指标
主要结局
Mean change from baseline in the COPD Assessment Test (CAT) score
时间窗: 12 weeks after treatment initiation
To estimate the change in COPD health status in patients initiating BGF after 12 weeks
次要结局
- Demographic and clinical characteristics at baseline(At baseline)
- Change from baseline in CAT score after 24 weeks of treatment(24 weeks from treatment initiation)
- Change in patient quality of life as measured by EQ-5D-5L at 12 and 24 weeks post-treatment initiation(12 and 24 weeks after treatment initiation)
- Change in measures of sleep quality using CASIS (COPD and Asthma Sleep Impact Scale) at weeks 12 and 24(12 and 24 weeks of treatment initiation)
- Percent responders of the CAT [MID=2] after 12 weeks treatment compared to baseline(12 weeks treatment compared to baseline)
- The annualized rate of moderate and severe exacerbations that occurred within the previous year is collected at the baseline visit and the number of moderate and severe exacerbations occurring during the study is collected at the final visit(Baseline (12 months prior to initiating BGF) and during the follow-up period (up to 6 months)))