IKANOS: A Prospective, Open-Label, Minimally Interventional Hybrid Study in the US Comparing Initiation of Breztri Maintenance Versus Any Non-Triple Inhaled Therapy at Discharge After a Hospitalization for a COPD Exacerbation
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- AstraZeneca
- 主要终点
- Proportion of patients with an all-cause readmission
研究概览
简要总结
This study will evaluate whether prompt initiation and maintenance of Breztri (a triple therapy) following a severe COPD exacerbation hospitalization, is associated with a lower risk of all-cause readmissions at 90 days post-discharge, compared to receiving any non-triple inhaled therapy.
详细描述
IKANOS is a prospective, open-label, minimally interventional Hybrid Study in the US Comparing Initiation of Breztri Maintenance versus Any Non-Triple Inhaled Therapy at Discharge after a Hospitalization for a COPD Exacerbation.
The interventional arm will be comprised of around 1000 patients for whom Breztri maintenance is prescribed, and the first dose is received prior to hospital discharge (the "index discharge") after a severe COPD exacerbation (the index admission).
At the end of the recruitment period of the interventional arm, the external comparator arm will be constructed from real-world data of patients contemporaneous with those in the interventional arm, from the same or similar integrated delivery network as the interventional arm and who are similar in key clinical and demographic characteristics.
Patients will be followed-up through their data and call center contact for up to 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Patients are excluded from the study if they meet any of the following criteria:
- •Having received triple inhaled maintenance therapy (fixed-dose, or open) for COPD or other indications 6 months prior to index admission.
- •Any documented use of respiratory biologics 6 months prior to index admission.
- •Patients on palliative care, including hospice.
- •Discharge to institutional care other than a rehabilitation facility (eg, other hospital, or similar). Patients discharged to rehabilitation facility are eligible to participate. Note: Because patients are enrolled in the intervention arm prior to discharge, this criterion should be assessed using the working knowledge of the treating physician at the time of patient enrollment.
- •Mortality on or before index discharge.
- •Conditions including lung surgery (excluding thoracentesis or chest tube insertion or thoracostomy) in 6 months prior to index admission, history of pulmonary lobectomy, cystic fibrosis, interstitial lung disease, lung cancer, or alpha-1 antitrypsin deficiency (A1ATD) inducing severe disease as recorded in the PHD-LRx-Dx database.
- •For females only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding or planning to become pregnant in the year following index discharge.
- •Additional exclusion criteria for the interventional arm:
- •Discharged on a triple inhaled maintenance therapy in addition to Breztri.
- •Patients who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinicanticholinergics, or any component of the MDI.
- •Patients who are clinically unstable, ie, still admitted within the intensive care unit,with ongoing dyspnea, requiring vasopressors or round-the-clock positive airway pressure ventilatory support.
研究组 & 干预措施
Breztri
-
Interventional Arm: patients receive :
-
First dose of Breztri during hospitalization and discharge with 7-day Breztri inhaler
-
Breztri refills to cover 12-month follow-up period, mailed in 90-day supply from a central pharmacy. Emergency resupply is also available if needed.
干预措施: Budesonide/glycopyrrolate/formoterol fumarate (Breztri Aerosphere) 320 μg/18 μg/9.6 μg administered as two inhalations, twice daily. (Drug)
External Comparator - Non-Triple
- External Comparator Arm: patient who receive any non-triple inhaled therapy following a hospitalization for severe COPD exacerbation. This arm will be constructed of de-Identified patient.
干预措施: External Comparator (Other)
结局指标
主要结局
Proportion of patients with an all-cause readmission
时间窗: 90 days post-index discharge
次要结局
- Number of all-cause readmissions(90 days post-index discharge)
- Time to first all-cause readmission(1 year post-index discharge)
- Proportion of patients with all-cause readmissions(30 days and 1 year post-index discharge)
- number of all-cause readmissions per time period(30 days and 1 year post-index discharge)
- time to all-cause mortality(1 year post-index discharge)
- proportion of patients experiencing COPD moderate/severe exacerbations(30 days, 90 days and 1 year post-index discharge)
- proportion of patients experiencing COPD severe exacerbations(30 days, 90 days, and 1 year post-index discharge)
- number of COPD moderate/severe exacerbations per time period(30 days, 90 days, and 1 year post-index discharge)
- number of COPD severe exacerbations per time period(30 days, 90 days, and 1 year post-index discharge)
- time to first COPD moderate/severe exacerbations(1 year post-index discharge)
- time to first COPD severe exacerbations(1 year post-index discharge)
- proportion of patients experiencing all-cause mortality(90 days and 1 year post-index discharge)