Non-inferiority Evaluation of Trimbow in Critically Ill Patients Admitted in ICU Compared to Standard of Care
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 200
- 主要终点
- Evaluate the non inferiority of Trimbow associated with the standard of care in comparison with the standard of care alone.
研究概览
简要总结
Objective: To evaluate non-inferiority of Trimbow, an approved therapy for treatment of severe COPD, in ICU compared to the standard of care which is based on the same therapeutic approach.
Study location: CHU Sart-Tilman, 4000 Liège, Belgium Study duration: 2 years
Type : Interventional
Methodology: Prospective clinical trial Number of patients: 200 (randomized 1:1)
Main Inclusion criteria :
- Maintenance therapy (LAMA or LABA) for COPD
- Age >18
- Admission for AE of COPD
- Signed Inform consent
- Admitted in ICU >24h
详细描述
In the ICU, the standard of care is still focused on the use of aerosolized therapies. These therapies are time consuming and largely used unless the lack of proven superiority in comparison with Pressurised metered dose inhalers (pMDIs) which are as effective and easier to use. Moreover, aerosolized therapies are associated with an increased risk of oropharyngeal deposition and not always efficiently delivered.
The use of new ventilation techniques like high flow canula oxygen therapy is also challenging in the particular context of inhaled therapies. Nowadays, no data are available to confirm the appropriate deposition of the inhaled therapies. Therefore, it's necessary to have to move forward the evaluation of pMDIs in the particular context of non invasive ventilation (for example with high-flow nasal oxygen therapy).
As the use of triple therapy is now the standard of care in COPD patients experiencing a severe exacerbation, it is the objective to propose the introduction of Trimbow as soon as possible following the onset of a severe exacerbation, even in critically ill patients.
3 Study objectives
3.1 Main objective
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Maintenance therapy (LAMA or LABA) for COPD
- •Admission for AE of COPD
- •Signed Inform consent (see protocol attached)
- •Admitted in ICU >24h and less than 72h
排除标准
- •No CI for studied medication
- •Not treated with studied medication for at least 3 months
- •Admitted in ICU for AE of COPD within the past 3 months
- •Intolerance to studied medication
- •Hospitalized since >6 days
- •ARDS condition (PAFI <200)
- •Admitted in ICU >72H
- •Patient with severe asthma
- •The use of high dose of ICS as baseline therapy
- •Right/left heart failure
- •Immunocompromized
- •Acute myocardial infaction
- •Left heart insufficiency (LVEF<35%)
- •Stroke <6 months prior to hospital admission
结局指标
主要结局
Evaluate the non inferiority of Trimbow associated with the standard of care in comparison with the standard of care alone.
时间窗: 2 years
Composite primary Endpoint associating the ICU Length of stay (in days) and Time of Ventilation (in days also)
次要结局
- Assessment of the risk of exacerbation in the year.(2 years)
研究者
PARZIBUT Gilles
MD, adjoint head of clinics in university hospital of liege, departement ICU
University of Liege