TriMaximize: A Multicentre, Prospective, Non-interventional Trial Monitoring Therapy Pathways of Asthma Patients Treated With an Extra-fine ICS/LABA/LAMA Single-inhaler Triple Therapy in a Real-world Setting and Characterizing the Effects on Health-related Outcomes.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice.
研究概览
简要总结
TriMaximize: A multicentre, prospective, non-interventional trial monitoring therapy pathways of asthma patients treated with an extra-fine ICS/LABA/LAMA single-inhaler triple therapy in a real-world setting and characterizing the effects on health-related outcomes.
详细描述
The goals of asthma therapy for all degrees of disease severity are minimising asthma symptoms, maximising lung function, and preventing asthma exacer-bations. Despite the existing treatment options and differentiated guidelines, 35 % to 45 % of the GINA 4/5 patients suffer from inadequately controlled symptoms. To investigate the cause of unsatisfactory treatment results, it is essential to monitor therapy pathways of asthma patients in a real-world set-ting. Resulting data can be compared to therapy guidelines and generate hy-potheses for future clinical trials.
Trimbow® is a fixed triple therapy containing a long-acting muscarinic antago-nist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclomethasone). Trimbow® MS (medium strength) contains 100 µg beclomethasone whereas Trimbow® HS (high strength) contains 200 µg beclomethasone. Both formulations are investigated in this study.
Trimbow® has shown major clinical benefits in randomised controlled trials. However, the effects of Trimbow® on changes in patients' symptom burden and quality of life, adherence and clinical outcomes have not been yet as-sessed in a real-world asthma patient population.
The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow® in real world practice.
Secondary objectives include:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients ≥ 18 years of age,
- •Patients with confirmed leading diagnosis of asthma with or without concomitant COPD,
- •Physician decision to start fixed triple therapy with ICS/LABA/LAMA (Trimbow® MS or HS) according to its current authorised indication. The treatment decision must be made independently from participation in this NIS,
- •Patients willing and able to sign an informed consent for use of their pseudonymised clinical data within the present non-interventional study.
排除标准
- •Participation in an interventional clinical trial within 30 days prior to en-rolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
结局指标
主要结局
The primary objective is to describe patient characteristics and therapy path-ways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice.
时间窗: 12 months
Primary outcome measures include: Descriptive analisys of patients demografic Descriptive analisys of patient demographic
次要结局
- Treatment adherence(12 months)
- Assess quality of life To measure the functional impairments(12 months)
- Lung function(12 months)
- Persistent airflow limitation(12 months)
- Systemic corticosteroids use(12 months)
- Small airways parameters(12 months)
- Adverse events occurence(12 months)
- Assess asthma control (ACT)(12 months)
- Airway inflammation(12 months)
- Asthma exacerbations(12 months)
- Rescue medication use(12 months)
- Retention rate with Trimbow(12 months)