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
- 发起方
- Chiesi SAS
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- To describe patient characteristics and therapy pathways 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 non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
详细描述
TriMaximize, a non-interventional trial aims to collect prospective, longitudinal data from asthma patients under routine care, for whom their treating physician has decided to prescribe Trimbow® (beclometasone/formoterol/glycopyrronium).
Trimbow is a fixed triple therapy containing a long-acting muscarinic antagonist (LAMA, glycopyrronium), a long-acting beta-adrenergic agonist (LABA, formoterol) and an inhaled corticosteroid (ICS, beclometasone).
Asthma patients often need to use multiple inhalers as part of their therapy, which require different inhalation techniques. It has been shown that the use of several inhalers of different mode of action, design and dosage requirements may have a detrimental effect on patient adherence and subsequent treatment outcomes.
In this prospective, non-interventional trial, the investigators aim to evaluate aspects of adherence to Trimbow, a single-inhaler triple therapy (SITT) as a maintenance treatment of asthma, to gather knowledge from routine care on whether appropriate step-up to SITT leads to greater adherence and better health outcomes.
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
- 18 Years 至 —（Adult, Older Adult）
- 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,
- •Patient must be covered by a social security scheme,
- •Patient must be treated by one of the practitioners of the centre (at office or at hospital).
排除标准
- •Participation in an interventional clinical trial within 30 days prior to enrolment into the present non-interventional study or planned enrolment in an interventional clinical trial during the observational period.
- •Patients unable to understand scope of study or patients unwilling to participate in study.
结局指标
主要结局
To describe patient characteristics and therapy pathways for patients with a diagnosis of moderate to severe asthma who are treated with Trimbow in real world practice
时间窗: 12 months
Descriptive analysis of patient demographics.
次要结局
- Assess adverse events associated with use of Trimbow(12 months)
- Analyse parameters of asthma-related airway inflammation(12 months)
- Analyse parameters of lung function using spirometry(12 months)
- Assess asthma control (ACT)(12 months)
- Analyse parameters of small airways disease(12 months)
- Analyse the incidence of asthma exacerbations(12 months)
- Analyse use of rescue medication(12 months)
- Assess retention rate with Trimbow(12 months)
- Assess quality of life(12 months)
- Analyse use of systemic corticosteroids(12 months)
- Assess treatment adherence(12 months)
- Analyse parameters of persistent airflow limitation(12 months)
- Analyse the severity of asthma exacerbations as defined by the American Thoracic Society/European Respiratory Society (ATS/ERS) classification of asthma exacerbations(12 months)