A Prospective Non-Interventional Real-world Study Assessing the Effectiveness of Extrafine BDP/FF/G HS Single Inhaler Triple Therapy (SITT) on Symptom Scores in Asthma Patients After 6 Months Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 18
- 主要终点
- Asthma Control Test
研究概览
简要总结
The mainstay of asthma treatment are ICSs, mostly combined with LABA. In the past decade LAMA had been accepted as an add-on treatment for patients at GINA steps 4 and 5. Recently, RCTs proved the efficacy and safety of fixed triple combinations of moderate and high dose of ICS and LABA, LAMA in a very selected asthmatic population, resulting in the market authorisation of these products. However, there is a lack of evidence on the real-world effectiveness of these therapies, especially with regards to improvement in symptom scores and adherence.
详细描述
Study design Multicentre, national, non-interventional, prospective study evaluating the effectiveness of Trimbow 172/5/9 μg pMDI on symptom scores in 6 months after switch from previous LABA-high dose ICS containing treatment in asthmatics.
Dosage regimen and administration Name of the product: Trimbow 172 micrograms/5 micrograms/9 micrograms pressurised inhalation, solution (henceforth abbreviated as Trimbow 172/5/9 µg pMDI) . Each delivered dose (the dose leaving the mouthpiece) contains 172 µg of beclometasone dipropionate, 5 µg of formoterol fumarate dihydrate and 9 µg of glycopyrronium (as 11 µg glycopyrronium bromide). Each metered dose (the dose leaving the valve) contains 200 µg of beclometasone dipropionate, 6 µg of formoterol fumarate dihydrate and 10 µg of glycopyrronium (as 12.5 µg glycopyrronium bromide). The recommended dose is two inhalations twice daily. The maximum dose is two inhalations twice daily.
- AIM OF THE STUDY (research objective)
Primary objective:
The main objective is to assess the effectiveness of BDP/FF/G 172/5/9 μg fixed triple combination in a real-world setting, with regards to improvements in symptom scores (ACT).
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
- •Physician-confirmed clinical diagnosis of asthma according to GINA guidelines and treated for at least 3 years before inclusion
- •Patients ≥ 18 years of age in ambulatory care
- •Uncontrolled asthma according to the physician's clinical assessment despite the use of:
- •LABA and high dose ICS or
- •LABA and high-dose ICS + LAMA multi-inhaler triple therapy for a minimum of three months.
- •Patients who are eligible for the use of Trimbow 172/5/9 μg pMDI according to the SmPC :
- •at least on exacerbation, requiring systemic (oral or intravenous) corticosteroids in the previous 12 months
- •uncontrolled asthma (ACT≤15) or partially controlled asthma (15<ACT<20)
- •FEV1<80% at baseline
- •Inhaled asthma therapy was changed to Trimbow 172/5/9 μg pMDI no more than 1 week prior to OR on the day of study inclusion
- •Patient provided written, informed consent to study participation
排除标准
- •Participation in any clinical trial within 30 days prior to enrolment
- •Patients hospitalized due to an exacerbation of their asthma within the last 4 weeks prior to enrolment
- •Another respiratory condition, apart from asthma or COPD, that may interfere with the effectiveness of the treatment studied AND/OR another important clinical situation that may interfere with patient's compliance with the treatment.
- •Continuous use of oral (>5 mg prednisolone/day OR >4 mg methylprednisolone/day) OR intravenous corticosteroids
- •Use of continuous oxygen therapy
- •Any malignant disease in the last 5 years
- •Tuberculosis (active or anamnestic)
- •Actual or previous use of biologics for asthma treatment in the past 12 months
- •All exclusion criteria listed in Trimbow 172/5/9 μg pMDI SmPC
结局指标
主要结局
Asthma Control Test
时间窗: 6 months
Change (improvement) of asthma control test (ACT) score, during the 6 months of treatment (Visit 3), compared to the score at baseline.
Asthma Control Test 2
时间窗: 6 months
The percentage of patients achieving an improvement in asthma control test (ACT) score of 3 points (MCID, minimum clinically important difference) or more, after the 6 months treatment (Visit 3) compared to baseline.
次要结局
- Asthma Control Test Change(6 months)
- Test of Adherence to Inhalers (TAI)(6 months)
- Lung Function(6 months)