Safety and Efficacy of the SyMap Bronchial Ablation System for Treatment of Severe Asthma: A Prospective, Multicenter, Randomized Controlled Clinical Trial (Bronchial Ablation for Treatment of Asthma (BATA) Trial)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 160
- 试验地点
- 15
- 主要终点
- Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)
研究概览
简要总结
To evaluate the safety and efficacy of a bronchial radiofrequency ablation system (SyMap Medical (Suzhou) Ltd) in a population of subjects with severe asthma who are still symptomatic despite being managed on high-dose Inhaled Corticosteroids (ICS) and Long-Acting β2-adrenergic Agonists (LABA).
详细描述
This will be a prospective, multicenter, randomized, clinical study comparing the SyMap bronchial radiofrequency ablation system to the Boston Scientific Bronchial Thermoplasty System (Alair System). The study population consisted of subjects with severe asthma who are still symptomatic despite being managed on high dose ICS and LABA. Patients with severe asthma who still have symptoms, despite the standard drug maintenance recommended by the guidelines, after signing the informed consent, who meet the inclusion exclusion criteria enter the baseline period and continued to use uniform ICS and LABA, which will last at least 4 weeks. Patients with at least two days asthma symptoms during the baseline period, and meet the eligibility criteria are assigned to the experimental or control group at a 1:1 ratio based on a central randomized system. A total of 160 subjects will be enrolled, 80 in the experimental group and 80 in the control group. The experimental group is treated with SyMap radiofrequency ablation system, and the control group is treated with the same procedure using Boston Scientific Bronchial Thermoplasty Aliar System. For subjects in the experimental group and the control group, follow-up by telephone call will be performed at 1, 2, 7 days after each procedure and at 1, 2, 4, 5, 7, 8, 9, 10, 11, 15, 18, 21, 27, 30, 33, 39, 42, 45, 51, 54, and 57 months after the third procedure, and outpatient follow-up will be performed at 6 weeks, 3, 6，12，24, 36, 48 and 60 months after the third procedure. ICS and LABA are administered within five years after the third procedure. The difference in the rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year), at 12 months after bronchial radiofrequency ablation, is the primary endpoint of the study, and the success rate of procedure, postoperative adverse events, and serious adverse events are safety endpoints.
This study is conducted by an independent clinical monitoring organization, a data management and statistical center to collect and statistically analyze all relevant clinical and laboratory data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
The enrolled patients are blinded until 12 months after procedure. Physicians who perform post-procedure patient management and physicians who perform bronchial ablation/ bronchial thermoplasty procedures are blinded to each other.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is an adult between the ages of 18 to 65 years;
- •Diagnosed with asthma who required regular asthma maintenance medication in the past 6 months as follows:
- •ICS ≥1000 μg/day beclomethasone or equivalent and LABA ≥1000μg /day salmeterol or equivalent.
- •Other medications were allowed, including leukotriene modifiers, and Oral Corticosteroids (OCS) ≤ 10mg/day.
- •At least two days of asthma symptoms during 4-weeks of the baseline period.
- •Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 45% of predicted.
- •Non-smoker (less than 10 pack per year) last for 1 year or greater.
- •Baseline AQLQ Score less than or equal to 6.25
- •Willingness and ability to comply with the outpatient follow-up.
排除标准
- •Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of less than 45% of predicted.
- •3 or more hospitalizations for exacerbations of asthma in the past 12 months;
- •More than 3 lower respiratory tract infections requiring antibiotics in the past 12 months
- •More than 4 of oral steroid use for exacerbations of asthma in the past 12 months
- •Chronic sinusitis
- •Uncontrolled gastroesophageal reflux disease, defined as a significant increase in treatment over the past 6 weeks
- •Sensitivity to medications required to perform bronchoscopy (such as lidocaine and benzodiazepines)
- •Use of an implantable electrical stimulation device, such as a pacemaker, a cardiac defibrillator or a deep nerve or deep brain stimulator;
- •Severe emphysema caused by chronic obstructive pulmonary disease (COPD).
- •Use of systemic immunosuppressants, beta adrenergic blockers, or anticoagulants.
- •History of fatal asthma.
- •Uncontrolled obstructive sleep apnea
- •Intubation or admission to the ICU for asthma exacerbations within 2 years prior to treatment
- •Hemorrhagic or malignant tumors or Coagulopathy.
- •Lower bronchial stenosis or distal complete atelectasis or other severe bronchial and pulmonary lesions, as Thoracic spiral CT showed
- •Poor compliance judged by the investigator, or other medical conditions that are not suitable for the study
- •Related contraindications for bronchoscopy
- •Pregnant, lactating women, or patients with a birth plan in the next year
- •Previously undergone bronchial thermoplasty
研究组 & 干预措施
SyMap Bronchial Ablation Group
The experimental group is treated using SyMap Bronchial Radiofrequency Ablation system, including disposable bronchial radiofrequency ablation catheter (Model: BA125T) and Bronchial radiofrequency ablation instrument (Model: ELATION S3).
干预措施: SyMap Bronchial Ablation System (Device)
Boston Scientific Bronchial Thermoplasty Group
The control group is treated using Boston Scientific Alair System, including Bronchial radiofrequency ablation catheter Alair (Model: ATS2-5 ) and Bronchial radiofrequency ablation instrument (Model: ATS200)
干预措施: Boston Scientific Alair System (Device)
结局指标
主要结局
Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)
时间窗: 12 months
Definition of severe asthma exacerbations: 1. Patients who do not receive oral corticosteroids maintenance, systemic corticosteroids (tablets, suspensions or injections) need to be used, or ICS doses doubled, due to increased asthma symptoms. 2. Patients who have been treated with oral corticosteroids maintenance daily or every other day, the daily dose of systemic corticosteroids needs to be increased, due to increased asthma symptoms; Note: Severe asthma exacerbations of the above described two conditions, after treatment with corticosteroids, stabilized for 1 week or more, then recurring asthma symptoms will be counted as a single severe asthma exacerbations.
次要结局
- Rate of severe asthma exacerbations per year(24, 36, 48 and 60 months)
- Change in Integrated Asthma Quality of Life Questionnaire (Integrated AQLQ) Score from baseline(3, 6, 12, 24, 36, 48 and 60 months)
- Numbers of severe asthma exacerbations(6 weeks, 12, 24, 36, 48 and 60 months)
- Asthma Quality of Life Questionnaire Score (AQLQ)(6 weeks, 3, 6, 12, 24, 36, 48 and 60months)
- Percent of Symptom-Free Days(12 months)
- Forced Expiratory Volume in one second (FEV1)(6 weeks, 12, 24, 36, 48 and 60months)
- Modified Asthma Control Questionnaire (ACQ-6) Score(6 weeks, 3, 6, 12, 24, 36, 48 and 60months)
- Peak expiratory flow (PEF)(6 weeks, 12 , 24, 36, 48 and 60 months)