Clinical trial NCT03765307: Bronchial Ablation for Treatment of Asthma (BATA) Trial
Official title: 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Asthma
Bronchial Ablation
Bronchial Thermoplasty
Lead sponsor: SyMap Medical (Suzhou), Ltd.
Sponsor class: INDUSTRY
Collaborators: name: JieNuo Medical(Beijing)Co.,Ltd
First posted: 2018-12-05
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients with severe asthma are assigned to the experimental or control group at a 1:1 ratio based on a central randomized system.
Primary purpose: TREATMENT

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)
timeFrame: 12 months
Secondary outcomes:
measure: Change in Integrated Asthma Quality of Life Questionnaire (Integrated AQLQ) Score from baseline
timeFrame: 3, 6, 12, 24, 36, 48 and 60 months
measure: Asthma Quality of Life Questionnaire Score (AQLQ)
timeFrame: 6 weeks, 3, 6, 12, 24, 36, 48 and 60months
measure: Modified Asthma Control Questionnaire (ACQ-6) Score
timeFrame: 6 weeks, 3, 6, 12, 24, 36, 48 and 60months
measure: Percent of Symptom-Free Days
timeFrame: 12 months
measure: Numbers of severe asthma exacerbations
timeFrame: 6 weeks, 12, 24, 36, 48 and 60 months
measure: Forced Expiratory Volume in one second (FEV1)
timeFrame: 6 weeks, 12, 24, 36, 48 and 60months
measure: Peak expiratory flow (PEF)
timeFrame: 6 weeks, 12 , 24, 36, 48 and 60 months
measure: Rate of severe asthma exacerbations per year
timeFrame: 24, 36, 48 and 60 months
Other outcomes:
measure: Emergency Room Visits days
timeFrame: 12, 24, 36, 48 and 60 months
measure: Hospitalization days
timeFrame: 12, 24, 36, 48 and 60 months
measure: Absence of work/school due to asthma symptoms, or days affecting daily actives
timeFrame: 12 months
measure: Successful rate of procedure
timeFrame: During the procedure
measure: Safety of the procedure
timeFrame: During the procedure
measure: Adverse events (AEs), serious adverse events (SAEs) after procedure
timeFrame: 1, 2 days, and 7 days after procedure
measure: Rate of Adverse events (AEs), serious adverse events (SAEs)
timeFrame: 6 weeks, 3, 6, 12, 24, 36, 48 and 60 months
Locations:
city: Beijing
country: China
facility: Chinese Pla General Hospital
state: Beijing
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
city: Shenzhen
country: China
facility: University of Chinese Academy of Sciences Shenzhen Hospital
state: Guangdong
city: Shijiazhuang
country: China
facility: Hebei Chest Hospital
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Qiqihar
country: China
facility: The Third Affiliated Hospital Of Qiqihar Medical University
state: Heilongjiang
city: Nanjing
country: China
facility: The First Affilated Hospital with Nanjing Medical University
state: Jiangsu
city: Suzhou
country: China
facility: Suzhou Municipal Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University
state: Jiangsu
city: Yangzhou
country: China
facility: Northern Jiangsu People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: Northern Theater Command General Hospital
state: Liaoning
city: Yantai
country: China
facility: Yantai Yuhuangding Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
state: Shanghai
city: Xi'an
country: China
facility: Tangdu Hospital, Second Affiliated Hospital of Air Force Medical University
state: Shanxi
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: The First Affiliated Hospital of Guangzhou Medical University
name: Shiyue LI, MD
role: PRINCIPAL_INVESTIGATOR
References: