Back to resultsBronchial Ablation for Treatment of Asthma (BATA) Trial (BATA)
Primary Purpose
Asthma
Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
SyMap Bronchial Ablation System
Boston Scientific Alair System
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Bronchial Ablation, Bronchial Thermoplasty
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 50% 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 50% 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
Sites / Locations
- Chinese Pla General Hospital
- The First Affiliated Hospital of Guangzhou Medical University
- University of Chinese Academy of Sciences Shenzhen Hospital
- Hebei Chest Hospital
- The Second Hospital of Hebei Medical University
- The Third Affiliated Hospital Of Qiqihar Medical University
- The First Affilated Hospital with Nanjing Medical University
- Suzhou Municipal Hospital
- The Affiliated Hospital of Xuzhou Medical University
- Northern Jiangsu People's Hospital
- Northern Theater Command General Hospital
- Yantai Yuhuangding Hospital
- Shanghai Tenth People's Hospital
- Tangdu Hospital, Second Affiliated Hospital of Air Force Medical University
- The Second Affiliated Hospital Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SyMap Bronchial Ablation Group
Boston Scientific Bronchial Thermoplasty Group
Arm Description
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).
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)
Outcomes
Primary Outcome Measures
Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)
Definition of severe asthma exacerbations:
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.
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.
Secondary Outcome Measures
Change in Integrated Asthma Quality of Life Questionnaire (Integrated AQLQ) Score from baseline
Asthma Quality of Life Questionnaire consists of 32 items covering asthma-related symptoms and limitations during the 2 weeks preceding administration of the questionnaire, the responses are scored on a scale of 1 to 7, with higher numbers indicating a better quality of life. Integrated AQLQ is the average of the 6-, 9-, and 12- month scores.The proportion of subjects within each group that achieved an AQLQ score change of 0.5 or greater is analyzed.
Asthma Quality of Life Questionnaire Score (AQLQ)
Asthma Quality of Life Questionnaire consists of 32 items covering asthma-related symptoms and limitations during the 2 weeks preceding administration of the questionnaire, the responses are scored on a scale of 1 to 7, with higher numbers indicating a better quality of life.
Modified Asthma Control Questionnaire (ACQ-6) Score
Modified Asthma Control Questionnaire (ACQ-6) Consists of six questions (1 for bronchodilator use and 5 for asthma symptoms). The scores range from 0 (full control) to 6 (seriously uncontrolled). The ACQ-6 average score is the mean of the patient score. The average score ≤ 0.75 indicates that the asthma control is good, 0.75 ~ ≤ 1.5 prompts partial control, > 1.5 prompts poor control. The proportion of subjects within each group that achieved an AQLQ score change of 0.5 or greater was analyzed.
Percent of Symptom-Free Days
Numbers of severe asthma exacerbations
Forced Expiratory Volume in one second (FEV1)
Peak expiratory flow (PEF)
Rate of severe asthma exacerbations per year
the number of severe asthma exacerbations per person per year
Full Information
NCT ID
NCT03765307
First Posted
December 2, 2018
Last Updated
July 31, 2023
Sponsor
SyMap Medical (Suzhou), Ltd.
Collaborators
JieNuo Medical(Beijing)Co.,Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03765307
Brief Title
Bronchial Ablation for Treatment of Asthma (BATA) Trial
Acronym
BATA
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 18, 2019 (Actual)
Primary Completion Date
August 15, 2024 (Anticipated)
Study Completion Date
December 31, 2028 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
SyMap Medical (Suzhou), Ltd.
Collaborators
JieNuo Medical(Beijing)Co.,Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Bronchial Ablation, Bronchial Thermoplasty
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SyMap Bronchial Ablation Group
Arm Type
Experimental
Arm Description
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).
Arm Title
Boston Scientific Bronchial Thermoplasty Group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Device
Intervention Name(s)
SyMap Bronchial Ablation System
Intervention Description
The Bronchial Ablation is performed using SyMap Bronchial Ablation System in three sessions at least three weeks apart between each session: Right Lung Lobe, Left Lung Lobe, Right Up Lobe and Left Up Lobe.
Intervention Type
Device
Intervention Name(s)
Boston Scientific Alair System
Intervention Description
The Bronchial Thermoplasty is performed using Boston Scientific Alair System in three sessions at least three weeks apart between each session: Right Lung Lobe, Left Lung Lobe, Right Up Lobe and Left Up Lobe.
Primary Outcome Measure Information:
Title
Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)
Description
Definition of severe asthma exacerbations:
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.
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in Integrated Asthma Quality of Life Questionnaire (Integrated AQLQ) Score from baseline
Description
Asthma Quality of Life Questionnaire consists of 32 items covering asthma-related symptoms and limitations during the 2 weeks preceding administration of the questionnaire, the responses are scored on a scale of 1 to 7, with higher numbers indicating a better quality of life. Integrated AQLQ is the average of the 6-, 9-, and 12- month scores.The proportion of subjects within each group that achieved an AQLQ score change of 0.5 or greater is analyzed.
Time Frame
3, 6, 12, 24, 36, 48 and 60 months
Title
Asthma Quality of Life Questionnaire Score (AQLQ)
Description
Asthma Quality of Life Questionnaire consists of 32 items covering asthma-related symptoms and limitations during the 2 weeks preceding administration of the questionnaire, the responses are scored on a scale of 1 to 7, with higher numbers indicating a better quality of life.
Time Frame
6 weeks, 3, 6, 12, 24, 36, 48 and 60months
Title
Modified Asthma Control Questionnaire (ACQ-6) Score
Description
Modified Asthma Control Questionnaire (ACQ-6) Consists of six questions (1 for bronchodilator use and 5 for asthma symptoms). The scores range from 0 (full control) to 6 (seriously uncontrolled). The ACQ-6 average score is the mean of the patient score. The average score ≤ 0.75 indicates that the asthma control is good, 0.75 ~ ≤ 1.5 prompts partial control, > 1.5 prompts poor control. The proportion of subjects within each group that achieved an AQLQ score change of 0.5 or greater was analyzed.
Time Frame
6 weeks, 3, 6, 12, 24, 36, 48 and 60months
Title
Percent of Symptom-Free Days
Time Frame
12 months
Title
Numbers of severe asthma exacerbations
Time Frame
6 weeks, 12, 24, 36, 48 and 60 months
Title
Forced Expiratory Volume in one second (FEV1)
Time Frame
6 weeks, 12, 24, 36, 48 and 60months
Title
Peak expiratory flow (PEF)
Time Frame
6 weeks, 12 , 24, 36, 48 and 60 months
Title
Rate of severe asthma exacerbations per year
Description
the number of severe asthma exacerbations per person per year
Time Frame
24, 36, 48 and 60 months
Other Pre-specified Outcome Measures:
Title
Emergency Room Visits days
Time Frame
12, 24, 36, 48 and 60 months
Title
Hospitalization days
Time Frame
12, 24, 36, 48 and 60 months
Title
Absence of work/school due to asthma symptoms, or days affecting daily actives
Time Frame
12 months
Title
Successful rate of procedure
Description
defned by whether the catheter can be engaged in the correct position in the bronchus to successfully complete the bronchial radiofrequency ablation
Time Frame
During the procedure
Title
Safety of the procedure
Description
related adverse events and complications during the procedure
Time Frame
During the procedure
Title
Adverse events (AEs), serious adverse events (SAEs) after procedure
Time Frame
1, 2 days, and 7 days after procedure
Title
Rate of Adverse events (AEs), serious adverse events (SAEs)
Time Frame
6 weeks, 3, 6, 12, 24, 36, 48 and 60 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiyue LI, MD
Organizational Affiliation
The First Affiliated Hospital of Guangzhou Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese Pla General Hospital
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The First Affiliated Hospital of Guangzhou Medical University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Facility Name
University of Chinese Academy of Sciences Shenzhen Hospital
City
Shenzhen
State/Province
Guangdong
Country
China
Facility Name
Hebei Chest Hospital
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Second Hospital of Hebei Medical University
City
Shijiazhuang
State/Province
Hebei
Country
China
Facility Name
The Third Affiliated Hospital Of Qiqihar Medical University
City
Qiqihar
State/Province
Heilongjiang
Country
China
Facility Name
The First Affilated Hospital with Nanjing Medical University
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Suzhou Municipal Hospital
City
Suzhou
State/Province
Jiangsu
Country
China
Facility Name
The Affiliated Hospital of Xuzhou Medical University
City
Xuzhou
State/Province
Jiangsu
Country
China
Facility Name
Northern Jiangsu People's Hospital
City
Yangzhou
State/Province
Jiangsu
Country
China
Facility Name
Northern Theater Command General Hospital
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Facility Name
Tangdu Hospital, Second Affiliated Hospital of Air Force Medical University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
The Second Affiliated Hospital Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Our decision on whether to share the individual participant data depends on the opinions of the regulatory authorities in China, but so far the regulatory agencies have no clear instructions yet, thus we cannot make a decision at present.
Learn more about this trial
Bronchial Ablation for Treatment of Asthma (BATA) Trial
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