AsthmaBATANCT03765307
Bronchial Ablation for Treatment of Asthma (BATA) Trial
A study testing SyMap Bronchial Ablation System and Boston Scientific Alair System in people with Asthma, run by SyMap Medical (Suzhou), Ltd. at 15 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- SyMap Bronchial Ablation System and Boston Scientific Alair System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 15 sitesChina
- Study dates
- 18 Jun 2019to 31 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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
Show all 19Show fewer
- 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
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
China15 sites
Chinese Pla General Hospital
Beijing, Beijing Municipality
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510120
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang
The First Affilated Hospital with Nanjing Medical University
Nanjing, Jiangsu, 210029
The Third Affiliated Hospital Of Qiqihar Medical University
Qiqihar, Heilongjiang
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
Northern Theater Command General Hospital
Shenyang, Liaoning
University of Chinese Academy of Sciences Shenzhen Hospital
Shenzhen, Guangdong
Hebei Chest Hospital
Shijiazhuang, Hebei
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei
Suzhou Municipal Hospital
Suzhou, Jiangsu
Tangdu Hospital, Second Affiliated Hospital of Air Force Medical University
Xi’an, Shanxi
The Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu
Northern Jiangsu People's Hospital
Yangzhou, Jiangsu
Yantai Yuhuangding Hospital
Yantai, Shandong
About this study
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)
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).
Read the 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.
- Conditions
- Asthma
- Being tested
- SyMap Bronchial Ablation System, Boston Scientific Alair System
- Keywords
- Asthma, Bronchial Ablation, Bronchial Thermoplasty
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SyMap Bronchial Ablation SystemDevice
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.
Boston Scientific Alair SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| SyMap Bronchial Ablation Group | Experimental | 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). Receives: Device: SyMap Bronchial Ablation System |
| Boston Scientific Bronchial Thermoplasty Group | Active comparator | 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) Receives: Device: Boston Scientific Alair System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (8)
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.
Measured: 3, 6, 12, 24, 36, 48 and 60 months
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.
Measured: 6 weeks, 3, 6, 12, 24, 36, 48 and 60months
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.
Measured: 6 weeks, 3, 6, 12, 24, 36, 48 and 60months
Percent of Symptom-Free Days
Measured: 12 months
Numbers of severe asthma exacerbations
Measured: 6 weeks, 12, 24, 36, 48 and 60 months
Forced Expiratory Volume in one second (FEV1)
Measured: 6 weeks, 12, 24, 36, 48 and 60months
Peak expiratory flow (PEF)
Measured: 6 weeks, 12 , 24, 36, 48 and 60 months
Rate of severe asthma exacerbations per year
the number of severe asthma exacerbations per person per year
Measured: 24, 36, 48 and 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start18 Jun 2019
- Primary completion15 Aug 2024 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- SyMap Medical (Suzhou), Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- JieNuo Medical(Beijing)Co.,Ltd
- Responsible party
- Sponsor
- Investigators
- Shiyue LI, MD, Principal investigator, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765307
- Sponsor's protocol ID
- 201801
- Acronym
- BATA
- Status last verified
- Jul 2023
- First submitted
- 2 Dec 2018
- Last updated
- 2 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03765307
- Acronym / sponsor ID
- BATA / 201801
- Conditions
- Asthma
- Keywords
- Asthma, Bronchial Ablation, Bronchial Thermoplasty
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 160 participants (actual)
- Lead sponsor
- SyMap Medical (Suzhou), Ltd.Industry (pharma, biotech, devices)
- Collaborators
- JieNuo Medical(Beijing)Co.,Ltd
- Study start
- 18 Jun 2019 (actual)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 5 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| SyMap Bronchial Ablation Group | Experimental | Device: SyMap Bronchial Ablation SystemThe 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). |
| Boston Scientific Bronchial Thermoplasty Group | Active comparator | Device: Boston Scientific Alair SystemThe 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (19 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SyMap Bronchial Ablation SystemThe 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. | Device | SyMap Bronchial Ablation Group |
| Boston Scientific Alair SystemThe 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. | Device | Boston Scientific Bronchial Thermoplasty Group |
Primary outcome
Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)
Time frame: 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.
8 secondary outcomes
Change in Integrated Asthma Quality of Life Questionnaire (Integrated AQLQ) Score from baseline
Time frame: 3, 6, 12, 24, 36, 48 and 60 months
Asthma Quality of Life Questionnaire Score (AQLQ)
Time frame: 6 weeks, 3, 6, 12, 24, 36, 48 and 60months
Modified Asthma Control Questionnaire (ACQ-6) Score
Time frame: 6 weeks, 3, 6, 12, 24, 36, 48 and 60months
Percent of Symptom-Free Days
Time frame: 12 months
Numbers of severe asthma exacerbations
Time frame: 6 weeks, 12, 24, 36, 48 and 60 months
Forced Expiratory Volume in one second (FEV1)
Time frame: 6 weeks, 12, 24, 36, 48 and 60months
Peak expiratory flow (PEF)
Time frame: 6 weeks, 12 , 24, 36, 48 and 60 months
Rate of severe asthma exacerbations per year
Time frame: 24, 36, 48 and 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2023.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiyue LI, MD principal investigator
The First Affiliated Hospital of Guangzhou Medical University
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SyMap Bronchial Ablation System and Boston Scientific Alair System in people with Asthma, run by SyMap Medical (Suzhou), Ltd. at 15 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 2 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2023.