<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03765307</url>
  </required_header>
  <id_info>
    <org_study_id>201801</org_study_id>
    <nct_id>NCT03765307</nct_id>
  </id_info>
  <brief_title>Bronchial Ablation for Treatment of Asthma (BATA) Trial</brief_title>
  <acronym>BATA</acronym>
  <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)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SyMap Medical (Suzhou), Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>JieNuo Medical(Beijing)Co.,Ltd</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>SyMap Medical (Suzhou), Ltd.</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the safety and efficacy of a bronchial radiofrequency ablation system (SyMap&#xD;
      Medical (Suzhou) Ltd) in a population of subjects with severe asthma who are still&#xD;
      symptomatic despite being managed on high-dose Inhaled Corticosteroids (ICS) and Long-Acting&#xD;
      β2-adrenergic Agonists (LABA).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This will be a prospective, multicenter, randomized, clinical study comparing the SyMap&#xD;
      bronchial radiofrequency ablation system to the Boston Scientific Bronchial Thermoplasty&#xD;
      System (Alair System). The study population consisted of subjects with severe asthma who are&#xD;
      still symptomatic despite being managed on high dose ICS and LABA. Patients with severe&#xD;
      asthma who still have symptoms, despite the standard drug maintenance recommended by the&#xD;
      guidelines, after signing the informed consent, who meet the inclusion exclusion criteria&#xD;
      enter the baseline period and continued to use uniform ICS and LABA, which will last at least&#xD;
      4 weeks. Patients with at least two days asthma symptoms during the baseline period, and meet&#xD;
      the eligibility criteria are assigned to the experimental or control group at a 1:1 ratio&#xD;
      based on a central randomized system. A total of 160 subjects will be enrolled, 80 in the&#xD;
      experimental group and 80 in the control group. The experimental group is treated with SyMap&#xD;
      radiofrequency ablation system, and the control group is treated with the same procedure&#xD;
      using Boston Scientific Bronchial Thermoplasty Aliar System. For subjects in the experimental&#xD;
      group and the control group, follow-up by telephone call will be performed at 1, 2, 7 days&#xD;
      after each procedure and at 1, 2, 4, 5, 7, 8, 9, 10, 11, 15, 18, 21, 27, 30, 33, 39, 42, 45,&#xD;
      51, 54, and 57 months after the third procedure, and outpatient follow-up will be performed&#xD;
      at 6 weeks, 3, 6，12，24, 36, 48 and 60 months after the third procedure. ICS and LABA are&#xD;
      administered within five years after the third procedure. The difference in the rate of&#xD;
      severe asthma exacerbations per year (the number of severe asthma exacerbations per person&#xD;
      per year), at 12 months after bronchial radiofrequency ablation, is the primary endpoint of&#xD;
      the study, and the success rate of procedure, postoperative adverse events, and serious&#xD;
      adverse events are safety endpoints.&#xD;
&#xD;
      This study is conducted by an independent clinical monitoring organization, a data management&#xD;
      and statistical center to collect and statistically analyze all relevant clinical and&#xD;
      laboratory data.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">June 18, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2028</completion_date>
  <primary_completion_date type="Anticipated">August 15, 2024</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)</measure>
    <time_frame>12 months</time_frame>
    <description>Definition of severe asthma exacerbations:&#xD;
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.&#xD;
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;&#xD;
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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Integrated Asthma Quality of Life Questionnaire (Integrated AQLQ) Score from baseline</measure>
    <time_frame>3, 6, 12, 24, 36, 48 and 60 months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Quality of Life Questionnaire Score (AQLQ)</measure>
    <time_frame>6 weeks, 3, 6, 12, 24, 36, 48 and 60months</time_frame>
    <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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Modified Asthma Control Questionnaire (ACQ-6) Score</measure>
    <time_frame>6 weeks, 3, 6, 12, 24, 36, 48 and 60months</time_frame>
    <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, &gt; 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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent of Symptom-Free Days</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numbers of severe asthma exacerbations</measure>
    <time_frame>6 weeks, 12, 24, 36, 48 and 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced Expiratory Volume in one second (FEV1)</measure>
    <time_frame>6 weeks, 12, 24, 36, 48 and 60months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak expiratory flow (PEF)</measure>
    <time_frame>6 weeks, 12 , 24, 36, 48 and 60 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of severe asthma exacerbations per year</measure>
    <time_frame>24, 36, 48 and 60 months</time_frame>
    <description>the number of severe asthma exacerbations per person per year</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Emergency Room Visits days</measure>
    <time_frame>12, 24, 36, 48 and 60 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Hospitalization days</measure>
    <time_frame>12, 24, 36, 48 and 60 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Absence of work/school due to asthma symptoms, or days affecting daily actives</measure>
    <time_frame>12 months</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Successful rate of procedure</measure>
    <time_frame>During the procedure</time_frame>
    <description>defned by whether the catheter can be engaged in the correct position in the bronchus to successfully complete the bronchial radiofrequency ablation</description>
  </other_outcome>
  <other_outcome>
    <measure>Safety of the procedure</measure>
    <time_frame>During the procedure</time_frame>
    <description>related adverse events and complications during the procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Adverse events (AEs), serious adverse events (SAEs) after procedure</measure>
    <time_frame>1, 2 days, and 7 days after procedure</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Rate of Adverse events (AEs), serious adverse events (SAEs)</measure>
    <time_frame>6 weeks, 3, 6, 12, 24, 36, 48 and 60 months</time_frame>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">160</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>SyMap Bronchial Ablation Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Boston Scientific Bronchial Thermoplasty Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SyMap Bronchial Ablation System</intervention_name>
    <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.</description>
    <arm_group_label>SyMap Bronchial Ablation Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Boston Scientific Alair System</intervention_name>
    <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.</description>
    <arm_group_label>Boston Scientific Bronchial Thermoplasty Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is an adult between the ages of 18 to 65 years;&#xD;
&#xD;
          -  Diagnosed with asthma who required regular asthma maintenance medication in the past 6&#xD;
             months as follows:&#xD;
&#xD;
        ICS ≥1000 μg/day beclomethasone or equivalent and LABA ≥1000μg /day salmeterol or&#xD;
        equivalent.&#xD;
&#xD;
        Other medications were allowed, including leukotriene modifiers, and Oral Corticosteroids&#xD;
        (OCS) ≤ 10mg/day.&#xD;
&#xD;
          -  At least two days of asthma symptoms during 4-weeks of the baseline period.&#xD;
&#xD;
          -  Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or&#xD;
             equal to 45% of predicted.&#xD;
&#xD;
          -  Non-smoker (less than 10 pack per year) last for 1 year or greater.&#xD;
&#xD;
          -  Baseline AQLQ Score less than or equal to 6.25&#xD;
&#xD;
          -  Willingness and ability to comply with the outpatient follow-up.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of less than 45% of&#xD;
             predicted.&#xD;
&#xD;
          -  3 or more hospitalizations for exacerbations of asthma in the past 12 months;&#xD;
&#xD;
          -  More than 3 lower respiratory tract infections requiring antibiotics in the past 12&#xD;
             months&#xD;
&#xD;
          -  More than 4 of oral steroid use for exacerbations of asthma in the past 12 months&#xD;
&#xD;
          -  Chronic sinusitis&#xD;
&#xD;
          -  Uncontrolled gastroesophageal reflux disease, defined as a significant increase in&#xD;
             treatment over the past 6 weeks&#xD;
&#xD;
          -  Sensitivity to medications required to perform bronchoscopy (such as lidocaine and&#xD;
             benzodiazepines)&#xD;
&#xD;
          -  Use of an implantable electrical stimulation device, such as a pacemaker, a cardiac&#xD;
             defibrillator or a deep nerve or deep brain stimulator;&#xD;
&#xD;
          -  Severe emphysema caused by chronic obstructive pulmonary disease (COPD).&#xD;
&#xD;
          -  Use of systemic immunosuppressants, beta adrenergic blockers, or anticoagulants.&#xD;
&#xD;
          -  History of fatal asthma.&#xD;
&#xD;
          -  Uncontrolled obstructive sleep apnea&#xD;
&#xD;
          -  Intubation or admission to the ICU for asthma exacerbations within 2 years prior to&#xD;
             treatment&#xD;
&#xD;
          -  Hemorrhagic or malignant tumors or Coagulopathy.&#xD;
&#xD;
          -  Lower bronchial stenosis or distal complete atelectasis or other severe bronchial and&#xD;
             pulmonary lesions, as Thoracic spiral CT showed&#xD;
&#xD;
          -  Poor compliance judged by the investigator, or other medical conditions that are not&#xD;
             suitable for the study&#xD;
&#xD;
          -  Related contraindications for bronchoscopy&#xD;
&#xD;
          -  Pregnant, lactating women, or patients with a birth plan in the next year&#xD;
&#xD;
          -  Previously undergone bronchial thermoplasty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shiyue LI, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The First Affiliated Hospital of Guangzhou Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese Pla General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Guangzhou Medical University</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510120</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chinese Academy of Sciences Shenzhen Hospital</name>
      <address>
        <city>Shenzhen</city>
        <state>Guangdong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hebei Chest Hospital</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of Hebei Medical University</name>
      <address>
        <city>Shijiazhuang</city>
        <state>Hebei</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Affiliated Hospital Of Qiqihar Medical University</name>
      <address>
        <city>Qiqihar</city>
        <state>Heilongjiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affilated Hospital with Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210029</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suzhou Municipal Hospital</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Xuzhou Medical University</name>
      <address>
        <city>Xuzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Jiangsu People's Hospital</name>
      <address>
        <city>Yangzhou</city>
        <state>Jiangsu</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Theater Command General Hospital</name>
      <address>
        <city>Shenyang</city>
        <state>Liaoning</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Yantai Yuhuangding Hospital</name>
      <address>
        <city>Yantai</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shanghai Tenth People's Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tangdu Hospital, Second Affiliated Hospital of Air Force Medical University</name>
      <address>
        <city>Xi'an</city>
        <state>Shanxi</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <state>Zhejiang</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>December 2, 2018</study_first_submitted>
  <study_first_submitted_qc>December 4, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 5, 2018</study_first_posted>
  <last_update_submitted>July 31, 2023</last_update_submitted>
  <last_update_submitted_qc>July 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Asthma</keyword>
  <keyword>Bronchial Ablation</keyword>
  <keyword>Bronchial Thermoplasty</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_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.</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03765307
org study id: 201801
nct id: NCT03765307
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
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).
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.
allocation: Randomized
intervention model: Parallel Assignment
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
masking: Double (Participant, Outcomes 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.
measure: Rate of severe asthma exacerbations per year (the number of severe asthma exacerbations per person per year)
time frame: 12 months
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.
measure: Change in Integrated Asthma Quality of Life Questionnaire (Integrated AQLQ) Score from baseline
time frame: 3, 6, 12, 24, 36, 48 and 60 months
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.
measure: Asthma Quality of Life Questionnaire Score (AQLQ)
time frame: 6 weeks, 3, 6, 12, 24, 36, 48 and 60months
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.
measure: Modified Asthma Control Questionnaire (ACQ-6) Score
time frame: 6 weeks, 3, 6, 12, 24, 36, 48 and 60months
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.
measure: Percent of Symptom-Free Days
time frame: 12 months
measure: Numbers of severe asthma exacerbations
time frame: 6 weeks, 12, 24, 36, 48 and 60 months
measure: Forced Expiratory Volume in one second (FEV1)
time frame: 6 weeks, 12, 24, 36, 48 and 60months
measure: Peak expiratory flow (PEF)
time frame: 6 weeks, 12 , 24, 36, 48 and 60 months
measure: Rate of severe asthma exacerbations per year
time frame: 24, 36, 48 and 60 months
description: the number of severe asthma exacerbations per person per year
measure: Emergency Room Visits days
time frame: 12, 24, 36, 48 and 60 months
measure: Hospitalization days
time frame: 12, 24, 36, 48 and 60 months
measure: Absence of work/school due to asthma symptoms, or days affecting daily actives
time frame: 12 months
measure: Successful rate of procedure
time frame: During the procedure
description: defned by whether the catheter can be engaged in the correct position in the bronchus to successfully complete the bronchial radiofrequency ablation
measure: Safety of the procedure
time frame: During the procedure
description: related adverse events and complications during the procedure
measure: Adverse events (AEs), serious adverse events (SAEs) after procedure
time frame: 1, 2 days, and 7 days after procedure
measure: Rate of Adverse events (AEs), serious adverse events (SAEs)
time frame: 6 weeks, 3, 6, 12, 24, 36, 48 and 60 months
arm group label: SyMap Bronchial Ablation Group
arm group type: Experimental
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 group label: Boston Scientific Bronchial Thermoplasty Group
arm group type: Active Comparator
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: SyMap Bronchial Ablation System
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.
arm group label: SyMap Bronchial Ablation Group
intervention type: Device
intervention name: Boston Scientific Alair System
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.
arm group label: Boston Scientific Bronchial Thermoplasty Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Shiyue LI, MD
role: Principal Investigator
affiliation: The First Affiliated Hospital of Guangzhou Medical University
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: China
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: Undecided
ipd 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.