<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/NCT02206269</url>
  </required_header>
  <id_info>
    <org_study_id>E7100</org_study_id>
    <nct_id>NCT02206269</nct_id>
  </id_info>
  <brief_title>China Alair System Registry Study-CARE Study</brief_title>
  <acronym>CARE</acronym>
  <official_title>Registry of Bronchial Thermoplasty (BT) Procedures in China</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BSC International Medical Trading (Shanghai) Co., Ltd.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BSC International Medical Trading (Shanghai) Co., Ltd.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this Registry is to collect real-world outcome data for bronchial&#xD;
      thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic&#xD;
      despite taking standard of care maintenance medications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and&#xD;
      the anticipated reduction in healthcare utilization events and cost by way of a reduction in&#xD;
      severe asthma exacerbations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">April 2015</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Year</target_duration>
  <primary_outcome>
    <measure>Incidence of severe asthma exacerbations following BT with the Alair System.</measure>
    <time_frame>1 year</time_frame>
    <description>Severe asthma exacerbation is defined as worsening of asthma symptoms requiring use of systemic corticosteroids (tablets, suspension, or injection) (NAEPP Guidelines, 2007).&#xD;
For patients already taking oral corticosteroids on a daily or alternate day basis, a severe asthma exacerbation is defined as a worsening of asthma symptoms requiring any increase in daily dose of systemic corticosteroids.&#xD;
For consistency, courses of corticosteroids separated by 1 week or more will be treated as separate severe exacerbations.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quarlity of life of Patients</measure>
    <time_frame>1 year</time_frame>
    <description>Asthma Quality of Life Questionnaire (AQLQ) score Asthma Control Questionnaire(ACQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Health care utilization</measure>
    <time_frame>1 year</time_frame>
    <description>Emergency Department Visits,Hospitalizations,Unscheduled office visits including urgent care visits</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>FEV1</measure>
    <time_frame>1 year</time_frame>
    <description>Pre- and post-bronchodilator FEV1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious respiratory adverse events</measure>
    <time_frame>1 year</time_frame>
    <description>Rates of and proportion of patients with serious respiratory adverse events</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">225</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Alair System</arm_group_label>
    <description>This is a single arm study with Alair system used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Alair System</intervention_name>
    <description>The Alair system is used for doing bronchial thermoplasty.</description>
    <arm_group_label>Alair System</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The real world patient polulaiton who undergo BT in China&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient is an adult aged 18 years or older with severe persistent asthma who remains&#xD;
             symptomatic despite taking standard of care maintenance medications.&#xD;
&#xD;
          2. Patient is able to read, understand, and sign a written Informed Consent to&#xD;
             participate in the Registry and able to comply with the study requirements.&#xD;
&#xD;
          3. Patient is able to undergo bronchoscopy in the opinion of the Investigator or per&#xD;
             hospital guidelines and as described in the Alair System Directions for Use (DFU).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient has an implanted electrical stimulation device (e.g., a pacemaker, cardiac&#xD;
             defibrillator, or deep nerve or deep brain stimulator).&#xD;
&#xD;
          2. Patient has any other medical condition that would make them inappropriate for study&#xD;
             participation, in the Investigator's opinion.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiangtao Lin, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>China-Japan Friendship Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BSC International Medical Trading (Shanghai) Co., Ltd.</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200023</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2018</verification_date>
  <study_first_submitted>July 24, 2014</study_first_submitted>
  <study_first_submitted_qc>July 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 1, 2014</study_first_posted>
  <last_update_submitted>February 22, 2018</last_update_submitted>
  <last_update_submitted_qc>February 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02206269
org study id: E7100
nct id: NCT02206269
lead sponsor: 
has dmc: No
The objective of this Registry is to collect real-world outcome data for bronchial
      thermoplasty (BT) procedures in patients with severe persistent asthma who remain symptomatic
      despite taking standard of care maintenance medications.
Data will be used to confirm the impact of BT on safety, effectiveness, quality of life, and
      the anticipated reduction in healthcare utilization events and cost by way of a reduction in
      severe asthma exacerbations.
observational model: Cohort
time perspective: Prospective
measure: Incidence of severe asthma exacerbations following BT with the Alair System.
time frame: 1 year
description: Severe asthma exacerbation is defined as worsening of asthma symptoms requiring use of systemic corticosteroids (tablets, suspension, or injection) (NAEPP Guidelines, 2007).
For patients already taking oral corticosteroids on a daily or alternate day basis, a severe asthma exacerbation is defined as a worsening of asthma symptoms requiring any increase in daily dose of systemic corticosteroids.
For consistency, courses of corticosteroids separated by 1 week or more will be treated as separate severe exacerbations.
measure: Quarlity of life of Patients
time frame: 1 year
description: Asthma Quality of Life Questionnaire (AQLQ) score Asthma Control Questionnaire(ACQ)
measure: Health care utilization
time frame: 1 year
description: Emergency Department Visits,Hospitalizations,Unscheduled office visits including urgent care visits
measure: FEV1
time frame: 1 year
description: Pre- and post-bronchodilator FEV1
measure: Serious respiratory adverse events
time frame: 1 year
description: Rates of and proportion of patients with serious respiratory adverse events
arm group label: Alair System
description: This is a single arm study with Alair system used.
intervention type: Device
intervention name: Alair System
description: The Alair system is used for doing bronchial thermoplasty.
arm group label: Alair System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jiangtao Lin, Professor
role: Principal Investigator
affiliation: China-Japan Friendship Hospital
facility: 
country: China
responsible party type: Sponsor