<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/NCT03243292</url>
  </required_header>
  <id_info>
    <org_study_id>92115848</org_study_id>
    <nct_id>NCT03243292</nct_id>
  </id_info>
  <brief_title>Bronchial Thermoplasty 10+ Year Study</brief_title>
  <official_title>Ten Year Follow-up of Subjects From 3 Landmark Randomized Controlled Bronchial Thermoplasty (BT) Studies</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>No</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 confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years&#xD;
      follow-up or beyond in subjects previously enrolled in any of the following Boston&#xD;
      Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compare rates of severe asthma exacerbations of subjects during the first and fifth year&#xD;
      after BT treatment with the proportion of subjects who experience severe asthma exacerbations&#xD;
      during the 12 months period prior to enrollment.&#xD;
&#xD;
      Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to&#xD;
      examine if there are any clinically significant post-treatment respiratory changes following&#xD;
      BT defined as bronchiectasis or bronchial stenosis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 11, 2017</start_date>
  <completion_date type="Actual">January 10, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.</measure>
    <time_frame>The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.</time_frame>
    <description>Following BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary Volumetric HRCT scan at the BT 10+study visit in those3 subjects who had baseline Volumetric HRCT scan in the AIR2 study. Baseline and 10+ year HRCTs are to be read by an independent radiologist and also assessed by an independent pulmonologist.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.</measure>
    <time_frame>The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.</time_frame>
    <description>Durability of the treatment effect by comparing the proportion of subjects who experience severe asthma exacerbations during the first and fifth years after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 month period prior to the BT 10+ study visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severe asthma exacerbation rates exacerbations</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe asthma exacerbation rates subject</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Severe asthma exacerbation rates year</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rates of emergency room visits for respiratory adverse events</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>proportion of subjects with emergency room visits for respiratory adverse events</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of hospitalizations for respiratory adverse events</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with hospitalizations for respiratory adverse events</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rates of Respiratory Serious Adverse Events (SAEs)</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects with respiratory SAEs)</measure>
    <time_frame>One day visit</time_frame>
    <description>evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">192</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Treated</arm_group_label>
    <description>Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Subjects that participated in prior study (AIR) or (RISA) but did not receive Bronchial Thermoplasty Treatment. Determine if the Control group of subjects asthma has progressed any different from those subjects treated with BT.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham</arm_group_label>
    <description>Subjects that participated in the AIR2 study, were blinded and did not receive the treatment. Determine if the Sham group of subjects asthma has progressed any different from those subjects treated with BT.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bronchial Thermoplasty</intervention_name>
    <description>patients had radio frequency ablation of the smooth muscle for asthma</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Sham</arm_group_label>
    <arm_group_label>Treated</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects that participated in one one or more of the prior studies (AIR, RISA, or AIR2)&#xD;
        will be invited to participate in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Subjects previously enrolled in AIR, RISA or AIR2&#xD;
&#xD;
          -  Subjects who received active BT treatment and had last BT treatment at least 10 years&#xD;
             and 6 weeks prior to enrollment&#xD;
&#xD;
          -  Control/Sham subjects with at least 10 years of long-term follow-up from index date&#xD;
             plus 6 weeks&#xD;
&#xD;
          -  Subject is able to read, understand and sign a written Informed Consent to participate&#xD;
             in the Study and able to comply with the study requirements&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe asthma exacerbation or chest infection in the past 4 weeks. Subject entry into&#xD;
             this study should be delayed until free from severe asthma exacerbation or chest&#xD;
             infection for a minimum of 4 weeks.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thomas Bowman, MD</last_name>
    <role>Study Director</role>
    <affiliation>Medical Director, Boston Scientific</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Southern California</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90033</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202-268</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Regions Hospital Health Partners Specialty Center</name>
      <address>
        <city>Saint Paul</city>
        <state>Minnesota</state>
        <zip>55130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110-1093</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cleveland Clinic</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44195</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pulmonary Associates of Northern Virginia</name>
      <address>
        <city>Arlington</city>
        <state>Virginia</state>
        <zip>22205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imandade Santa Casa de Misercordia</name>
      <address>
        <city>Pôrto Alegre</city>
        <state>RS</state>
        <zip>90035074</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Faculdade da Medicina do ABC</name>
      <address>
        <city>Santo André</city>
        <state>Sao Paulo</state>
        <zip>09060-650</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gente Clube de Vida Promoção E Serviços 9 Centro de Pesquisa Maimônides</name>
      <address>
        <city>Pôrto Alegre</city>
        <zip>90480-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instituto de Doenças do Tórax /Universidade Federal do Rio de Janeiro/UFRJ</name>
      <address>
        <city>Rio De Janeiro</city>
        <zip>21949-900</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montreal Chest Institute</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H4A 3J1</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institute Universitaire de Cardiologie et Pneumologie de Quebec</name>
      <address>
        <city>Quebec City</city>
        <state>Quebec</state>
        <zip>G1V4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitair Medisch Centrum Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9713 GZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>Chelsea</city>
        <state>London</state>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gartnavel General Hospital</name>
      <address>
        <city>Glasgow</city>
        <state>Scotland</state>
        <zip>G12 OYN</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Leicester Glenfield Hospital</name>
      <address>
        <city>Leicester</city>
        <zip>LE5 4PW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hospital, University of Manchester</name>
      <address>
        <city>Manchester</city>
        <zip>M23 9LT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Netherlands</country>
    <country>United Kingdom</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Australia</country>
  </removed_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>August 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 8, 2017</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bronchial Thermoplasty</keyword>
  <keyword>Alair</keyword>
  <keyword>Registry</keyword>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>May 30, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/92/NCT03243292/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03243292
org study id: 92115848
nct id: NCT03243292
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To confirm the long-term efficacy and safety of Bronchial Thermoplasty (BT) at 10 years
      follow-up or beyond in subjects previously enrolled in any of the following Boston
      Scientific-sponsored, controlled pre-approval studies: AIR, RISA and AIR2.
Compare rates of severe asthma exacerbations of subjects during the first and fifth year
      after BT treatment with the proportion of subjects who experience severe asthma exacerbations
      during the 12 months period prior to enrollment.

      Compare baseline HRCT scans from subjects from the AIR2 study that enroll in BT 10+ study to
      examine if there are any clinically significant post-treatment respiratory changes following
      BT defined as bronchiectasis or bronchial stenosis.
observational model: Case-Only
time perspective: Prospective
measure: Primary Safety Endpoint: Absence of clinically significant post-treatment respiratory changes from Baseline (pre-Bronchial Thermoplasty) CT.
time frame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
description: Following BT, defined as bronchiectasis or bronchial stenosis, as confirmed by Pulmonary Volumetric HRCT scan at the BT 10+study visit in those3 subjects who had baseline Volumetric HRCT scan in the AIR2 study. Baseline and 10+ year HRCTs are to be read by an independent radiologist and also assessed by an independent pulmonologist.
measure: Primary Effectiveness: Endpoints at 10 or more years following the subjects' last BT procedure; Asthma Exacerbations, ER Visits, Hospitalizations, and respiratory Serious Adverse Events.
time frame: The BT 10+ study's single visit must occur 10 years after the subject's last BT procedure.
description: Durability of the treatment effect by comparing the proportion of subjects who experience severe asthma exacerbations during the first and fifth years after BT treatment with the proportion of subjects who experience severe asthma exacerbations during the 12 month period prior to the BT 10+ study visit.
measure: Severe asthma exacerbation rates exacerbations
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
measure: Severe asthma exacerbation rates subject
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
measure: Severe asthma exacerbation rates year
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
measure: rates of emergency room visits for respiratory adverse events
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
measure: proportion of subjects with emergency room visits for respiratory adverse events
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
measure: Rates of hospitalizations for respiratory adverse events
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
measure: Proportion of subjects with hospitalizations for respiratory adverse events
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
measure: Rates of Respiratory Serious Adverse Events (SAEs)
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
measure: Proportion of subjects with respiratory SAEs)
time frame: One day visit
description: evaluated for the 12 month period prior to the BT 10+ study visit and will be compared to the first and fifth years after BT treatment:
arm group label: Treated
description: Subjects that received Bronchial Thermoplasty in a prior study (AIR, RISA, or AIR2)
arm group label: Control
description: Subjects that participated in prior study (AIR) or (RISA) but did not receive Bronchial Thermoplasty Treatment. Determine if the Control group of subjects asthma has progressed any different from those subjects treated with BT.
arm group label: Sham
description: Subjects that participated in the AIR2 study, were blinded and did not receive the treatment. Determine if the Sham group of subjects asthma has progressed any different from those subjects treated with BT.
intervention type: Other
intervention name: Bronchial Thermoplasty
description: patients had radio frequency ablation of the smooth muscle for asthma
arm group label: Control
arm group label: Sham
arm group label: Treated
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Thomas Bowman, MD
role: Study Director
affiliation: Medical Director, Boston Scientific
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Brazil
country: Canada
country: Netherlands
country: United Kingdom
country: United States
country: Australia
responsible party type: Sponsor
provided document: 