<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/NCT02975284</url>
  </required_header>
  <id_info>
    <org_study_id>NL53703.018.15</org_study_id>
    <nct_id>NCT02975284</nct_id>
  </id_info>
  <brief_title>Unraveling Targets of Therapy in Bronchial Thermoplasty in Severe Asthma (TASMA) Extension Study</brief_title>
  <official_title>TASMA Extension Study: Long Term Efficacy and Safety of Bronchial Thermoplasty in Severe</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study evaluates the longterm clinical outcomes, including safety and efficacy parameters&#xD;
      after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included&#xD;
      in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date>August 2015</start_date>
  <completion_date type="Anticipated">September 2024</completion_date>
  <primary_completion_date type="Anticipated">September 2024</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Severe exacerbations rate</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Emergency room visit for respiratory symptoms rate</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>emergency room visits for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hospitalization for respiratory symptoms rate</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>hospitalizations for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>provocative concentration causing a 20% fall (PC20 ) methacholine test</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fractional exhaled nitric oxide (FeNO)</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway-resistance (sRaw) mechanics</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway-conductance(sGaw) mechanics</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>forced oscillation technique (FOT)</measure>
    <time_frame>measured over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Control Questionnaire (ACQ) scores</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Asthma Quality of Life Questionnaire (AQLQ) scores</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance dose of oral steroids</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maintenance dose of inhaled steroids</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rescue medication use</measure>
    <time_frame>measured yearly over 5 years</time_frame>
    <description>measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Airway smooth muscle (ASM) mass</measure>
    <time_frame>2 years after inclusion, 2,5 years after BT</time_frame>
    <description>ASM mass as determined by percentage/absolute ASM surface area and distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>optical coherence tomography (OCT) determined changes</measure>
    <time_frame>2 years after inclusion, 2,5 years after BT</time_frame>
    <description>OCT determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw).</description>
  </secondary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Severe Asthma</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Two years after BT blood DNA/RNA will be retained&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects who underwent BT treatment in the TASMA study (protocol No.NL45394.018.13) and&#xD;
        were not lost to follow-up at the end of the 30 week pre-marked visit, and those willing to&#xD;
        comply with the study protocol and routine visits for the duration of the study will be&#xD;
        included. The expected number of patients included in the TASMA study is n=40. These are&#xD;
        patients with severe asthma despite maximal asthma therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject participation in the TASMA study&#xD;
&#xD;
          -  Ability and willingness to provide informed consent.&#xD;
&#xD;
          -  Ability to comply with the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject participating in another clinical trial involving respiratory intervention&#xD;
             which in the opinion of the investigator might interfere with the study.&#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>Peter Bonta, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Academisch Medisch Centrum</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>July 2019</verification_date>
  <study_first_submitted>November 21, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>July 2, 2019</last_update_submitted>
  <last_update_submitted_qc>July 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Prof J.T. Annema</investigator_full_name>
    <investigator_title>Prof. Dr. J.T. Annema</investigator_title>
  </responsible_party>
  <keyword>bronchial thermoplasty</keyword>
  <keyword>long term</keyword>
  <keyword>interventional bronchoscopy</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>
  </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/NCT02975284
org study id: NL53703.018.15
nct id: NCT02975284
lead sponsor: 
collaborator: 
has dmc: No
This study evaluates the longterm clinical outcomes, including safety and efficacy parameters
      after Bronchial Thermoplasty (BT) treatment over a period of 5 years. All patients included
      in de TASMA trial in the Netherlands will be asked to participate in the TASMA extension
      study.
observational model: Cohort
time perspective: Prospective
measure: Severe exacerbations rate
time frame: measured yearly over 5 years
description: exacerbations / subject / year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
measure: Emergency room visit for respiratory symptoms rate
time frame: measured yearly over 5 years
description: emergency room visits for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
measure: Hospitalization for respiratory symptoms rate
time frame: measured yearly over 5 years
description: hospitalizations for respiratory symptoms/subject/year measured yearly over 5 years will be compared to the health care utilization pre- and 6 months post BT-treatment.
measure: Pre-and post bronchodilator forced expiratory volume at one second (FEV1) and related FEV1 % reversibility
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: provocative concentration causing a 20% fall (PC20 ) methacholine test
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Fractional exhaled nitric oxide (FeNO)
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Airway-resistance (sRaw) mechanics
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Airway-conductance(sGaw) mechanics
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: forced oscillation technique (FOT)
time frame: measured over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Asthma Control Questionnaire (ACQ) scores
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Asthma Quality of Life Questionnaire (AQLQ) scores
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Maintenance dose of oral steroids
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Maintenance dose of inhaled steroids
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Rescue medication use
time frame: measured yearly over 5 years
description: measured yearly over 5 years compared to the parameters measured pre- and 6 months post-BT treatment
measure: Airway smooth muscle (ASM) mass
time frame: 2 years after inclusion, 2,5 years after BT
description: ASM mass as determined by percentage/absolute ASM surface area and distance of reticular basement membrane (RBM) to ASM layer in endobronchial biopsies
measure: optical coherence tomography (OCT) determined changes
time frame: 2 years after inclusion, 2,5 years after BT
description: OCT determined changes in structural airway remodelling as measured by changes in lumen area (Ai) and airway wall thickness (Aaw).
Two years after BT blood DNA/RNA will be retained
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Peter Bonta, MD PhD
role: Principal Investigator
affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Prof J.T. Annema
investigator title: Prof. Dr. J.T. Annema
mesh term: Asthma
sharing ipd: Undecided