<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/NCT03264768</url>
  </required_header>
  <id_info>
    <org_study_id>s60207</org_study_id>
    <nct_id>NCT03264768</nct_id>
  </id_info>
  <brief_title>Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium</brief_title>
  <acronym>BEVA</acronym>
  <official_title>Endoscopic Long Volume Reduction by Endobronchial Valves in Belgium</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This a single center non-randomised non-sham controlled intervention study evaluating the&#xD;
      effectiveness and safety of endoscopic lung volume reduction by endobronchial valves&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary objective of the current study is to explore the effect of targeted lobar&#xD;
      endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent&#xD;
      collateral ventilation, on lung function, exercise capacity and physical activity. As a&#xD;
      secondary objective, changes in physical activity as result of a 3 month activity coaching&#xD;
      program delivered between 3 to 6 months post intervention will be investigated. Exploratory&#xD;
      objectives are to extend insight in the clinical characteristics of responders and&#xD;
      non-responders and to address relationships between lung function response, physical&#xD;
      functioning and its impact on inflammation, skeletal and cardiac function. Furthermore,&#xD;
      comparison of the effects on lung function, exercise capacity, quality of life and physical&#xD;
      activity between endoscopic lung volume reduction and surgical lung volume reduction will be&#xD;
      made.&#xD;
&#xD;
      The study will also explore if treatment response can be optimised by an intermediate&#xD;
      evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning&#xD;
      of the endobronchial valves will be imposed in case no lober atelectasis is visualised.&#xD;
&#xD;
      .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>response rate of FEV1 at 3 months post intervention</measure>
    <time_frame>3 months</time_frame>
    <description>proportion of patients with a minimal change of FEV1 &gt; 100 ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>response rate on SGRQ at 3 months and 6 months post intervention</measure>
    <time_frame>3 months and 6 months post intervention</time_frame>
    <description>proportion of patients with a minimal change of -4 points on SGRQ</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention</measure>
    <time_frame>3 months and 6 months post intervention</time_frame>
    <description>proportion of patients with a minimal improvement of 30 meters on 6MWD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response rate on residual volume (RV) at 3 months and 6 months post intervention</measure>
    <time_frame>3 months and 6 months post intervention</time_frame>
    <description>proportion of patients with a minimal reduction of 400 ml on residual volume</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response rate on FEV1 at 6 months post intervention</measure>
    <time_frame>6 months</time_frame>
    <description>proportion of patients with a minimal change of FEV1 &gt; 100 ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention</measure>
    <time_frame>3 months and 6 months post intervention</time_frame>
    <description>proportion of patients with a minimal change of -1 point on TDI</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention</measure>
    <time_frame>3 months and 6 months post intervention</time_frame>
    <description>Absolute difference from baseline values (liters)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in RV/TLC ratio (%) at 3 and 6 months post intervention</measure>
    <time_frame>3 months and 6 months post intervention</time_frame>
    <description>Absolute difference from baseline values (%)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in 6MWD (meters) at 3 and 6 months post intervention</measure>
    <time_frame>3 months and 6 months post intervention</time_frame>
    <description>Absolute difference from baseline values (meters)</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in physical activity at 3 months post intervention</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Absolute difference in stepcounts per day (n) from baseline values</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in ProActive clinical visit questionnaire</measure>
    <time_frame>3 months post intervention</time_frame>
    <description>Absolute difference in points from baseline values</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in BODE index</measure>
    <time_frame>3 months and 6 months post intervention</time_frame>
    <description>Absolute difference in points from baseline values</description>
  </other_outcome>
  <other_outcome>
    <measure>changes in physical activity between 3 and 6 months of follow up (telecoaching period)</measure>
    <time_frame>3 months - 6 months post allocation</time_frame>
    <description>Absolute difference in stepcounts per day (n) 3 months - 6 months post allocation</description>
  </other_outcome>
  <other_outcome>
    <measure>changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period)</measure>
    <time_frame>3 months - 6 months post allocation</time_frame>
    <description>Absolute difference in points 3 months - 6 months post allocation</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparing change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post EBV and LVRS</measure>
    <time_frame>3 months and 6 months post intervention (endoscopic or surgical)</time_frame>
    <description>Absolute difference from baseline values (liters) for both interventions</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparing change in 6MWD at 3 and 6 months post EBV and LVRS</measure>
    <time_frame>3 months and 6 months post intervention (endoscopic or surgical)</time_frame>
    <description>Absolute difference from baseline values (meters) for both interventions</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparing change in physical activity at 3 and 6 months post EBV and LVRS</measure>
    <time_frame>3 months and 6 months post intervention (endoscopic or surgical)</time_frame>
    <description>Absolute difference from baseline values (amount of steps per day) for both interventions</description>
  </other_outcome>
  <other_outcome>
    <measure>Comparing change in SGRQ at 3 and 6 months post EBV and LVRS</measure>
    <time_frame>3 months and 6 months post intervention (endoscopic or surgical)</time_frame>
    <description>Absolute difference from baseline values for both interventions</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endobronchial valves</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>endobronchial valves</intervention_name>
    <description>A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.</description>
    <arm_group_label>Endobronchial valves</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>physical activity tele coaching</intervention_name>
    <description>3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.</description>
    <arm_group_label>Endobronchial valves</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lung volume reduction surgery (LVRS)</intervention_name>
    <description>Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.</description>
    <arm_group_label>Endobronchial valves</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 40 - 75 years&#xD;
&#xD;
          -  Confluent or destructive heterogeneous emphysema on CT&#xD;
&#xD;
          -  Smoking cessation for at least 6m (proven by urinary cotinine levels)&#xD;
&#xD;
          -  FEV1 &lt; 60 %predicted, RV &gt; 150 %predicted, TLC &gt; 90 %predicted&#xD;
&#xD;
          -  RV/TLC ratio ≥ 0.55&#xD;
&#xD;
          -  6MWD &lt; 450 meter&#xD;
&#xD;
          -  mMRC ≥ 2&#xD;
&#xD;
          -  Visual estimation of 70% complete fissure between target lobe and adjacent lobe on CT&#xD;
             of referring physician&#xD;
&#xD;
          -  LABA-LAMA bronchodilator therapy as a minimum therapy&#xD;
&#xD;
          -  Able to sign informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Homogenous emphysema&#xD;
&#xD;
          -  PaCO2 &gt; 60 mmHg with ambient air&#xD;
&#xD;
          -  PaO2 &lt; 45 mmHg with ambient air&#xD;
&#xD;
          -  Previous LVRS, lung transplantation, lobectomy&#xD;
&#xD;
          -  TLCO or FEV1 &lt; 20% predicted&#xD;
&#xD;
          -  Significant pulmonary hypertension (PaPsyst &gt; 50 mm Hg)&#xD;
&#xD;
          -  Heart failure with reduced EF (&lt; 40%)&#xD;
&#xD;
          -  6MWD &lt; 100 meter&#xD;
&#xD;
          -  BODE index ≥ 7 and eligible for transplantation&#xD;
&#xD;
          -  Active cancer&#xD;
&#xD;
          -  Life expectancy &lt; 3 months&#xD;
&#xD;
          -  Significant lung disease other than COPD/emphysema&#xD;
&#xD;
          -  Unable to comply with study procedures&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wim Janssens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University hospital Leuven, Belgium</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dooms Christophe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospial Leuven, Belgium</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Karen Denaux, sc, nurse</last_name>
    <phone>016 34 19 66</phone>
    <phone_ext>0032</phone_ext>
    <email>karen.denaux@uzleuven.be</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kristien De Bent, sc</last_name>
    <phone>016 34 17 01</phone>
    <phone_ext>0032</phone_ext>
    <email>krisiten.debent@uzleuven.be</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Flanders</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>October 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>October 23, 2019</last_update_submitted>
  <last_update_submitted_qc>October 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">October 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Wim Janssens</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>valves</keyword>
  <keyword>Chronic Obstructive Pulmonary Disease</keyword>
  <keyword>endoscopic long volume reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03264768
org study id: s60207
nct id: NCT03264768
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This a single center non-randomised non-sham controlled intervention study evaluating the
      effectiveness and safety of endoscopic lung volume reduction by endobronchial valves
The primary objective of the current study is to explore the effect of targeted lobar
      endobronchial lung volume reduction in symptomatic patients with severe emphysema and absent
      collateral ventilation, on lung function, exercise capacity and physical activity. As a
      secondary objective, changes in physical activity as result of a 3 month activity coaching
      program delivered between 3 to 6 months post intervention will be investigated. Exploratory
      objectives are to extend insight in the clinical characteristics of responders and
      non-responders and to address relationships between lung function response, physical
      functioning and its impact on inflammation, skeletal and cardiac function. Furthermore,
      comparison of the effects on lung function, exercise capacity, quality of life and physical
      activity between endoscopic lung volume reduction and surgical lung volume reduction will be
      made.

      The study will also explore if treatment response can be optimised by an intermediate
      evaluation with CT scan one month after intervention. Endoscopic evaluation and repositioning
      of the endobronchial valves will be imposed in case no lober atelectasis is visualised.

      .
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: response rate of FEV1 at 3 months post intervention
time frame: 3 months
description: proportion of patients with a minimal change of FEV1 > 100 ml
measure: response rate on SGRQ at 3 months and 6 months post intervention
time frame: 3 months and 6 months post intervention
description: proportion of patients with a minimal change of -4 points on SGRQ
measure: response rate on 6 minutes walking distance (6MWD) at 3 months and 6 months post intervention
time frame: 3 months and 6 months post intervention
description: proportion of patients with a minimal improvement of 30 meters on 6MWD
measure: response rate on residual volume (RV) at 3 months and 6 months post intervention
time frame: 3 months and 6 months post intervention
description: proportion of patients with a minimal reduction of 400 ml on residual volume
measure: response rate on FEV1 at 6 months post intervention
time frame: 6 months
description: proportion of patients with a minimal change of FEV1 > 100 ml
measure: response rate on Transitional dyspnee index (TDI) at 3 months and 6 months post intervention
time frame: 3 months and 6 months post intervention
description: proportion of patients with a minimal change of -1 point on TDI
measure: Change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post intervention
time frame: 3 months and 6 months post intervention
description: Absolute difference from baseline values (liters)
measure: Change in RV/TLC ratio (%) at 3 and 6 months post intervention
time frame: 3 months and 6 months post intervention
description: Absolute difference from baseline values (%)
measure: Change in 6MWD (meters) at 3 and 6 months post intervention
time frame: 3 months and 6 months post intervention
description: Absolute difference from baseline values (meters)
measure: Change in physical activity at 3 months post intervention
time frame: 3 months post intervention
description: Absolute difference in stepcounts per day (n) from baseline values
measure: Change in ProActive clinical visit questionnaire
time frame: 3 months post intervention
description: Absolute difference in points from baseline values
measure: Change in BODE index
time frame: 3 months and 6 months post intervention
description: Absolute difference in points from baseline values
measure: changes in physical activity between 3 and 6 months of follow up (telecoaching period)
time frame: 3 months - 6 months post allocation
description: Absolute difference in stepcounts per day (n) 3 months - 6 months post allocation
measure: changes in ProActive clinical visit questionnaire between 3 and 6 months of follow up (telecoaching period)
time frame: 3 months - 6 months post allocation
description: Absolute difference in points 3 months - 6 months post allocation
measure: Comparing change in FEV1 (liters), FVC (liters), RV (liters), TLC (liters) at 3 and 6 months post EBV and LVRS
time frame: 3 months and 6 months post intervention (endoscopic or surgical)
description: Absolute difference from baseline values (liters) for both interventions
measure: Comparing change in 6MWD at 3 and 6 months post EBV and LVRS
time frame: 3 months and 6 months post intervention (endoscopic or surgical)
description: Absolute difference from baseline values (meters) for both interventions
measure: Comparing change in physical activity at 3 and 6 months post EBV and LVRS
time frame: 3 months and 6 months post intervention (endoscopic or surgical)
description: Absolute difference from baseline values (amount of steps per day) for both interventions
measure: Comparing change in SGRQ at 3 and 6 months post EBV and LVRS
time frame: 3 months and 6 months post intervention (endoscopic or surgical)
description: Absolute difference from baseline values for both interventions
arm group label: control
arm group type: Other
description: standard care in case collateral ventilation is observed (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post allocation.
arm group label: Endobronchial valves
arm group type: Experimental
description: Endobronchial valves in case collateral ventilation is absent (by Chartis) with 3 months physical activity tele coaching between 3 and 6 months post intervention.
intervention type: Device
intervention name: endobronchial valves
description: A ambulatory diagnostic bronchoscopy under general anesthesia will evaluate the presence or absence of collateral ventilation . The targeted lobar airway is temporarily occluded by means of a balloon catheter, which blocks inspiratory flow but allows expiratory flow, in order to assess whether the air flow gradually declines to zero, meaning absence of collateral ventilation. Only in case collateral ventilation is excluded, a therapeutic bronchoscopy will be scheduled to insert the one-directional endobronchial valves in the targeted lobar airways. We will only perform a unilateral intervention during which we will treat one or maximal two lobes at one side.
arm group label: Endobronchial valves
intervention type: Behavioral
intervention name: physical activity tele coaching
description: 3 month physical activity tele coaching intervention consisting of a project tailored smartphone application in combination with a step counter providing direct feedback.
arm group label: Endobronchial valves
arm group label: control
intervention type: Procedure
intervention name: Lung volume reduction surgery (LVRS)
description: Patients not eligible for endoscopic lung volume reduction (or non responders of this intervention) can be referred for surgical lung volume reduction. With this procedure, the most emphysematous parts of the lungs will be surgically removed.
arm group label: Endobronchial valves
arm group label: control
criteria: 
gender: All
minimum age: 40 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wim Janssens, MD
role: Principal Investigator
affiliation: University hospital Leuven, Belgium
last name: Dooms Christophe, MD
role: Principal Investigator
affiliation: University Hospial Leuven, Belgium
last name: Karen Denaux, sc, nurse
phone: 016 34 19 66
phone ext: 0032
email: karen.denaux@uzleuven.be
last name: Kristien De Bent, sc
phone: 016 34 17 01
phone ext: 0032
email: krisiten.debent@uzleuven.be
facility: 
status: Recruiting
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Wim Janssens
investigator title: Clinical Professor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No