<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/NCT03299764</url>
  </required_header>
  <id_info>
    <org_study_id>DZL PBLV Trial</org_study_id>
    <nct_id>NCT03299764</nct_id>
  </id_info>
  <brief_title>Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD</brief_title>
  <official_title>Evaluation of Non-invasive Pursed-lip Breathing Ventilation (PLBV) in Advanced COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Research Center Borstel</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Research Center Borstel</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>
      Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing&#xD;
      ventilation (PLBV) ventilation in advanced COPD&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention:&#xD;
&#xD;
      Non-invasive ventilation with dynamic positive pressure during expiration (pursed-lip&#xD;
      breathing ventilation, PLBV) Control Conventional bi-level non-invasive ventilation (NIV)&#xD;
      with static positive pressures Duration of intervention per patient 3 months as randomized&#xD;
      (1:1) followed by 9 months as chosen by patient&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">July 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">November 1, 2021</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Walking distance in 6-minutes walking test</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of hospital admissions</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Non-invasive ventilation with pursed lip breathing ventilation device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Non-invasive ventilation with standard non-invasive ventilation device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pursed lip breathing ventilation</intervention_name>
    <description>A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard non-invasive ventilation</intervention_name>
    <description>Standard non-invasive ventilation</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Signed informed consent&#xD;
&#xD;
          2. Age &gt;40 years&#xD;
&#xD;
          3. COPD diagnosis known for at least 12 months&#xD;
&#xD;
          4. NIV therapy for at least 3 months&#xD;
&#xD;
        4. Regular use of NIV with extrapolated usage time of at least 700 hours / year 5. Current&#xD;
        inspiratory NIV pressure ≥20 mbar 6. Patient understands the requirements of the study 7.&#xD;
        Patient is able to follow the study protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Current COPD exacerbation (is allowed 4 weeks after end of treatment)&#xD;
&#xD;
          2. Radiologically proven pneumonia within the past month&#xD;
&#xD;
          3. Other leading pulmonary illness&#xD;
&#xD;
          4. Tracheostomy&#xD;
&#xD;
          5. Pneumothorax&#xD;
&#xD;
          6. Pregnancy or lactation&#xD;
&#xD;
          7. BMI &gt;35 kg/m²&#xD;
&#xD;
          8. Steroid therapy with &gt;15 mg prednisolon daily for &gt;1 month&#xD;
&#xD;
          9. Condition causing hypercapnia other than COPD&#xD;
&#xD;
         10. 6MWT distance of &gt;300 meters within the last 7 days&#xD;
&#xD;
         11. Previous therapy with the Vigaro NIV device&#xD;
&#xD;
         12. Weight loss of more than 5 kg / 12 months&#xD;
&#xD;
         13. Further criteria to exclude confounding factors&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Christian Herzmann, MD</last_name>
    <phone>+494537</phone>
    <phone_ext>1888080</phone_ext>
    <email>lippenbremse@fz-borstel.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>Thoraxklinik Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>69126</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M Schellenberg, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Waldburg-Zeil Kliniken - Fachkliniken Wangen</name>
      <address>
        <city>Wangen</city>
        <state>Baden-Württemberg</state>
        <zip>88239</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Susanne Hirschmann, SN</last_name>
      <phone>+49-7522797</phone>
      <phone_ext>1037</phone_ext>
      <email>susanne.hirschmann@wz-kliniken.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Research Center Borstel</name>
      <address>
        <city>Borstel</city>
        <state>Schleswig-Holstein</state>
        <zip>23845</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>C Herzmann, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>LungenClinic Großhansdorf</name>
      <address>
        <city>Großhansdorf</city>
        <state>Schleswig-Holstein</state>
        <zip>22937</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>M Oldigs, MD</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>Lungenklinik Hemer</name>
      <address>
        <city>Hemer</city>
        <zip>58675</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Michael Westhoff, MD</last_name>
      <phone>+49-2372 908</phone>
      <phone_ext>2201</phone_ext>
      <email>michael.westhoff@lkhemer.de</email>
    </contact>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</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/NCT03299764
org study id: DZL PBLV Trial
nct id: NCT03299764
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Comparison of a conventional non-invasive ventilation to a non-invasive pursed-lip breathing
      ventilation (PLBV) ventilation in advanced COPD
Intervention:

      Non-invasive ventilation with dynamic positive pressure during expiration (pursed-lip
      breathing ventilation, PLBV) Control Conventional bi-level non-invasive ventilation (NIV)
      with static positive pressures Duration of intervention per patient 3 months as randomized
      (1:1) followed by 9 months as chosen by patient
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Walking distance in 6-minutes walking test
time frame: 3 months
measure: Mortality
time frame: 12 months
measure: Number of hospital admissions
time frame: 12 months
arm group label: Intervention
arm group type: Experimental
description: Non-invasive ventilation with pursed lip breathing ventilation device
arm group label: Control
arm group type: Active Comparator
description: Non-invasive ventilation with standard non-invasive ventilation device
intervention type: Device
intervention name: Pursed lip breathing ventilation
description: A non-invasive ventilation device mimicking the pursed lip breathing in COPD patients will be used.
arm group label: Intervention
intervention type: Device
intervention name: Standard non-invasive ventilation
description: Standard non-invasive ventilation
arm group label: Control
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Christian Herzmann, MD
phone: +494537
phone ext: 1888080
email: lippenbremse@fz-borstel.de
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: Germany
responsible party type: Sponsor