<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/NCT04419428</url>
  </required_header>
  <id_info>
    <org_study_id>SRC_HRC_VectorEUReg_2019_10820</org_study_id>
    <nct_id>NCT04419428</nct_id>
  </id_info>
  <brief_title>A40 Expiratory Flow Limitation Registry</brief_title>
  <official_title>A40 EFL Registry: A Multicenter Prospective Study to Determine the Role of Expiratory Flow Limitation (EFL) in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Home Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Philips Clinical &amp; Medical Affairs Global</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Philips Clinical &amp; Medical Affairs Global</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>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective observational multicenter registry study will include adults greater than 40&#xD;
      years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive&#xD;
      ventilation as part of standard medical care. For the purposes of this study, chronic&#xD;
      obstructive pulmonary disease is defined as chronic respiratory failure consisting of&#xD;
      historical spirometry vales (FEV1 &lt;60% predicted and FEV1/VC &lt; 0.7) and chronic increased&#xD;
      daytime carbon dioxide levels greater than 6.0 kPa or 45 mmHg. In addition, participants&#xD;
      diagnosed with major organ system diseases or obstructive sleep apnea will be excluded. At&#xD;
      least 100 men and women who consent and meet the inclusion/exclusion criteria will be asked&#xD;
      to participate. The anticipated study duration will be 6 months. The study will involve an&#xD;
      initial visit for the standard of care initiation of home noninvasive ventilation. At this&#xD;
      time, potential participants will be screened for participation. If eligible once consented,&#xD;
      medical history will be collected and baseline questionnaires related to their respiratory&#xD;
      disease will be completed. The registry study will include 6 month of home use of the&#xD;
      noninvasive ventilator using the BiPAP A40 EFL device. Study staff will reach out to&#xD;
      participants on a monthly basis to review any issues, medication changes, unscheduled visits,&#xD;
      and device data download. Additional phone calls and or visits may occur on an as needed&#xD;
      basis if issues arise. The final visit will be an in facility visit. The primary endpoint&#xD;
      will be the overall prevalence of Expiratory Flow Limitation (EFL) in ventilated hypercapnic&#xD;
      COPD patients, as defined as the percentage participants exhibiting a DeltaXrs value greater&#xD;
      than or equal to 2.8 during one or more nights of therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospective observational multicenter registry study for chronic obstructive pulmonary&#xD;
      disease patients who require noninvasive ventilation in the home setting as part of standard&#xD;
      medical care. The registry includes one in person screening or baseline visit, monthly&#xD;
      follow-up phone calls (monitoring for medication changes, unscheduled visits and adverse&#xD;
      events) and device data downloads, and a final in person study visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">February 2024</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Anticipated">September 2025</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Screening Expiratory flow limitation</measure>
    <time_frame>Screening</time_frame>
    <description>Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 at the time of screening.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Expiratory flow limitation post therapy</measure>
    <time_frame>6 months</time_frame>
    <description>Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 during one of more nights of therapy.</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BiPAP A40 Expiratory Flow Limitation (EFL)</intervention_name>
    <description>All participants in the observational registry will be using the BiPAP A40 EFL noninvasive ventilator as part of standard of care and will be participating in the same follows up and data collection. The BiPAP A-40 EFL ventilator is intended to provide non-invasive ventilatory support to treat adult patients with Respiratory Insufficiency with the primary cause being COPD. It is intended to be used within the home, institution/hospital, and diagnostic laboratory environments.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female adults greater than 40 years old, diagnosed with chronic obstructive&#xD;
        pulmonary disease, requiring home noninvasive ventilation as part of standard medical care.&#xD;
        For the purposes of this study, chronic obstructive pulmonary disease is defined as chronic&#xD;
        respiratory failure consisting of historical spirometry vales (FEV1 &lt;60% predicted and&#xD;
        FEV1/VC &lt; 0.7) and chronic increased daytime carbon dioxide levels greater than 6.0 kPa or&#xD;
        45 mmHg. In addition, participants diagnosed with major organ system diseases or&#xD;
        obstructive sleep apnea will be excluded. At least 100 men and women who consent and meet&#xD;
        the inclusion/exclusion criteria will be asked to participate.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic Obstructive Pulmonary Disease&#xD;
&#xD;
          -  Forced Expiratory Volume (FEV1) &lt; 60% predicted&#xD;
&#xD;
          -  Forced Expiratory Volume (FEV1) / Vital Capacity (VC) ratio &lt; 0.7&#xD;
&#xD;
          -  Greater than 40 years old&#xD;
&#xD;
          -  Chronic hypercapnia (daytime carbon dioxide level PaCO2 &gt; 6.0 kPa)&#xD;
&#xD;
          -  No clinical diagnosis of Obstructive Sleep Apnea&#xD;
&#xD;
          -  Smoking history &gt; 10 pack year&#xD;
&#xD;
          -  Body mass index (BMI) ≤ 35kg/m2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypercapnic respiratory acidosis defined as pH (measure of hydrogen ion, measure of&#xD;
             the acidity or alkalinity of a fluid) &lt;7.35&#xD;
&#xD;
          -  Acute coronary syndrome and unstable angina&#xD;
&#xD;
          -  Cognitive impairment that would prevent informed consent into the trial and/or&#xD;
             inability to comply with the protocol&#xD;
&#xD;
          -  Patients undergoing renal replacement therapy&#xD;
&#xD;
          -  Patients with serious comorbidities confirming prognosis likely to be less than&#xD;
             12-months&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Congestive Heart Failure (CHF) with ejection fraction (EF) less than 45% determined by&#xD;
             Echo if available&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Michael Polkey, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Royal Brompton &amp; Harefield NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lynn Ostrowski, BSN, RN</last_name>
    <phone>412-542-3709</phone>
    <email>lynn.ostrowski@philips.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Chuck Cain, BS</last_name>
    <phone>412-542-3605</phone>
    <email>chuck.cain@philips.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Royal Brompton Hospital</name>
      <address>
        <city>London</city>
        <zip>SW3 6NP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <contact>
      <last_name>Michael Polkey, MD, PhD</last_name>
      <phone>0044 20 7352 8121</phone>
      <email>M.Polkey@rbht.nhs.uk</email>
    </contact>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>May 14, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 5, 2020</study_first_posted>
  <last_update_submitted>April 25, 2023</last_update_submitted>
  <last_update_submitted_qc>April 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Noninvasive ventilation</keyword>
  <keyword>Daytime Hypercapnia</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/NCT04419428
org study id: SRC_HRC_VectorEUReg_2019_10820
nct id: NCT04419428
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This prospective observational multicenter registry study will include adults greater than 40
      years old, diagnosed with chronic obstructive pulmonary disease, requiring home noninvasive
      ventilation as part of standard medical care. For the purposes of this study, chronic
      obstructive pulmonary disease is defined as chronic respiratory failure consisting of
      historical spirometry vales (FEV1 <60% predicted and FEV1/VC < 0.7) and chronic increased
      daytime carbon dioxide levels greater than 6.0 kPa or 45 mmHg. In addition, participants
      diagnosed with major organ system diseases or obstructive sleep apnea will be excluded. At
      least 100 men and women who consent and meet the inclusion/exclusion criteria will be asked
      to participate. The anticipated study duration will be 6 months. The study will involve an
      initial visit for the standard of care initiation of home noninvasive ventilation. At this
      time, potential participants will be screened for participation. If eligible once consented,
      medical history will be collected and baseline questionnaires related to their respiratory
      disease will be completed. The registry study will include 6 month of home use of the
      noninvasive ventilator using the BiPAP A40 EFL device. Study staff will reach out to
      participants on a monthly basis to review any issues, medication changes, unscheduled visits,
      and device data download. Additional phone calls and or visits may occur on an as needed
      basis if issues arise. The final visit will be an in facility visit. The primary endpoint
      will be the overall prevalence of Expiratory Flow Limitation (EFL) in ventilated hypercapnic
      COPD patients, as defined as the percentage participants exhibiting a DeltaXrs value greater
      than or equal to 2.8 during one or more nights of therapy.
Prospective observational multicenter registry study for chronic obstructive pulmonary
      disease patients who require noninvasive ventilation in the home setting as part of standard
      medical care. The registry includes one in person screening or baseline visit, monthly
      follow-up phone calls (monitoring for medication changes, unscheduled visits and adverse
      events) and device data downloads, and a final in person study visit.
observational model: Case-Only
time perspective: Prospective
measure: Screening Expiratory flow limitation
time frame: Screening
description: Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 at the time of screening.
measure: Expiratory flow limitation post therapy
time frame: 6 months
description: Percentage of participants exhibiting an expiratory flow limitation (Delta Xrs value) greater than or equal to 2.8 during one of more nights of therapy.
intervention type: Device
intervention name: BiPAP A40 Expiratory Flow Limitation (EFL)
description: All participants in the observational registry will be using the BiPAP A40 EFL noninvasive ventilator as part of standard of care and will be participating in the same follows up and data collection. The BiPAP A-40 EFL ventilator is intended to provide non-invasive ventilatory support to treat adult patients with Respiratory Insufficiency with the primary cause being COPD. It is intended to be used within the home, institution/hospital, and diagnostic laboratory environments.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 85 Years
last name: Michael Polkey, MD, PhD
role: Principal Investigator
affiliation: Royal Brompton & Harefield NHS Foundation Trust
last name: Lynn Ostrowski, BSN, RN
phone: 412-542-3709
email: lynn.ostrowski@philips.com
last name: Chuck Cain, BS
phone: 412-542-3605
email: chuck.cain@philips.com
facility: 
contact: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No