<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/NCT02258191</url>
  </required_header>
  <id_info>
    <org_study_id>eCOPD 001</org_study_id>
    <nct_id>NCT02258191</nct_id>
  </id_info>
  <brief_title>Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients</brief_title>
  <acronym>eCOPD</acronym>
  <official_title>Pilot Study Evaluating Feasibility and Benefits of Telemonitored NIV Treatment on COPD Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>ResMed</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>ResMed</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive&#xD;
      ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.&#xD;
&#xD;
      Multicentric Randomized Controlled Trial&#xD;
&#xD;
      Primary Objective:&#xD;
&#xD;
      To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term&#xD;
      treatment efficacy and patient compliance&#xD;
&#xD;
      Secondary Objectives:&#xD;
&#xD;
      To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To&#xD;
      carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with&#xD;
      NIV&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Compliance evolution: mean duration usage (hour per day)</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Non-Intentional leaks</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peripheral oxygen saturation (SP02)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apnea Hypopnea Index (AHI)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen desaturation Index (ODI)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time with peripheral oxygen saturation (SP02) &lt; 90%</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>St Georges Quality of Life questionnaire</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6 Minutes Walking Test (6MWT)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Epworth Sleepiness Scale (ESS)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of patients with Ventilatory asynchronisms</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Noninvasive Ventilation (NIV) use duration (hour/day)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of days with noninvasive Ventilation (NIV) use ≥ 4h/day</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of days with noninvasive Ventilation (NIV) use &lt; 4h/day</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>% of days with no Noninvasive Ventilation (NIV) use</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>NIV treatment with telemonitoring</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>telemonitoring is used to manage NIV treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIV treatment with sham telemonitoring</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>sham telemonitoring (data not used for NIV management)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>telemonitoring</intervention_name>
    <arm_group_label>NIV treatment with telemonitoring</arm_group_label>
    <other_name>Easy Care online</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham telemonitoring</intervention_name>
    <arm_group_label>NIV treatment with sham telemonitoring</arm_group_label>
    <other_name>Easy Care online</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patient already treated by NIV requiring therapy assessment in their routine care&#xD;
             Follow-Up or&#xD;
&#xD;
          -  COPD patient requiring de Novo NIV therapy according to routine care rules (NIV&lt;12h)&#xD;
&#xD;
          -  Patient requiring NIV therapy by S9 VPAP ST +/- oxygen therapy&#xD;
&#xD;
          -  Patient willing to participate to the study&#xD;
&#xD;
          -  Patient or attendant able to complete patient passport and to come to Follow-Up&#xD;
             visits.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  NIV therapy Failure during screening phase (intolerance, patient refusal, significant&#xD;
             leaks, significant AHI or Oxymetry events)&#xD;
&#xD;
          -  Hospitalization conducting to NIV discontinuation for at least 1 week during the&#xD;
             screening phase&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thibaut Gentina, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Privé la Louvière - Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital privé la Louvière</name>
      <address>
        <city>Lille</city>
        <zip>59000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 24, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <last_update_submitted>January 22, 2018</last_update_submitted>
  <last_update_submitted_qc>January 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NIV</keyword>
  <keyword>COPD</keyword>
  <keyword>telemonitoring</keyword>
  <!-- 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/NCT02258191
org study id: eCOPD 001
nct id: NCT02258191
lead sponsor: 
has dmc: No
Pilot study evaluating feasibility and benefits of telemonitored NIV (noninvasive
      ventilation) treatment on COPD (chronic obstructive pulmonary disease) patients.

      Multicentric Randomized Controlled Trial

      Primary Objective:

      To evaluate benefits of telemonitoring system, Easy Care Online (ECO), on NIV long term
      treatment efficacy and patient compliance

      Secondary Objectives:

      To determine predictive factors of COPD exacerbation in patients treated by NIV with ECO To
      carry out a health economic evaluation on telemonitoring benefits in COPD pts treated with
      NIV
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Blood Gaz and nocturnal transcutaneous carbon dioxyde partial pressure (PtCO2) evolution
time frame: 12 months
measure: Compliance evolution: mean duration usage (hour per day)
time frame: 12 months
measure: Non-Intentional leaks
time frame: 12 months
measure: Peripheral oxygen saturation (SP02)
time frame: 12 months
measure: Apnea Hypopnea Index (AHI)
time frame: 12 months
measure: Oxygen desaturation Index (ODI)
time frame: 12 months
measure: Time with peripheral oxygen saturation (SP02) < 90%
time frame: 12 months
measure: St Georges Quality of Life questionnaire
time frame: 12 months
measure: 6 Minutes Walking Test (6MWT)
time frame: 12 months
measure: The Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity - (BODE) Index
time frame: 12 months
measure: Epworth Sleepiness Scale (ESS)
time frame: 12 months
measure: % of patients with Ventilatory asynchronisms
time frame: 12 months
measure: Mean Noninvasive Ventilation (NIV) use duration (hour/day)
time frame: 12 months
measure: % of days with noninvasive Ventilation (NIV) use ≥ 4h/day
time frame: 12 months
measure: % of days with noninvasive Ventilation (NIV) use < 4h/day
time frame: 12 months
measure: % of days with no Noninvasive Ventilation (NIV) use
time frame: 12 months
arm group label: NIV treatment with telemonitoring
arm group type: Active Comparator
description: telemonitoring is used to manage NIV treatment
arm group label: NIV treatment with sham telemonitoring
arm group type: Sham Comparator
description: sham telemonitoring (data not used for NIV management)
intervention type: Device
intervention name: telemonitoring
arm group label: NIV treatment with telemonitoring
other name: Easy Care online
intervention type: Device
intervention name: sham telemonitoring
arm group label: NIV treatment with sham telemonitoring
other name: Easy Care online
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Thibaut Gentina, MD
role: Principal Investigator
affiliation: Hôpital Privé la Louvière - Lille
facility: 
country: France
responsible party type: Sponsor