<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/NCT01722773</url>
  </required_header>
  <id_info>
    <org_study_id>NPPV</org_study_id>
    <nct_id>NCT01722773</nct_id>
  </id_info>
  <brief_title>Trial of Non-invasive Ventilation for Stable COPD</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Iowa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Iowa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic&#xD;
      obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded&#xD;
      variable effects on survival, quality of life and dyspnea. The investigators hypothesized&#xD;
      that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Chronic obstructive pulmonary disease (COPD) is associated with progressive decline in lung&#xD;
      function with resultant chronic respiratory failure. This leads to significant rates of&#xD;
      hospitalization, disability, and death. COPD is also associated with sleep disordered&#xD;
      breathing and nocturnal hypoventilation, resulting in nocturnal and daytime hypoxemia and&#xD;
      hypercapnia. These, in turn, can contribute to fatigue, dyspnea and impaired quality of life.&#xD;
      Presence of hypercapnia is associated with a 33% 5-year survival. Nocturnal NPPV can&#xD;
      theoretically rest overloaded respiratory muscles, prevent nocturnal hypoventilation, and&#xD;
      reset central respiratory drive in patients with hypercapnia. The use of non-invasive&#xD;
      positive pressure ventilation (NPPV) in late stage COPD appears logical to change this&#xD;
      inexorable course, to alleviate symptoms and to improve quality of life. While NPPV has a&#xD;
      definite role in the management of acute hypercapnic respiratory failure, its role in the&#xD;
      management of late stage stable COPD is controversial. Multiple studies have shown no&#xD;
      survival benefit for nocturnal NPPV in chronic hypercapnic stable COPD patients. The effects&#xD;
      on quality of life and dyspnea scores in such patients have been inconsistent. The variable&#xD;
      efficacy might have been due to late administration of the intervention in the course of&#xD;
      disease, in the presence of advanced hypercapnic respiratory failure. We sought to assess the&#xD;
      effect of applying NPPV on indices of health-related quality of life in patients with&#xD;
      relative normocapnia. We hypothesized that patients with stable severe COPD have improved&#xD;
      quality of life and reduced dyspnea with the use of NPPV.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2001</start_date>
  <completion_date type="Actual">April 2004</completion_date>
  <primary_completion_date type="Actual">April 2004</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>CRDQ</measure>
    <time_frame>6 months</time_frame>
    <description>Chronic Respiratory Disease Questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>6-minutes walk test</measure>
    <time_frame>6 months</time_frame>
    <description>Walking distances in feet</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>TDI</measure>
    <time_frame>6 months</time_frame>
    <description>Transitional Dyspnea Index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PO2</measure>
    <time_frame>6 months</time_frame>
    <description>Oxygenation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIF</measure>
    <time_frame>6 months</time_frame>
    <description>Negative Inspiratory force</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Side effect questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Side effects with mask use</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>Bipap</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bipap</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard of care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Bipap (Respironics, Inc)</intervention_name>
    <description>Bipap every night pressure at 15/5 with heated humidifier</description>
    <arm_group_label>Bipap</arm_group_label>
    <other_name>Non-invasive Positive pressure ventilation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  stable chronic obstructive pulmonary disease (COPD) defined as forced expiratory&#xD;
             volume in the first second (FEV1)/forced vital capacity (FVC) ratio of &lt;0.70, with at&#xD;
             least 10 pack-years smoking history&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  congestive heart failure, obstructive sleep apnea, chronic respiratory conditions&#xD;
             other than COPD, age &lt; 35 years, any disease limiting life expectancy to less than two&#xD;
             years, active malignancy other than non-melanotic skin cancer in the previous two&#xD;
             years, and with any anatomic variation or disease process that precluded wearing a&#xD;
             nasal mask&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Univeristy of IOwa</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52241</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 1, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 5, 2012</last_update_submitted>
  <last_update_submitted_qc>November 5, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 7, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Iowa</investigator_affiliation>
    <investigator_full_name>Lakshmi Durairaj</investigator_full_name>
    <investigator_title>Staff Physician</investigator_title>
  </responsible_party>
  <keyword>COPD</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/NCT01722773
org study id: NPPV
nct id: NCT01722773
lead sponsor: 
has dmc: No
The use of domiciliary non-invasive positive pressure ventilation (NPPV) in stable chronic
      obstructive pulmonary disease (COPD) with chronic hypercapnic respiratory failure has yielded
      variable effects on survival, quality of life and dyspnea. The investigators hypothesized
      that use of NPPV in stable COPD might result in improvement in quality of life and dyspnea.
Chronic obstructive pulmonary disease (COPD) is associated with progressive decline in lung
      function with resultant chronic respiratory failure. This leads to significant rates of
      hospitalization, disability, and death. COPD is also associated with sleep disordered
      breathing and nocturnal hypoventilation, resulting in nocturnal and daytime hypoxemia and
      hypercapnia. These, in turn, can contribute to fatigue, dyspnea and impaired quality of life.
      Presence of hypercapnia is associated with a 33% 5-year survival. Nocturnal NPPV can
      theoretically rest overloaded respiratory muscles, prevent nocturnal hypoventilation, and
      reset central respiratory drive in patients with hypercapnia. The use of non-invasive
      positive pressure ventilation (NPPV) in late stage COPD appears logical to change this
      inexorable course, to alleviate symptoms and to improve quality of life. While NPPV has a
      definite role in the management of acute hypercapnic respiratory failure, its role in the
      management of late stage stable COPD is controversial. Multiple studies have shown no
      survival benefit for nocturnal NPPV in chronic hypercapnic stable COPD patients. The effects
      on quality of life and dyspnea scores in such patients have been inconsistent. The variable
      efficacy might have been due to late administration of the intervention in the course of
      disease, in the presence of advanced hypercapnic respiratory failure. We sought to assess the
      effect of applying NPPV on indices of health-related quality of life in patients with
      relative normocapnia. We hypothesized that patients with stable severe COPD have improved
      quality of life and reduced dyspnea with the use of NPPV.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: CRDQ
time frame: 6 months
description: Chronic Respiratory Disease Questionnaire
measure: 6-minutes walk test
time frame: 6 months
description: Walking distances in feet
measure: TDI
time frame: 6 months
description: Transitional Dyspnea Index
measure: PO2
time frame: 6 months
description: Oxygenation
measure: NIF
time frame: 6 months
description: Negative Inspiratory force
measure: Side effect questionnaire
time frame: 6 months
description: Side effects with mask use
arm group label: Bipap
arm group type: Active Comparator
description: Bipap
arm group label: Standard of care
arm group type: No Intervention
description: No intervention
intervention type: Device
intervention name: Bipap (Respironics, Inc)
description: Bipap every night pressure at 15/5 with heated humidifier
arm group label: Bipap
other name: Non-invasive Positive pressure ventilation
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Iowa
investigator full name: Lakshmi Durairaj
investigator title: Staff Physician