<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/NCT01684384</url>
  </required_header>
  <id_info>
    <org_study_id>FLUI-2011-79</org_study_id>
    <nct_id>NCT01684384</nct_id>
  </id_info>
  <brief_title>Research to Evaluate a Possible Relation Between Values Obtained After Processing CT Images, Lung Function Tests and the Experience of the Patient During an Exacerbation in COPD Patients.</brief_title>
  <official_title>Correlation of Functional Respiratory Imaging Parameters With Lung Function Parameters and Patient Reported Outcome Measures During Exacerbation of COPD.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>FLUIDDA nv</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>FLUIDDA nv</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the consequences of exacerbations will be visualized by high resolution&#xD;
      computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity&#xD;
      (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based&#xD;
      airway dimensions and computational fluid dynamic (CFD) -based resistance values will be&#xD;
      correlated with changes in patient reported outcomes (PROs) and lung function tests recorded&#xD;
      at the same time.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2014</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes in functional respiratory imaging parameters</measure>
    <time_frame>Baseline (= during exacerbation) and after about 6 weeks (= after recovering)</time_frame>
    <description>The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in lung function parameters</measure>
    <time_frame>Baseline (= during exacerbation) and after about 6 weeks (= after recovering)</time_frame>
    <description>The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in patient reported outcome (PRO) measures</measure>
    <time_frame>Baseline (= during exacerbation) and after about 6 weeks (= after recovering)</time_frame>
    <description>The secondary objective is to check if the changes in CFD data actually correlate better with changes in PRO than changes in lung function parameters.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Reproducibility of segmentation</measure>
    <time_frame>Within 1 month of visit</time_frame>
    <description>As tertiary objective the reproducibility of the segmentations done by the centers will be evaluated. To accomplish reproducible segmentations the multiple centers will be guided to perform accurate segmentations, and bottlenecks in the usage of the program will be identified and resolved in order to simplify it where necessary and possible.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Functional Respiratory Imaging</intervention_name>
    <description>HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.</description>
    <arm_group_label>No treatment</arm_group_label>
    <other_name>HRCT scan</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female, ≥ 40 years old&#xD;
&#xD;
          -  COPD as defined by the global Initiative on obstructive lung disease4&#xD;
&#xD;
          -  Post-bronchodilator FEV1/FVC &lt; 70% AND post-bronchodilator FEV1 &lt;80%pred as documented&#xD;
             in the last 5 years.&#xD;
&#xD;
          -  Smoking history of at least 10 pack-years&#xD;
&#xD;
          -  At entry in the study experiencing an exacerbation defined as an acute change in the&#xD;
             patient 's baseline dyspnea, cough, and/or sputum that is beyond normal day to day&#xD;
             variations, and that necessitates the administration or doubling of systemic&#xD;
             corticosteroid treatment.&#xD;
&#xD;
          -  Patients must be able to understand and complete protocol requirements, instructions,&#xD;
             questionnaires and protocol-stated restrictions.&#xD;
&#xD;
          -  Written and signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating females&#xD;
&#xD;
          -  Patient diagnosed with asthma&#xD;
&#xD;
          -  Patient with pneumonia as defined radiologically at the start of the exacerbation&#xD;
&#xD;
          -  Patient with a history of or presence of lung cancer&#xD;
&#xD;
          -  Patient with an indication for non-invasive ventilation&#xD;
&#xD;
          -  Patient unlikely to comply with the protocol or unable to understand the nature, scope&#xD;
             and possible consequences of the study.&#xD;
&#xD;
          -  Patient who received any investigational new drug within the last 4 weeks prior to&#xD;
             visit 1.&#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_official>
    <last_name>Wilfried De Backer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Antwerp</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Huib AM Kerstjens, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Emiel FM Wouters, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Maastricht University Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Massimo Pistolesi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Florence</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Antwerp University Hospital</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Florence</name>
      <address>
        <city>Florence</city>
        <zip>50134</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <zip>9700RB</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maastricht University Medical Center</name>
      <address>
        <city>Maastricht</city>
        <zip>6229HX</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Italy</country>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>November 2014</verification_date>
  <study_first_submitted>September 6, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 13, 2012</study_first_posted>
  <last_update_submitted>November 26, 2014</last_update_submitted>
  <last_update_submitted_qc>November 26, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary Disease, Chronic Obstructive</keyword>
  <keyword>COPD</keyword>
  <keyword>Exacerbation</keyword>
  <keyword>Functional Respiratory Imaging</keyword>
  <keyword>High Resolution Computed Tomography</keyword>
  <keyword>HRCT scan</keyword>
  <keyword>Patient Reported Outcome</keyword>
  <keyword>PRO</keyword>
  <keyword>Computational Fluid Dynamic</keyword>
  <keyword>CFD</keyword>
  <keyword>Lung function parameters</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01684384
org study id: FLUI-2011-79
nct id: NCT01684384
lead sponsor: 
has dmc: No
In this study the consequences of exacerbations will be visualized by high resolution
      computed tomography (HRCT) scan at functional residual capacity (FRC) and total lung capacity
      (TLC) as taken during an episode of exacerbation and after recovering. Changes in HRCT based
      airway dimensions and computational fluid dynamic (CFD) -based resistance values will be
      correlated with changes in patient reported outcomes (PROs) and lung function tests recorded
      at the same time.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Changes in functional respiratory imaging parameters
time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
description: The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
measure: Changes in lung function parameters
time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
description: The primary objective of this study is to evaluate whether changes in HRCT based airway dimensions and Computational Fluid Dynamic (CFD)-based resistance values correlate with changes in lung function parameters, under the conditions of exacerbation of COPD as well as after recovering from exacerbation.
measure: Changes in patient reported outcome (PRO) measures
time frame: Baseline (= during exacerbation) and after about 6 weeks (= after recovering)
description: The secondary objective is to check if the changes in CFD data actually correlate better with changes in PRO than changes in lung function parameters.
measure: Reproducibility of segmentation
time frame: Within 1 month of visit
description: As tertiary objective the reproducibility of the segmentations done by the centers will be evaluated. To accomplish reproducible segmentations the multiple centers will be guided to perform accurate segmentations, and bottlenecks in the usage of the program will be identified and resolved in order to simplify it where necessary and possible.
arm group label: No treatment
arm group type: Experimental
description: CT-scans will be taken in the study. The EC of the University hospital antwerp considers this as an intervention.
intervention type: Radiation
intervention name: Functional Respiratory Imaging
description: HRCT scan at FRC and TLC as taken during an episode of exacerbation and after recovering.
arm group label: No treatment
other name: HRCT scan
criteria: 
gender: All
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Wilfried De Backer, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Antwerp
last name: Huib AM Kerstjens, MD
role: Principal Investigator
affiliation: University Medical Center Groningen
last name: Emiel FM Wouters, MD
role: Principal Investigator
affiliation: Maastricht University Medical Center
last name: Massimo Pistolesi, MD
role: Principal Investigator
affiliation: University of Florence
facility: 
facility: 
facility: 
facility: 
country: Belgium
country: Italy
country: Netherlands
responsible party type: Sponsor
mesh term: Lung Diseases
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Chronic Disease