<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/NCT03287921</url>
  </required_header>
  <id_info>
    <org_study_id>MBW-hyperinflation</org_study_id>
    <nct_id>NCT03287921</nct_id>
  </id_info>
  <brief_title>Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD</brief_title>
  <official_title>Diagnostic and Therapeutic Approaches to Hyperinflation and Small Airway Disease in COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universitätsmedizin Mannheim</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universitätsmedizin Mannheim</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current guideline-based criteria defining COPD do not meet the challenges set by the complex&#xD;
      pathophysiology of the disease. Hyperinflation and affection of the small airways are two&#xD;
      components that are not represented in current diagnostic concepts and may relate to early&#xD;
      stages of the disease. Moreover, optimal therapeutic interventions in patients with these&#xD;
      distinct features remain unclear. The investigators therefore aimed to evaluate novel or not&#xD;
      widely used diagnostic approaches for the detection and initiating therapeutic strategies in&#xD;
      early stage COPD within the GOLD recommendations.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2, 2017</start_date>
  <completion_date type="Actual">April 11, 2019</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>residual volume</measure>
    <time_frame>8 weeks</time_frame>
    <description>change in residual volume from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>D5-20</measure>
    <time_frame>8 weeks</time_frame>
    <description>change in frequency dependence of resistance from baseline</description>
  </primary_outcome>
  <primary_outcome>
    <measure>LCI</measure>
    <time_frame>8 weeks</time_frame>
    <description>change in lung clearance index from baseline</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>tpeak</measure>
    <time_frame>8 weeks</time_frame>
    <description>increase in exercise duration from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IC</measure>
    <time_frame>8 weeks</time_frame>
    <description>increase in inspiratory capacity (isotime and resting) from baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>SGRQ</measure>
    <time_frame>8 weeks</time_frame>
    <description>improvement in St. George's Respiratory Questionaire from baseline</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">26</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>mono bronchodilatation</arm_group_label>
    <description>patients with COPD and features of hyperinflation and small airway disease</description>
  </arm_group>
  <arm_group>
    <arm_group_label>dual bronchodilatation</arm_group_label>
    <description>patients with COPD and features of hyperinflation and small airway disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>mono bronchodilatation</intervention_name>
    <description>within indication according to current GOLD recommendation</description>
    <arm_group_label>dual bronchodilatation</arm_group_label>
    <arm_group_label>mono bronchodilatation</arm_group_label>
    <other_name>bronchodilator monotherapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>dual bronchodilatation</intervention_name>
    <description>within indication according to current GOLD recommendation</description>
    <arm_group_label>dual bronchodilatation</arm_group_label>
    <arm_group_label>mono bronchodilatation</arm_group_label>
    <other_name>dual bronchodilator therapy</other_name>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      blood samples&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        hospitalized patients and out-patients with known or firstly diagnosed COPD&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  known or first diagnosis of COPD&#xD;
&#xD;
          -  lung function testing consistent with hyperinflation or peripheral obstruction&#xD;
&#xD;
          -  emphysema in imaging&#xD;
&#xD;
          -  symptoms (dyspnea, cough, sputum) and risk factors (&gt;= 10 pack years)&#xD;
&#xD;
          -  indication for bronchodilator therapy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  GOLD stages 3 and 4 (spirometric)&#xD;
&#xD;
          -  indication for dual bronchodilator therapy, triple therapy or inhaled steroid&#xD;
&#xD;
          -  contraindication for cardiopulmonary exercise testing&#xD;
&#xD;
          -  unwilling to participate&#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>Frederik Trinkmann, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Mannheim</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Mannheim</name>
      <address>
        <city>Mannheim</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 17, 2017</study_first_submitted>
  <study_first_submitted_qc>September 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 19, 2017</study_first_posted>
  <last_update_submitted>March 29, 2020</last_update_submitted>
  <last_update_submitted_qc>March 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universitätsmedizin Mannheim</investigator_affiliation>
    <investigator_full_name>Dr. Frederik Trinkmann</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>pulmonary care</keyword>
  <keyword>COPD</keyword>
  <keyword>small airway disease</keyword>
  <keyword>hyperinflation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchodilator Agents</mesh_term>
  </intervention_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/NCT03287921
org study id: MBW-hyperinflation
nct id: NCT03287921
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Current guideline-based criteria defining COPD do not meet the challenges set by the complex
      pathophysiology of the disease. Hyperinflation and affection of the small airways are two
      components that are not represented in current diagnostic concepts and may relate to early
      stages of the disease. Moreover, optimal therapeutic interventions in patients with these
      distinct features remain unclear. The investigators therefore aimed to evaluate novel or not
      widely used diagnostic approaches for the detection and initiating therapeutic strategies in
      early stage COPD within the GOLD recommendations.
observational model: Case-Crossover
time perspective: Prospective
measure: residual volume
time frame: 8 weeks
description: change in residual volume from baseline
measure: D5-20
time frame: 8 weeks
description: change in frequency dependence of resistance from baseline
measure: LCI
time frame: 8 weeks
description: change in lung clearance index from baseline
measure: tpeak
time frame: 8 weeks
description: increase in exercise duration from baseline
measure: IC
time frame: 8 weeks
description: increase in inspiratory capacity (isotime and resting) from baseline
measure: SGRQ
time frame: 8 weeks
description: improvement in St. George's Respiratory Questionaire from baseline
arm group label: mono bronchodilatation
description: patients with COPD and features of hyperinflation and small airway disease
arm group label: dual bronchodilatation
description: patients with COPD and features of hyperinflation and small airway disease
intervention type: Drug
intervention name: mono bronchodilatation
description: within indication according to current GOLD recommendation
arm group label: dual bronchodilatation
arm group label: mono bronchodilatation
other name: bronchodilator monotherapy
intervention type: Drug
intervention name: dual bronchodilatation
description: within indication according to current GOLD recommendation
arm group label: dual bronchodilatation
arm group label: mono bronchodilatation
other name: dual bronchodilator therapy
blood samples
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Frederik Trinkmann, MD
role: Principal Investigator
affiliation: University Medical Center Mannheim
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Universitätsmedizin Mannheim
investigator full name: Dr. Frederik Trinkmann
investigator title: Principal Investigator
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Bronchodilator Agents
sharing ipd: No