<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/NCT03820427</url>
  </required_header>
  <id_info>
    <org_study_id>MBW-asthma</org_study_id>
    <nct_id>NCT03820427</nct_id>
  </id_info>
  <brief_title>Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma</brief_title>
  <official_title>Evaluation of Novel Lung Function Parameters in Patients With Bronchial Asthma</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>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Current guideline-based criteria defining bronchial asthma do not always meet the challenges&#xD;
      set by the complex pathophysiology of the disease. The investigators therefore aimed to&#xD;
      evaluate novel or not widely used functional diagnostic approaches for the detection and&#xD;
      therapeutic monitoring of patients with asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2015</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Global ventilation heterogeneity</measure>
    <time_frame>30 minutes</time_frame>
    <description>lung clearance index (LCI) derived from sulphur hexafluoride multiple breath washout</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Local ventilation heterogeneity</measure>
    <time_frame>30 minutes</time_frame>
    <description>Sacin, Scond (Phase III slopes) derived from sulphur hexafluoride multiple breath washout</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">147</enrollment>
  <condition>Bronchial Asthma</condition>
  <condition>Pulmonary Healthy Controls</condition>
  <arm_group>
    <arm_group_label>bronchial asthma</arm_group_label>
    <description>Patients with known or suspected asthma.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pulmonary healthy controls</arm_group_label>
    <description>Patients without known or suspected pulmonary disease</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>impulse oscillometry</intervention_name>
    <description>impulse oscillometry</description>
    <arm_group_label>bronchial asthma</arm_group_label>
    <arm_group_label>pulmonary healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>multiple breath washout test</intervention_name>
    <description>multiple breath washout test</description>
    <arm_group_label>bronchial asthma</arm_group_label>
    <arm_group_label>pulmonary healthy controls</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>body plethysmography</intervention_name>
    <description>body plethysmography</description>
    <arm_group_label>bronchial asthma</arm_group_label>
    <arm_group_label>pulmonary healthy controls</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        patients with indication for routine lung function testing&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  known or suspected bronchial asthma&#xD;
&#xD;
          -  known or suspected obstructive ventilation disorder&#xD;
&#xD;
          -  pulmonary healthy controls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  inability to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 27, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>January 27, 2019</last_update_submitted>
  <last_update_submitted_qc>January 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</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/NCT03820427
org study id: MBW-asthma
nct id: NCT03820427
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Current guideline-based criteria defining bronchial asthma do not always meet the challenges
      set by the complex pathophysiology of the disease. The investigators therefore aimed to
      evaluate novel or not widely used functional diagnostic approaches for the detection and
      therapeutic monitoring of patients with asthma.
observational model: Cohort
time perspective: Cross-Sectional
measure: Global ventilation heterogeneity
time frame: 30 minutes
description: lung clearance index (LCI) derived from sulphur hexafluoride multiple breath washout
measure: Local ventilation heterogeneity
time frame: 30 minutes
description: Sacin, Scond (Phase III slopes) derived from sulphur hexafluoride multiple breath washout
arm group label: bronchial asthma
description: Patients with known or suspected asthma.
arm group label: pulmonary healthy controls
description: Patients without known or suspected pulmonary disease
intervention type: Diagnostic Test
intervention name: impulse oscillometry
description: impulse oscillometry
arm group label: bronchial asthma
arm group label: pulmonary healthy controls
intervention type: Diagnostic Test
intervention name: multiple breath washout test
description: multiple breath washout test
arm group label: bronchial asthma
arm group label: pulmonary healthy controls
intervention type: Diagnostic Test
intervention name: body plethysmography
description: body plethysmography
arm group label: bronchial asthma
arm group label: pulmonary healthy controls
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Universitätsmedizin Mannheim
investigator full name: Dr. Frederik Trinkmann
investigator title: Principal Investigator
mesh term: Asthma
sharing ipd: No