<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/NCT04412044</url>
  </required_header>
  <id_info>
    <org_study_id>s58608</org_study_id>
    <nct_id>NCT04412044</nct_id>
  </id_info>
  <brief_title>Effect of Anti-interleukin 5 (IL5) Therapy on Sputum Cells and Cytokines</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</source>
  <oversight_info>
    <has_dmc>No</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>
      22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were&#xD;
      followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine&#xD;
      measurements were analyzed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2016</start_date>
  <completion_date type="Actual">March 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Airway inflammation</measure>
    <time_frame>Day 1 and after 6 months</time_frame>
    <description>Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (&gt;3% eosinophils, &lt;61% neutrophils), neutrophilic (&lt;3% eosinophils and &gt;61% neutrophils), pauci-granulocytic (&lt;3% eosinophils and &lt;61% neutrophils) and mixed granulocytic airway inflammation (&gt;3% eosinophils and &gt;61% neutrophils).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Forced Expiratory Volume in 1 seconds (FEV1)</measure>
    <time_frame>Day 1 and after 6 months</time_frame>
    <description>The forced expiratory Volume in 1 second will be measured using spirometry</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cytokine pattern in the airways</measure>
    <time_frame>Day 1 and after 6 months</time_frame>
    <description>Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cytokine pattern in the bloodstream</measure>
    <time_frame>Day 1 and after 6 months</time_frame>
    <description>Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in asthma control</measure>
    <time_frame>Day 1 and after 6 months</time_frame>
    <description>Asthma control will be determined using the Asthma Control Questionnaire (ACQ-6), including 6 questions. Each question will be scored from 0-6 and added together. This final score will be divided by the number of questions. If ACQ-6 &lt; 0.75 = controlled asthma, ACQ-6 from 0.75-1.5 = partly controlled asthma and ACQ-6 &gt; 1.5 = uncontrolled asthma.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Biomarkers for airway inflammation</measure>
    <time_frame>Day 1 and after 6 months</time_frame>
    <description>Fraction exhaled Nitric Oxid (FeNO) will be used as biomarker for eosinophilic airway inflammation. FeNO &lt; 25 ppb = eosinophilic inflammation less likely, FeNO between 25 and 50 ppm = need further interpretation with additional clinical information, FeNO &gt; 50 ppm = indication of eosinophilic airway inflammation (according to the American Thoracic Society guidelines)</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Asthmatics</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients receive anti-IL5 treatment as part of their prescribed routine. Immunological and clinical parameters will be evaluated at the start of the treatment and after 6 months of treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mepolizumab Injection [Nucala]</intervention_name>
    <description>Patients receive monthly injection with 100 mg mepolizumab</description>
    <arm_group_label>Asthmatics</arm_group_label>
    <other_name>Anti-IL5 treatment</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FEV1 &lt; 80% in the last 12 months&#xD;
&#xD;
          -  use of high dose inhaled corticosteroids (ICS) in combination with other additional&#xD;
             medication or continuous use of oral corticosteroids (OCS)&#xD;
&#xD;
          -  at least 2 exacerbations in the last 12 months&#xD;
&#xD;
          -  at least 300 blood eosinophils/µl once in the last 12 months and at the time of&#xD;
             inclusion&#xD;
&#xD;
          -  Anti-IL5 treatment prescribed by the physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not completing all visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tatjana Decaesteker</last_name>
    <role>Principal Investigator</role>
    <affiliation>KU Leuven</affiliation>
  </overall_official>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Tatjana Decaesteker</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <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/NCT04412044
org study id: s58608
nct id: NCT04412044
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
22 asthmatics, in which mepolizumab was to be started, gave permission for inclusion and were
      followed up prospectively. Clinical and lung functional data, sputum analyses and cytokine
      measurements were analyzed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Airway inflammation
time frame: Day 1 and after 6 months
description: Bronchial airway inflammation. Differential cell count will be performed on sputum samples, determining eosinophilic (>3% eosinophils, <61% neutrophils), neutrophilic (<3% eosinophils and >61% neutrophils), pauci-granulocytic (<3% eosinophils and <61% neutrophils) and mixed granulocytic airway inflammation (>3% eosinophils and >61% neutrophils).
measure: Change in Forced Expiratory Volume in 1 seconds (FEV1)
time frame: Day 1 and after 6 months
description: The forced expiratory Volume in 1 second will be measured using spirometry
measure: Cytokine pattern in the airways
time frame: Day 1 and after 6 months
description: Cytokines concentrations (pg/ml) will also be determined in sputum supernatant using a U-plex assay.
measure: Cytokine pattern in the bloodstream
time frame: Day 1 and after 6 months
description: Cytokines concentrations (pg/ml) will also be determined in serum using a U-plex assay.
measure: Change in asthma control
time frame: Day 1 and after 6 months
description: Asthma control will be determined using the Asthma Control Questionnaire (ACQ-6), including 6 questions. Each question will be scored from 0-6 and added together. This final score will be divided by the number of questions. If ACQ-6 < 0.75 = controlled asthma, ACQ-6 from 0.75-1.5 = partly controlled asthma and ACQ-6 > 1.5 = uncontrolled asthma.
measure: Biomarkers for airway inflammation
time frame: Day 1 and after 6 months
description: Fraction exhaled Nitric Oxid (FeNO) will be used as biomarker for eosinophilic airway inflammation. FeNO < 25 ppb = eosinophilic inflammation less likely, FeNO between 25 and 50 ppm = need further interpretation with additional clinical information, FeNO > 50 ppm = indication of eosinophilic airway inflammation (according to the American Thoracic Society guidelines)
arm group label: Asthmatics
arm group type: Experimental
description: Patients receive anti-IL5 treatment as part of their prescribed routine. Immunological and clinical parameters will be evaluated at the start of the treatment and after 6 months of treatment
intervention type: Drug
intervention name: Mepolizumab Injection [Nucala]
description: Patients receive monthly injection with 100 mg mepolizumab
arm group label: Asthmatics
other name: Anti-IL5 treatment
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Tatjana Decaesteker
role: Principal Investigator
affiliation: KU Leuven
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Tatjana Decaesteker
investigator title: Principal Investigator
sharing ipd: No