<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/NCT03779152</url>
  </required_header>
  <id_info>
    <org_study_id>2008/0813</org_study_id>
    <secondary_id>2008-A00370-55</secondary_id>
    <nct_id>NCT03779152</nct_id>
  </id_info>
  <brief_title>Regulation of CCL18 by Corticosteroids in Severe Asthma</brief_title>
  <acronym>CCL18</acronym>
  <official_title>Regulation of CCL18 by Corticosteroids in Severe Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment,&#xD;
      however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids&#xD;
      and its dysfunction may correlate with phenotypes of asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 2009</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">February 2017</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between CCL18 rate and asthma phenotypes by elisa test</measure>
    <time_frame>Baseline: one session</time_frame>
  </primary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Actual">48</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>non asthmatic subjects</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>intermittent asthmatics</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>severe asthmatics sensitive to corticosteroids</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>severe asthmatics resistant to corticosteroids</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>moderate asthmatics</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        patients consulting for either asthma or chronic rhinitis and meeting the criteria of the&#xD;
        control group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. control subjects =&#xD;
&#xD;
               -  non-atopic and non-smoking&#xD;
&#xD;
               -  cutting to negative pneumoallergens,&#xD;
&#xD;
               -  Total IgE levels less than 100 ku / L&#xD;
&#xD;
               -  no clinical history of asthma&#xD;
&#xD;
               -  without background treatment&#xD;
&#xD;
          2. patients with intermittent asthma =&#xD;
&#xD;
               -  being asymptomatic between asthma attacks,&#xD;
&#xD;
               -  with symptoms less than once a week&#xD;
&#xD;
               -  having a forced expiratory volume per second (FEV1) of at least 80% of the&#xD;
                  theoretical.&#xD;
&#xD;
               -  treated by ß2 mimetics on demand and will not have inhaled corticosteroids.&#xD;
&#xD;
          3. severe asthma insensitive to corticosteroid therapy =&#xD;
&#xD;
               -  continuous or nearly continuous treatment with oral corticosteroids (≥ 50% of the&#xD;
                  year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent&#xD;
                  (BDP)] airway obstruction fixed with FEV1 ranging from less than 15% after 7 days&#xD;
                  of oral corticosteroid therapy to 40 mg / day of prednisolone;&#xD;
&#xD;
               -  Followed at the immunoallergology pneumology consultation for at least 1 year&#xD;
                  will be recruited.&#xD;
&#xD;
          4. Severe corticosensitive asthma = continuous or near continuous treatment with oral&#xD;
             corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg&#xD;
             beclomethasone dipropionate equivalent (BDP)]&#xD;
&#xD;
               -  reversibility of FEV1 after treatment with oral corticosteroids.&#xD;
&#xD;
               -  Followed at the immunoallergology pneumology consultation for at least 1 year&#xD;
                  will be recruited.&#xD;
&#xD;
          5. controlled moderate asthma treated with inhaled corticosteroids &lt;1500μg equivalent of&#xD;
             beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or&#xD;
             theophylline) for at least 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  existence of a chronic inflammatory pathology other than asthma&#xD;
&#xD;
          -  active smoking&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  have received oral corticosteroid treatment in the previous 3 weeks,&#xD;
&#xD;
          -  have received non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 2 weeks.&#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>
  <overall_official>
    <last_name>Benoit Wallaert, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Calmette, CHRU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 20, 2018</last_update_submitted>
  <last_update_submitted_qc>December 20, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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/NCT03779152
org study id: 2008/0813
secondary id: 2008-A00370-55
nct id: NCT03779152
lead sponsor: 
has dmc: No
The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment,
      however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids
      and its dysfunction may correlate with phenotypes of asthma.
observational model: Cohort
time perspective: Prospective
measure: Correlation between CCL18 rate and asthma phenotypes by elisa test
time frame: Baseline: one session
arm group label: non asthmatic subjects
arm group label: intermittent asthmatics
arm group label: severe asthmatics sensitive to corticosteroids
arm group label: severe asthmatics resistant to corticosteroids
arm group label: moderate asthmatics
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Benoit Wallaert, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Asthma
sharing ipd: No