<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/NCT03307278</url>
  </required_header>
  <id_info>
    <org_study_id>CMUH106-REC3-115</org_study_id>
    <nct_id>NCT03307278</nct_id>
  </id_info>
  <brief_title>House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance</brief_title>
  <official_title>Effects and Mechanism of House Dust Mite Induced Inflammasome Activation on Corticosteroid Resistance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China Medical University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China Medical University Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      In this project, PBMCs will be isolated from HDM allergic and non allergic patient and then&#xD;
      stimulated with HDM crude extract. The expression of inflammasome and the correlation of&#xD;
      inflammasome activation and steroid resistance will be investigated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The research project cannot be implemented because the project has not received funding&#xD;
    subsidies&#xD;
  </why_stopped>
  <start_date type="Anticipated">November 30, 2017</start_date>
  <completion_date type="Anticipated">September 6, 2018</completion_date>
  <primary_completion_date type="Anticipated">September 6, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>inflammasome activation by HDM</measure>
    <time_frame>6 hours</time_frame>
    <description>The expression of NLRP3 in PBMCs will be measured by western blot after HDM stimulation.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Steroid receptor phosphorylation by HDM</measure>
    <time_frame>6 hours</time_frame>
    <description>The expression of steroid receptor will be detected by western blot and real-time PCR after HDM stimulation.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Allergic Asthma</condition>
  <arm_group>
    <arm_group_label>Steroid resistance in HDM allergic patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Steroid resistance in non HDM allergic subjects</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>House dust mite</intervention_name>
    <description>As a stimulant to induce inflammasome activation</description>
    <arm_group_label>Steroid resistance in HDM allergic patients</arm_group_label>
    <arm_group_label>Steroid resistance in non HDM allergic subjects</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  HDM allergic and non allergic subjects&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant subject, cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>September 26, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>July 27, 2021</last_update_submitted>
  <last_update_submitted_qc>July 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03307278
org study id: CMUH106-REC3-115
nct id: NCT03307278
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this project, PBMCs will be isolated from HDM allergic and non allergic patient and then
      stimulated with HDM crude extract. The expression of inflammasome and the correlation of
      inflammasome activation and steroid resistance will be investigated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: inflammasome activation by HDM
time frame: 6 hours
description: The expression of NLRP3 in PBMCs will be measured by western blot after HDM stimulation.
measure: Steroid receptor phosphorylation by HDM
time frame: 6 hours
description: The expression of steroid receptor will be detected by western blot and real-time PCR after HDM stimulation.
arm group label: Steroid resistance in HDM allergic patients
arm group type: Experimental
arm group label: Steroid resistance in non HDM allergic subjects
arm group type: Experimental
intervention type: Biological
intervention name: House dust mite
description: As a stimulant to induce inflammasome activation
arm group label: Steroid resistance in HDM allergic patients
arm group label: Steroid resistance in non HDM allergic subjects
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
sharing ipd: Undecided