<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/NCT01691612</url>
  </required_header>
  <id_info>
    <org_study_id>2012P001029</org_study_id>
    <nct_id>NCT01691612</nct_id>
  </id_info>
  <brief_title>Role of the Isomerase Pin-1 in the Development and Treatment of Asthma</brief_title>
  <acronym>Pin1</acronym>
  <official_title>Role of the Isomerase Pin-1 in the Development and Treatment of Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil&#xD;
      survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal&#xD;
      pathways in multiple cells in asthma.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will test their hypothesis that Pin1 regulates TLR/IL-1R signaling pathways&#xD;
      in asthma by examining Pin1 and related pathway activation in BAL-derived eosinophils after&#xD;
      house dust mite allergen challenge. The investigators will perform segmental allergen&#xD;
      challenge. BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr&#xD;
      later and activation of Pin1 and related pathways will be examined.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours</measure>
    <time_frame>from baseline to 48 hours</time_frame>
    <description>Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:&#xD;
Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours</measure>
    <time_frame>from baseline to 48 hours</time_frame>
    <description>Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours</measure>
    <time_frame>from baseline to 48 hours</time_frame>
    <description>Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours</measure>
    <time_frame>from baseline to 48 hours</time_frame>
    <description>Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>D. pteronyssinus allergens</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>installation of D. pteronyssinus allergens</intervention_name>
    <description>We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later</description>
    <arm_group_label>D. pteronyssinus allergens</arm_group_label>
    <other_name>D. pteronyssinus allergens exposure</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
          -  Subjects 18-55 years of age, diagnosed with asthma for at least 1 year;&#xD;
&#xD;
          -  And FEV1 &gt; 70% predicted on only short acting beta agonists e.g albuterol&#xD;
&#xD;
          -  And methacholine PC20 &lt; 8 mg/ml&#xD;
&#xD;
          -  Positive skin prick test to Dermatophagoides pteronyssinus(DerP)&#xD;
&#xD;
          -  No prior history of intubation for asthma&#xD;
&#xD;
          -  No use of inhaled corticosteroids for 1 month prior to entry&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Current smoking or smoking history of greater than 10 pack-years&#xD;
&#xD;
          -  Any other clinically important comorbidity determined by the principal investigator to&#xD;
             affect subject safety, including uncontrolled diabetes, uncontrolled coronary artery&#xD;
             disease, acute or chronic renal failure, and uncontrolled hypertension that would&#xD;
             increase the risk of significant adverse events during bronchoscopy,&#xD;
&#xD;
          -  Worsening of asthma symptoms requiring treatment with steroids within 4 weeks of&#xD;
             screening&#xD;
&#xD;
          -  Respiratory infection within four weeks&#xD;
&#xD;
          -  Women of child-bearing potential, defined as all women physiologically capable of&#xD;
             becoming pregnant or who are currently pregnant or lactating.&#xD;
&#xD;
        Unless they:&#xD;
&#xD;
          -  Are women whose career, lifestyle, or sexual orientation precludes intercourse with a&#xD;
             male partner&#xD;
&#xD;
          -  Are women whose partners have been sterilized by vasectomy or other means&#xD;
&#xD;
          -  Use one acceptable birth control method. Adequate barrier methods of contraception&#xD;
             include: diaphragm, condom (by the partner), intrauterine device (copper or hormonal),&#xD;
             sponge or spermicide. Hormonal contraceptives include any marketed contraceptive agent&#xD;
             that includes an estrogen and/or a progestational agent.&#xD;
&#xD;
          -  Pre-existing lung disease other than asthma&#xD;
&#xD;
          -  History of coagulation disorders or abnormal PT/PTT testing at screening&#xD;
&#xD;
          -  History of immunodeficiency diseases, including HIV&#xD;
&#xD;
          -  A disability that may prevent the patient from completing all study requirements&#xD;
&#xD;
          -  Use of other investigational drugs at the time of enrollment, or within 30 days or 5&#xD;
             half-lives of enrollment, whichever is longer&#xD;
&#xD;
          -  History of malignancy of any organ system (other than localized basal cell carcinoma&#xD;
             of the skin), treated or untreated, within the past 5 years, regardless of whether&#xD;
             there is evidence of local recurrence or metastases.&#xD;
&#xD;
          -  Diagnosis of Hepatitis B or C.&#xD;
&#xD;
          -  History of alcohol abuse (as determined by the principal investigator) within 6 months&#xD;
             of screening.&#xD;
&#xD;
          -  History of illicit drug abuse (as determined by the principal investigator) within 6&#xD;
             months of screening.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kun P Lu, M.D., PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beth Israel Deaconess Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Elliot Israel, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Womens Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Asthma Research Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2017</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2012</study_first_posted>
  <results_first_submitted>March 6, 2017</results_first_submitted>
  <results_first_submitted_qc>June 6, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">July 3, 2017</results_first_posted>
  <last_update_submitted>June 6, 2017</last_update_submitted>
  <last_update_submitted_qc>June 6, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">July 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Elliot Israel, MD</investigator_full_name>
    <investigator_title>Physician</investigator_title>
  </responsible_party>
  <keyword>Role of Pin-1 enzyme in Asthma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>D. Pteronyssinus Allergens</title>
          <description>Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments&#xD;
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="14"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>First Visit (Allergen Challenge)</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Second Visit (Bronchoscopy)</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>deemed ineligible after 1st visit</title>
              <participants_list>
                <participants group_id="P1" count="6"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Adverse Event</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>D. Pteronyssinus Allergens</title>
          <description>Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments&#xD;
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="8"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24.9" spread="3.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours</title>
        <description>Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:&#xD;
Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]</description>
        <time_frame>from baseline to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>D. Pteronyssinus Allergens</title>
            <description>Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments&#xD;
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours</title>
          <description>Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:&#xD;
Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]</description>
          <units>percent of white blood cells</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="82.11" lower_limit="0.24" upper_limit="88.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours</title>
        <description>Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]</description>
        <time_frame>from baseline to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>D. Pteronyssinus Allergens</title>
            <description>Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments&#xD;
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours</title>
          <description>Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]</description>
          <units>percent change</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-64.3" lower_limit="-100" upper_limit="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours</title>
        <description>Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]</description>
        <time_frame>from baseline to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>D. Pteronyssinus Allergens</title>
            <description>Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments&#xD;
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours</title>
          <description>Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]</description>
          <units>percent change</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="-82.4" lower_limit="-89.3" upper_limit="-5.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours</title>
        <description>Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours</description>
        <time_frame>from baseline to 48 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>D. Pteronyssinus Allergens</title>
            <description>Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments&#xD;
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours</title>
          <description>Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours</description>
          <units>percent of white blood cells</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="-5" upper_limit="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>D. Pteronyssinus Allergens</title>
          <description>Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments&#xD;
installation of D. pteronyssinus allergens: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Allergic reaction</sub_title>
                <counts group_id="E1" events="2" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>bronchitis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
              <event>
                <sub_title>increased asthma symptoms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="14"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Elliot Israel, M.D.</name_or_title>
      <organization>Brigham &amp; Women's Hospital</organization>
      <phone>617-732-8110</phone>
      <email>eisrael@partners.org</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01691612
org study id: 2012P001029
nct id: NCT01691612
lead sponsor: 
has dmc: No
Pin1 is activated in asthmatic airways, increasing cytokine mRNA stability and eosinophil
      survival. This study is designed to test whether the Pin1 enzyme regulates TLR/IL-1R signal
      pathways in multiple cells in asthma.
The investigators will test their hypothesis that Pin1 regulates TLR/IL-1R signaling pathways
      in asthma by examining Pin1 and related pathway activation in BAL-derived eosinophils after
      house dust mite allergen challenge. The investigators will perform segmental allergen
      challenge. BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr
      later and activation of Pin1 and related pathways will be examined.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change From Baseline in the Percentage of Total White Blood Cell That Were Eosinophils at 48 Hours
time frame: from baseline to 48 hours
description: Measure Pin1 activity in BAL-derived eosinophils after House Dust Mite (HDM) allergen challenge:
Eosinophils post-challenge change from pre-challenge is reported: absolute change = [eosinophils post (%) - eosinophils pre (%)]
measure: Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Lymphocytes at 48 Hours
time frame: from baseline to 48 hours
description: Percent change in percentage of total white blood cell that were lymphocytes is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]
measure: Percent Change From Baseline in the Percentage of Total White Blood Cell That Were Macrophages at 48 Hours
time frame: from baseline to 48 hours
description: Percent change in percentage of total white blood cell that were macrophages is measured from pre-challenge to post-challenge as: [100% * ((Post-Pre)/Pre)]
measure: Change From Baseline in the Percentage of Total White Blood Cell That Were Neutrophils at 48 Hours
time frame: from baseline to 48 hours
description: Neutrophils have some zero values pre-challenge, so absolute change is reported instead of percent change: post-pre from baseline to 48 hours
arm group label: D. pteronyssinus allergens
arm group type: Experimental
description: Single arm study exploring the role of Pin-1 enzyme in development of Asthma. Bronchoscopy before and 48 hours after installation of D. pteronyssinus allergens into the lung segments
intervention type: Biological
intervention name: installation of D. pteronyssinus allergens
description: We will perform bronchoscopy and segmental allergen challenges. Subjects will undergo bronchoscopy with segmental installation of 5 ml of D. pteronyssinus (DerP). BAL and lung biopsy of the allergen-challenged segments will be performed 48 hr later
arm group label: D. pteronyssinus allergens
other name: D. pteronyssinus allergens exposure
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
last name: Kun P Lu, M.D., PhD
role: Principal Investigator
affiliation: Beth Israel Deaconess Medical Center
last name: Elliot Israel, M.D
role: Principal Investigator
affiliation: Brigham and Womens Hospital
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Elliot Israel, MD
investigator title: Physician
mesh term: Asthma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 