<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/NCT03825302</url>
  </required_header>
  <id_info>
    <org_study_id>PGE2 in asthma</org_study_id>
    <nct_id>NCT03825302</nct_id>
  </id_info>
  <brief_title>Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma</brief_title>
  <official_title>Prostaglandin E2 as a Critical Mediator of Sex Disparities in Asthma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vanderbilt University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vanderbilt University Medical Center</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>
      This study seeks to understand how biological sex influences airway hyperresponsiveness in&#xD;
      adult asthma.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    No funding available.&#xD;
  </why_stopped>
  <start_date type="Anticipated">December 1, 2021</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males</measure>
    <time_frame>Baseline</time_frame>
    <description>Males only</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in females</measure>
    <time_frame>Baseline</time_frame>
    <description>Females only during the luteal phase of the menstrual cycle</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Males with asthma</arm_group_label>
    <description>Induced sputum, methacholine challenge, and mannitol challenge will be performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Females with asthma</arm_group_label>
    <description>Induced sputum, methacholine challenge, and mannitol challenge will be performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Methacholine challenge</intervention_name>
    <description>Methacholine inhalation challenge will be administered to both male and females with asthma</description>
    <arm_group_label>Females with asthma</arm_group_label>
    <arm_group_label>Males with asthma</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Mannitol challenge</intervention_name>
    <description>Mannitol inhalation challenge will be administered to both male and females with asthma</description>
    <arm_group_label>Females with asthma</arm_group_label>
    <arm_group_label>Males with asthma</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Sputum, blood, nasal fluid, urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Asthmatics at VUMC&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be able to understand and provide informed consent&#xD;
&#xD;
          -  Age 18-50&#xD;
&#xD;
          -  A history of physician-diagnosed asthma well controlled as assessed by ACQ-6 &lt;1.5 and&#xD;
             FEV1&gt;70% of predicted and FEV1 &gt;1.5 liters.&#xD;
&#xD;
          -  Asthma must be persistent, defined by the requirement of a daily controller agent.&#xD;
&#xD;
          -  Use of a stable dose of daily inhaled corticosteroids for the prior 3 months.&#xD;
&#xD;
          -  Female subjects of childbearing potential must have a negative pregnancy test upon&#xD;
             study entry and at each study visit.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability or unwillingness of a participant to give written informed consent or comply&#xD;
             with study protocol.&#xD;
&#xD;
          -  Hypogonadism, irregular menstrual cycles, polycystic ovarian syndrome (PCOS),&#xD;
             exogenous hormonal supplements or contraception.&#xD;
&#xD;
          -  Any chronic lung condition outside of asthma including chronic obstructive pulmonary&#xD;
             disease (COPD), interstitial lung disease, eosinophilic granulomatosis with&#xD;
             polyangiitis, allergic bronchopulmonary aspergillosis.&#xD;
&#xD;
          -  Inability or unwillingness to hold the following medications prior to mannitol and&#xD;
             methacholine inhalational challenge(s): Short-Acting Beta 2 Agonists &gt;8 hours, Inhaled&#xD;
             Corticosteroids and Anticholinergic Bronchodilators &gt;12 hours, Phosphodiesterase&#xD;
             Inhibitors or Adenosine Receptors &gt;24 hours, Long-acting Beta 2 Agonists &gt;36 hours,&#xD;
             Long-acting Anticholinergics or Short-Acting Antihistamines &gt;48 hours, Long-Acting&#xD;
             Antihistamines &gt;72 hours, and Leukotriene-Receptor Antagonist or 5-Lipooxygenase&#xD;
             Inhibitors &gt;4 days.&#xD;
&#xD;
          -  For males, a screening morning serum total testosterone level (obtained between 8-10&#xD;
             AM) below the normal reference lab value.&#xD;
&#xD;
          -  Current pregnancy, breast-feeding, or plans to become pregnant during the study&#xD;
             period.&#xD;
&#xD;
          -  Oral or systemic corticosteroid use or biologic agent for asthma in the previous 3&#xD;
             months or ED/Hospitalization for asthma within 6 months.&#xD;
&#xD;
          -  Use of investigational drugs within 12 weeks of participation.&#xD;
&#xD;
          -  Known hypersensitivity or allergy to mannitol, gelatin or methacholine.&#xD;
&#xD;
          -  Upper or lower respiratory tract infection within the proceeding 6 weeks.&#xD;
&#xD;
          -  A history of uncontrolled hypertension, coronary artery disease, stroke, epilepsy,&#xD;
             urinary tract obstruction, untreated thyroid disease, or a chronic lung disease other&#xD;
             than asthma.&#xD;
&#xD;
          -  Daily use of a beta-blocker.&#xD;
&#xD;
          -  Intolerance to anticholinergic medications.&#xD;
&#xD;
          -  Inability to produce an adequate sputum sample.&#xD;
&#xD;
          -  Past or current medical problems or findings from physical examination or laboratory&#xD;
             testing that are not listed above, which, in the opinion of the investigator, may pose&#xD;
             additional risks from participation in the study, may interfere with the participant's&#xD;
             ability to comply with study requirements or that may impact the quality or&#xD;
             interpretation of the data obtained from the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Katherine Cahill, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vanderbilt University Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vanderbilt University Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37232</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 31, 2019</study_first_posted>
  <last_update_submitted>March 2, 2022</last_update_submitted>
  <last_update_submitted_qc>March 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Vanderbilt University Medical Center</investigator_affiliation>
    <investigator_full_name>Katherine Cahill</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Asthma</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mannitol</mesh_term>
    <mesh_term>Methacholine Chloride</mesh_term>
  </intervention_browse>
  <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/NCT03825302
org study id: PGE2 in asthma
nct id: NCT03825302
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study seeks to understand how biological sex influences airway hyperresponsiveness in
      adult asthma.
observational model: Case-Control
time perspective: Prospective
measure: Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in males
time frame: Baseline
description: Males only
measure: Provacative dose of mannitol that elicits a 15% decline in forced expiratory volume in females
time frame: Baseline
description: Females only during the luteal phase of the menstrual cycle
arm group label: Males with asthma
description: Induced sputum, methacholine challenge, and mannitol challenge will be performed.
arm group label: Females with asthma
description: Induced sputum, methacholine challenge, and mannitol challenge will be performed.
intervention type: Diagnostic Test
intervention name: Methacholine challenge
description: Methacholine inhalation challenge will be administered to both male and females with asthma
arm group label: Females with asthma
arm group label: Males with asthma
intervention type: Diagnostic Test
intervention name: Mannitol challenge
description: Mannitol inhalation challenge will be administered to both male and females with asthma
arm group label: Females with asthma
arm group label: Males with asthma
Sputum, blood, nasal fluid, urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Katherine Cahill, MD
role: Principal Investigator
affiliation: Vanderbilt University Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Vanderbilt University Medical Center
investigator full name: Katherine Cahill
investigator title: Assistant Professor
mesh term: Asthma
mesh term: Mannitol
mesh term: Methacholine Chloride
sharing ipd: Undecided