<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/NCT02264691</url>
  </required_header>
  <id_info>
    <org_study_id>08-128</org_study_id>
    <nct_id>NCT02264691</nct_id>
  </id_info>
  <brief_title>UTMB Research on Severe Asthma (UROSA) Study</brief_title>
  <acronym>UROSA</acronym>
  <official_title>UTMB Research on Severe Asthma (UROSA) Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Medical Branch, Galveston</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Medical Branch, Galveston</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To identify and understand biologic aspects of severe asthma compared to subjects with mild&#xD;
      to moderate asthma and subjects without asthma (normal or healthy volunteers).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It has been shown that severe asthma differs from milder asthma in its pathophysiology; in&#xD;
      particular we are interested in examining why patients with severe asthma have disease that&#xD;
      is resistant to corticosteroids. While we will be studying patients with severe asthma, we&#xD;
      also need to study subjects to act as controls. To this end we will recruit subjects into the&#xD;
      following groups: Normal volunteers; Mild asthmatics not taking inhaled corticosteroids; Mild&#xD;
      to moderate asthmatics requiring and using inhaled corticosteroids and Severe asthmatics.&#xD;
&#xD;
      Subjects between the ages of 18 and 65 will be enrolled in this study. We aim to recruit&#xD;
      enough subjects such that 120 male and female participants (30 in each of the above groups)&#xD;
      will complete the bronchoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2009</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>evaluate patients with severe asthma</measure>
    <time_frame>7 Years</time_frame>
    <description>To evaluate patients with severe asthma and to establish the mechanisms by which the lack of response to treatment may occur.</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">131</enrollment>
  <condition>Asthma</condition>
  <arm_group>
    <arm_group_label>Normal (healthy volunteers)</arm_group_label>
    <description>No Research Intervention. Clinically indicated interventions only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild Asthmatics</arm_group_label>
    <description>No Research Intervention. Clinically indicated interventions only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mild to Moderate Asthmatics</arm_group_label>
    <description>No Research Intervention. Clinically indicated interventions only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Severe Asthmatics</arm_group_label>
    <description>No Research Intervention. Clinically indicated interventions only.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Normal volunteers; Mild asthmatics not taking inhaled corticosteroids; Mild to moderate&#xD;
        asthmatics requiring and using inhaled corticosteroids and Severe asthmatics&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All participants must be in good general health (with exception to asthma). • Normal&#xD;
             controls / healthy volunteers (NC) subjects with no past history of asthma or other&#xD;
             lung disease. To determine this, subjects must have an FEV1 equal to or greater than&#xD;
             80% of predicted value and have a normal FEV1/FVC ratio.&#xD;
&#xD;
        Asthma subjects Eligible asthmatic participants must have a physician diagnosis of asthma&#xD;
        for at least 1 year. Participants must either have historical evidence of reversibility of&#xD;
        FEV1 of at least 12%, or demonstrate such a change during the study visits, or must have&#xD;
        historical evidence of a PC20 for methacholine &lt; 8mg/ml.&#xD;
&#xD;
          -  Mild Asthma with no Corticosteroids (MANC) will be defined as control of asthma with&#xD;
             short acting β2-agonists or leukotrine antagonist or both, but not requiring inhaled&#xD;
             corticosteroids.&#xD;
&#xD;
          -  Mild to Moderate asthma (MMA) will be defined as control of asthma with an inhaled&#xD;
             corticosteroid (less than or equal to 250 mcg daily inhaled fluticasone equivalent) in&#xD;
             addition to the medications listed in the MANC group or long acting β2-agonists.&#xD;
&#xD;
          -  Severe asthma (SA) will be defined according to the ATS criteria for Refractory Asthma&#xD;
             (10)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria apply for all subjects:&#xD;
&#xD;
               -  Current smoker, or former smoker with &gt;10 pack years history or having quit&#xD;
                  within the past year&#xD;
&#xD;
               -  Asthma exacerbation, requiring a new or increased dose of oral corticosteroids,&#xD;
                  within the past 30 days&#xD;
&#xD;
               -  Pregnant or lactating female&#xD;
&#xD;
               -  Significant/uncontrolled medical condition (uncontrolled diabetes, coronary&#xD;
                  artery disease, uncontrolled hypertension)&#xD;
&#xD;
               -  Diagnosis of emphysema or other significant pulmonary disease&#xD;
&#xD;
               -  If, in the opinion of the PI (WJC) the subject has co-morbid conditions that make&#xD;
                  them unsafe to undergo bronchoscopy, subjects will be given the choice to&#xD;
                  withdraw from the study or allowed to complete visits 1-3 only.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>William Calhoun, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>UTMB</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Medical Branch</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 8, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 2014</study_first_posted>
  <last_update_submitted>October 25, 2016</last_update_submitted>
  <last_update_submitted_qc>October 25, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2016</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>
  <!-- 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/NCT02264691
org study id: 08-128
nct id: NCT02264691
lead sponsor: 
has dmc: No
To identify and understand biologic aspects of severe asthma compared to subjects with mild
      to moderate asthma and subjects without asthma (normal or healthy volunteers).
It has been shown that severe asthma differs from milder asthma in its pathophysiology; in
      particular we are interested in examining why patients with severe asthma have disease that
      is resistant to corticosteroids. While we will be studying patients with severe asthma, we
      also need to study subjects to act as controls. To this end we will recruit subjects into the
      following groups: Normal volunteers; Mild asthmatics not taking inhaled corticosteroids; Mild
      to moderate asthmatics requiring and using inhaled corticosteroids and Severe asthmatics.

      Subjects between the ages of 18 and 65 will be enrolled in this study. We aim to recruit
      enough subjects such that 120 male and female participants (30 in each of the above groups)
      will complete the bronchoscopy.
observational model: Cohort
time perspective: Prospective
measure: evaluate patients with severe asthma
time frame: 7 Years
description: To evaluate patients with severe asthma and to establish the mechanisms by which the lack of response to treatment may occur.
arm group label: Normal (healthy volunteers)
description: No Research Intervention. Clinically indicated interventions only.
arm group label: Mild Asthmatics
description: No Research Intervention. Clinically indicated interventions only.
arm group label: Mild to Moderate Asthmatics
description: No Research Intervention. Clinically indicated interventions only.
arm group label: Severe Asthmatics
description: No Research Intervention. Clinically indicated interventions only.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: William Calhoun, M.D.
role: Principal Investigator
affiliation: UTMB
facility: 
country: United States
responsible party type: Sponsor
mesh term: Asthma