<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/NCT01667042</url>
  </required_header>
  <id_info>
    <org_study_id>12-000304</org_study_id>
    <nct_id>NCT01667042</nct_id>
  </id_info>
  <brief_title>Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough</brief_title>
  <official_title>Scleroderma Lung: Role of Gastroesophageal Reflux, Microaspiration and Cough</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a mechanistic research study to evaluate the relationship between cough, reflux, and&#xD;
      aspiration in patients with systemic sclerosis (scleroderma).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2014</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Airway pepsin concentration</measure>
    <time_frame>cross-sectional</time_frame>
    <description>Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">7</enrollment>
  <condition>Scleroderma Lung</condition>
  <arm_group>
    <arm_group_label>Without Interstitial lung disease (ILD)</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>With Interstitial lung disease (ILD)</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive adult patients seen at the Mayo Clinic in Florida with a confirmed&#xD;
        diagnosis of systemic sclerosis (SSc) will be eligible.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients ≥ 18 years old.&#xD;
&#xD;
          -  Fulfilling the American College of Rheumatology criteria for SSc.&#xD;
&#xD;
          -  For ILD subgroup (n=6):&#xD;
&#xD;
               -  An upright chest-roentgenogram (chest x-ray) is abnormal and compatible with an&#xD;
                  interstitial lung disease.&#xD;
&#xD;
               -  HRCT of the chest confirms the presence of bilateral reticular, ground glass,&#xD;
                  and/or honeycomb abnormalities that is otherwise unexplained by an alternative&#xD;
                  process&#xD;
&#xD;
               -  The HRCT fibrosis score must be ≥ 7.&#xD;
&#xD;
               -  The total lung capacity (TLC, measured by body plethysmography) and/or the&#xD;
                  diffusing capacity of the lung for carbon monoxide (DLCO) is below the predicted&#xD;
                  normal.&#xD;
&#xD;
               -  The forced vital capacity (FVC) is reduced below the predicted normal.&#xD;
&#xD;
               -  The patient is symptomatic (i.e. dyspnea and/or a chronic cough) for more than 8&#xD;
                  weeks that is otherwise unexplained by an alternative mechanism.&#xD;
&#xD;
          -  For No ILD subgroup (n=6):&#xD;
&#xD;
               -  No radiographic evidence of ILD on plain chest x-ray.&#xD;
&#xD;
               -  The HRCT fibrosis score, when performed) must be &lt; 7&#xD;
&#xD;
               -  The TLC and FVC are within their predicted normal.&#xD;
&#xD;
               -  The DLCO is within the predicted normal, except when reduced in isolation by&#xD;
                  pulmonary hypertension.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Active smoking within the 6 months.&#xD;
&#xD;
          -  Pneumonia or bronchitis in past 4 weeks.&#xD;
&#xD;
          -  Active acute illness such as uncontrolled heart failure, infection, or asthma.&#xD;
&#xD;
          -  Use of more than 3 liters per minute (LPM) of oxygen by nasal cannula at rest.&#xD;
&#xD;
          -  Coordinator, investigator, or clinician concerns on the patient's compliance, safety,&#xD;
             or in ability to complete study requirements.&#xD;
&#xD;
          -  Morbid condition not expected to live more than 1 year.&#xD;
&#xD;
          -  Alternative cause or diagnosis for the patient's ILD besides SSc.&#xD;
&#xD;
          -  Pregnancy.&#xD;
&#xD;
          -  Obstructive lung disease with an FEV1 (forced expiratory volume in 1 second) to FVC&#xD;
             ratio less than 0.7, nor radiographic evidence of emphysema on CT.&#xD;
&#xD;
          -  Planned therapeutic procedures involving the esophagus (e.g. dilation, surgery) prior&#xD;
             to completion of study tests&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Augustine Lee, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Florida</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32224</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>January 7, 2016</last_update_submitted>
  <last_update_submitted_qc>January 7, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 8, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Augustine S. Lee</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Scleroderma Lung</keyword>
  <keyword>Gastroesophageal Reflux</keyword>
  <keyword>Microaspiration</keyword>
  <keyword>Cough</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Scleroderma, Diffuse</mesh_term>
    <mesh_term>Scleroderma, Localized</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/NCT01667042
org study id: 12-000304
nct id: NCT01667042
lead sponsor: 
has dmc: No
This is a mechanistic research study to evaluate the relationship between cough, reflux, and
      aspiration in patients with systemic sclerosis (scleroderma).
observational model: Cohort
time perspective: Cross-Sectional
measure: Airway pepsin concentration
time frame: cross-sectional
description: Cross-sectional comparison between airway pepsin level, cough frequency, FVC, DLCO, and CT fibrosis score
arm group label: Without Interstitial lung disease (ILD)
arm group label: With Interstitial lung disease (ILD)
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Augustine Lee, M.D.
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Augustine S. Lee
investigator title: M.D.
mesh term: Gastroesophageal Reflux
mesh term: Scleroderma, Systemic
mesh term: Scleroderma, Diffuse
mesh term: Scleroderma, Localized