<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/NCT02183753</url>
  </required_header>
  <id_info>
    <org_study_id>13-3076</org_study_id>
    <secondary_id>5R01ES013611-09</secondary_id>
    <nct_id>NCT02183753</nct_id>
  </id_info>
  <brief_title>Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers</brief_title>
  <acronym>Woodsies</acronym>
  <official_title>Effects of Wood Smoke Particles on Influenza-induced Nasal Inflammation in Normal Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of North Carolina, Chapel Hill</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Environmental Protection Agency (EPA)</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Environmental Health Sciences (NIEHS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of North Carolina, Chapel Hill</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is focused on the pathophysiology underlying the association between exposure to&#xD;
      particulate pollutants and risk for/response to viral infection. The investigators&#xD;
      hypothesize that exposure to wood smoke particles (WSP) enhances influenza virus-induced&#xD;
      granulocyte and NK cell activation, via hyaluronic acid-mediated effects on IFNg production.&#xD;
      Oxidant stress and viral replication may also be affected. As an NIH funded ViCTER project,&#xD;
      the purpose of the study is also to test novel assays of granulocyte activation (Doershuk&#xD;
      lab) and lipid mediator activation (Albritton lab) which have not previously been used in&#xD;
      this type of research.&#xD;
&#xD;
      Healthy, nonsmoking adults age 18-40 years will be recruited. This is a randomized, placebo&#xD;
      controlled study comparing NLF granulocyte responses to LAIV administered after either WSP or&#xD;
      clean air, in normal healthy volunteers. Subjects receive either WSP or placebo (clean air),&#xD;
      followed by a standardized dose of LAIV and serial post-infection sampling of nasal lavage&#xD;
      fluids, nasal biopsy and blood&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</primary_completion_date>
  <phase>Early Phase 1</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>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>IL-13</measure>
    <time_frame>1-21 days</time_frame>
    <description>Change in IL-13 and ECP in nasal lavage fluids (NLF) compared to pre-virus baseline</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">39</enrollment>
  <condition>Response of Viral Infection to Woodsmoke</condition>
  <arm_group>
    <arm_group_label>Wood smoke</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The dose of WSP to be used (500 µg/m3 for 2 hours) is based on prior studies which indicate the exposure is well tolerated, and is similar to that found in some indoor exposures in homes heated by wood burning (24-26). The route of administration (breathing air containing WSP at rest, nasally) is intended to mimic natural exposures.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>clean air</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Chapel Hill air which has been filtered to remove ambient air pollutants.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>wood smoke</intervention_name>
    <arm_group_label>Wood smoke</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>clean air</intervention_name>
    <arm_group_label>clean air</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Normal lung function, defined as (Knudson 1976/1984 predicted set): FVC &gt; 75 %&#xD;
             predicted for gender, ethnicity, age and height; FEV1 &gt;75 % predicted ; FEV1/FVC ratio&#xD;
             &gt;0.70 and &lt; 0.90.&#xD;
&#xD;
          2. Oxygen saturation of &gt; 94%&#xD;
&#xD;
          3. Normal blood pressure (Systolic between 140 - 90, Diastolic between 90-60 mm Hg)&#xD;
&#xD;
          4. Symptom Score no greater than 6 (out of a possible 39) for total symptom score&#xD;
&#xD;
          5. On the day of a challenge, body temperature must be no greater than 37.8 degrees,&#xD;
             measured orally&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. A history of significant chronic illnesses (to include diabetes, autoimmune diseases,&#xD;
             immunodeficiency state, known ischemic heart disease, chronic respiratory diseases&#xD;
             such as chronic obstructive pulmonary disease or asthma, hypertension)&#xD;
&#xD;
          2. Positive pregnancy test within 48 hours of the time of challenge&#xD;
&#xD;
          3. Use of any inhaled substance (for medical or recreational purposes). Nonsmokers must&#xD;
             have been abstinent from smoking for the prior 12 months, having not smoked more than&#xD;
             1 pack over the course of the previous year and does not smoke at all 1 week prior to&#xD;
             entrance in the study.&#xD;
&#xD;
          4. Receipt of LAIV in the current season&#xD;
&#xD;
          5. History of allergy to eggs&#xD;
&#xD;
          6. Acute, non-chronic, medical conditions, including (but not limited to) pneumonia or&#xD;
             bronchitis requiring antibiotics, febrile illnesses, flu-like symptoms must be totally&#xD;
             resolved symptomatically for 3 weeks&#xD;
&#xD;
          7. Unspecified illnesses, which in the judgment of the investigator increase the risk&#xD;
             associated with the experimental LAIV infection, will be a basis for exclusion.&#xD;
&#xD;
          8. Expected exposure of subject to immunocompromised individuals (who can be infected by&#xD;
             LAIV) for the 3 weeks following LAIV inoculation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Terry Noah, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of North Carolina, Chapel Hill</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>center for envionmental medicine asthma an lung biology at the EPA</name>
      <address>
        <city>Chapel Hill</city>
        <state>North Carolina</state>
        <zip>27599</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2015</verification_date>
  <study_first_submitted>June 3, 2014</study_first_submitted>
  <study_first_submitted_qc>July 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 8, 2014</study_first_posted>
  <last_update_submitted>June 9, 2015</last_update_submitted>
  <last_update_submitted_qc>June 9, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 11, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>LAIV</keyword>
  <keyword>Flumist</keyword>
  <keyword>wood smoke</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Virus Diseases</mesh_term>
    <mesh_term>Inflammation</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/NCT02183753
org study id: 13-3076
secondary id: 5R01ES013611-09
nct id: NCT02183753
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
This study is focused on the pathophysiology underlying the association between exposure to
      particulate pollutants and risk for/response to viral infection. The investigators
      hypothesize that exposure to wood smoke particles (WSP) enhances influenza virus-induced
      granulocyte and NK cell activation, via hyaluronic acid-mediated effects on IFNg production.
      Oxidant stress and viral replication may also be affected. As an NIH funded ViCTER project,
      the purpose of the study is also to test novel assays of granulocyte activation (Doershuk
      lab) and lipid mediator activation (Albritton lab) which have not previously been used in
      this type of research.

      Healthy, nonsmoking adults age 18-40 years will be recruited. This is a randomized, placebo
      controlled study comparing NLF granulocyte responses to LAIV administered after either WSP or
      clean air, in normal healthy volunteers. Subjects receive either WSP or placebo (clean air),
      followed by a standardized dose of LAIV and serial post-infection sampling of nasal lavage
      fluids, nasal biopsy and blood
allocation: Randomized
intervention model: Parallel Assignment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: IL-13
time frame: 1-21 days
description: Change in IL-13 and ECP in nasal lavage fluids (NLF) compared to pre-virus baseline
arm group label: Wood smoke
arm group type: Active Comparator
description: The dose of WSP to be used (500 µg/m3 for 2 hours) is based on prior studies which indicate the exposure is well tolerated, and is similar to that found in some indoor exposures in homes heated by wood burning (24-26). The route of administration (breathing air containing WSP at rest, nasally) is intended to mimic natural exposures.
arm group label: clean air
arm group type: Placebo Comparator
description: Chapel Hill air which has been filtered to remove ambient air pollutants.
intervention type: Other
intervention name: wood smoke
arm group label: Wood smoke
intervention type: Other
intervention name: clean air
arm group label: clean air
criteria: 
gender: All
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Terry Noah, MD
role: Principal Investigator
affiliation: University of North Carolina, Chapel Hill
facility: 
country: United States
responsible party type: Sponsor
mesh term: Virus Diseases
mesh term: Inflammation